# Cohen Healthcare Law Group | Healthcare Lawyers | FDA & FTC Law > Advising Health and Wellness Ventures ## Pages - [Healthcare Dispute Resolution & Neutral Services](https://cohenhealthcarelaw.com/healthcare-dispute-resolution-neutral-services/): Healthcare Arbitration and Mediation ServicesHealthcare and life sciences arbitrator and mediator — 35 years of regulatory, transactional, and compliance expertise... - [Advertising and Marketing (Claims)](https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-marketing-claims/): FTC Advertising Substantiation Health Claims GuidanceHealthcare Advertising Compliance That Protects Your Brand and Your BusinessWe help healthcare, wellness, and life-science... - [Biotechnology](https://cohenhealthcarelaw.com/fda-ftc-law/biotechnology/): Biotech Lawyers Experienced Biotech Lawyers Protecting Your Innovations Our biotech lawyers and life sciences attorneys help biotechnology and life sciences... - [Business Legal Services for Health and Wellness Practices](https://cohenhealthcarelaw.com/health-wellness-practice-business-legal-services/): Business Legal Services for Health and Wellness Practices The health and wellness industry is rapidly growing and creating exciting opportunities.... - [Cosmetics](https://cohenhealthcarelaw.com/fda-ftc-law/cosmetics/): Cosmetics Lawyer in California A cosmetics lawyer in California is a legal professional who advises cosmetic companies, beauty brands, and... - [Quality Assurance](https://cohenhealthcarelaw.com/quality-assurance/): Quality AssuranceJTNDc2NyaXB0JTIwdHlwZSUzRCUyMnRleHQlMkZqYXZhc2NyaXB0JTIyJTIwc3JjJTNEJTIyaHR0cHMlM0ElMkYlMkZmb3JtLmpvdGZvcm0uY29tJTJGanNmb3JtJTJGMjIyNTYwODA5ODcwMDU2JTIyJTNFJTNDJTJGc2NyaXB0JTNF - [Nurses](https://cohenhealthcarelaw.com/services/nurses/): NursesLaws surrounding Nursing Corporation depend from state to state, that is why it is crucial for nurses that plans or... - [Pharmacies](https://cohenhealthcarelaw.com/services/pharmacies/): PharmaciesOur legal team have helped many different kinds of healthcare venture, from healthcare start-ups, digital healthcare & telemedicine, dietary supplement... - [Feedback Thank You](https://cohenhealthcarelaw.com/feedback-thank-you/): Your Feedback is Important to Us. 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 - [Medical Practice Questionnaire](https://cohenhealthcarelaw.com/medical-practice-questionnaire/): Medical Practice 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Cohen: Fee-Splitting Legal](https://cohenhealthcarelaw.com/video-library/michael-h-cohen-fee-splitting-legal/): Michael H. Cohen: Fee-Splitting LegalMany clients call me once they have already gotten themselves into an illegal contract for fee... - [Why Compliance is not a Secret Healthcare Lawyer's Word](https://cohenhealthcarelaw.com/video-library/why-compliance-is-not-a-secret-healthcare-lawyers-word/): Why Compliance is not a Secret Healthcare Lawyer’s WordIf you’re a healthcare company, whether you’re a healthcare start up or... - [Complementary and Alternative Medicine Legal Issues](https://cohenhealthcarelaw.com/video-library/complementary-and-alternative-medicine-legal-issues/): Complementary and Alternative Medicine Legal IssuesContext for CAM regulation, tying in some history of medicine with the history of regulation.... - [Michael H. Cohen Health Care Lawyer for Psychologists](https://cohenhealthcarelaw.com/video-library/michael-h-cohen-health-care-lawyer-for-psychologists/): Michael H. Cohen Health Care Lawyer for PsychologistsOne of my clients was a very reputable psychologist in the community. Unfortunately,... - [HIPAA in the Real World (Part 2): Breach Notification](https://cohenhealthcarelaw.com/video-library/hipaa-in-the-real-world-part-2-breach-notification/): HIPAA in the Real World (Part 2): Breach NotificationSo the first thing was I helped them to draft a letter... - [HIPAA in the Real World (Part 1): Why Compliance Matters](https://cohenhealthcarelaw.com/video-library/hipaa-in-the-real-world-part-1-why-compliance-matters/): HIPAA in the Real World (Part 1): Why Compliance MattersNow, I know this HIPAA stuff can seem a bit dry... - [Dietary Supplement Laws and FDA Regulations](https://cohenhealthcarelaw.com/video-library/dietary-supplement-laws-and-fda-regulations/): Dietary Supplement Laws and FDA RegulationsAn example of how we integrate ancient knowledge with modern technological progress, and it all... - [Telemedicine and Online Health: Legal & Regulatory Pathways to Future Medicine](https://cohenhealthcarelaw.com/video-library/telemedicine-and-online-health-legal-regulatory-pathways-to-future-medicine/): Telemedicine and Online Health: Legal & Regulatory Pathways to Future MedicineTelemedicine is the medicine of the future. We’re moving from... - [Safeguarding Your License & Avoiding Malpractice: Standard of Care in Integrative Medicine](https://cohenhealthcarelaw.com/video-library/safeguarding-your-license-avoiding-malpractice-standard-of-care-in-integrative-medicine/): Safeguarding Your License & Avoiding Malpractice: Standard of Care in Integrative MedicineWhether you're practicing conventional medicine or integrative anti-aging or... - [Avoiding Malpractice Through Strong Informed Consent Practices](https://cohenhealthcarelaw.com/video-library/avoiding-malpractice-through-strong-informed-consent-practices/): Avoiding Malpractice Through Strong Informed Consent PracticesInformed consent is critical in all areas of healthcare and medicine. It takes on... - [Breaking Away Into Your New Practice and Common Insurance Issues](https://cohenhealthcarelaw.com/video-library/breaking-away-into-your-new-practice-and-common-insurance-issues/): Breaking Away Into Your New Practice and Common Insurance IssuesLet me talk for a moment about clarifying insurance issues. If... - [Liability Protection & the Practice of Medicine for Non-Physicians](https://cohenhealthcarelaw.com/video-library/liability-protection-the-practice-of-medicine-for-non-physicians/): Liability Protection & the Practice of Medicine for Non-PhysiciansWhat's the difference between a professional corporation and a general corporation, and... - [Five Steps to Meet HIPAA Obligations and Privacy & Security Compliance](https://cohenhealthcarelaw.com/video-library/five-steps-to-meet-hipaa-obligations-and-privacy-security-compliance/): Five Steps to Meet HIPAA Obligations and Privacy & Security ComplianceIf you're submitting claims electronically for reimbursement, you are under... - [How can MDs practice functional medicine without undue fear of legal risk?](https://cohenhealthcarelaw.com/video-library/how-can-mds-practice-functional-medicine-without-undue-fear-of-legal-risk/): How can MDs practice functional medicine without undue fear of legal risk? Hello. Good morning. Good day. Good afternoon. Buenos... - [How Healthcare Ventures Can Craft a Corporate Practice of Medicine Legal Strategy](https://cohenhealthcarelaw.com/how-healthcare-ventures-can-craft-a-corporate-practice-of-medicine-legal-strategy/): How Healthcare Ventures Can Craft a Corporate Practice of Medicine Legal StrategySegments in this Podcast: Welcome – your Healthcare Legal... - [FDA Warning Letters](https://cohenhealthcarelaw.com/fda-ftc-law/fda-warning-letters/): FDA Warning LettersIf the FDA finds, after the investigation, that the company is violating the law or failing to comply... - [HTM 2019](https://cohenhealthcarelaw.com/htm2019/): The Best Thing I Did for My Law Firm in 2018! Welcome to our Resources page for Sales 3. 0.... - [Got HIPAA? Get HIPAA? Joyce explains why and how](https://cohenhealthcarelaw.com/podcast/got-hipaa-get-hipaa-joyce-explains-why-and-how/): Got HIPAA? Get HIPAA? Joyce explains why and howSegments in this Podcast: Healthcare Legal Adventures Begin Our expert – HIPAA... - [San Jose](https://cohenhealthcarelaw.com/san-jose/): Healthcare Lawyers San JoseCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area,... - [Houston](https://cohenhealthcarelaw.com/houston/): Healthcare Lawyers HoustonCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California... - [Newport Beach](https://cohenhealthcarelaw.com/newport-beach/): Healthcare Lawyers Newport BeachCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area,... - [San Francisco Bay Area](https://cohenhealthcarelaw.com/san-francisco-bay-area/): Healthcare Lawyers San Francisco Bay AreaCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the... - [San Diego](https://cohenhealthcarelaw.com/san-diego/): Healthcare Lawyers San DiegoCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area,... - [Areas We Serve](https://cohenhealthcarelaw.com/areas-we-serve/): Areas We ServeCaliforniaAdelanto Agoura Hills Alameda Albany Alhambra Aliso Viejo Alturas Amador City American Canyon Anaheim Anderson Angels Camp Antioch... - [Sacramento](https://cohenhealthcarelaw.com/sacramento/): Healthcare Lawyers SacramentoCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California... - [Close Encounters of the Healthcare Legal Kind](https://cohenhealthcarelaw.com/podcast/close-encounters-of-the-healthcare-legal-kind/): Close Encounters of the Healthcare Legal KindSegments in this Podcast: Introducing me Some clients don’t convert Monks chant a lawyer... - [Austin](https://cohenhealthcarelaw.com/austin/): Healthcare Lawyers AustinCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California... - [Dallas](https://cohenhealthcarelaw.com/dallas/): Healthcare Lawyers DallasCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California... - [Irvine](https://cohenhealthcarelaw.com/irvine/): Healthcare Lawyers IrvineCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California... - [New York](https://cohenhealthcarelaw.com/new-york/): Healthcare Lawyers New YorkCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area,... - [Los Angeles](https://cohenhealthcarelaw.com/los-angeles/): Healthcare Lawyers Los AngelesCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area,... - [How to Choose a Healthcare Lawyer](https://cohenhealthcarelaw.com/resources/how-to-choose-a-healthcare-lawyer/): How to Choose a Healthcare LawyerHow to Choose a Healthcare LawyerSubscribe to our mailing list to receive your copy of... - [Avoid These 8 Common Legal Mistakes Before Signing Physician Agreements](https://cohenhealthcarelaw.com/resources/avoid-these-8-common-legal-mistakes-before-signing-physician-agreements/): Avoid These 8 Common Legal Mistakes Before Signing Physician Agreements Subscribe to our mailing list to receive your copy of... - [5 Mistakes in Dietary Supplement Labeling](https://cohenhealthcarelaw.com/resources/5-mistakes-in-dietary-supplement-labeling/): 5 Mistakes in Dietary Supplement Labeling 5 Mistakes in Dietary Supplement Labeling Subscribe to our mailing list to receive your... - [Feedback-Contact](https://cohenhealthcarelaw.com/feedback-contact/): We strive for 100% customer satisfaction. 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Cohen Bio - Curriculum Vitae](https://cohenhealthcarelaw.com/michael-h-cohen-bio-curriculum-vitae/): MICHAEL H. COHEN - CURRICULUM VITAE2019 CV (click to download) * * * * * * * * * *... - [Legal Services for Cutting-Edge Healthcare and FDA Technologies](https://cohenhealthcarelaw.com/healthcare-law/nanotechnology-law-nano-medicine-and-nanobot-legal-services/): Emerging Healthcare Technology Lawyers Healthcare is evolving rapidly, and new technologies are reshaping the way treatments are developed, delivered, and... - [Practice Purchases & Sales](https://cohenhealthcarelaw.com/healthcare-law/practice-purchases-sales/): M&A (Acquisitions & Sales of Healthcare Businesses)We work on joint venture agreements, leases and subleases, management agreements, offering memoranda, operating... - [Physician-Hospital Agreements and Clinician Employment Agreements](https://cohenhealthcarelaw.com/healthcare-corporate-transactional-law/physician-hospital-agreements-and-clinician-employment-agreements/): Physician-Hospital Agreements and Clinician Employment Agreements ServicesIn the health care industry, our legal services include drafting and negotiating agreements for... - [Management Services Organizations (MSO) Agreements](https://cohenhealthcarelaw.com/healthcare-law/management-services-organizations-mso-agreements/): Management Services Organizations (MSO) IssuesOur healthcare lawyers advise Management Services Organizations (MSOs) on legal issues affecting MSOs and the way... - [Concierge Medicine](https://cohenhealthcarelaw.com/healthcare-law/concierge-medicine/): Concierge & Direct Primary Care Medical Practices Legal Guidance for Concierge, Direct Primary Care, and Boutique Medical Models As a... - [Unlicensed Provider (SB 577)](https://cohenhealthcarelaw.com/healthcare-compliance-regulatory/unlicensed-provider-sb-577/): Unlicensed Provider (SB 577)We represent non-licensed practitioners of the healing arts, including individuals practicing: Aromatherapy Ayurvedic Medicine Energy Healing Homeopathy... - [Telemedicine and E-Health](https://cohenhealthcarelaw.com/healthcare-law/telemedicine-and-e-health/): Telemedicine VenturesEvery state has its own laws concerning telehealth practices. The general rule is that telehealth is governed both by... ## Posts - [SB 351 and AB 1415: California’s New Framework for Healthcare Transactions and Corporate Practice Oversight](https://cohenhealthcarelaw.com/sb-351-and-ab-1415-californias-new-framework-for-healthcare-transactions-and-corporate-practice-oversight/): California’s new healthcare framework, established by SB 351 and AB 1415, codifies strict clinical independence protections while requiring private equity... - [Doctors Review Solicitation](https://cohenhealthcarelaw.com/guidelines-for-soliciting-reviews-from-patients/): The Federal Trade Commission guidelines for when and how physicians can and can’t seek solicitations from their patients, employees, and... - [Understanding the Medicare Whistleblower Reward Process](https://cohenhealthcarelaw.com/medicare-whistleblower-reward/): The medicare whistleblower reward allows eligible individuals to receive financial compensation for reporting Medicare fraud under the federal False Claims... - [Navigating False Claim Act in Healthcare Litigation](https://cohenhealthcarelaw.com/false-claim-act-in-healthcare/): The False Claims Act in healthcare is one of the most powerful federal statutes used to combat fraud, waste, and... - [Stark Law Examples](https://cohenhealthcarelaw.com/stark-law-examples/): Stark law examples often involve situations where physicians make prohibited physician referrals for designated health services (DHS) to an entity... - [How California AB 1501 Affects Physician Assistants](https://cohenhealthcarelaw.com/california-ab-1501/): California AB 1501 is a new law that directly affects how Physician Assistants (PAs) practice, tightening supervision rules, reshaping scope-of-practice... - [SB 1451 in California](https://cohenhealthcarelaw.com/sb-1451-california/): SB 1451 is now in effect (as of January 1, 2025) and brings major updates for nurse practitioners and other... - [What Does AB 1415 Mean for Your Practice in CA?](https://cohenhealthcarelaw.com/ab-1415/): AB 1415 is a new California law that starts on January 1, 2026, which increases supervision of transactions involving private... - [California AB 890 Guide for NP 103 and NP 104](https://cohenhealthcarelaw.com/ab-890/): California’s AB 890 is a landmark law that allows qualified nurse practitioners to practice with greater independence, especially those under... - [Accused Of Intentionally Committing Fraud For Personal Gains](https://cohenhealthcarelaw.com/accused-of-intentionally-committing-fraud-for-personal-gain/): If you’ve been accused of intentionally committing fraud for personal gains, the first thing you should do is stop communicating... - [California Medical Corporation Name Requirements Explained](https://cohenhealthcarelaw.com/california-medical-corporation-name-requirements/): California Medical Corporation Name Requirements include strict regulations, restrictions, and guidelines that determine how a medical corporation, professional medical corporation,... - [Compliance Tips for Complementary and Alternative Medicine Providers](https://cohenhealthcarelaw.com/legal-strategies-for-complementary-medicine-providers-compliance-for-alternative-therapies/): Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses essential legal strategies for complementary and... - [Dietary Supplement Regulation](https://cohenhealthcarelaw.com/navigating-fda-and-healthcare-laws-for-dietary-supplements-compliance-made-clear/): Learn essential FDA and healthcare compliance requirements for dietary supplements, including labeling, marketing claims, and manufacturing practices. Insights from Cohen... - [Corporate Practice of Medicine Compliance Checklist](https://cohenhealthcarelaw.com/managing-corporate-practice-of-medicine-compliance-for-healthcare-entities/): Explore essential strategies to maintain compliance with corporate practice of medicine laws for healthcare entities, covering ownership structures, management agreements,... - [Understanding the 5 Elements of Fraud in Healthcare](https://cohenhealthcarelaw.com/5-elements-of-fraud/): Understanding the 5 elements of fraud is essential for any healthcare provider seeking to avoid fraudulent behavior patterns, protect their... - [Confidentiality Agreement for Medical Practice](https://cohenhealthcarelaw.com/confidentiality-agreement-medical-practice/): A confidentiality agreement for medical practice is a legally binding document that ensures patient information, business data, and proprietary processes... - [Can a Nurse Open a Med Spa in California?](https://cohenhealthcarelaw.com/can-a-nurse-open-a-med-spa-in-california/): If you’ve ever wondered, “Can a nurse open a med spa in California? ” the short answer is that nurses... - [How to Create a Durable Power of Attorney for Healthcare](https://cohenhealthcarelaw.com/durable-power-of-attorney-for-healthcare/): A durable power of attorney for healthcare is an important legal document that allows you to appoint someone you trust... - [How to Achieve Medical Laboratory Compliance Efficiently](https://cohenhealthcarelaw.com/laboratory-compliance/): Laboratory compliance is foundational to safe, legal, and credible medical testing operations. Whether you run a diagnostic lab, clinical research... - [How to Use AI in Healthcare Compliance?](https://cohenhealthcarelaw.com/ai-in-healthcare-compliance/): AI in healthcare compliance is transforming how healthcare organizations maintain regulatory standards, reduce risks, and ensure patient safety. By leveraging... - [How to Keep Your Medical Office Compliance Checklist](https://cohenhealthcarelaw.com/keep-your-medical-office-compliance-checklist/): Keeping your medical office compliant with ever-changing healthcare regulations can be challenging, but it’s essential to avoid costly penalties and... - [OIG Compliance Program Guidance](https://cohenhealthcarelaw.com/oig-compliance-program-guidance/): The OIG compliance program guidance serves as a roadmap for healthcare organizations. It helps them establish effective compliance programs, reduce... - [Additional Protections Researchers Can Include for Compliance](https://cohenhealthcarelaw.com/additional-protections-researchers-can-include/): When it comes to healthcare research, compliance is not only about meeting the minimum requirements set by regulators. It also... - [What Is a Healthcare Defense Attorney?](https://cohenhealthcarelaw.com/healthcare-defense-attorney/): A healthcare defense attorney is a legal professional who represents healthcare providers, organizations, and businesses when they face investigations, regulatory... - [Healthcare Legal Advice to Accelerate Health and Wellness](https://cohenhealthcarelaw.com/healthcare-legal-advice-accelerate-health-wellness/): Healthcare and wellness businesses face complex regulations that can impact growth, compliance, and patient trust. From HIPAA and licensing to... - [Can You Take Patient Records When Leaving a Medical Practice?](https://cohenhealthcarelaw.com/can-you-take-patient-records-when-leaving-a-medical-practice/): No, you generally cannot take original patient records when leaving a medical practice, as they belong to the practice, not... - [What Are the OTC Drug Label Requirements?](https://cohenhealthcarelaw.com/otc-drug-label-requirements/): Over-the-counter (OTC) drugs must follow strict FDA labeling requirements to ensure consumer safety. Proper labels include active ingredients, uses, dosage... - [Health Care Proxy vs Durable Power of Attorney](https://cohenhealthcarelaw.com/health-care-proxy-vs-durable-power-of-attorney/): Understand the differences between a Health Care Proxy and Durable Power of Attorney, and learn why having both ensures your... - [Can Medical Offices Go Corporate?](https://cohenhealthcarelaw.com/can-medical-offices-go-corporate/): Medical offices can go corporate, transitioning from physician-owned practices to entities managed by corporations, private equity groups, or healthcare management... - [FDA and FTC Legal Boundaries for Cosmetics](https://cohenhealthcarelaw.com/fda-and-ftc-legal-boundaries-for-cosmetics/): Navigating the legal boundaries for cosmetics in the U. S. requires understanding the distinct roles of the FDA and FTC.... - [What Are FDA Warning Letters and How Do They Impact You?](https://cohenhealthcarelaw.com/fda-warning-letters/): FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or... - [AKS Safe Harbors](https://cohenhealthcarelaw.com/aks-safe-harbors/): When it comes to healthcare law, few regulations are as critical and as complex as the Anti-Kickback Statute (AKS). This... - [Can an RN Start an IV Hydration Business?](https://cohenhealthcarelaw.com/what-are-the-legal-risks-involved-with-an-iv-therapy-business/): Doctors, registered nurses and EMTs should review with an experienced healthcare attorney - corporate practice of medicine issues, medical and... - [Are Kickbacks Illegal?](https://cohenhealthcarelaw.com/are-kickbacks-illegal/): Kickbacks are improper payments or compensation made in exchange for preferential treatment, services, or referrals. They are illegal in many... - [Does Stark Law Apply to Medicaid Patients?](https://cohenhealthcarelaw.com/does-stark-law-apply-to-medicaid-patients/): The Stark Law, also known as the Physician Self-Referral Law, is a federal statute that prohibits physicians from referring patients... - [Doctor Not Paying Rent for Surgery](https://cohenhealthcarelaw.com/doctor-not-paying-rent/): A doctor not paying rent for a surgery space, equipment, or medical suite leads to consequences that extend beyond a... - [How to Transfer Medical Records Between Doctors Safely](https://cohenhealthcarelaw.com/patient-notification-requirements-when-medical-practices-merge-or-are-acquired/): Physicians and medical practices who merge their practices, sell, or acquire a medical practice need to notify their clients about... - [Examples of Pharmacy HIPAA Violations](https://cohenhealthcarelaw.com/hipaa-compliance-for-pharmacies-violations-and-faqs-2/): Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for... - [Healthcare Legal Pitfalls: Why AI and Web Searches Can’t Replace a Healthcare Attorney](https://cohenhealthcarelaw.com/healthcare-legal-pitfalls-why-ai-and-web-searches-cant-replace-a-healthcare-attorney/): Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the limitations of relying on AI... - [Why Healthcare Providers Need More Than AI and Web-Based Legal Guidance](https://cohenhealthcarelaw.com/why-healthcare-providers-need-more-than-ai-and-web-based-legal-guidance/): Join Michael H. Cohen, founding attorney of Cohen Healthcare Law Group, as he delves into the complexities of healthcare law... - [Can I Open a Clinic Without Being a Doctor?](https://cohenhealthcarelaw.com/can-i-own-a-medical-practice-if-i-am-not-a-doctor-an-overview-of-corporate-practice-of-medicine/): We spoke about a series of webinars talking about a trending topic in the legal aspects of corporate medicine, Management... - [MSO Rules for Med Spas](https://cohenhealthcarelaw.com/what-is-an-mso-msa-and-how-does-an-mso-msa-benefit-my-med-spa/): A MSO helps separate the medical side of a med spa from the business side of the med spa. A... - [The Risks of Relying on Generic Legal Information in Healthcare: Why an FDA Attorney Is Essential](https://cohenhealthcarelaw.com/the-risks-of-relying-on-generic-legal-information-in-healthcare-why-an-fda-attorney-is-essential/): In this video, Michael H. Cohen, the founding attorney of Cohen Healthcare Law Group, discusses the significant risks associated with... - [Durable Medical Equipment Compliance](https://cohenhealthcarelaw.com/compliance-issues-for-durable-medical-equipment-companies/): Durable medical equipment companies need to review the Anti-Kickback Statute, Stark Law, HIPAA, CMS requirements, and other federal and state... - [Why Healthcare Businesses Must Rely on Experienced Healthcare Attorneys, Not the Internet or AI: Risks and Rewards](https://cohenhealthcarelaw.com/why-healthcare-businesses-must-rely-on-experienced-healthcare-attorneys-not-the-internet-or-ai-risks-and-rewards/): Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, discusses why businesses in the health and wellness sector should... - [Clinical Trial Compliance Key FDA Regulations for Research Organizations](https://cohenhealthcarelaw.com/clinical-trial-compliance-key-fda-regulations-for-research-organizations/): Clinical trial companies must comply with FDA regulations, informed consent laws, and IRB requirements to ensure ethical and legal compliance.... - [Legal Guidance for Fertility Clinics: Compliance, Patient Consent, and Data Privacy](https://cohenhealthcarelaw.com/legal-guidance-for-fertility-clinics-compliance-patient-consent-and-data-privacy/): Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the key legal considerations for fertility... - [Navigating FDA’s cGMP Standards for Dietary Supplement Manufacturers](https://cohenhealthcarelaw.com/navigating-fdas-cgmp-standards-for-dietary-supplement-manufacturers/): Ensure your dietary supplement business stays FDA-compliant with this in-depth guide to cGMP standards under 21 CFR Part 111. Learn... - [Mobile Health Apps Legal Compliance Essentials for FDA and FTC Standards](https://cohenhealthcarelaw.com/mobile-health-apps-legal-compliance-essentials-for-fda-and-ftc-standards/): Mobile health apps must comply with FDA regulations, HIPAA privacy laws, and FTC advertising guidelines to avoid enforcement actions. Learn... - [Recent Dietary Supplement FDA Alerts and Warning Letters](https://cohenhealthcarelaw.com/recent-dietary-supplement-fda-alerts-and-warning-letters/): The Food and Drug Administration regulates dietary supplements by sending out warning letters and enforcing those letters. FDA also provides... - [Risk Management and Compliance for Direct-to-Consumer Genetic Testing Companies](https://cohenhealthcarelaw.com/risk-management-and-compliance-for-direct-to-consumer-genetic-testing-companies/): Direct-to-consumer genetic testing companies must navigate complex FDA regulations, HIPAA compliance, and state laws to avoid enforcement actions. Learn how... - [FDA Guidance on Studying and Marketing Medical Devices – Part Two](https://cohenhealthcarelaw.com/fda-guidance-on-studying-and-marketing-medical-devices-part-two/): The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss... - [Growing Your Business – Scaling Legally and Strategically](https://cohenhealthcarelaw.com/growing-your-business-scaling-legally-and-strategically/): Join us for the final installment of the IV Hydration Webinar series, 'Growing Your Business, Scaling Legally and Strategically. '... - [Legal and Compliance Strategies for Health Coaching Businesses](https://cohenhealthcarelaw.com/legal-and-compliance-strategies-for-health-coaching-businesses/): Health coaching businesses must comply with state licensing laws, corporate practice of medicine rules, HIPAA, and FTC regulations when offering... - [FDA Guidance on Studying and Marketing Medical Devices – Part One](https://cohenhealthcarelaw.com/fda-guidance-on-studying-and-marketing-medical-devices-part-one/): The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss... - [Advertising Compliance for Medical Devices: FTC and FDA Requirements](https://cohenhealthcarelaw.com/advertising-compliance-for-medical-devices-ftc-and-fda-requirements/): The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both... - [Healthcare Mergers and Acquisitions: Legal Considerations for Providers](https://cohenhealthcarelaw.com/healthcare-mergers-and-acquisitions-legal-considerations-for-providers/): Explore essential legal considerations for healthcare mergers and acquisitions, covering due diligence, regulatory compliance, and structuring agreements. Insights from Cohen... - [Medical Spa Ownership Structures: Navigating Legal and Compliance Challenges](https://cohenhealthcarelaw.com/medical-spa-ownership-structures-navigating-legal-and-compliance-challenges/): Discover legal compliance strategies for medical spa ownership, covering corporate practice of medicine, MSO structures, and physician partnerships. Insights from... - [Telehealth Platforms and HIPAA: Data Privacy Compliance for Remote Services](https://cohenhealthcarelaw.com/telehealth-platforms-and-hipaa-data-privacy-compliance-for-remote-services/): Explore essential HIPAA compliance guidelines for telehealth platforms, covering data security, privacy requirements, and best practices for protecting patient information.... - [Legal Considerations for Home Health Agencies: Compliance and Risk Management](https://cohenhealthcarelaw.com/legal-considerations-for-home-health-agencies-compliance-and-risk-management/): From compliance programs and proper licensing to thorough documentation, learn how to mitigate risks and navigate the complex regulatory landscape... - [Compliance in Value-Based Care: Legal Strategies for Healthcare Providers](https://cohenhealthcarelaw.com/compliance-in-value-based-care-legal-strategies-for-healthcare-providers/): Learn essential compliance strategies for value-based care, covering regulatory requirements, Anti-Kickback Statute, Stark Law, and risk mitigation for healthcare providers.... - [Legal Strategies for Health Coaches: Ensuring Compliance and Building Trust](https://cohenhealthcarelaw.com/legal-strategies-for-health-coaches-ensuring-compliance-and-building-trust/): Learn about defining your scope of practice, developing effective disclaimers, ensuring detailed informed consent, and navigating complex multi-state licensing regulations. - [Understanding the Stark Law: Compliance Essentials for Healthcare Practices](https://cohenhealthcarelaw.com/understanding-the-stark-law-compliance-essentials-for-healthcare-practices/): Learn the key compliance requirements for the Stark Law, covering prohibited self-referrals, permissible exceptions, and risk mitigation strategies for healthcare... - [Anti-Kickback Statute Compliance for Healthcare Providers and Facilities](https://cohenhealthcarelaw.com/anti-kickback-statute-compliance-for-healthcare-providers-and-facilities/): Learn essential Anti-Kickback Statute compliance strategies for healthcare providers and facilities, including safe harbor provisions and risk management tips. Insights... - [What Is Emergency Use Authorization?](https://cohenhealthcarelaw.com/what-is-emergency-use-authorization/): Medical manufacturers and medical practitioners need to understand the FDA rules for developing and prescribing emergency use authorization vaccines and... - [Legal Guidelines for Functional Medicine Practices: Navigating Regulations and Compliance](https://cohenhealthcarelaw.com/legal-guidelines-for-functional-medicine-practices-navigating-regulations-and-compliance/): Explore key legal and compliance guidelines for functional medicine practices, covering scope of practice, informed consent, and multistate licensing. Insights... - [Compliant Marketing and Product Safety for Cosmetics Companies: Legal Must-Haves](https://cohenhealthcarelaw.com/compliant-marketing-and-product-safety-for-cosmetics-companies-legal-must-haves/): Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the intricacies of FDA regulations and... - [How to Use the MSO Structure to Build Your Medical Spa](https://cohenhealthcarelaw.com/how-to-use-the-mso-structure-to-build-your-medical-spa/): Join us for an insightful webinar on "How to Use the MSO Structure to Build Your Medical Spa," where you... - [Compliance Tips for Nutritional Supplement Companies: Navigating FDA and FTC Regulations](https://cohenhealthcarelaw.com/compliance-tips-for-nutritional-supplement-companies-navigating-fda-and-ftc-regulations/): Learn essential compliance tips for nutritional supplement companies to meet FDA and FTC standards, covering labeling, health claims, and risk... - [Marketing Cosmetics Safely: FDA Compliance Tips for Cosmetic Companies](https://cohenhealthcarelaw.com/marketing-cosmetics-safely-fda-compliance-tips-for-cosmetic-companies/): Discover key FDA compliance tips for cosmetic companies, including labeling, claims, and ingredient safety to avoid regulatory issues. Insights from... - [Coaching and Counseling Across State Lines: Legal Compliance for Multistate Wellness Businesses](https://cohenhealthcarelaw.com/coaching-and-counseling-across-state-lines-legal-compliance-for-multistate-wellness-businesses/): Learn key legal compliance essentials for providing coaching and counseling services across state lines, including licensing, scope of practice, and... - [Functional and Integrative Medicine: Compliance Essentials for Your Practice](https://cohenhealthcarelaw.com/functional-and-integrative-medicine-compliance-essentials-for-your-practice/): Explore key compliance essentials for functional and integrative medicine practices, including licensing, scope of practice, and patient privacy requirements. Insights... - [The Complete Guide to Healthcare Provider and Facility Licensing and Accreditation](https://cohenhealthcarelaw.com/the-complete-guide-to-healthcare-provider-and-facility-licensing-and-accreditation/): Learn about essential licensing and accreditation requirements for healthcare providers and facilities, including key differences and compliance strategies. Insights from... - [How Biotech Companies Can Legally Navigate FDA, IP, and Clinical Trials](https://cohenhealthcarelaw.com/how-biotech-companies-can-legally-navigate-fda-ip-and-clinical-trials/): Learn about regulatory planning for FDA approval, essential intellectual property protection steps, and meeting the high standards for clinical trials.... - [How to Structure Your Medical Spa with Professional Medical Corporations and MSOs](https://cohenhealthcarelaw.com/how-to-structure-your-medical-spa-with-professional-medical-corporations-and-msos/): Learn how to legally structure your medical spa using Professional Medical Corporations (PMCs) and Management Services Organizations (MSOs) to ensure... - [Building A Legally Sound Anti-Aging And Functional Medicine Business](https://cohenhealthcarelaw.com/building-a-legally-sound-anti-aging-and-functional-medicine-business/): This episode covers key strategies for managing legal risks, including the importance of clear patient consent forms, compliance in marketing... - [Medical Spas and Aesthetic Clinics: Key Legal Insights for Safe and Compliant Operations](https://cohenhealthcarelaw.com/medical-spas-and-aesthetic-clinics-key-legal-insights-for-safe-and-compliant-operations/): The popularity of medical spas has soared, offering clients advanced treatments like IV hydration, injectables, and aesthetic enhancements. However, medical... - [3 Legal Keys to know when Starting an IV Hydration Clinic or Medical Spa](https://cohenhealthcarelaw.com/3-legal-keys-to-know-when-starting-an-iv-hydration-clinic-or-medical-spa/): Are you planning to start an IV Hydration Clinic or Medical Spa in Florida or perhaps expand across multiple states?... - [Telemedicine Across State Lines: Essential Legal Tips for Compliance](https://cohenhealthcarelaw.com/telemedicine-across-state-lines-essential-legal-tips-for-compliance/): Explore essential legal tips for telemedicine compliance across state lines, including licensing, patient privacy, and prescribing standards. Insights from Cohen... - [What Legal Protections Do I Need in a Contract Manufacturing Agreement for Dietary Supplements?](https://cohenhealthcarelaw.com/what-legal-protections-do-i-need-in-a-contract-manufacturing-agreement-for-dietary-supplements/): In today’s video, we’ll explore the critical legal protections you need in a Contract Manufacturing Agreement (CMA) for dietary supplements.... - [FDA’s Discussion of Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions](https://cohenhealthcarelaw.com/fdas-discussion-of-disease-awareness-and-prescription-drug-communications-on-television-evidence-for-conflation-and-misleading-product-impressions/): The FDA’s Center for Drug Evaluation and Research conducted a study examining the relationship between disease communications and prescription drug... - [4 Things to Know When Naming a California Professional Medical Corporation](https://cohenhealthcarelaw.com/4-things-to-know-when-naming-a-california-professional-medical-corporation/): In today’s video, we’ll explore the essential steps and legal guidelines for naming a Professional Medical Corporation (PMC) in California. - [How Do Nursing and EMT Licenses and Certifications Differ?](https://cohenhealthcarelaw.com/how-do-nursing-and-emt-licenses-and-certifications-differ/): Generally, nurses must obtain their state nursing license by having the proper degree(s) and passing a state nursing exam. Nurses... - [Does a Professional Medical Corporation Prevent Liability?](https://cohenhealthcarelaw.com/does-a-professional-medical-corporation-prevent-liability/): In today's video, we're going to talk about whether owning and operating a professional medical corporation actually protects the physician... - [Can an MSO Switch Medical Directors?](https://cohenhealthcarelaw.com/can-an-mso-switch-medical-directors/): In today's video, we'll talk about the role of the medical director in a med spa, or an IV hydration... - [Good Faith Exams](https://cohenhealthcarelaw.com/good-faith-exams/): So, one of our clients was asking about the good faith exam. Now, does this need to be an actual... - [Can an MSO Get Paid More Than Fair Market Value?](https://cohenhealthcarelaw.com/can-an-mso-get-paid-more-than-fair-market-value/): In this video, we're going to talk about the MSO and whether it is possible to transfer all the money... - [Starting up a Second Medical Corporation](https://cohenhealthcarelaw.com/starting-up-a-second-medical-corporation/): Sally, a licensed MD, is looking to open a second medical practice across the hall from her main practice so... - [Can a Paramedic Own and Operate an IV Hydration Business?](https://cohenhealthcarelaw.com/can-a-paramedic-own-and-operate-an-iv-hydration-business/): Today's question is: Can a paramedic own and operate an IV hydration clinic? - [What Does a Medical Compliance Officer Do?](https://cohenhealthcarelaw.com/what-does-a-medical-compliance-officer-do/): A medical compliance officer should work with a healthcare lawyer to understand the federal and state laws and regulations that... - [Can a Physician Pass Through Marketing Fees to the MSO?](https://cohenhealthcarelaw.com/can-a-physician-pass-through-marketing-fees-to-the-mso/): In today's video, George is a marketing professional who does SEO and digital marketing in house for physicians and health... - [How Mergers and Acquisitions Affect Employees](https://cohenhealthcarelaw.com/how-mergers-and-acquisitions-affect-employees/): Medical practices and companies who merge with or acquire another practice or company need to understand and plan for how... - [Can the MSO Charge a Variable Digital Marketing Fee?](https://cohenhealthcarelaw.com/can-the-mso-charge-a-variable-digital-marketing-fee/): In this video, we answer an MSO question, so can the MSO have a digital marketing fee as its expense,... - [Complying with HIPAA De-Identification Standards](https://cohenhealthcarelaw.com/complying-with-hipaa-de-identification-standards/): In this short video, we're going to talk about how one of our clients is planning to do a clinical... - [Should NPs, PAs and MDs be 1099 or Employees?](https://cohenhealthcarelaw.com/should-nps-pas-and-mds-be-1099-or-employees/): In today's video, we'll discuss whether nurse practitioners and physician assistants can be 1099 contractors in a medical practice in... - [Understanding the Different Types of Nursing Jobs and Corresponding Compliance Issues - Part One](https://cohenhealthcarelaw.com/understanding-the-different-types-of-nursing-jobs-and-corresponding-compliance-issues-part-one/): The nursing profession includes many different levels of jobs based on a nurse’s education and job duties. All nurses are... - [MSOs and Compliance Issues for Anti-Aging Aesthetic Clinics](https://cohenhealthcarelaw.com/msos-and-compliance-issues-for-anti-aging-aesthetic-clinics/): The doctors and owners of anti-aging medical practices need to understand what procedures and treatments require FDA approval, who can... - [Can the MSO Management Fee be More Than 90% of the Revenue of the Medical Practice?](https://cohenhealthcarelaw.com/can-the-mso-management-fee-be-more-than-90-of-the-revenue-of-the-medical-practice/): The anti-kickback laws require these fees to be fair market value and not take into consideration the referral of any... - [What Can a Nursing Corporation in California be Used For?](https://cohenhealthcarelaw.com/what-can-a-nursing-corporation-in-california-be-used-for/): The Medical Board has issued a number of different opinions that the medical spa must be a medical corporation, not... - [HIPAA Compliance for Pharmacies – Violations and FAQs](https://cohenhealthcarelaw.com/hipaa-compliance-for-pharmacies-violations-and-faqs/): Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for... - [Should the MSO be an S-Corp and the Medical Practice be a C-Corp or Vice Versa?](https://cohenhealthcarelaw.com/should-the-mso-be-an-s-corp-and-the-medical-practice-be-a-c-corp-or-vice-versa/): We always recommend getting a CPA involved to help determine what tax election you should make and so that would... ## Employees - [Dr. Ismail Sayeed MBBS, MMed](https://cohenhealthcarelaw.com/team/dr-ismail-sayeed-mbbs-mmed/) - [Camille Lesar](https://cohenhealthcarelaw.com/team/camille-lesar/) - [Holly Siegel](https://cohenhealthcarelaw.com/team/holly-siegel/) - [Lisa McDonald](https://cohenhealthcarelaw.com/team/lisa-mcdonald/) - [Danniel Jacques](https://cohenhealthcarelaw.com/team/danniel-jacques/) - [Samer Hamadeh](https://cohenhealthcarelaw.com/team/samer-hamadeh/) # # Detailed Content ## Pages - Published: 2026-02-26 - Modified: 2026-06-08 - URL: https://cohenhealthcarelaw.com/healthcare-dispute-resolution-neutral-services/ Healthcare Arbitration and Mediation ServicesHealthcare and life sciences arbitrator and mediator — 35 years of regulatory, transactional, and compliance expertise across the full spectrum of healthcare lawLet's Get StartedCredentials at a Glance 35+ years of legal experience in healthcare, regulatory, and corporate law Judicial clerk, Chief Judge Griesa, U. S. District Court, SDNY Corporate associate, Davis Polk & Wardwell (banking, securities, M&A) Harvard Medical School — Assistant Professor of Medicine Adjunct Assistant Professor, Harvard T. H. Chan School of Public Health 6 books on healthcare law and policy; 100+ published articles Panel arbitrator and mediator, American Health Lawyers Association (since 2022); Hearing Officer, NAM — National Arbitration and Mediation (2026); Panelist, AAA — American Arbitration Association Healthcare Panel (2026); Panelist, WIPO Mediation and Arbitration Center (2026); 3 ADR training certificates Bar admissions: California · New York · Nevada · Massachusetts · Washington DC Why Select Michael H. Cohen as Your Neutral? Deep Expertise in the Disputes That Matter Most The disputes that reach healthcare ADR panels are regulatory disputes first and contract disputes second. Anti-Kickback Statute safe harbor analysis, Stark Law exception requirements, CPOM compliance in MSO structures, FDA device classification, HIPAA breach exposure — these are not background context. They are the substance of the conflict. With 35 years of national healthcare regulatory and transactional practice and faculty appointments at Harvard Medical School and the Harvard T. H. Chan School of Public Health, the subject matter expertise here is not generic legal skill applied to healthcare. It is the... - Published: 2025-12-30 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-marketing-claims/ FTC Advertising Substantiation Health Claims GuidanceHealthcare Advertising Compliance That Protects Your Brand and Your BusinessWe help healthcare, wellness, and life-science businesses navigate complex Federal Trade Commission (FTC) advertising rules with confidence. With 26 years of experience and deep regulatory insight, we have a proven track record of advising hundreds of innovators. We ensure your marketing claims are accurate, FTC-compliant, and fully aligned with federal requirements. This enables you to promote your services without costly missteps. First Name Last Name Email Address Phone Number Please tell us how we can help you. Why FTC Advertising Compliance MattersFTC advertising compliance protects your brand, supports consumer trust, and prevents costly legal consequences. The Federal Trade Commission closely monitors health claims, digital advertising, and marketing materials across all platforms. Even a single false impression or misleading statement can expose companies to regulatory scrutiny and damage long-term business growth. The FTC imposes multimillion-dollar penalties for practices such as false advertising, false claims, and deceptive marketing. Liability includes injunctions, corrective advertising, and disgorgement, each of which can impact investor confidence and revenue. FTC rules apply to all health-related claims, including environmental claims, establishment claims, product benefits, and comparative claims. Enforcement covers websites, social media, funnels, influencers, apps, ads, and any content affecting commerce. Noncompliance undermines consumer trust. It affects purchase decisions and can slow business expansion. Marketers need competent and reliable scientific evidence to support all health, safety, or efficacy claims their ads convey to consumers expressly or by implication. And they need it in hand... - Published: 2025-11-23 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/fda-ftc-law/biotechnology/ Biotech Lawyers Experienced Biotech Lawyers Protecting Your Innovations Our biotech lawyers and life sciences attorneys help biotechnology and life sciences companies navigate complex FDA regulations, intellectual property protection, and regulatory compliance challenges. With extensive experience spanning over 25 years representing biotech clients, medical device manufacturers, and pharmaceutical companies, our team understands the evolving legal landscape of the life sciences sector. Ready to protect your biotech innovation? Speak with an experienced FDA attorney and biotech lawyer who understands the unique challenges of the life sciences industry. SCHEDULE A CONSULTATION First Name Last Name Email Address Phone Number Please tell us how we can help you. Biotechnology Legal & Compliance Guidance Biotechnology and life sciences companies can face a host of regulatory requirements, from the FDA, FTC, and other three-letter agencies, and require a realistic appraisal of the regulatory barriers and what they can do to overcome them. Agreements for Biotechnology & Life Sciences Clients Our biotechnology and life sciences lawyers understand FDA, FTC, and relevant state laws that apply to your business. We provide regulatory compliance advice and corporate legal services, and can help you with: Acquisition Agreements Clinical Research Agreements Collaboration Agreements Dietary Supplement Structure/Function Claims Distribution and Manufacturing Agreements Drafting FDA-Compliant Product Labels Financing Agreements Intellectual Property and Technology Transfer Joint Venture Agreements Legal Review of Marketing Materials for FDA and FTC Compliance Licensing Agreements Manufacturing Agreements Medical Device 510(k) Review Private Label Agreements Regulatory Advice on Food Supplements Sales Representative Agreements In the biotech and life sciences industry,... - Published: 2025-09-19 - Modified: 2025-12-17 - URL: https://cohenhealthcarelaw.com/health-wellness-practice-business-legal-services/ Business Legal Services for Health and Wellness Practices The health and wellness industry is rapidly growing and creating exciting opportunities. The sector also comes with complex legal and regulatory challenges. At Cohen Healthcare Law Group, our experienced healthcare lawyers provide comprehensive legal services tailored to the unique needs of health and wellness practices and companies nationwide. From licensing and compliance to business structure, risk management, and agreements, our law firm helps you navigate the evolving healthcare landscape with confidence. Contact us today to protect your business! SCHEDULE A CONSULTATION ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("156fef20-6999-4765-9769-d9cb5d8efb3e", "lm-embedded-script", {}); Why Your Health & Wellness Practice Needs Legal Services Operating a health and wellness practice requires navigating complex legal, business, and regulatory issues. Without the right support, wellness businesses risk costly mistakes that can damage both reputation and financial stability. This is why partnering with an experienced healthcare law firm is essential. One of the most important reasons to seek legal guidance is to protect against liability and lawsuits. Even well-established practices can face disputes from clients, employees, or regulatory bodies. By working with skilled attorneys, you gain access to strategies for minimizing risk, drafting clear agreements, and defending your interests in case of litigation. Compliance with healthcare regulations is another critical concern. The health and wellness industry is governed by federal, state, and local requirements, along with oversight from agencies such... - Published: 2025-09-05 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/fda-ftc-law/cosmetics/ Cosmetics Lawyer in California A cosmetics lawyer in California is a legal professional who advises cosmetic companies, beauty brands, and personal care product manufacturers on the complex laws governing the cosmetic industry. These attorneys help clients understand and comply with the Food, Drug, and Cosmetic Act (FDCA), the Fair Packaging and Labeling Act, and regulations enforced by agencies such as the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and the Consumer Product Safety Commission. First Name Last Name Email Address Phone Number Please tell us how we can help you. Cosmetics Legal & Compliance Guidance Under the Federal Food, Drug, and Cosmetic Act (FDCA), dietary supplements and cosmetic ingredients (except for color additives) are not subject to FDA premarket approval. However, the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), and other state agencies can take legal action against companies, distributors, or individuals who fail to comply with regulatory requirements regarding product labeling, advertising claims, good manufacturing practices, or overall safety. Cosmetics companies can make claims for their products, provided they are mindful of the way FDA and FTC laws and regulations shape the marketing environment. Our Focus on Cosmetics Companies’ Legal Needs Our legal team’s focus on cosmetics, dietary supplements, and medical devices gives us the expertise to help clients navigate FDA and FTC issues. We advise a range of clients on FDA and FTC legal questions, including: We excel at helping clients make claims that pack as much marketing power as possible, without... - Published: 2022-09-14 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/quality-assurance/ Quality Assurance - Published: 2022-09-01 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/services/nurses/ NursesLaws surrounding Nursing Corporation depend from state to state, that is why it is crucial for nurses that plans or have already established their own Professional Corporation to seek professional help from the right legal expert. First Name Last Name Email Address Phone Number Please tell us how we can help you. Nurses Legal & Compliance GuidanceWe help Nursing practices and nurses who have built or plan to build their Professional Corporation, in these areas: IV Hydration Therapy Business Formation or Start-up IV Hydration Therapy Business Regulatory Compliance Employment Legislation Contract Drafting and Review Fee-Splitting Management Services Organization or MSO Practice Restrictions HIPAA Dispute Resolution Mitigation The duties of Nurses include functions, such as basic health care requiring a substantial amount of scientific knowledge and technical skill, given to those people having difficulties living their normal life due to health problems, illness, or medical treatment that led them to that state. And this includes: (1) Direct and indirect care ensuring safety, comfort, hygiene, and protection, (2) Direct and indirect care that requires the administration of medications necessary, (3) Skin testing, immunization techniques, blood draw or venipuncture. Nursing ethics revolve around 7 key principles and these are: Justice – Fairness. Nurses need to be fair, just and equitable when distributing care amongst their patients. Beneficence – They have to ensure that they demonstrate care only for the good and benefit of their patient. Nonmaleficence – Doing no harm whether it be intentional or unintentional based on their Oath. Accountability – Taking... - Published: 2022-08-06 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/services/pharmacies/ PharmaciesOur legal team have helped many different kinds of healthcare venture, from healthcare start-ups, digital healthcare & telemedicine, dietary supplement & cosmetics companies, medical spas, medical & chiropractic practices, biotech & life sciences, wellness products & services; and we take pride in giving outstanding service to our clients in any shape or form. First Name Last Name Email Address Phone Number Please tell us how we can help you. Pharmacies Legal & Compliance GuidancePharmacy practice revolves around the distribution, compounding, disposal, and preparation of medications and this activity is regulated by the state and the Food and Drug Administration (FDA). The distribution of drugs in the US Healthcare system created to manage patient care is classified into: Generic (These are pharmaceuticals that are patented but can be produced by many different companies), Branded (Pharmaceuticals that are patented and manufactured exclusively by a company), and Specialty (which are made to address costly medical issues). The Food and Drug Administration (FDA) was founded because of the Pure Food and Drug Act (1906), which focused in regulating and prohibiting misbranding of food and drugs. The key reason as to why this Act eventually became The Food, Drug, and Cosmetics Act (1938) was due to the Supreme Court ruling that the Act only prohibit misleading therapeutic claims, not false therapeutic statements. The Act highlights the importance to the safety and criminalization of false therapeutic claims, and that it requires distributors’ transparency to list ingredients, warnings, and indications. This extended to medical (therapeutic) devices and... - Published: 2022-07-09 - Modified: 2025-03-10 - URL: https://cohenhealthcarelaw.com/feedback-thank-you/ Your Feedback is Important to Us. Thank you for taking the time to let us know how we did. If you have any questions, please reach out to chlgteam@glpm25. sg-host. com - Published: 2022-04-16 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/webinar-feedback/ Webinar Feedback Thank You for Attending Our Webinar! Your feedback will help us improve our future webinars. Your Name Your email Feedback for our Webinar - Published: 2020-10-30 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/chiropractors/ Lawyer for ChiropractorsState licensing boards exist to protect public health and welfare, which is why the chiropractic practice is heavily regulated in all 50 states and in more than 25 countries worldwide. As a chiropractic physician or healthcare provider, navigating these regulations can be complex, especially when your license, your chiropractic clinic, or your ability to treat patients is at risk. We provide experienced legal representation for chiropractors, delivering the guidance and defense you need to protect your chiropractic practice, address legal issues, and respond to disciplinary matters. First Name Last Name Email Address Phone Number Please tell us how we can help you. Chiropractors Legal & Compliance GuidanceAccording to the Federation of Chiropractic Licensing Boards, from 2017 to 2018, there were well over 90,000 chiropractors in the US who actively underwent several board exams to be state licensed. And as the managed healthcare system learns to embrace chiropractic treatment better, medical practitioners start experiencing rising numbers of malpractice claims. Such an increase has resulted in high demand for chiropractic legal aid. Our Healthcare Legal Team is one of the few that specially caters to the legal and regulatory demands of healthcare providers specializing in this area, including: Musculoskeletal chiropractors Traditional wellness chiropractors Medical institutions that employ chiropractorse Chiropractic Legal Issues Chiropractors face legal challenges that general lawyers often fully fail to understand. While many attorneys know business or contract law, they may not grasp the unique regulations governing chiropractic treatment, professional licensing, medical records obligations, scope-of-practice limits, or the... - Published: 2020-09-11 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/non-licensed-provider-questionnaire/ Non-Licensed Provider Questionnaire var ifr = document. getElementById("JotFormIFrame-202541086432448"); if(window. location. href && window. location. href. indexOf("? ") > -1) { var get = window. location. href. substr(window. location. href. indexOf("? ") + 1); if(ifr && get. length > 0) { var src = ifr. src; src = src. indexOf("? ") > -1 ? src + "&" + get : src + "? " + get; ifr. src = src; } } window. handleIFrameMessage = function(e) { if (typeof e. data === 'object') { return; } var args = e. data. split(":"); if (args. length > 2) { iframe = document. getElementById("JotFormIFrame-" + args); } else { iframe = document. getElementById("JotFormIFrame"); } if (! iframe) { return; } switch (args) { case "scrollIntoView": iframe. scrollIntoView; break; case "setHeight": iframe. style. height = args + "px"; break; case "collapseErrorPage": if (iframe. clientHeight > window. innerHeight) { iframe. style. height = window. innerHeight + "px"; } break; case "reloadPage": window. location. reload; break; case "loadScript": var src = args; if (args. length > 3) { src = args + ':' + args; } var script = document. createElement('script'); script. src = src; script. type = 'text/javascript'; document. body. appendChild(script); break; case "exitFullscreen": if (window. document. exitFullscreen) window. document. exitFullscreen; else if (window. document. mozCancelFullScreen) window. document. mozCancelFullScreen; else if (window. document. mozCancelFullscreen) window. document. mozCancelFullScreen; else if (window. document. webkitExitFullscreen) window. document. webkitExitFullscreen; else if (window. document. msExitFullscreen) window. document. msExitFullscreen; break; } var isJotForm = (e. origin. indexOf("jotform") > -1) ? true... - Published: 2020-08-06 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/medical-practice-questionnaire/ Medical Practice Questionnaire var ifr = document. getElementById("JotFormIFrame-202181814470449"); if(window. location. href && window. location. href. indexOf("? 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" + get; ifr. src = src; } } window. handleIFrameMessage = function(e) { if (typeof e. data === 'object') { return; } var args = e. data. split(":"); if (args. length > 2) { iframe = document. getElementById("JotFormIFrame-" + args); } else { iframe = document. getElementById("JotFormIFrame"); } if (! iframe) { return; } switch (args) { case "scrollIntoView": iframe. scrollIntoView; break; case "setHeight": iframe. style. height = args + "px"; break; case "collapseErrorPage": if (iframe. clientHeight > window. innerHeight) { iframe. style. height = window. innerHeight + "px"; } break; case "reloadPage": window. location. reload; break; case "loadScript": var src = args; if (args. length > 3) { src = args + ':' + args; } var script = document. createElement('script'); script. src = src; script. type = 'text/javascript'; document. body. appendChild(script); break; case "exitFullscreen": if (window. document. exitFullscreen) window. document. exitFullscreen; else if (window. document. mozCancelFullScreen) window. document. mozCancelFullScreen; else if (window. document. mozCancelFullscreen) window. document. mozCancelFullScreen; else if (window. document. webkitExitFullscreen) window. document. webkitExitFullscreen; else if (window. document. msExitFullscreen) window. document. msExitFullscreen; break; } var isJotForm = (e. origin. indexOf("jotform") > -1) ? true... - Published: 2020-08-01 - Modified: 2021-01-08 - URL: https://cohenhealthcarelaw.com/legal-adventure-book/ Michael H Cohen’s book, Your Healthcare Company’s Excellent Legal Adventure: Legal Strategies & Solutions Health and Wellness Ventures Can Profitably Deploy, shares legal case studies and lessons that every healthcare business needs to know. Author of leading books on healthcare law, Michael previously served as Assistant Professor of Medicine at Harvard Medical School, Adjunct Assistant Professor at the Harvard School of Public Health, and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School. On behalf of the Cohen Healthcare Law Group, again, enjoy your gift! We appreciate you joining our legal family! Download Digital Copy We would so appreciate your nice feedback and are so grateful to have you as part of our community. You rock, and we want to rock with you! Send Feedback - Published: 2020-08-01 - Modified: 2020-09-15 - URL: https://cohenhealthcarelaw.com/welcome/ A short message from our founder, Michael H. Cohen If you are on a mobile device and unable to see the button to get your free book at the end of the video, please click on the button below. Get free Book! - Published: 2020-07-03 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/mso-questionnaire/ MSO Questionnaire - Published: 2020-06-09 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/telemedicine-attorney/ Need A Telemedicine Attorney? Book A Call Now! First Name * Last Name * Email * Phone Number * Type of Company —Please choose an option—Hospital or health systemPhysician or healthcare professionalMedical group or clinicDevice manufacturerInformation technology companyWeb-service providerInvestorOther Top Rated Telemedicine Attorneys (310) 945-2348 30+ Years Experience5-Star Reviews On Google and Yelp500+ Satisfied ClientsWe Handle Your Telemedicine Legal NeedsYou focus on running your businessClients We ServeWe Serve the Following Businesses & Professionals:Hospitals & Health SystemsPhysicians & Healthcare ProfessionalsMedical Groups & ClinicsDevice ManufacturersInformation Technology CompaniesWeb-Service Providers & Investors500+ Clients and 5-Star RatingsOur reviews speak for themselves. Our clients' satisfaction and excellent results are our #1 priority. "Their skill and knowledge was impressive. I highly recommend them to anyone who needs someone amazing in healthcare law. " ~ Mona Misra, MD "I found them very capable and extremely professional. I would be very comfortable in recommending their services. " ~ Danniel Jacques, Owner, MediWise "A great asset to my addiction treatment center. Tons of insight and experience in the field of health care law. On top of that, they always call back within a short time after my call. Highly recommended! " ~ Scott Kiloby, Director of the Kiloby Center for Recovery, Inc. "Very knowledgeable in their field pertaining to healthcare, especially telehealth medicine. We hired them for our company to help produce contracts to different healthcare facilities. Our business is certainly growing because of their help and expertise. " ~ Sheetal Patel, MD, TeleHealth Solutions Ready to get started? 1.... - Published: 2020-06-04 - Modified: 2024-12-26 - URL: https://cohenhealthcarelaw.com/your-call/ Thank You! We received your request and one of our highly trained, experienced professionals will be in touch with you soon. In the meanwhile, watch a message from our Founding Attorney Michael H Cohen below. Back to Home - Published: 2020-01-29 - Modified: 2025-09-10 - URL: https://cohenhealthcarelaw.com/data-deletion-request/ Data Deletion Request The firm values the privacy of its clients and Web/blog site viewers. Any of the following personal information that may be made available to the firm when browsing or navigating the site shall be kept confidential: First and last name Address, City, State, Zip Code Telephone number Email address Examples of scenarios where our visitors provide their personal information include, but may not be limited, to: Emailing, calling or communicating with the firm, via the contact form on the website. Posting a question or comment through the site. Registering to attend a seminar or any event. Participating in an online survey. Requesting inclusion in an email or other mailing list. Submitting an entry for a contest or other promotions. Any other business-related reason. Some pages on this site may use “cookies”-small files that the site places on your hard drive for identification purposes. A cookie file can contain information such as a user ID to track the pages visited, but the only personal information a cookie can contain is information you supply yourself. These files are used for site registration and customization the next time you visit us. Some parts of the site may also use cookies to track user traffic patterns. The firm does this in order to determine the usefulness of our Web site information to our users and to see how effective our navigational structure is in helping users reach that information. Please note that cookies cannot read data off of your hard drive.... - Published: 2019-08-19 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/services/home-health-care/ HOME HEALTH CAREHome health care includes a wide range of health care services that can be given in a patient’s home for an illness or injury. Home health care is usually less expensive, more convenient, and as effective as care elsewhere such as, at times, in a hospital or skilled nursing facility (SNF). Examples of skilled home health services include: Wound care for pressure sores or a surgical wound Patient and caregiver education Intravenous or nutrition therapy Injections Monitoring serious illness and unstable health status In general, the goal of home health care is to treat an illness or injury. Home health care helps you: Get better Regain your independence Become as self-sufficient as possible Maintain your current condition or level of function Slow decline Source: Medicare. gov Cohen Healthcare Law assists Home Health Care providers with strategic advice on Healthcare Transactions & Business Law and Regulatory Compliance. Providers need to make sure that their contracts and agreements are handled properly including but not limited to: business formation documents, physician contracts, purchase and sales agreements and employment agreements. Furthermore, Home Health Care Providers need to keep ahead of the ever changing regulatory requirements especially with regards to licensing, operational and reimbursement compliance. We can help you navigate your way through the complex legal requirements and craft a viable compliance strategy for your healthcare 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 - Published: 2019-08-19 - Modified: 2025-03-10 - URL: https://cohenhealthcarelaw.com/services/faith-based-health-care-organizations/ FAITH-BASED HEALTH CARE ORGANIZATIONS What We Do: Business Law & Transactions Legal & Regulatory Compliance Life Sciences Law (FDA & FTC) Who We Serve Academic Medical Centers Addiction Treatment Centers, Behavior & Mental Healthcare Providers, and Life Coaches Allied Health Providers Ambulatory Surgery Centers (ASCs) Anti-Aging & Functional Medicine Practices Cannabis Ventures Chiropractors Complementary & Integrative Medicine Providers Dental Practice Digital & Mobile Health Companies Faith-based Health Care Organizations Healthcare Facilities Home Health Care Hospice Management Services Organizations Medical Groups, Medical Centers Medical Spas Nurses OTC & Homeopathic Drug Companies Pharmacies Speech Therapists (SLPs) Telemedicine Ventures Urgent Care Centers Veterinarians Faith-based health care is a religious-oriented alternative to standard health care. Health care sharing ministries offer faith-based plans that operate with exemption from the mandates of the Affordable Care Act (ACA) or Obamacare. Faith-based plans do not intend to function as insurance policies. Instead, faith-based plans operate as health care sharing among large groups of people, wherein each member pays a monthly premium. When one of the members becomes ill or needs treatment for an injury, his or her contributions cover the expenses, in conjunction with the collective input of fellow members. As such, the premiums are lower in comparison to those of traditional health care. Christian health ministries typically administer these faith-based plans. Cohen Healthcare Law Group can provide legal advice to this growing alternative to standard healthcare organizations as they need to adhere to all applicable laws and accreditation standards. Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process.... - Published: 2019-08-19 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/services/dental-practice/ DENTAL PRACTICEDentistry is defined as the evaluation, diagnosis, prevention and/or treatment (nonsurgical, surgical or related procedures) of diseases, disorders and/or conditions of the oral cavity, maxillofacial area and/or the adjacent and associated structures and their impact on the human body; provided by a dentist, within the scope of his/her education, training and experience, in accordance with the ethics of the profession and applicable law. (As adopted by the 1997 ADA House of Delegates). Dentistry played a major role in our healthcare system and is one of the more important parts of primary health care. There are healthcare regulations to deal with such as dental practice financing, insurance, joint ventures, employment, and even the sale and purchase of practices. Our healthcare lawyers at Cohen Healthcare Law Group can advise dentists and dental practices on many legal and regulatory issues they may face in the dental industry. DENTAL TELEMEDICINE MSO—IS IT LEGAL? “WE’RE JUST A TECHNOLOGY PLATFORM” As telemedicine has exploded into many forms – tele-dermatology, tele-gerontology, tele-counseling, tele-psychiatry, and other areas of medicine and healthcare – we’re also seeing DENTAL LICENSING BOARD’S MONOPOLY POWER CHALLENGED BY U. S. SUPREME COURT The Supreme Court case of North Carolina Board of Dental Examiners v. FTC is, in some ways, a watershed in terms of judicial resistance to monopolization of health care practices by a licensing board. 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 - Published: 2019-08-19 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/services/ambulatory-surgery-centers-ascs/ AMBULATORY SURGERY CENTERSAmbulatory Surgery Centers—known as ASCs—are modern health care facilities focused on providing same-day surgical care, including diagnostic and preventive procedures. ASCs have transformed the outpatient experience for millions of Americans by providing them with a more convenient alternative to hospital-based outpatient procedures—and done so with a strong track record of quality care and positive patient outcomes. Source: ASC Ambulatory Surgery Centers are complex operations to run and manage. The many legal and regulatory compliance burdens add to the complexity. Stark Law, Anti-kickback statue, Safe harbor compliance, HIPAA, Informed consent processes, are just to name a few of the many legal issues ASCs must address. At Cohen Healthcare Law Group, we also help ASC owners with fraud and abuse concerns, operating agreements and transactions, and other legal issues within the boundaries of the complex healthcare regulatory system. 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 - Published: 2019-08-19 - Modified: 2025-10-22 - URL: https://cohenhealthcarelaw.com/services/academic-medical-centers/ ACADEMIC MEDICAL CENTERSAcademic medical centers and teaching hospitals have unique legal needs, especially those that train employ medical professionals such as physicians, nurses, and physician assistants. There are over 1,000 teaching hospitals that directly employ 2. 7 million people and are among the largest employers in their communities. Cohen Healthcare Law Group understands that Academic Medical Centers have a large scope of work and legal review is necessary to help with regulatory compliance as well as the myriad of employment agreements with clinical professionals and other healthcare contract needs. The legal and regulatory needs of academic medical centers and their affiliated hospitals includes: Compliance with clinical research rules. Informed consent issues. Intellectual property protection. FDA regulatory classification of healthcare technology including medical devices, healthcare software, and breakthroughs in nutritional products. Privacy law and cybersecurity, HIPAA Medicare issues Other healthcare legal issues Academic medical centers and their affiliated hospitals and hospital systems are uniquely poised to make seminal contributions to our nation’s intellectual capital, and accordingly, deserve specialized healthcare legal advice. 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 - Published: 2019-05-31 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/how-is-an-llc-different-than-an-incorporation/ How Is an LLC Different than an Incorporation? An LLC is like a corporation, in that it also affords limited liability protection. However, it's different from a corporation in two fundamental respects. Number one, it's taxed like a partnership, so that the income, the gains, and the losses flow through to the members of the LLC. Secondly, there are typically fewer corporate formalities, so an LLC is a little bit easier to run. The caveat is that if you're planning to have a large company over time, you probably want to have a corporation instead of an LLC, because there's a better body of law, which will help you manage the corporation. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("dc3ee907-2eb7-46f0-bcd1-9a0d923b9b65", "form-2", {}); - Published: 2019-05-31 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/how-can-you-transform-an-idea-into-a-business/ How Can You Transform an Idea into a Business? There are a couple of things you want to do to transform your idea into a viable business. The first is to incorporate. Once you do that, you've created an official, formal, legally-sanctioned structure for your enterprise. You want to look at the various packages online, consult with your attorney and accountant and figure out how to put together the best structure for your business. Secondly, you want to protect your intellectual property. You want to take your creativity, your brain power, all of your good ideas, and make sure that you have some legal protection, whether through copyright, trademark, trade secrets or patent law. Thirdly, you want to get your business contracts together so that your suppliers, key vendors, customers, distributors, agents and everyone with whom you do business have a legally-binding agreement that spells out everybody's rights and obligations. A little bit of advance legal work up front can save you a lot of trouble down the road. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics.... - Published: 2019-05-31 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-business-and-healthcare-attorney/ Michael H. Cohen, Business and Healthcare Attorney Hello, my name is Michael H. Cohen. I'm an attorney. I practice law in Beverly Hills, California. I practice in the area of healthcare law and corporate law or general business law. My clients range from individual practitioners to very new startup ventures, all the way up to small, medium, and very large corporations. I help many individuals get through their legal issues, whether they involve a civil lawsuit or an investigation by regulatory board, or simply trying to create a business structure that's legally compliant. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("dc3ee907-2eb7-46f0-bcd1-9a0d923b9b65", "form-2", {}); - Published: 2019-05-31 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/life-coaching-and-psychology-licensure/ Life Coaching and Psychology Licensure There are two legal issues that tend to come up in my clientele with psychology. One is the unauthorized practice of psychology, people who are practicing psychology, but they don't know it. Who are we talking about? Life coaches. Now, I know that there are hundreds of thousands of life coaches out there and that there are organizations that grant credentials to life coaching. Nonetheless, I've seen several instances where the Board of Psychology has come down hard on practitioners for the unlicensed practice of psychology. The lines are not always clear. Especially where people are not lawyers, they can somewhat innocently step over a trip wire. So, if you're doing any type of life coaching, it's important to have dos and don'ts. It's important to have legal counsel to make sure that you can practice in as compliant and legally safe way as possible and that you don't communicate with your clients, whether through a workshop, or through email, or by phone, or in person, or otherwise, in a way that could land you in an unwanted Board of Psychology criminal investigation. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i.... - Published: 2019-05-30 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-complementary-and-alternative-medicine/ Michael H. Cohen: Complementary and Alternative Medicine My first book is entitled “Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives”. Now, I know that's a long title, but it's a very rich book. It's heavily footnoted and referenced, and it basically puts together all the law that I could find at the time about how alternative therapies are regulated in the United States. This book, which was published by Johns Hopkins University Press, talks about licensing of practitioners, what gives the state the right to decide who can and cannot be licensed, how far that authority goes, the scope of practice, what practitioners like chiropractors, acupuncturists, massage therapists can and can't do, the status of naturopath licensing, naturopathy in the United States. It talks about therapies like homeopathic medicine, the development of homeopathy, the role of the American Medical Association in terms of the development of the legal framework in the United States, how the FDA regulates dietary supplements. It talks about insurance reimbursement, malpractice liability, and a host of topics. It's a really terrific reference book for people who want to know the legal landscape for the field. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i.... - Published: 2019-05-28 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-standard-of-care-issues-in-healthcare-practice/ Michael H. Cohen: Standard of Care Issues in Healthcare Practice Also, remember that if you have a license, you will be held to a very high standard of care. Don't let your license lapse, and don't assume that if you are or were a licensed professional, that you can simply call yourself something else like a life coach, and then miraculously the board is going to leave you alone. You will be held accountable for the license that you have had or currently have. If you are or were a licensed health care professional, like a medical doctor or a psychologist, and you're creating some kind of alternative health care product or service than what you did or had in your clinical practice, don't assume that you're going to be fine. Be sure to retain expert, legal counsel so that you're protected. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("dc3ee907-2eb7-46f0-bcd1-9a0d923b9b65", "form-2", {}); - Published: 2019-05-28 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-medical-board-discipline-integrative-medicine/ Michael H. Cohen: Medical Board Discipline & Integrative MedicineIf you're a licensed medical doctor who's offering integrative medicine or complementary therapies to his patient, it's important to get good legal advice. You need to have robust consent forms, and a legal strategy that will help protect you against risk of medical board discipline, or a patient lawsuit based on standard of care, and other allegations. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-28 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-multi-disciplinary-clinical-practices/ Michael H. Cohen: Multi-disciplinary Clinical PracticesOne of the questions that arises in integrative care is what happens if you're a chiropractor, an acupuncturist, or a massage therapist, or a licensed naturopathic physician and you're working side by side or in collaboration with a medical doctor? Are you held to the standard of care of your profession, or are you somehow held to a higher standard of care, because you're practicing in an integrative fashion? This question really depends on exactly what your practice looks like. Are you, for example, in a solo practice? Are you renting space? Are you renting from a medical facility? Are you simply referring back and forth? How closely are you cooperating with the medical side? Each of these nuances is going to affect your liability scenario. One thing that I do for my clients is I provide a risk assessment. I will canvass your existing practice and look at all the different areas that could expose you to liability. One of the things that my law firm does is conduct a detailed risk assessment, looking for all the possible holes in your practice, all the possible sources of liability. We will then give you detailed recommendations as to how the protect yourself and minimize possible liability risks. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-25 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-online-health-services-and-products/ Michael H. Cohen: Online Health Services and ProductsHello, I'm Michael H. Cohen, principal of The Cohen Healthcare Law Group in Beverly Hills, California. If you have a website and you're offering any type of healthcare information, products, or services, there are at least two things you need to concern yourself with. One, is the FDA. Two, is the Federal Trade Commission. I'll talk about these in a little bit more detail. First the FDA. If you're offering any type of dietary supplement, you need to make sure that the information you provide on the website is consistent with FDA rules. One of the FDA rules that people are sometimes not aware of, is that information on the website can potentially be considered part of the label. Therefore, you have to be careful not to make disease claims for dietary supplements. Dietary supplements can make claims about structure and function, including well-being, but they cannot make medical claims. This is a very nuanced area, and it's important to get legal review of all your marketing materials, including your website to make sure that they're compliant. The second area, is FTC compliance. The FTC, or Federal Trade Commission, insures that websites and other marketing materials are not false and misleading. The FTC goes after advertising that is false, deceptive, or misleading to the consumer. And so the FTC requires that you have substantiation for your healthcare information, products, and services. And if these products are dietary supplement products, then you have to... - Published: 2019-05-25 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-fda-and-ftc-legal-issues-in-online-ventures/ Michael H. Cohen: FDA and FTC Legal Issues in Online VenturesOne of my clients recently copied their website wholesale from a company that had FDA approval for their medical device. Interestingly, it wasn't the FDA that came after my client, it was the State Attorney General, for false and deceptive advertising. My client would have saved a lot of money had she gotten legal review before the enforcement disaster happened. That's why I sometimes say don't roll the dice, get legal advice. It's true. An ounce of prevention is worth a pound of cure. Get legal review before committing yourself to a website that's going to go out and be broadcast to the whole world. TestimonialsJTNDJTIxLS0lMjBTdGFydCUyMExhd21hdGljcyUyMEVtYmVkZGVkJTIwU25pcHBldCUyMC0tJTNFJTBEJTBBJTNDc2NyaXB0JTIwaWQlM0QlMjJmb3JtLTIlMjIlM0UlMjAlMEQlMEElMjFmdW5jdGlvbiUyOGUlMkN0JTJDbiUyQ2ElMkNzJTJDYyUyQ2klMjklN0JpZiUyOCUyMWUlNUJzJTVEJTI5JTdCaSUzRGUlNUJzJTVEJTNEZnVuY3Rpb24lMjglMjklN0JpLnByb2Nlc3MlM0ZpLnByb2Nlc3MuYXBwbHklMjhpJTJDYXJndW1lbnRzJTI5JTNBaS5xdWV1ZS5wdXNoJTI4YXJndW1lbnRzJTI5JTdEJTJDaS5xdWV1ZSUzRCU1QiU1RCUyQ2kudCUzRDElMkFuZXclMjBEYXRlJTNCdmFyJTIwbyUzRHQuY3JlYXRlRWxlbWVudCUyOG4lMjklM0JvLmFzeW5jJTNEMSUyQ28uc3JjJTNEYSUyQiUyMiUzRnQlM0QlMjIlMkJNYXRoLmNlaWwlMjhuZXclMjBEYXRlJTJGYyUyOSUyQWMlM0J2YXIlMjByJTNEdC5nZXRFbGVtZW50c0J5VGFnTmFtZSUyOG4lMjklNUIwJTVEJTNCci5wYXJlbnROb2RlLmluc2VydEJlZm9yZSUyOG8lMkNyJTI5JTdEJTdEJTI4d2luZG93JTJDZG9jdW1lbnQlMkMlMjJzY3JpcHQlMjIlMkMlMjJodHRwcyUzQSUyRiUyRm5hdmkubGF3bWF0aWNzLmNvbSUyRmludGFrZS5taW4uanMlMjIlMkMlMjJsbV9pbnRha2UlMjIlMkM4NjRlNSUyOSUyQ2xtX2ludGFrZSUyOCUyMmRjM2VlOTA3LTJlYjctNDZmMC1iY2QxLTlhMGQ5MjNiOWI2NSUyMiUyQyUyMCUyMmZvcm0tMiUyMiUyQyUyMCU3QiU3RCUyOSUzQiUyMCUwRCUwQSUzQyUyRnNjcmlwdCUzRSUyMCUwRCUwQSUzQyUyMS0tJTIwRW5kJTIwTGF3bWF0aWNzJTIwRW1iZWRkZWQlMjBTbmlwcGV0JTIwLS0lM0U= Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-25 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-dietary-supplements-and-natural-products/ Michael H. Cohen: Dietary Supplements and Natural ProductsHello, my name is Michael H. Cohen. I'm principal of the Cohen Healthcare Law Group in Beverly Hills, California. My law firm represents dietary supplement manufacturers and distributors. There are at least three things you need to be concerned about if you are a dietary supplement manufacturer or distributor. Number one, claims. Number two, labeling. Number three, substantiation. Claims are a very critical area, under the Dietary Supplement Health Education Act or the DSHEA, you can make structure function claims, you cannot make disease claims. Sometimes it's difficult to distinguish between the two. For that reason, you need expert legal counsel to review your claims to be sure that they're not prohibited under the DSHEA. Labeling is highly complex, specific and nuanced. You want to be sure that those labels that go on the back of the bottle or on the package are 100% compliant with what the FDA and the FTC require. Three, you'll want to have a backup file substantiating all of the claims that you make on your website, in your marketing materials and on the product. Remember that your marketing materials can be considered part of the labeling. So you'll want to be compliant with FDA, FTC and other legal rules in all respects. TestimonialsJTNDJTIxLS0lMjBTdGFydCUyMExhd21hdGljcyUyMEVtYmVkZGVkJTIwU25pcHBldCUyMC0tJTNFJTBEJTBBJTNDc2NyaXB0JTIwaWQlM0QlMjJmb3JtLTIlMjIlM0UlMjAlMEQlMEElMjFmdW5jdGlvbiUyOGUlMkN0JTJDbiUyQ2ElMkNzJTJDYyUyQ2klMjklN0JpZiUyOCUyMWUlNUJzJTVEJTI5JTdCaSUzRGUlNUJzJTVEJTNEZnVuY3Rpb24lMjglMjklN0JpLnByb2Nlc3MlM0ZpLnByb2Nlc3MuYXBwbHklMjhpJTJDYXJndW1lbnRzJTI5JTNBaS5xdWV1ZS5wdXNoJTI4YXJndW1lbnRzJTI5JTdEJTJDaS5xdWV1ZSUzRCU1QiU1RCUyQ2kudCUzRDElMkFuZXclMjBEYXRlJTNCdmFyJTIwbyUzRHQuY3JlYXRlRWxlbWVudCUyOG4lMjklM0JvLmFzeW5jJTNEMSUyQ28uc3JjJTNEYSUyQiUyMiUzRnQlM0QlMjIlMkJNYXRoLmNlaWwlMjhuZXclMjBEYXRlJTJGYyUyOSUyQWMlM0J2YXIlMjByJTNEdC5nZXRFbGVtZW50c0J5VGFnTmFtZSUyOG4lMjklNUIwJTVEJTNCci5wYXJlbnROb2RlLmluc2VydEJlZm9yZSUyOG8lMkNyJTI5JTdEJTdEJTI4d2luZG93JTJDZG9jdW1lbnQlMkMlMjJzY3JpcHQlMjIlMkMlMjJodHRwcyUzQSUyRiUyRm5hdmkubGF3bWF0aWNzLmNvbSUyRmludGFrZS5taW4uanMlMjIlMkMlMjJsbV9pbnRha2UlMjIlMkM4NjRlNSUyOSUyQ2xtX2ludGFrZSUyOCUyMmRjM2VlOTA3LTJlYjctNDZmMC1iY2QxLTlhMGQ5MjNiOWI2NSUyMiUyQyUyMCUyMmZvcm0tMiUyMiUyQyUyMCU3QiU3RCUyOSUzQiUyMCUwRCUwQSUzQyUyRnNjcmlwdCUzRSUyMCUwRCUwQSUzQyUyMS0tJTIwRW5kJTIwTGF3bWF0aWNzJTIwRW1iZWRkZWQlMjBTbmlwcGV0JTIwLS0lM0U= - Published: 2019-05-25 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-medical-spas-legal-issues-medical-board-issues/ Michael H. Cohen: Medical Spas - Legal Issues, Medical Board IssuesMedical spas are governed by several interlocking areas of state law. There are at least three areas that we need to be concerned with: One: Corporate Practice in Medicine. Two: Anti-Kickback and Fee Splitting; and- Three: Professional Corporation Rules. I'll address each one in a bit more detail. One, corporate practice of medicine. Under the laws of some states, as a lay person, you cannot hire a medical doctor. You have to be extremely careful about the way you structure your agreements so that they don't run afoul of the corporate practice of medicine. Corporate practice of medicine is basically a rule that prohibits non-physicians from engaging in what could appear to be the unlicensed practice of medicine. If you run afoul of this tripwire, the medical board will investigate and potentially refer this to the FDA as a crime. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-21 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-unlicensed-medical-practice/ Michael H. Cohen: Unlicensed Medical PracticeHello. I'm Michael H. Cohen, principal of the Michael H. Cohen Law Group in Beverly Hills, California. If you violate the corporate practice of medicine rule, you could be at risk of unlicensed medical practice, which is considered a crime. If you violate the anti-kickback and fee splitting laws, that's also considered criminal activity, potentially under federal as well as state law. If you don't get the right professional corporation, your corporation could be invalid, and there could be a host of other consequences. Therefore, it's extremely important to get careful business legal advice whenever you structure a medical spa or any kind of multidisciplinary healthcare entity that brings these three very different, yet interconnected, legal rules into play. My legal team has over 76 years of combined experience in many different areas of law. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-21 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-fee-splitting-legal/ Michael H. Cohen: Fee-Splitting LegalMany clients call me once they have already gotten themselves into an illegal contract for fee splitting. There is both federal and state law to consider. If Medicare is involved, we have to worry about Stark, which is a federal self-referral law, and the federal anti-kickback law. On the state level we have similar self-referral and anti-kickback, and sometimes also patient brokering provisions. If you are interested in detail about fee splitting and anti-kickback laws, there is a wealth of detail available on the complementary and alternative medicine law blog. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-21 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/why-compliance-is-not-a-secret-healthcare-lawyers-word/ Why Compliance is not a Secret Healthcare Lawyer's WordIf you're a healthcare company, whether you're a healthcare start up or a mature healthcare company. You probably know that compliance is not a boring word. Compliance is something that you think about, it's part and parcel of being in the health and wellness industry. It's just what you do. It's what you do as a company, you pay attention to compliance. And you might be robust enough that you've got a compliance officer, or a regulatory officer, or healthcare lawyer that you consult. Let me talk a little bit about compliance today, and tell you why it's, not only not boring, but it's one of the most important things that you can think about in your healthcare venture, especially when you're starting up. I'm doing this from my car, as you can see. I was like a scrappy start up, I'm just getting into that vibe today. I've been listening to stories of entrepreneurs, so it's just me, gluten free. Low production value, but high content value. Propping up my iPhone with an empty box of crackers actually, off the car. But that's okay, because I'm going to talk about things that matter. One thing that clients who are interested in compliance ask over and over is they say, I want such and such done, how much does it cost? And, from a sales perspective we know it's about two things. The pain points and the benefits. Ultimately price is never... - Published: 2019-05-09 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/complementary-and-alternative-medicine-legal-issues/ Complementary and Alternative Medicine Legal IssuesContext for CAM regulation, tying in some history of medicine with the history of regulation. Secondly, I'll discuss key legal issues that are confronting providers and institutions. Thirdly, risk management strategies and finally some thoughts about the future, the evolution of CAM regulation. So first I'd like to say that politics, perception and economic control of healthcare have created and continue to create the legal environment for CAM. Let me give you some examples. In the early part of our history, the first 150 years we had sectarian medicine, rivalries between competing sex and this directly led to medical licensing statutes, which happened to define the practice of medicine extremely broadly and made unauthorized practice criminal. In the next 70 years, we had the rise of scientific medicine, the growth of the AMA and the Flexner Report and this led to U. S. versus Dent in 1888, in which the Supreme Court decided that states have very broad, virtually unlimited police power in health care licensing and other affairs. The next part of our history, 40 years, we have technological triumphs, increasing scientific optimism and also the phenomenon of medical paternalism, the idea that the white coat doctors knows best, patients not having the authority to make decisions. And in the regulatory side, we have successful prosecution of individuals practicing naturopathy, chiropractic massage, hypnotism, even things such as ear piercing, tattooing and iridology and midwifery, all these providers are prosecuted under that broad definition of... - Published: 2019-05-09 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/michael-h-cohen-health-care-lawyer-for-psychologists/ Michael H. Cohen Health Care Lawyer for PsychologistsOne of my clients was a very reputable psychologist in the community. Unfortunately, she was very tenacious and responsible in trying to help a patient who had borderline personality disorder. This patient claimed that the psychologist got angry at her and threw a dish across the room. Of course, according to my client, this accusation was completely unfounded. But because of it, we had to respond together to a very difficult Board of Psychology investigation. That threatened her license. What I did was I got the facts from her, I wrote a cogent response letter to the Board, and ultimately, we succeeded in getting the investigation closed. If you're practicing psychology and a licensed psychologist, or if you're a life coach, or even if you're another type of professional, or non-professional, who's giving advice that could potentially cross into the emotional counseling, mental healthcare arena, it's very important that you seek expert legal advice. At the Cohen Healthcare Law Group, we provide clear legal advice to grow your business. Contact us today at cohenhealthcarelaw. com. 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 Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-05-09 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/hipaa-in-the-real-world-part-2-breach-notification/ HIPAA in the Real World (Part 2): Breach NotificationSo the first thing was I helped them to draft a letter informing both the government and the patients about the circumstances. Of course you want to be accurate but you also want to portray the circumstances in a way that shows that the organization has done the best that it could to help prevent this kind of thing from happening. Now, we live in an electronic age, nothing is 100% secure. But it's important to know what your compliance obligations are and to show that you've done a reasonably good job of trying to meet them. So thankfully again some of the basics were in place, they were a long way from being compliant but I didn't think that they were guilty of willful neglect either. This was a first time violation and so the hope was that all they would get would be a regulatory slap on the wrist. Now, after drafting the breach notification letter, I made sure that they notified the patients. Another thing they had to do was to mitigate the risks of the breach. So they offered the patients two years of free identify theft protection to help them with all the consequences. Because if you're a patient and you get a letter saying that your name, your address, your social security, the name of your minister, your treatments, everything's been compromised, you're going to be worried. So they had to do something to help these... - Published: 2019-05-09 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/hipaa-in-the-real-world-part-1-why-compliance-matters/ HIPAA in the Real World (Part 1): Why Compliance MattersNow, I know this HIPAA stuff can seem a bit dry and arcane, and we've covered a lot of different rules. But, let me show you how this can come up in real life. I got a call on my cell phone from the CEO of a large medical group in Los Angeles. They were absolutely panicked. It was a Sunday afternoon, and they'd just learned that one of their nurses had been in a lovely barbecue, but unfortunately, she'd brought a bunch of patient files. As I mentioned, she left them in the car. And all the files were gone. So, someone had broken in, and the files involved 100 patients. Now, it could have involved three, but it happened to be 100, which is bad news. It means that someone got names, phone numbers, addresses, social security numbers, drivers licenses, a lot of sensitive information. What the patients were being treated for, who their doctors were, the drugs that they'd been on, every kind of treatment, even who their ministers were. This wasn't good. So, the CEO was furious, and the HR director was wondering what to do. Frankly, they were doing the math. 100 patients, violations per patient, it was starting to add up. They were wondering, was someone going to find willful neglect? Had they really covered their bases before? How bad was this going to be? And they were wondering about the media implications as well.... - Published: 2019-05-03 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/video-library/dietary-supplement-laws-and-fda-regulations/ Dietary Supplement Laws and FDA RegulationsAn example of how we integrate ancient knowledge with modern technological progress, and it all centers around the legal regulation, is how we regulate dietary supplements. There's a company that has an herbal medicine product for weight loss. The challenge is that the FDA says, "When you have a dietary supplement, if you make a claim that it helps cure a disease, it gets regulated as a drug. " And when it's a drug, you need new drug application, and that's very expensive to bring a product to market. So you don't want to do that. You want to make a proper structure function claim such as, "Supports healthy weight loss. " Now, one of the customers of this company posted on their Facebook page that the product was so good that it helped the client lose an incredible amount of weight, such a huge, staggering amount of weight that it's simply scientifically untenable and unbelievable. It's just preposterous. And one of the company's marketing people got so enthusiastic that they liked this post on their Facebook page. And the FDA said that by doing this, the company was making a disease claim, and therefore, the product had to be regulated as a drug and had to be pulled off the market or they needed a new drug application. Well, this got the company in really, really deep trouble. I mean, it was a huge expense. So when you bring a dietary supplement to market,... - Published: 2019-05-03 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/telemedicine-and-online-health-legal-regulatory-pathways-to-future-medicine/ Telemedicine and Online Health: Legal & Regulatory Pathways to Future MedicineTelemedicine is the medicine of the future. We're moving from brick and mortar to virtual practice. We're moving from the old world, which is going to the family doctor that would make house calls, to the world where people go into a space to see physicians and get treatment, to a world where you have to go no further than your own phone or your own monitor. And you'll be able to access health care from anywhere in the world. We're going from telemedicine anywhere to telemedicine everywhere. It's becoming ubiquitous. Now as we do this, there is some very specific legal challenges that telemedicine companies need to surmount. There are issues of privacy and confidentiality. On a federal US level, we have HIPAA for example. You have to be HIPAA compliant if you've got a telemedicine product. There are FDA issues of regulation of medical devices. And there are state law issues about regulating practitioners, because licensure is governed by state law. And when a practitioner engages in telemedicine, they're governed by the law of the state where the patient is located, where that practitioner may not be licensed. So in order to bring a product to market, you've got to surmount these regulatory obstacles, in a very strategic way. However, once we do this, we are able to bring something that's going to benefit millions of people. It's going to transform medicine from that one on one encounter... - Published: 2019-04-20 - Modified: 2025-08-26 - URL: https://cohenhealthcarelaw.com/video-library/safeguarding-your-license-avoiding-malpractice-standard-of-care-in-integrative-medicine/ Safeguarding Your License & Avoiding Malpractice: Standard of Care in Integrative Medicine Whether you're practicing conventional medicine or integrative anti-aging or functional medicine, if there's ever a hint of trouble medical boards will look to see whether you've covered the bases of standard of care. You may be using therapies or modalities that are not 100% mainstream. If so, you'll want to follow these best practices. Number one: make sure that most physicians wouldn't consider the therapy to be too risky or dangerous. This can be achieved by establishing that there is a respectable minority. The respectable minority is a defense to a medical malpractice claim based on standard of care. Remember that physicians are allowed to engage in clinical innovation to benefit the patient. Two: you'll want to have a reasonably defensible body of evidence that supports your complementary and integrative medical therapies. One of the most efficient ways to gain this support is to get trained in anti-aging integrative or functional medicine, for example, the A4M and the Metabolic Medicine Institute offer a variety of fellowships that can help support your efforts. Fellowships are also offered by many other organizations. Number three relates to understanding the limitations of your non-mainstream medical treatment. If the complementary therapy isn't working and the patient needs conventional care—for example, in the case of an aggressive cancer—be sure to offer the conventional approach or refer out for it. If you follow these three guidelines you'll go a long way towards safeguarding your practice... - Published: 2019-04-20 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/avoiding-malpractice-through-strong-informed-consent-practices/ Avoiding Malpractice Through Strong Informed Consent Practices Informed consent is critical in all areas of healthcare and medicine. It takes on even added importance when you're suggesting a non-mainstream approach. Give the patient good information about your reasons for going down a particular therapeutic pathway. Be sure to cover all the benefits and risks of the proposed alternatives. Be sure the patient understands exactly what you're saying. Answer any questions. Tell the patient why the treatment you're proposing is different than the conventional route, and what are the pros and cons. In other words, make sure you cover the bases of informed consent. And then, document everything you've talked about in the medical chart. Be sure you have written documentation and confirmation of the conversation. The reason? Poor informed consent can be grounds for a malpractice lawsuit by a patient independent of any negligence. On the other hand, strong and robust informed consent practices can help you with legal risk mitigation. If you have any questions about your consent forms, or consent form practices, give us a call. We'd be glad to talk to you. Testimonials I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable. Richard Freedland GRAMedical, CEO Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes. James Riviezzo Practice On Your Terms Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue.... - Published: 2019-04-20 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/breaking-away-into-your-new-practice-and-common-insurance-issues/ Breaking Away Into Your New Practice and Common Insurance Issues Let me talk for a moment about clarifying insurance issues. If you are already employed within a hospital or medical group or within another medical setting and planning to breakaway, be sure to understand the existing arrangements that you may have with third party reimbursement carriers. For example, are you in network and bound by the existing insurance contracts as a participating physician? Do those contracts apply to you? Do they require that the insurance company concent before you bill outside and breakaway? Are you bound to submit all claims no matter what they're origin through the insurer, even if they're delivered offsite or in a new practice? Do the contracts follow you personally, do they follow your NPI or do they follow your employer? Do you need permission from your employer to breakaway? Sometimes we suggest the clients write the insurance company or head of department announcing the plans to create a new practice, well asserted in the letter that the physician is not bound in the new practice by existing arrangements with the employer. We ask the insurer to write within 30 days if it disputes this assertion. In the absence of a reply we would argue that silence equals acceptance. On a separate note, for your own practice, please look into professional liability insurance, premises liability insurance, general umbrella liability coverage and cyber liability coverage for HIPAA and data breach issues. Make sure that any professional liability... - Published: 2019-04-20 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/liability-protection-the-practice-of-medicine-for-non-physicians/ Liability Protection & the Practice of Medicine for Non-Physicians What's the difference between a professional corporation and a general corporation, and why do you need each? In most states clinical practice can only be provided through the professional corporation or PC. In this case a professional medical corporation. Using a professional corporation has several advantages: First, the corporation at most - but not all cases, provides protection against personal liability for exposures such as liability for slip and falls, or breach of contract. It's the corporation that faces liability, not the person. Although corporations can shield you against claims for professional negligence for providing medical services, they can usually protect you from most other kinds of liability. The second advantage of a professional corporation, is to help buttress the physician against corporate practice of medicine concerns. Non-physician in general corporations cannot practice medicine. There's a lot of enforcement against entrepreneurs who try to team up with doctors. If the practice of medicine is housed within a professional medical corporation, that helps create a clearer separation between clinical medical care on one hand, and administrative management and marketing functions on the other. One of the areas in which I provide guidance, is for non-physicians such as entrepreneurs, who want to "partner" with physicians. In most states, they can't partner, because this would be considered "corporate" practice of medicine. What most non-physicians can do, is create an MSO, which stands for Medical Services Organization. The MSO can contract with a physician's professional... - Published: 2019-04-20 - Modified: 2025-03-17 - URL: https://cohenhealthcarelaw.com/video-library/five-steps-to-meet-hipaa-obligations-and-privacy-security-compliance/ Five Steps to Meet HIPAA Obligations and Privacy & Security Compliance If you're submitting claims electronically for reimbursement, you are under HIPAA. This subjects you to all the privacy and security obligations of HIPAA. Simply having an electronic medical record system that says, HIPAA Compliant, is not going to be enough. At a minimum your HIPAA should include these five steps: Appoint a privacy officer. Appoint a security officer. Have a privacy and security manual that is specifically tailored to your health care practice facility or institution. The manual should include privacy and security policies, procedures and forms. Ensure that all staff have HIPAA training, and Perform a security risk assessment and address security vulnerabilities. The following story shows how these steps can safeguard your healthcare business or practices. One of my clients found themselves in deep HIPAA waters when one of their nurses took some patient files home and left them in the unlocked passenger seat of his car. You know what happens next. Someone broke into the car. The files were stolen, and investigators came knocking. Clearly there was a HIPAA violation, but fortunately the nursing home had documented that they had trained all employees beforehand. They also had policies and procedures in place including a commitment to terminating employees who violate HIPAA safeguards. This allowed the client to escape stiff penalties and to get off with a slap on the wrist. Now remember, HIPAA liability can extend even to small or solo physician practices so even if... - Published: 2019-04-19 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/video-library/how-can-mds-practice-functional-medicine-without-undue-fear-of-legal-risk/ How can MDs practice functional medicine without undue fear of legal risk? Hello. Good morning. Good day. Good afternoon. Buenos Dias. Shalom. Wherever you are. I'm Michael H. Cohen, a healthcare and FDA lawyer. Today's topic is how can functional and integrative medicine doctors practice without undue fear of legal jeopardy? Now that's a long sentence. I'm a lawyer. You'll notice I didn't say without fear. I said without undue fear. There are lots of things that one can be afraid of in this world and it's certainly legal jeopardy is one of them. We don't want to be so afraid that we just don't make a move. As always, it's good to have legal counsel at your back, especially once you get into this kind of area. Let me see if I can set your mind at ease by going through a couple of topics. Let me start with a story. Just the other day a medical doctor called me and he's affiliated with a hospital somewhere. That's his day job. His contract is going to end in six months and he wants to know can he launch his functional medicine practice? Should he launch his functional integrative medicine practice? A lot of times people call, they're looking for advice, and sometimes it's very, very specific advice. Other times I get this sense that underlying everything there's kind of a gestalt of is this feasible? Feasibility analysis or can I really do this? Sometimes it's, "Can you give me... - Published: 2019-02-14 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/how-healthcare-ventures-can-craft-a-corporate-practice-of-medicine-legal-strategy/ How Healthcare Ventures Can Craft a Corporate Practice of Medicine Legal StrategySegments in this Podcast: Welcome - your Healthcare Legal Adventure Corporate Practice of Medicine Woes Strong v. weak corporate practice of medicine Healthcare entrepreneurs face corporate practice of medicine legal challenges Unlicensed practice of medicine cuts broadly Craft your corporate practice of medicine legal and regulatory strategy Continuing your healthcare legal adventure Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2019-02-13 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/fda-ftc-law/fda-warning-letters/ FDA Warning Letters If the FDA finds, after the investigation, that the company is violating the law or failing to comply with the regulations, it will issue a formal warning letter to the company. FDA warning letters can be sent to developers, manufacturers, distributors, retailers, individuals, and other entities. First Name Last Name Email Address Phone Number Please tell us how we can help you. What We Do: Healthcare Law Life Sciences (FDA & FTC) Law Advertising and Marketing Claims Biotechnology Issues Cosmetics Claims Dietary Supplements Claims & Labeling FDA Warning Letters FTC Compliance Medical Device & Mobile Medical App Issues Off-Label Use OTC & Homeopathic Drug Companies Who We Serve FDA Legal & Compliance Guidance Our FDA compliance and regulatory lawyers are highly experienced in FDA compliance matters. We advise companies on the steps to take to help mitigate the prospect of receiving an FDA warning letter. We also advise businesses and individuals on the best ways to respond to an FDA warning letter, including compliance steps they need to take to preserve their business while appropriately responding to FDA concerns. Failure to respond successfully to an FDA warning letter can result in more than just the cessation of the product’s development and sales. The FDA can follow up the warning letter with civil fines, seizure of property, injunctions, and even (in the case of public safety concerns or intentional/reckless conduct), criminal prosecutions. In addition, the Federal Trade Commission (FTC) and state regulatory authorities can piggyback off an FDA... - Published: 2018-12-22 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/htm2019/ The Best Thing I Did for My Law Firm in 2018! Welcome to our Resources page for Sales 3. 0. Click on the icons below to get our From Sale to Scale PowerPoint, and our bonus opportunity to Guest on our Podcast. Find the Holy Grail—Sales 3. 0 ... and go from Sale to Scale. Warmly, Michael Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. - Published: 2018-12-15 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/podcast/got-hipaa-get-hipaa-joyce-explains-why-and-how/ Got HIPAA? Get HIPAA? Joyce explains why and how Update Required To play the media you will need to either update your browser to a recent version or update your Flash plugin. Segments in this Podcast: Healthcare Legal Adventures Begin Our expert – HIPAA privacy and security law HIPAA Policies Drive Medical Risk Management (Joyce Speaks) Healthcare Legal Adventures Continue - Published: 2018-12-02 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/san-jose/ Healthcare Lawyers San JoseCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in San Jose, Ca. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as San Jose. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the... - Published: 2018-12-02 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/houston/ Healthcare Lawyers HoustonCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Houston, TX. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Houston. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting edge of... - Published: 2018-12-02 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/newport-beach/ Healthcare Lawyers Newport BeachCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Newport Beach. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Newport Beach. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting... - Published: 2018-12-02 - Modified: 2025-12-23 - URL: https://cohenhealthcarelaw.com/san-francisco-bay-area/ Healthcare Lawyers San Francisco Bay AreaCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in San Francisco Bay Area, CA. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as San Francisco Bay Area. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical... - Published: 2018-12-02 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/san-diego/ Healthcare Lawyers San DiegoCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in San Diego, CA. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as San Diego. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the... - Published: 2018-12-01 - Modified: 2025-09-23 - URL: https://cohenhealthcarelaw.com/areas-we-serve/ Areas We Serve California Adelanto Agoura Hills Alameda Albany Alhambra Aliso Viejo Alturas Amador City American Canyon Anaheim Anderson Angels Camp Antioch Apple Valley Arcadia Arcata Arroyo Grande Artesia Arvin Atascadero Atherton Atwater Auburn Avalon Avenal Azusa Bakersfield Baldwin Park Banning Barstow Beaumont Bell Bell Gardens Bellflower Belmont Belvedere Benicia Berkeley Beverly Hills Big Bear Lake Biggs Bishop Blue Lake Blythe Bradbury Brawley Brea Brentwood Brisbane Buellton Buena Park Burbank Burlingame Calabasas Calexico California City Calimesa Calipatria Calistoga Camarillo Campbell Canyon Lake Capitola Carlsbad Carmel-by-the-Sea Carpinteria Carson Cathedral City Ceres Cerritos Chico Chino Chino Hills Chowchilla Chula Vista Citrus Heights Claremont Clayton Clearlake Cloverdale Clovis Coachella Coalinga Colfax Colma Colton Colusa Commerce Compton Concord Corcoran Corning Corona Coronado Corte Madera Costa Mesa Cotati Covina Crescent City Cudahy Culver City Cupertino Cypress Daly City Dana Point Danville Davis Del Mar Del Rey Oaks Delano Desert Hot Springs Diamond Bar Dinuba Dixon Dorris Dos Palos Downey Duarte Dublin Dunsmuir East Palo Alto Eastvale El Cajon El Centro El Cerrito El Monte El Segundo Elk Grove Emeryville Encinitas Escalon Escondido Etna Eureka Exeter Fairfax Fairfield Farmersville Ferndale Fillmore Firebaugh Folsom Fontana Fort Bragg Fort Jones Fortuna Foster City Fountain Valley Fowler Fremont Fresno Fullerton Galt Garden Grove Gardena Gilroy Glendale Glendora Goleta Gonzales Grand Terrace Grass Valley Greenfield Gridley Grover Beach Guadalupe Gustine Half Moon Bay Hanford Hawaiian Gardens Hawthorne Hayward Healdsburg Hemet Hercules Hermosa Beach Hesperia Hidden Hills Highland Hillsborough Hollister Holtville Hughson Huntington Beach Huntington Park Huron Imperial Imperial Beach Indian... - Published: 2018-12-01 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/sacramento/ Healthcare Lawyers SacramentoCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Sacramento, CA. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Sacramento. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting edge of... - Published: 2018-11-22 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/podcast/close-encounters-of-the-healthcare-legal-kind/ Close Encounters of the Healthcare Legal Kind Update Required To play the media you will need to either update your browser to a recent version or update your Flash plugin. Segments in this Podcast: Introducing me Some clients don’t convert Monks chant a lawyer up Praying moodily Is it religion or healthcare? Deeper into healthcare vs spirituality Wrap up - Published: 2018-11-21 - Modified: 2025-03-10 - URL: https://cohenhealthcarelaw.com/austin/ Healthcare Lawyers Austin Cohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Austin, TX. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Austin. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting edge... - Published: 2018-11-21 - Modified: 2026-01-28 - URL: https://cohenhealthcarelaw.com/dallas/ Healthcare Lawyers DallasCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Dallas, TX. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Dallas. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting edge of... - Published: 2018-11-21 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/irvine/ Healthcare Lawyers IrvineCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Irvine, CA. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Irvine. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the cutting edge of... - Published: 2018-11-21 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/new-york/ Healthcare Lawyers New YorkCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in New York, NY. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as New York. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the... - Published: 2018-11-21 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/los-angeles/ Healthcare Lawyers Los AngelesCohen Healthcare Law Group is a Healthcare and FDA Law Firm with offices in the Bay Area, California and San Diego, California. We provide FDA, HIPAA, and Legal Services based on Federal law to clients nationwide. As healthcare and FDA lawyers, our FDA legal team at Cohen Healthcare Law Group provides legal strategies and solutions to healthcare practices and healthcare businesses such as those located in Los Angeles, CA. Healthcare law can provide a myriad of legal challenges to healthcare businesses and practices because of the dense regulatory overlay that healthcare industry players must tackle. From HIPAA to FDA law to FTC requirements for advertising healthcare products or services, to potential intervention by the state Medical Board, the Attorney General or District Attorney, or a host of other federal or state agencies, healthcare entrepreneurs and physicians must be savvy in retaining a healthcare and FDA law firm that understands the complex legal and regulatory environment for health and wellness. Cohen Healthcare Law Group has experience representing a diverse array of healthcare practices and businesses over many years including healthcare companies located in healthcare hubs such as Los Angeles. Our clients include medical and wellness clinics, integrative medicine and functional medicine doctors, chiropractors, acupuncturists, nutrition professionals, cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine companies, healthcare software companies, mobile medical app developers, manufacturers and distributors of dietary supplements, manufacturers and distributors of cosmetics and beauty industry products, medical device makers, and businesses at the... - Published: 2018-10-29 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/resources/how-to-choose-a-healthcare-lawyer/ How to Choose a Healthcare LawyerHow to Choose a Healthcare LawyerSubscribe to our mailing list to receive your copy of How to Choose a Healthcare LawyerMore great resourcesMichael H Cohen's new book is now available on Amazon: Your Healthcare Company’s Excellent Legal Adventure: Legal Strategies & Solutions Health and Wellness Ventures Can Profitably Deploy - Published: 2018-10-29 - Modified: 2025-09-11 - URL: https://cohenhealthcarelaw.com/resources/avoid-these-8-common-legal-mistakes-before-signing-physician-agreements/ Avoid These 8 Common Legal Mistakes Before Signing Physician Agreements Subscribe to our mailing list to receive your copy of Avoid These 8 Common Legal Mistakes Before Signing Physician Agreements More great resources Michael H Cohen's new book is now available on Amazon: Your Healthcare Company’s Excellent Legal Adventure: Legal Strategies & Solutions Health and Wellness Ventures Can Profitably Deploy - Published: 2018-10-29 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/resources/5-mistakes-in-dietary-supplement-labeling/ 5 Mistakes in Dietary Supplement Labeling 5 Mistakes in Dietary Supplement Labeling Subscribe to our mailing list to receive your copy of 5 Mistakes in Dietary Supplement LabelingMore great resourcesMichael H Cohen's new book is now available on Amazon: Your Healthcare Company’s Excellent Legal Adventure: Legal Strategies & Solutions Health and Wellness Ventures Can Profitably Deploy - Published: 2018-10-08 - Modified: 2025-03-10 - URL: https://cohenhealthcarelaw.com/feedback-contact/ We strive for 100% customer satisfaction. If we fell short, please tell us more so we can address your concerns. Your Name (required) Entity Name (required) Phone Email (required) Message var getUrlParameter = function getUrlParameter(sParam) { var sPageURL = decodeURIComponent(window. location. search. substring(1)), sURLVariables = sPageURL. split('&'), sParameterName, i; for (i = 0; i < sURLVariables. length; i++) { sParameterName = sURLVariables. split('='); if (sParameterName === sParam) { return sParameterName === undefined ? true : sParameterName; } } }; var ratingvalue = getUrlParameter('rating'); if (ratingvalue ! = null) { document. getElementById('your-rating'). value = ratingvalue; } - Published: 2018-09-14 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/licensing-agreements-ip-protection/ Licensing Agreements & IP ProtectionThe law of trade secrets is complex. Employers should seek legal counsel on ways to protect trade secrets from subsequent disclosure following employment, while employees should seek legal counsel to understand the breadth of the employer’s trade secret language, and find ways to minimize miscommunication and mitigate potential later legal exposure. First Name Last Name Email Address Phone Number Please tell us how we can help you. Licensing, Legal & Compliance GuidanceProtecting and safeguarding intellectual property is at the heart of the healthcare business’s strategic plan. When we represent a start-up or inventor (for example, of a medical device), our client may wish to assign or license the technology to a third party. Or our client may want to provide access to services through a subscription arrangement. Protecting the Intellectual Property of a Healthcare Business or Practice We advise clients about protecting their intellectual property through:We also draft various agreements, such as: Licensing Agreements Publishing arrangements and book deals, co-author agreements Royalty-Sharing Agreements Other Agreements Involving Sharing of Technology The terms of the agreement often get worked out by the parties in a letter of intent prior to the formal, longer document. IP protection is something that healthcare practices and companies should think about early on in the game, before disputes arise. For example, the question of who owns the patient and customer lists is one that healthcare employers should address in the employment agreement. CONTACT US Feedback from Clients So grateful for Cohen Healthcare Law... - Published: 2018-09-14 - Modified: 2025-08-07 - URL: https://cohenhealthcarelaw.com/business-law-intellectual-property/mergers-acquisitions/ M&A (Acquisitions & Sales of Healthcare Businesses) - Published: 2018-09-14 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/services/management-service-organizations/ Management Services Organizations (MSOs)The key concept behind the MSO model is that the physician, chiropractor, acupuncturist, nutritionist or dietitian, physical therapist, psychologist, or other clinical healthcare provider is busily engaged with the clinical side of practice, while the MSO First Name Last Name Email Address Phone Number Please tell us how we can help you. Management Legal & Compliance GuidanceMany healthcare startups use MSOs to separate administrative and marketing functions from clinical duties, thus proactively clarifying that the business arm itself is not involved in the practice of “medicine. ” The Management Services Organization Model The Management Services Organization (MSO) model is one that many healthcare businesses use in order to help mitigate the risk of enforcement for corporate practice of medicine (CPM) and fee-splitting (kickbacks). The key concept behind the MSO model is that the physician, chiropractor, acupuncturist, nutritionist or dietitian, physical therapist, psychologist, or other clinical healthcare provider is busily engaged with the clinical side of practice, while the MSO Our healthcare lawyers understand the strengths, and limitations, of the MSO model. The MSO model can be deployed in many ways for the healthcare practice or healthcare venture that seeks to make a profit from the actual business side of health and wellness. For example: A licensed medical doctor has a successful plastic surgery, dermatology, and aesthetic and cosmetic medicine practice and wishes to duplicate this model, using his or her brand name, across cities. For instance: Beverly Hills, Palo Alto, Sacramento and San Diego. The MD would... - Published: 2018-09-14 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/services/allied-health-providers/ Legal Services for Allied Health Professionals (Dentists, Nurses, Psychologists) Learning to navigate the complicated landscape of healthcare law can be challenging for allied health professionals, including dentists, nurses, psychologists, physical therapists, speech-language pathologists, occupational therapists, nutritionists, and other allied health providers. The varying definitions of scope of practice, particularly for those looking to provide telehealth services or expand their practice across state lines, can create significant legal risks and compliance challenges. Generally, allied health professionals rely on a thorough understanding of health administration, patient care regulations, and state-specific licensing requirements to deliver quality health care services safely and legally. First Name Last Name Email Address Phone Number Please tell us how we can help you. Definition of Allied Health Professionals Allied health professionals are a diverse group of healthcare providers who are not physicians or nurses but who play a critical role in supporting health care systems, delivering patient care, and promoting disease prevention and optimum health. Allied health encompasses a wide range of professions, including physical therapists, occupational therapists, speech-language pathologists, respiratory therapists, diagnostic medical sonographers, nuclear medicine technologists, dental hygienists, medical assistants, dietitians, clinical laboratory scientists, and many other health professionals. These allied health professions are essential to diagnosing and treating acute and chronic diseases, developing treatment plans, providing rehabilitation services, and supporting patient education in health promotion and disease prevention. Allied health careers vary widely, with some requiring associate degrees or specialized training programs and others involving advanced education in medical technology, health administration, or human services.... - Published: 2017-08-03 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/services/cannabis-law-services/ Cannabis LawyersIn California, the medical board states that the use of telehealth for medical marijuana cannabis patients is permitted, so long as the telehealth practice is in compliance with Business & Professions Code, Section 2290. 5 and used in a manner consistent with the standard of care. First Name Last Name Email Address Phone Number Please tell us how we can help you. Cannabis Legal & Compliance GuidanceThe Cannabis Industry is expected to be worth $50 billion by 2026. California’s medical marijuana laws can be confusing and is important to have an experienced cannabis lawyer that understands the cannabis industry and relevant law. Our medical marijuana lawyers represent a wide variety of individuals seeking advice and representation in the area of medicinal marijuana. Clients and stakeholders include: Cannabis cooperatives Cannabis cultivators Cannabis distributors Cannabis manufacturers Cannabis retailers Investors in cannabis ventures Medical Marijuana dispensaries Physicians who recommend medical marijuana or cannabis Testing labs Throughout, we provide both regulatory and corporate and transactional legal advice to clients in this ever-evolving industry. Practice Areas Involving Medical Marijuana & Cannabis Law Our practice areas include: Counseling on corporate formation of companies offering cannabis products Corporation formation of MSOs pioneering cannabis clinics in ventures that will involve clinicians Drafting M&A documents for acquisition and sale of cannabis ventures Licensing of intellectual property (IP) involving cannabis Other contract drafting, review, and negotiation in the MMJ industry Real estate issues, including land use and zoning, and permits Complying with the complex laws and regulations governing the... - Published: 2017-05-31 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/retainer-payment-thank-you/ Thank you for your Payment We’ll be in touch soon, usually within 24 hours. We’re glad to be your partner on this journey, and we look forward to a long and healthy relationship with you. To make the most of our next steps, please read, Preparing for our Next-Level Work. Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. We provide legal strategies and solutions to businesses that accelerate health & healing - Published: 2017-04-22 - Modified: 2025-03-10 - URL: https://cohenhealthcarelaw.com/facebook-disclaimer/ Facebook Disclaimer This site is not a part of the Facebook website or Facebook, Inc. Additionally, this site is NOT endorsed by Facebook in any way. FACEBOOK is a trademark of FACEBOOK, INC. Contact Us ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("dc3ee907-2eb7-46f0-bcd1-9a0d923b9b65", "lm-embedded-script", {}); - Published: 2017-04-20 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/earnings-disclaimer/ Disclaimer: No Earnings Projections, Promises Or RepresentationsYou recognize and agree that we have made no implications, warranties, promises, suggestions, projections, representations or guarantees whatsoever to you about future prospects or earnings, or that you will earn any money, with respect to your purchase of Cohen Healthcare Law Group products and/or services, and that we have not authorized any such projection, promise, or representation by others. Any earnings or income statements, or any earnings or income examples, are only estimates of what we think you could earn. There is no assurance you will do as well as stated in any examples. If you rely upon any figures provided, you must accept the entire risk of not doing as well as the information provided. This applies whether the earnings or income examples are monetary in nature or pertain to advertising credits which may be earned (whether such credits are convertible to cash or not). There is no assurance that any prior successes or past results as to earnings or income (whether monetary or advertising credits, whether convertible to cash or not) will apply, nor can any prior successes be used, as an indication of your future success or results from any of the information, content, or strategies. Any and all claims or representations as to income or earnings (whether monetary or advertising credits, whether convertible to cash or not) are not to be considered as “average earnings”. (i) The Economy. The economy, both where you do business, and on a national and... - Published: 2017-04-04 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/resources/internet-things-iot-rocks-healthcare-lawyers-guide/ THE INTERNET OF THINGS (IOT) ROCKS HEALTHCARE: A LAWYER’S GUIDEFREE Webinar to Learn how IOT industry trends are shaped by legal issuesHow will the law handle the Internet of Things or IOT? What you should be aware of in terms of compliance, as well as big legal trends? Check out this webinar on the legal system’s response to IOT. You may be involved in: Digital health Mobile medical apps Telemedicine platforms Healthcare Software AI for patient care Virtual reality and wearable health tech Or in other healthcare services and wellness products. You may already be familiar with issues involving: HIPAA and healthcare privacy and security FDA medical device regulation FDA’s newer, hands-off approach to wellness products FTC’s rules governing online and mobile advertising Learn how IOT industry trends are shaped by legal issues, and where government can and can’t regulate the advent of IOT. 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 - Published: 2017-04-04 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/resources/medical-spa-legal-issues-primer-health-beauty-industry-entrepreneurs/ MEDICAL SPA LEGAL ISSUES: A PRIMER FOR HEALTH AND BEAUTY INDUSTRY ENTREPRENEURSFREE Audio Book to offer you insight on Medical Spa legal and compliance mattersYou have a medical spa or work as medical director to a medical spa, but you're worried about compliance. This downloadable resource offers key insights into the legal, compliance pitfalls that medical spas fall into, and ways that medical spas and medical spas physicians move forward. We’ll talk about the MSO structure, and how MSOs can help resolve corporate practice of medicine and fee-splitting issues. We’ll tell you why you should run if someone asks you to be Medical Director of a medi-spa. We’ll talk about physician supervision of mid-levels (nurses, nurse practitioners, physician assistants) and medical assistants and how physicians can stay compliant. If you’re involved in any way in a medical spa business or aesthetic medicine practice, this resource is for you! 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 - Published: 2017-02-24 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/strategy-session-thank-you/ Thank you for your PaymentWe’ll be in touch soon, usually within 24 hours. We’re glad to be your partner on this journey, and we look forward to a long and healthy relationship with you. To make the most of your Legal Strategy Session, please follow these simple steps:1. Read, Preparing for the Legal Strategy Session2. Book your session by visiting our online appointment page or call our office to schedule time. 3. Download your W9 and send to your accountant for year-end record-keeping. Welcome to our law firm family! Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. We provide legal strategies and solutions to businesses that accelerate health & wellnessJTNDJTIxLS0lMjBGYWNlYm9vayUyMFBpeGVsJTIwQ29kZSUyMC0tJTNFJTBBJTNDc2NyaXB0JTNFJTBBJTIxZnVuY3Rpb24lMjhmJTJDYiUyQ2UlMkN2JTJDbiUyQ3QlMkNzJTI5JTdCaWYlMjhmLmZicSUyOXJldHVybiUzQm4lM0RmLmZicSUzRGZ1bmN0aW9uJTI4JTI5JTdCbi5jYWxsTWV0aG9kJTNGJTBBbi5jYWxsTWV0aG9kLmFwcGx5JTI4biUyQ2FyZ3VtZW50cyUyOSUzQW4ucXVldWUucHVzaCUyOGFyZ3VtZW50cyUyOSU3RCUzQmlmJTI4JTIxZi5fZmJxJTI5Zi5fZmJxJTNEbiUzQiUwQW4ucHVzaCUzRG4lM0JuLmxvYWRlZCUzRCUyMTAlM0JuLnZlcnNpb24lM0QlMjcyLjAlMjclM0JuLnF1ZXVlJTNEJTVCJTVEJTNCdCUzRGIuY3JlYXRlRWxlbWVudCUyOGUlMjklM0J0LmFzeW5jJTNEJTIxMCUzQiUwQXQuc3JjJTNEdiUzQnMlM0RiLmdldEVsZW1lbnRzQnlUYWdOYW1lJTI4ZSUyOSU1QjAlNUQlM0JzLnBhcmVudE5vZGUuaW5zZXJ0QmVmb3JlJTI4dCUyQ3MlMjklN0QlMjh3aW5kb3clMkMlMEFkb2N1bWVudCUyQyUyN3NjcmlwdCUyNyUyQyUyN2h0dHBzJTNBJTJGJTJGY29ubmVjdC5mYWNlYm9vay5uZXQlMkZlbl9VUyUyRmZiZXZlbnRzLmpzJTI3JTI5JTNCJTBBZmJxJTI4JTI3aW5pdCUyNyUyQyUyMCUyNzE4ODMzMjMyNjUyMTgzMDElMjclMjklM0IlMjAlMkYlMkYlMjBJbnNlcnQlMjB5b3VyJTIwcGl4ZWwlMjBJRCUyMGhlcmUuJTBBZmJxJTI4JTI3dHJhY2slMjclMkMlMjAlMjdQdXJjaGFzZSUyNyUyOSUzQiUwQSUzQyUyRnNjcmlwdCUzRSUwQSUzQ25vc2NyaXB0JTNFJTNDaW1nJTIwaGVpZ2h0JTNEJTIyMSUyMiUyMHdpZHRoJTNEJTIyMSUyMiUyMHN0eWxlJTNEJTIyZGlzcGxheSUzQW5vbmUlMjIlMEFzcmMlM0QlMjJodHRwcyUzQSUyRiUyRnd3dy5mYWNlYm9vay5jb20lMkZ0ciUzRmlkJTNEMTg4MzMyMzI2NTIxODMwMSUyNmV2JTNEUGFnZVZpZXclMjZub3NjcmlwdCUzRDElMjIlMEElMkYlM0UlM0MlMkZub3NjcmlwdCUzRSUwQSUzQyUyMS0tJTIwRE8lMjBOT1QlMjBNT0RJRlklMjAtLSUzRSUwQSUzQyUyMS0tJTIwRW5kJTIwRmFjZWJvb2slMjBQaXhlbCUyMENvZGUlMjAtLSUzRQ== - Published: 2017-02-21 - Modified: 2025-07-31 - URL: https://cohenhealthcarelaw.com/firm-experience/ Firm Experience Represented manufacturers and distributors of potential medical foods on FDA regulatory requirements for market entry as a medical food. Drafted response to FDA warning letter received by pet nutritional company. ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("156fef20-6999-4765-9769-d9cb5d8efb3e", "lm-embedded-script", {}); Life Sciences (FDA Law) Dietary Supplements (Nutraceuticals) Claims & Labeling Provided FDA & FTC claims review for companies distributing dietary supplements from Omegas to pet supplements to traditional oriental medicine herbal products. Navigated an overseas manufacturer of supplements on FDA rules governing foreign research and substantiation issues. Gave FDA claims review to dietary supplement company targeted to athletes and patients with muscular and neurological issues. Counseled a pharmacy on legal issues surrounding development of a dietary supplement line. Medical Device Companies Advised an overseas manufacturer of a pain patch as to applicability of FDA medical device rules. Counseled mobile medical app developers on how to structure healthcare apps as lifestyle-oriented, consumer products rather than as regulated mobile medical apps. Advised healthcare fitness and medical app, software, and virtual reality developers as to their FDA obligations under FDA’s mobile medical app guidance. Co-counseled a dispute among medical device executives regarding rights and obligations with respect to their medical device startup. Guided health informatics company on FDA legal issues related to predictive analytics software intended for clinical decision-making. Advised manufacturer on FDA and FTC regulatory issues relating to “brain scan” device.... - Published: 2017-02-08 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/resources/ ResourcesAvoid These 8 Common Legal Mistakes Before Signing Physician AgreementsMEDICAL SPA LEGAL ISSUES: A PRIMER FOR HEALTH AND BEAUTY INDUSTRY ENTREPRENEURSTHE INTERNET OF THINGS (IOT) ROCKS HEALTHCARE: A LAWYER’S GUIDE Contact us today to learn how the Cohen Healthcare Law Group can help with your legal needs. Our team is here to provide experienced guidance and practical solutions. 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 - Published: 2016-08-08 - Modified: 2026-01-28 - URL: https://cohenhealthcarelaw.com/blog/ Healthcare & FDA Law BlogJTVCYmxvZ19wb3N0cyU1RA== Get Expert Legal Advice Contact Us Today! - Published: 2016-08-08 - Modified: 2025-11-03 - URL: https://cohenhealthcarelaw.com/services/ Legal ServicesOur healthcare compliance lawyers track the changing healthcare legal and regulatory environment as well as the technological developments that drive and accelerate healthcare business. We have an eye for risk management and for mitigating exposure to the alphabet soup of regulatory agencies, both federal and state, as well as plaintiff law firms, that can snare a growing health and wellness business. ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("156fef20-6999-4765-9769-d9cb5d8efb3e", "lm-embedded-script", {}); Your Legal Partner in a Rapidly Evolving Healthcare Landscape Whether you’re launching, scaling, or evolving, we provide the legal clarity and confidence healthcare entrepreneurs need to move forward. Healthcare Law Life Sciences (FDA & FTC) Law Who We Serve Allied Health Providers (Dentists, Nurses, Psychologists) Our healthcare legal team is attuned to the specialized legal and regulatory needs of allied healthcare providers. Allied healthcare providers often have special legal needs because of their... Read More Anti-Aging & Functional Medicine Practices As with other emerging sectors of the multi-trillion dollar, health and wellness industry, the law governing anti-aging, longevity, and functional medicine practices continues to evolve as the... Read More Behavioral & Mental Healthcare Providers and Life Coaches Behavioral and mental health care professionals have unique legal and regulatory needs, as they come under different Boards and regulatory structures than physicians. Our legal... Read More Biotechnology & Life Sciences Companies Our biotechnology and life sciences lawyers understand FDA, FTC, and... - Published: 2016-08-08 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/about/ About Us We have always understood medicine, in the broadest sense, to encompass all global healing traditions–whether ancient or modern, tribal or technological, herbal or pharmaceutical—and whether based on the biochemistry of the body of the anatomy of the spirit. First Name Last Name Email Address Phone Number Please tell us how we can help you. Our Firm was founded to represent practices and ventures that accelerate health and wellness. The firm’s founding mission statement reflected our focus on health and wellness as a commitment to the alleviation of suffering, to the regeneration of spirit, and to the endless unfolding of the human heart. Our founder, Michael H. Cohen, was an Assistant Professor in the Department of Medicine at Harvard Medical School, Adjunct Professor at the Harvard School of Public Health, and Director of Legal Programs for the Harvard Medical School Osher Institute, where he developed policies and procedures governing integrative medicine as models for 14 Harvard-affiliated hospitals. Back in private practice, Michael teamed up with attorneys known for their pioneering work and expertise representing healthcare businesses, practices, and facilities with complex regulatory and legal needs. And we continue to add rock stars in the health and wellness legal field. Today, the Firm provides thought leadership in the trillion-dollar health and wellness industry. Our attorneys represent clients from Sydney to London to Dubai to New York; from acupuncture clinics to cord blood cell banks, addiction treatment facilities, sleep centers, medical spas, telemedicine start-ups, mobile medical app developers, makers of healthcare... - Published: 2015-10-21 - Modified: 2026-07-26 - URL: https://cohenhealthcarelaw.com/contact-us/ Contact Us Get Expert Legal Advice Contact Us Today! Call Us 310-844-3173 - Published: 2015-02-13 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/ Healthcare LawOur healthcare compliance lawyers track the changing healthcare legal and regulatory environment as well as the technological developments that drive and accelerate the healthcare business. We have an eye for risk management and for mitigating exposure to the alphabet soup of regulatory agencies, both federal and state, as well as plaintiff law firms, that can snare a growing health and wellness business. First Name Last Name Email Address Phone Number Please tell us how we can help you. Healthcare Legal & Compliance GuidanceSuccessful healthcare companies leverage the advice of legal counsel to maneuver through the thicket of regulatory and compliance challenges and puzzles that healthcare ventures must resolve to dominate market share. Our Healthcare lawyers focus on resolving the thorny regulatory knots that stall or halt less determined healthcare industry players and summon the greatest creativity from healthcare industry innovators and disruptive pioneers. These legal and regulatory compliance challenges include:The healthcare industry is ever-evolving, as even established companies in other markets (such as, for example, consumer goods, online sales, and communications) add on features that track various health metrics (from number of steps walked to ECGs). Increasingly, new business models are restructuring healthcare practices. Concierge, VIP, and membership models reduce physician availability and drive patients into more exclusive, packaged healthcare programs. Corresponding with this surge in healthcare as a VIP service deliverable by practitioners, many companies are delivering healthcare as a product or software. The brick-and-mortar visit to the doctor often now takes place as an online or mobile... - Published: 2015-02-12 - Modified: 2026-08-11 - URL: https://cohenhealthcarelaw.com/ As of July 17, 2026 - Cohen Healthcare Law Group is no longer providing Legal Services. Please use the form below to get in touch with Michael H. Cohen as Affiliate Counsel at Offit Kurman. First Name Last Name Email Address Phone Number Please tell us how we can help you. 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 Healthcare Law Life Sciences (FDA & FTC) Law We've HelpedHealthcare StartupsFDA/FTC ClientsMSOsTelemedicine VenturesMedical SpasOther Businesses & PracticesWhat Our Clients SaySEE MORE TESTIMONIALSWho We ServeFrom emerging startups to established health organizations, we serve a diverse range of healthcare innovators navigating complex legal landscapes. Whether you're a dentist, a digital health entrepreneur, or leading a cutting-edge biotech company, our legal team brings deep regulatory knowledge and industry insight to support your mission. We understand that every healthcare provider operates within unique clinical, corporate, and compliance frameworks—and we tailor our strategies to fit your model, your vision, and your growth. Explore how we support allied health professionals, mental health providers, telemedicine pioneers, supplement brands, cannabis ventures, MSOs, and more—each with their own regulatory roadmaps. When your work is on the frontier of healthcare, you need legal counsel that’s just as forward-thinking. Anti-Aging & Functional Medicine PracticesREAD MOREChiropractorsREAD MOREConcierge & Direct Primary Care Medical PracticesREAD MOREDietary Supplement & Nutraceutical CompaniesREAD MOREManagement Services Organizations (MSO)READ MORETelemedicine VenturesREAD MOREMORE HEALTHCARE AND FDA LAW CLIENT TYPESAnti-Aging & Functional Medicine PracticesREAD MOREChiropractorsREAD MOREConcierge & Direct Primary Care Medical PracticesREAD MOREDietary Supplement & Nutraceutical CompaniesREAD MOREManagement Services Organizations (MSO)READ MORETelemedicine VenturesREAD MOREMORE HEALTHCARE AND FDA LAW CLIENT... - Published: 2015-01-03 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-compliance-regulatory/licensed-healthcare-facilities/ Healthcare Facilities (Hospitals, Labs, DME, Imaging)California has a confusing landscape of regulatory definitions, including: “adult residential facility,” “clinic,” “residential care facily for the elderly” (RCFE), “residential care facility for the chronically ill,” “social rehabilitation facility,” and “transitional housing placement program. ” First Name Last Name Email Address Phone Number Please tell us how we can help you. Counseling Healthcare FacilitiesHealthcare facilities face an array of legal and regulatory challenges in today’s ever-changing healthcare legal environment. Our healthcare and FDA lawyers counsel a variety of licensed and non-licensed healthcare facilities and ventures on regulatory and corporate compliance issues. Our clients include: Addiction treatment centers Ambulatory care facilities Clinical laboratories Clinical research organizations (CROs) Cord blood banks Diagnostics and screening facilities (including IDTFs) Clinical laboratories (CLIA and state law clinical laboratory issues) Home health agencies Hospices Hospitals Information technology companies Long-term care facilities mHealth, telemedicine, and information technology companies Outpatient service providers Psychiatric facilities Rehabilitation facilities Residential treatment facilities Senior services facilities Skilled nursing facilities Sober living facilities Urgent care centers Our transactional practice includes mergers and acquisitions, restructurings, financings, joint ventures, and other arrangements. California has a confusing landscape of regulatory definitions, including: “adult residential facility,” “clinic,” “community care facility,” “crisis nursery,” foster family agency,” “group home,” “health facility,” “residential care facily for the elderly” (RCFE), “residential care facility for the chronically ill,” “social rehabilitation facility,” and “transitional housing placement program. ” We advised several healthcare facilities on data breaches involving theft of electronic and/or paper records. We counseled a provider... - Published: 2015-01-03 - Modified: 2025-08-06 - URL: https://cohenhealthcarelaw.com/press/ Media Mentions Our healthcare compliance lawyers track the changing healthcare legal and regulatory environment as well as the technological developments that drive and accelerate healthcare business. We have an eye for risk management and for mitigating exposure to the alphabet soup of regulatory agencies, both federal and state, as well as plaintiff law firms, that can snare a growing health and wellness business. ! function(e,t,n,a,s,c,i){if(! e){i=e=function{i. process? i. process. apply(i,arguments):i. queue. push(arguments)},i. queue=,i. t=1*new Date;var o=t. createElement(n);o. async=1,o. src=a+"? t="+Math. ceil(new Date/c)*c;var r=t. getElementsByTagName(n);r. parentNode. insertBefore(o,r)}}(window,document,"script","https://navi. lawmatics. com/intake. min. js","lm_intake",864e5),lm_intake("156fef20-6999-4765-9769-d9cb5d8efb3e", "lm-embedded-script", {}); - Published: 2015-01-03 - Modified: 2025-03-16 - URL: https://cohenhealthcarelaw.com/michael-h-cohen-bio-curriculum-vitae/ MICHAEL H. COHEN - CURRICULUM VITAE 2019 CV (click to download) * * * * * * * * * * * * Michael H. Cohen - Publications Books Cohen MH. Creative writing for lawyers. New York: Citadel Press; 1991; 142 pages. Cohen MH. Complementary and alternative medicine: legal boundaries and regulatory perspectives. Baltimore: Johns Hopkins University Press; 1998; 180 pages. Cohen MH. Beyond complementary medicine: legal and ethical perspectives on health care and human evolution. Ann Arbor: University of Michigan Press; 2000; 214 pages. Cohen MH. Future medicine: ethical dilemmas, regulatory challenges, and therapeutic pathways to health and healing in human transformation. Ann Arbor: University of Michigan Press; 2003; 350 pages. Cohen MH. Legal issues in integrative medicine. Washington, D. C. : NAF Publications; 2005; 99 pages. Cohen MH. Healing at the borderland of medicine and religion. Chapel Hill, N. C. : University of North Carolina Press; 2006; 229 pages. Cohen MH, Ruggie M, Micozzi M. Integrative medicine: a legal and operational guide. New York: Springer; 2006; 202 pages. Original Articles in Peer-Reviewed Medical Journals Cohen MH. Malpractice considerations affecting the clinical integration of complementary and alternative medicine. Curr Prac of Med 1999;2:4:87-89. Ernst EE, Cohen MH. Informed consent in complementary and alternative medicine. Arch Intern Med 2001;161:19:2288-2292. Cohen MH, Eisenberg DM. Potential physician malpractice liability associated with complementary/integrative medical therapies. Ann Intern Med; 2002;136:596-603. Eisenberg DM, Cohen MH, Hrbek A, Grayzel J, van Rompay MI, Cooper, RA. Credentialing complementary and alternative medical providers. Ann Intern Med; 2002;137:965-973. Adams... - Published: 2014-09-12 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/nanotechnology-law-nano-medicine-and-nanobot-legal-services/ Emerging Healthcare Technology Lawyers Healthcare is evolving rapidly, and new technologies are reshaping the way treatments are developed, delivered, and regulated. From artificial intelligence (AI) in clinical decision support software to health information technology, mobile medical apps, and digital health platforms, the healthcare and life sciences industries face complex legal, transactional, and regulatory issues. First Name Last Name Email Address Phone Number Please tell us how we can help you. What We Do: Healthcare Law Anti-Kickback Law, Fee-Splitting & Stark Law Business Dispute Resolution Business Formation (S-Corp, Professional Corporation, Partnerships) Concierge Medicine Employment & Consulting Agreements E-commerce & Internet Issues Emerging Healthcare Technologies HIPAA Licensing Agreements & IP Protection Leases & Real Estate Liability & Risk Management M&A (Acquisitions & Sales of Healthcare Businesses) Technology Agreements Life Sciences (FDA & FTC) Law Who We Serve Why Emerging Healthcare Technology Needs Specialized Legal Counsel Healthcare innovation is moving at a rapid pace, from telemedicine and remote patient monitoring to emerging technologies such as bioprinting, nanomedicine, robotic surgery, and artificial intelligence in healthcare. These groundbreaking technologies create growth opportunities but also bring highly complex regulatory, transactional, and compliance challenges. Without the right legal strategy, companies risk exposure to federal and state regulatory issues, data privacy violations, and potential liability under laws such as the False Claims Act, the Stark Law, and the Health Insurance Portability and Accountability Act (HIPAA). At Cohen Healthcare Law Group, our emerging healthcare technology lawyers combine deep knowledge of healthcare regulatory compliance, intellectual property protection, and data security... - Published: 2014-09-12 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/practice-purchases-sales/ M&A (Acquisitions & Sales of Healthcare Businesses)We work on joint venture agreements, leases and subleases, management agreements, offering memoranda, operating agreements, partnership agreements, technology transfer agreements, and other contracts. First Name Last Name Email Address Phone Number Please tell us how we can help you. M&A Legal & Compliance GuidanceBuyers and sellers of healthcare practices and businesses know that the highly regulated healthcare industry requires extra expertise in the M&A space. Our healthcare transactional and M&A attorneys handle purchases and sales of healthcare practices such as:In addition, our M&A lawyers advise on purchases and sales of healthcare businesses such as: Addiction and rehab health facilities Behavioral health practices Cosmetics companies Dietary supplement companies Diagnostic imaging companies Long-term care facilities Health information companies Healthcare software and technology companies Home healthcare Medical groups Medical device manufacturers Medical marijuana (cannabis) companies Mobile medical app makers OTC drug companies Pharmacies Physician practices Feedback from Clients So grateful for Cohen Healthcare Law Group's Strategy Session. Attorney Mark Paxton saved us from a multitude of perils during just our first consult. Therefore, I am happy to say that Cohen Law will spearhead our 510k application. - Erik Hancock We recently engaged with a Drew and his team at Cohen Medical and the experience was exceptional. Their expertise in healthcare law was evident from the start, providing us with clear guidance and comprehensive support. - René Alvarado Cohen Law Group was great team to work with to develop my MSO/MSA for my business. Christian was very helpful... - Published: 2014-09-12 - Modified: 2025-10-26 - URL: https://cohenhealthcarelaw.com/healthcare-corporate-transactional-law/physician-hospital-agreements-and-clinician-employment-agreements/ Physician-Hospital Agreements and Clinician Employment Agreements ServicesIn the health care industry, our legal services include drafting and negotiating agreements for healthcare businesses and professionals. This includes: physician recruitment agreements, physician employment agreements, non-compete agreements, exclusive provider agreements, and other types of contracts in the health care industry. We can also draft agreements involving delegation of services — for example, between an MD and a physician assistant (PA). Healthcare entities and facilities require unique advice in the contract drafting arena as they are often subject to extensive regulation beyond rules applicable to most employers and businesses. Local law can also significantly affect contract drafting. For example, in California, issues of non-competes involved in employment and in the sale of a business frequently generate litigation. Our business and health care law attorneys are skilled in understanding the litigation background behind various contractual clauses and in advising clients accordingly so as to protect their interests in advance. We also have extensive experience with corporate founders, shareholders and operating agreements, buy-ins, compensation arrangements, practice sales and purchases. By drawing on the combined talents and experience of our attorneys, our clients will be aware of nuances of contracts and will comply with the requirements of state and federal fraud and abuse laws and other statutory and regulatory challenges unique to health care professional entities. - Published: 2014-09-12 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/management-services-organizations-mso-agreements/ Management Services Organizations (MSO) IssuesOur healthcare lawyers advise Management Services Organizations (MSOs) on legal issues affecting MSOs and the way they work with medical practices and healthcare practices. First Name Last Name Email Address Phone Number Please tell us how we can help you. Management Legal & Compliance GuidanceWe understand the depth and breadth of the MSO model and how the MSO can be used to help our healthcare clients mitigate risks of corporate practice of medicine, fee-splitting, and anti-kickback liability, and other regulatory hazards. Our legal services include: Advising on the legal structure and on mitigating the risk of Corporate Practice of Medicine and Fee-Splitting Drafting the Agreement between the MSO and the Professional Medical Corporation Forming the MSO (either as a general business corporation or LLC) Giving counsel on advertising and marketing for the MSO and/or the clinical practice Reviewing or drafting the sublease between the MSO and the medical or other clinical practice. Reviewing laws and regulations relevant to the structure of the overall venture and advising on compliance obligations Reviewing and advising on FDA mobile medical app issues, if triggered by an app developed by the MSO. See our longer article on how we provide legal services to MANAGEMENT SERVICES ORGANIZATIONS (MSOs). https://youtu. be/i_RIqQBzOkc? feature=sharedhttps://youtu. be/T7_frW32O6M? feature=sharedhttps://youtu. be/JNpQQeHjhzc? feature=shared Feedback from Clients So grateful for Cohen Healthcare Law Group's Strategy Session. Attorney Mark Paxton saved us from a multitude of perils during just our first consult. Therefore, I am happy to say that Cohen Law will... - Published: 2014-09-12 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/concierge-medicine/ Concierge & Direct Primary Care Medical Practices Legal Guidance for Concierge, Direct Primary Care, and Boutique Medical Models As a concierge or direct-pay physician navigating a complex legal landscape, you must address everything from HIPAA, marketing, and scope of practice issues to membership fees and compliance with federal and state laws. Our healthcare attorneys understand the nuances of this evolving model and can help you build a compliant, sustainable, and profitable practice. SCHEDULE A CONSULTATION First Name Last Name Email Address Phone Number Please tell us how we can help you. What Is Concierge Medicine? Concierge medicine, also known as boutique medicine, retainer medicine, or direct primary care (DPC), is a membership-based healthcare model in which patients pay an annual fee, monthly retainer, or access fee for enhanced patient care. Unlike traditional fee-for-service systems that rely heavily on third-party payers or insurance reimbursement, concierge medical practices limit the number of patients they serve and focus on providing same-day appointments, extended consultations, physical exams, and direct access to the concierge doctor. This concierge model can take different business structures, including hybrid models where physicians may still accept insurance or Medicare for covered services, while offering premium concierge services through a retainer fee. Many physicians are turning to concierge and direct primary care models to enhance the quality of care, reduce administrative burdens, and build a more sustainable medical practice. For primary care physicians, the shift to concierge medicine is driven by a desire to escape insurance-driven constraints and focus more deeply... - Published: 2014-09-12 - Modified: 2026-04-07 - URL: https://cohenhealthcarelaw.com/healthcare-compliance-regulatory/unlicensed-provider-sb-577/ Unlicensed Provider (SB 577)We represent non-licensed practitioners of the healing arts, including individuals practicing: Aromatherapy Ayurvedic Medicine Energy Healing Homeopathy Naturopathy (in some states) Nutrition and Nutritional Counseling Reiki Spiritual Counseling We also counsel clients on related practices, such as those involving: Functional Medicine HCG for Weight Loss Live Blood Cell Analysis Emerging Therapies Some states provide leeway for non-licensed practitioners under a state "medical freedom" act. For example, California has "SB 577," which has now been incorporated into the Business & Professions Code. Other states have stricter laws, leaving non-licensed practitioners vulnerable to investigation and discipline by professional regulatory boards, including: Board of Nutrition & Dietetics Board of Medicine Board of Psychology We advise clients both pro-actively, to help structure their practices, and represent clients under investigation by Boards. Helpful Links Arizona proposes licensing law for practitioners of homeopathy and nutrition Federal court case involving unlicensed health care practice Health care freedom debate continues with prosecution for colonic irrigation Health Care Provider Licensing Laws Spell Out Who Can Practice Hypnotherapy laws in California Licensure of Complementary and Alternative Medicine Practitioners New York's Strong Corporate Practice of Medicine Requires a Professional Corporation for Professional Services Psychologists, Counselors, and Mind-Body Professionals Scope of practice issues continue raise turf battles among health care professions Unlicensed health care provider statute interpreted in RI Unlicensed practice of medicine - advice on nutrition and diet 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 - Published: 2014-09-12 - Modified: 2026-08-05 - URL: https://cohenhealthcarelaw.com/healthcare-law/telemedicine-and-e-health/ Telemedicine VenturesEvery state has its own laws concerning telehealth practices. The general rule is that telehealth is governed both by the law of the state in which the physician is located (the “home state”) and the law of the state in which the patient is located (the “remote state”). First Name Last Name Email Address Phone Number Please tell us how we can help you. Telemedicine Legal & Compliance GuidanceTelemedicine or telehealth laws are providing a growing infrastructure of rules that healthcare practices and businesses can turn to when building out a model of healthcare beyond the brick-and-mortar practice. Telemedicine Law & Legal Issues We counsel a myriad of telemedicine, e-health, mobile health, and digital health clients on legal and regulatory issues in telehealth – be it telemedicine, tele-psychiatry, tele-dermatology, or other areas of mobile or online healthcare. The kinds of legal and regulatory issues we tackle include: Advice to telemedicine companies on legal safe harbors such as the provision of information and education only. Drafting Agreements between telehealth companies and hospitals, healthcare facilities, medical groups, and medical doctors or other healthcare practitioners. Compliance with fraud and abuse laws such as those prohibiting self-referral (Stark), kickbacks, and fee-splitting Licensing issues, including state-by-state telemedicine requirements (whether for diagnosis, treatment, or prescription) National telehealth professional standards and governmental regulations HIPAA, privacy, and security issues FDA mobile medical app and medical device guidance FTC issues for mobile apps and online health programs Telehealth compliance with federal and state laws related to telemedicine Transactional... ## Posts - Published: 2026-04-03 - Modified: 2026-04-03 - URL: https://cohenhealthcarelaw.com/sb-351-and-ab-1415-californias-new-framework-for-healthcare-transactions-and-corporate-practice-oversight/ California’s new healthcare framework, established by SB 351 and AB 1415, codifies strict clinical independence protections while requiring private equity groups and MSOs to provide the state with 90 days' advance notice for material transactions. Disclaimer: This content is provided for general informational purposes only and does not constitute legal advice. Laws and regulations governing healthcare marketing, patient reviews, and professional conduct vary by jurisdiction and may change over time. You should consult a qualified healthcare attorney regarding your specific circumstances before taking action. Effective January 1, 2026, California implemented two significant healthcare laws—Senate Bill 351 (SB 351) and Assembly Bill 1415 (AB 1415)—that materially affect healthcare practices, management services organizations (MSOs), private equity groups, hedge funds, and other investor structure ownership, management, and transactions in the state of California. Together, these laws codify California’s long‑standing corporate practice of medicine (CPOM) doctrine and significantly expand state oversight and enforcement authority of healthcare transactions through the Office of Health Care Affordability (OHCA) and the California Attorney General. SB 351: Codifying and Enforcing Corporate Practice Restrictions Purpose and Scope SB 351 codifies existing guidance and case law regarding California’s CPOM and corporate practice of dentistry (CPOD) doctrines, expressly targeting private equity groups, hedge funds, investors and the entities they control (MSO) from interfering with physician and dentist clinical judgement. Key Prohibitions Under SB 351, covered investors and entities may not interfere with, control, or direct a physician’s or dentist’s professional clinical judgment. The statute specifically prohibits influence over: Clinical decision‑making, including diagnoses, referrals, and treatment decisions Patient volume, scheduling, or hours worked Hiring, firing, or supervision of clinical personnel based on clinical competence Ownership or control of medical records Billing, coding, reimbursement strategies, or payer contracting Selection of medical equipment, supplies, or pharmaceuticals These... - Published: 2026-01-14 - Modified: 2026-01-18 - URL: https://cohenhealthcarelaw.com/guidelines-for-soliciting-reviews-from-patients/ The Federal Trade Commission guidelines for when and how physicians can and can’t seek solicitations from their patients, employees, and business contact. Disclaimer: This content is provided for general informational purposes only and does not constitute legal advice. Laws and regulations governing healthcare marketing, patient reviews, and professional conduct vary by jurisdiction and may change over time. You should consult a qualified healthcare attorney regarding your specific circumstances before taking action. Doctors review solicitation is a common search for healthcare providers who want to understand how they can legally encourage patient reviews without crossing ethical or legal lines. In our experience, physicians and medical practices often know reviews matter for prospective patients and local search results, but they’re unsure what federal and state laws actually allow when soliciting reviews or asking patients to leave feedback. At Cohen Healthcare Law Group, we’ve spent over 25 years advising healthcare providers on compliance, online reputation management, and high-risk marketing practices. We work closely with doctors, clinics, and other healthcare practices to make sure review requests, patient feedback systems, and responses to online reviews are done carefully, ethically, and in a way that protects your practice and your license. Reach out to us today! In this blog, we’ll break down how doctors can request patient reviews, what the Consumer Review Fairness Act means for medical practices, and why review gating, patient incentives, and incentivizing reviews can create legal risk. We’ll also cover best practices for responding to negative reviews, encouraging satisfied patients to write reviews across multiple channels, and using reviews as a compliant marketing tool that supports patient trust and informed healthcare choices. What is... - Published: 2025-12-22 - Modified: 2026-01-14 - URL: https://cohenhealthcarelaw.com/medicare-whistleblower-reward/ The medicare whistleblower reward allows eligible individuals to receive financial compensation for reporting Medicare fraud under the federal False Claims Act. To qualify, a whistleblower must provide original, non-public information about false claims or healthcare fraud, properly report it through a qui tam lawsuit, and meet specific eligibility criteria before any reward is paid. If you are an allied health professional considering reporting fraud, working with experienced legal counsel is best to protect your rights and maximize your potential recovery. At Cohen Healthcare Law Group, we bring over 25 years of experience representing healthcare whistleblowers and navigating complex federal investigations. Contact us today! In this post, we will explain how the Medicare whistleblower reward process works, who is eligible to participate, and how to report Medicare fraud correctly. We will also cover how rewards are calculated, what happens during a government investigation, and why legal guidance can make a significant difference in the outcome of a whistleblower case. What is a Medicare Whistleblower Reward? A Medicare whistleblower reward is a financial incentive paid to individuals who report Medicare fraud that leads to a successful government recovery under the federal False Claims Act. Its purpose is to encourage insiders within the healthcare industry to come forward with information about false claims, submitting false claims, Medicare overpayments, and other forms of healthcare fraud that drain taxpayer dollars and misuse Medicare funds. This reward program plays an important role in protecting government healthcare programs by uncovering fraud that would otherwise remain hidden from... - Published: 2025-12-15 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/false-claim-act-in-healthcare/ The False Claims Act in healthcare is one of the most powerful federal statutes used to combat fraud, waste, and abuse involving federal healthcare programs, such as Medicare and Medicaid. Originally enacted during the American Civil War, the False Claims Act (FCA) allows the government to pursue anyone who knowingly submits a false or fraudulent claim for federal funds. The method could be through fraudulent billing schemes, medically unnecessary services, or false statements that lead to a fraudulent claim paid by the government. With over 25 years of experience, Cohen Healthcare Law Group helps healthcare providers, practices, and companies navigate the complex landscape of healthcare fraud, whistleblower protections, qui tam provisions, FCA investigations, and regulatory compliance. If you need legal support in avoiding civil monetary penalties, addressing reverse false claims, or responding to government inquiries, our team of healthcare lawyers offers seasoned guidance backed by decades of industry-focused expertise. Contact us now! This post will cover what qualifies as a false claim and how healthcare organizations can prevent submitting false claims. It will also break down key enforcement mechanisms used by the federal government, ensuring you understand both the risks and the best practices for compliance. What is the False Claim Act in Healthcare? The False Claims Act in healthcare is a powerful federal statute that allows the federal government to hold individuals and entities accountable when they knowingly submit, cause to be submitted, or participate in submitting false or fraudulent claims for payment from federal healthcare programs, including Medicare... - Published: 2025-12-09 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/stark-law-examples/ Stark law examples often involve situations where physicians make prohibited physician referrals for designated health services (DHS) to an entity with which they or an immediate family member have a financial relationship. These violations happen under the physician self-referral law, which means that even if a doctor didn't mean to break the law, they can still face serious penalties like fines, having to pay back money, and possible legal issues for billing Medicare and Medicaid for the services they referred. Healthcare providers need to know that self-referrals, wrong payment deals, and illegal financial incentives can lead to Stark Law violations in federal health care programs. For help navigating healthcare law and avoiding costly Stark Law risks, Cohen Healthcare Law Group brings over 25 years of experience in guiding physicians, healthcare entities, and group practices through complex regulatory requirements, financial arrangements, and fraud-and-abuse rules. If you need legal advice, policy review, or strategic guidance, reach out to our experienced healthcare attorneys today! In this post, you’ll learn what the Stark Law is and review real-world Stark Law violation examples. You’ll also learn how healthcare organizations can remain compliant with the Stark Law. What Is Stark Law? The Stark Law, also known as the physician self-referral law, is a federal law that prohibits physicians from referring Medicare or Medicaid patients to healthcare entities that provide designated health services (DHS) if the physician or an immediate family member has a financial relationship with that entity. At its core, the law was created to... - Published: 2025-12-04 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/california-ab-1501/ California AB 1501 is a new law that directly affects how Physician Assistants (PAs) practice, tightening supervision rules, reshaping scope-of-practice requirements, and increasing compliance expectations for healthcare organizations. It matters because it changes how clinics, medical groups, MSOs, and businesses structure their operational and contractual relationships with PAs. It creates both new obligations and potential legal risks if not handled correctly. For over 25 years, Cohen Healthcare Law Group has helped healthcare providers and organizations navigate complex regulatory changes like AB 1501. If you want clarity, risk reduction, or support in restructuring agreements, our healthcare attorneys can help you. Contact us now! In this post, you’ll learn what AB 1501 is, how it impacts Physician Assistants, what it means for healthcare organizations and MSOs, and the steps businesses should take now to stay compliant. What Is California AB 1501? California AB 1501 is an assembly bill that updates and clarifies various statutory provisions governing physician assistants, physicians and surgeons, and Doctors of Podiatric Medicine. The bill provides a definition and background for multiple regulatory updates, including how the Medical Practice Act, Physician Assistant Practice Act, and Professions Code reference licensing, fees, and cross-agency procedures. In terms of legislative history, AB 1501 was introduced to correct outdated cross-references, streamline administrative processes within the Medical Board of California, Podiatric Medical Board, and Physician Assistant Board, and support future policy discussions involving allied health professionals, physician associates, and PA practice. Lawmakers proposed it to modernize statutory language, reduce confusion, and ensure that procedures... - Published: 2025-12-03 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/sb-1451-california/ SB 1451 is now in effect (as of January 1, 2025) and brings major updates for nurse practitioners and other health-care professionals. It broadens how clinical experience counts for 103 and 104 NPs, allows cumulative (even non-consecutive) hours over the past five years to qualify for their “transition-to-practice,” and clarifies disclosure and title-use rules (for example, restricting use of “MD,” “DO,” “Dr. ,” or “physician/doctor” by non-physicians). If you want expert guidance navigating SB 1451 and leveraging its provisions for independent practice, Cohen Healthcare Law Group is here for you. With over 25 years of experience representing nurses and healthcare providers, we can help you understand your rights, properly fulfill disclosure requirements, and ensure compliance under the new law. Contact us now! This post will cover what SB 1451 does, who it impacts, and how it changes clinical-experience requirements and licensing regulations. It will also touch on disclosure and title-use rules, as well as what this means for independent practice in 2026 under the bill. What Does SB 1451 in California Cover? SB 1451 in California is a major update to the business and professions code, specifically modifying AB 890 to make it easier for nurse practitioners to obtain NP 103 and NP 104 certifications while ensuring that existing law continues to protect patients. The bill, effective January 1, 2025, clarifies the statutory provisions that establish procedures for how a nurse practitioner shall complete their transition to practice, how they may practice independently, and what disclosures they must provide when... - Published: 2025-12-03 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/ab-1415/ AB 1415 is a new California law that starts on January 1, 2026, which increases supervision of transactions involving private equity, hedge funds, and Management Services Organizations (MSOs). It requires these groups to inform the Office of Health Care Affordability (OHCA) at least 90 days before finalizing certain deals or changes in control. This change means that MSOs and investors must now comply with new reporting and regulatory obligations, potentially slowing or complicating deals. If you’re navigating MSO agreements, acquisitions, or restructurings under MSO-driven models, it's vital to get legal guidance. At Cohen Healthcare Law Group, we have over 25 years of experience in offering expert support to ensure your transactions comply with AB 1415 and avoid regulatory pitfalls. Contact us today! This post will explain what AB 1415 is, why it matters, how it impacts MSOs and private-equity transactions in California, and what steps organizations should take now to stay compliant under the new rules. What Does AB 1415 Cover? AB 1415 updates California’s Health Care Quality and Affordability Act (HCQAA) by expanding oversight of agreements or transactions in the health care market. It adds new reporting duties for management service organizations (MSOs), private equity groups, hedge funds, and any newly created business entity involved in providing or furnishing health care services. These entities are now classified as noticing entities, which means they are required to send written notice to the Office of Health Care Affordability (OHCA) before finalizing certain deals. The law covers transactions that could affect health... - Published: 2025-12-02 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/ab-890/ California’s AB 890 is a landmark law that allows qualified nurse practitioners to practice with greater independence, especially those under NP 103 and NP 104 pathways. It removes the long-standing requirement for physician supervision once specific criteria are met, giving NPs expanded authority to serve patients more efficiently. This shift makes AB 890 essential for NPs navigating autonomy, compliance, and new professional responsibilities. If you need clarity on how AB 890 affects your scope, documentation, or transition to independent practice, Cohen Healthcare Law Group offers trusted legal guidance backed by over 25 years of healthcare regulatory experience. Our team helps nurses understand compliance obligations and avoid legal pitfalls. Reach out to us today! This post will break down AB 890 in simple terms, explain how NP 103 and NP 104 differ, and outline what NPs must do to stay compliant under the new framework. What Is California AB 890 and Why Does It Matter? California AB 890, signed into law by Governor Gavin Newsom in 2020, introduced a major shift in how nurse practitioners can provide health care services within the state’s healthcare system. The Assembly Bill did not expand the NP scope of practice. Instead, it set up two new types of nurse practitioners, NP 103 and NP 104, which let qualified NPs work on their own without needing a doctor to supervise them, as long as they complete certain training, clinical hours, and national certification requirements. Under this law, the Board of Registered Nursing works with national certifying... - Published: 2025-12-01 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/accused-of-intentionally-committing-fraud-for-personal-gain/ If you’ve been accused of intentionally committing fraud for personal gains, the first thing you should do is stop communicating with investigators and immediately consult an experienced attorney who understands both criminal fraud and healthcare regulatory risk. Typically, fraud allegations can escalate quickly into criminal charges, civil fraud exposure, or investigations under federal law. Therefore, early intervention is important to protect your rights, your financial records, your professional licenses, and your future. For over 25 years, Cohen Healthcare Law Group has defended clients facing alleged fraud, false claims, and anti-kickback investigations, helping them navigate complex financial data reviews, regulatory audits, and criminal fraud case exposure. If you’re dealing with accusations involving fraudulent intent, improper financial transactions, or potential violations of federal law such as the Anti-Kickback Statute, we can help you. Reach out to us today. In this post, you’ll learn what steps to take after facing fraud charges, the legal consequences of criminal fraud or civil fraud, how prosecutors try to prove guilt, and what types of fraud may apply. You’ll also understand what evidence fraud investigators look for and how an experienced attorney can guide you through the legal process to pursue a favorable outcome. What Is Healthcare Fraud? Healthcare fraud occurs when an individual or organization intentionally uses false statements, deceptive practices, or fraudulent activity to obtain money, services, or benefits they are not entitled to—typically for personal gain. In most cases, prosecutors look for clear evidence of intentional deception, meaning the act wasn’t a mistake but... - Published: 2025-11-26 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/california-medical-corporation-name-requirements/ California Medical Corporation Name Requirements include strict regulations, restrictions, and guidelines that determine how a medical corporation, professional medical corporation, or California professional medical corporation may legally identify itself. These rules define what a corporate name can include, which words are prohibited, and how the medical board interprets misleading business names for licensed professionals. Understanding these requirements ensures your medical corporation meets California state law and avoids compliance issues from the start. Our legal experts at Cohen Healthcare Law Group bring over 25 years of experience helping medical practitioners and licensed physicians navigate corporate structure and compliance. Whether you’re forming a professional corporation, choosing a fictitious business name, or interpreting California Corporations Code rules, we make the process clear and practical. Contact us today to get started. This article will comprehensively explain all the rules, restrictions, steps, and best practices you should be aware of when naming your California medical corporation. Why California Regulates Medical Corporation Names California regulates medical corporation names to prevent the public from being misled about who owns, controls, or provides professional services within a medical business. Medical professionals are authorized to practice medicine under a medical license. Additionally, corporations are legally recognized as distinct business entities, which leads California law to mandate truthfulness and precision in all corporate names. The medical board reviews names carefully to ensure they do not imply unauthorized practice, unearned specialties, or services beyond what California state law allows. For example, the name of a professional medical corporation cannot imply that... - Published: 2025-11-24 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/legal-strategies-for-complementary-medicine-providers-compliance-for-alternative-therapies/ Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses essential legal strategies for complementary and alternative medicine providers like acupuncturists, chiropractors, healers, and hypnotherapists. Complementary and alternative medicine (CAM) includes a range of practices and therapies used alongside or instead of conventional medical treatments, such as acupuncture, herbal remedies, and chiropractic care. Providers must understand the regulatory landscape to ensure their practices meet federal and state healthcare compliance requirements. Key compliance areas include patient consent, accurate billing, proper documentation, advertising standards, and adherence to scope-of-practice laws. For guidance tailored to your practice, Cohen Healthcare Law Group is here for you. We have over 25 years of experience in helping healthcare providers navigate complex compliance issues relating to complementary medicine. Schedule a consultation with us today! This post covers practical steps CAM providers can take to maintain compliance, minimize liability, and operate ethically while delivering high-quality patient care. What is Complementary and Alternative Medicine (CAM)? Complementary and alternative medicine (CAM) refers to a diverse set of healthcare practices used alongside or instead of conventional medicine. CAM practices include acupuncture, herbal remedies, chiropractic care, naturopathy, massage therapy, tai chi, and energy-based therapies such as qi gong. Many CAM therapies aim to restore balance, improve body functions, and promote overall well-being. Complementary medicine typically supports conventional medical care. For example, patients undergoing cancer treatment may use guided imagery, gentle exercise, or dietary supplements to reduce side effects. Alternative medicine, in contrast, replaces conventional treatment with practices such as traditional medicine or herbal medicines. Integrative medicine combines complementary approaches and conventional care into a coordinated treatment plan that addresses various aspects of human health. The popularity of CAM... - Published: 2025-11-21 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/navigating-fda-and-healthcare-laws-for-dietary-supplements-compliance-made-clear/ Learn essential FDA and healthcare compliance requirements for dietary supplements, including labeling, marketing claims, and manufacturing practices. Insights from Cohen Healthcare Law Group. The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) primarily oversee dietary supplement regulation in the United States. While the FDA regulates dietary supplement labeling, manufacturing, and safety, the FTC monitors advertising to ensure marketing claims are truthful and not misleading. Together, these agencies protect consumers and uphold public health standards under laws such as the Dietary Supplement Health and Education Act (DSHEA) and the Federal Food, Drug, and Cosmetic Act. With over 25 years of experience guiding clients through FDA and FTC compliance, Cohen Healthcare Law Group can help your company navigate the complexities of dietary supplement laws and protect your business from costly enforcement actions. Contact us today to schedule a consultation. In this post, we’ll explore how dietary supplements are regulated and what labeling and packaging requirements apply. We’ll also cover key considerations for dietary ingredient notifications and good manufacturing practices (GMPs). What Are Dietary Supplements? According to the Food and Drug Administration (FDA), dietary supplements are products intended to supplement the diet and contain one or more dietary ingredients. These could include vitamins, minerals, herbs or other botanicals, amino acids, or other substances that add nutritional value to the diet. Under U. S. dietary supplement regulation, these products are classified as a special category of food rather than drugs. This means they are not approved by the FDA before marketing. Instead, manufacturers are responsible for ensuring their products are safe, properly labeled, and compliant with FDA regulations and good manufacturing practices (GMPs). The... - Published: 2025-11-18 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/managing-corporate-practice-of-medicine-compliance-for-healthcare-entities/ Explore essential strategies to maintain compliance with corporate practice of medicine laws for healthcare entities, covering ownership structures, management agreements, and risk management. Insights from Cohen Healthcare Law Group A corporate practice of medicine compliance checklist is an essential tool for healthcare organizations to ensure they follow all applicable CPOM laws and regulations. This checklist helps medical practices, professional corporations, and healthcare organizations maintain compliance with state law, protect patients, and safeguard the practice’s reputation. The most important aspects of CPOM compliance include preventing non-physician staff or corporate entities from influencing clinical decisions, ensuring licensed physicians make all medical decisions, and adhering to key OSHA standards, such as the bloodborne pathogen standard and the ionizing radiation standard. With over 25 years of experience guiding healthcare organizations through complex CPOM requirements, Cohen Healthcare Law Group is your trusted partner in maintaining full compliance. We help you protect your practice, ensure regulatory adherence, and safeguard patient care by working with legal experts who understand CPOM laws inside and out. Contact us now! This post provides healthcare organizations, medical practices, and compliance officers with a detailed guide to corporate practice of medicine (CPOM) compliance. You’ll learn about state-specific CPOM laws, common compliance issues, and best practices for maintaining adherence to regulatory requirements. What is the Corporate Practice of Medicine? The corporate practice of medicine (CPOM) refers to state laws that prohibit non-physicians or corporate entities from owning or controlling medical practices in a way that influences clinical decisions. These laws exist to ensure that licensed physicians maintain full authority over patient care, treatment plans, and medical decisions, preventing outside business interests from compromising the quality of healthcare services. CPOM is the legal... - Published: 2025-11-17 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/5-elements-of-fraud/ Understanding the 5 elements of fraud is essential for any healthcare provider seeking to avoid fraudulent behavior patterns, protect their legal rights, and reduce the risk of fraud charges or litigation. In healthcare law, a fraud claim typically requires a false statement, knowledge of its falsity, intent to induce reliance, reasonable reliance by the alleged victim, and resulting harm. These elements help courts decide if a claimed misrepresentation is serious enough to be considered fraud and if the person making the claim needs to show that they reasonably depended on the misleading information. For experienced legal guidance in navigating fraud investigations and compliance issues, our healthcare attorneys are here for you. At Cohen Healthcare Law Group, we have over 25 years of experience in advising healthcare clients. Reach out to us today for a consultation. This post explains how regulators and courts analyze intent, material fact disputes, and the circumstances constituting fraud. It will help providers understand what actions may expose them to liability. What Is Considered Fraud in Healthcare? Fraud in healthcare occurs when a person makes a false statement or material misrepresentation with the intent to deceive another party. Typically, this entails actions intended to obtain payment, benefits, or advantages beyond their legal entitlements. Courts treat these actions seriously because fraudulent behavior patterns can harm patients, insurers, and government programs. A fraud claim also exposes the party charged to civil penalties, criminal liability, and extensive litigation. Healthcare fraud involves conduct that satisfies several key elements under common law... - Published: 2025-11-10 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/confidentiality-agreement-medical-practice/ A confidentiality agreement for medical practice is a legally binding document that ensures patient information, business data, and proprietary processes within a healthcare setting remain private and protected. In the medical field, confidentiality is a legal requirement under regulations like HIPAA. These agreements establish clear boundaries for how patient records and sensitive business information can be accessed, used, or shared by employees, contractors, and third parties. Without a proper confidentiality agreement, a medical practice risks data breaches, legal penalties, and loss of patient confidence. Ready to safeguard your medical practice with trusted legal protection? For over 25 years, Cohen Healthcare Law Group has helped healthcare professionals stay compliant with healthcare laws, protect patient data, and avoid costly legal risks. Contact our team today to get started. This post covers what a confidentiality agreement for medical practice is, why it’s essential for protecting patient information and healthcare compliance, and how an experienced healthcare attorney can help you draft one that meets legal standards. What Is a Confidentiality Agreement in a Medical Practice? A confidentiality agreement for medical practice, also known as a nondisclosure agreement (NDA), patient confidentiality agreement, or medical staff confidentiality contract, is a legal agreement designed to protect confidential information shared within a healthcare setting. The main goal is to protect private information, such as patient medical records, trade secrets, technical specifications, and business-sensitive information that belongs to the practice. This written agreement establishes a confidential relationship between the disclosing party (the medical practice) and the receiving party (such... - Published: 2025-11-03 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/can-a-nurse-open-a-med-spa-in-california/ If you’ve ever wondered, “Can a nurse open a med spa in California? ” the short answer is that nurses cannot directly own a med spa, but there are legal pathways available if they establish the right business structure. Under California’s strict corporate practice of medicine laws, only licensed physicians can own medical practices that provide medical services like aesthetic treatments and non-invasive cosmetic procedures performed at a medical spa. However, nurse practitioners (NPs), registered nurses (RNs), and physician assistants (PAs) can play a key role in the operation and management of a med spa, provided they maintain compliance with California medical board regulations. To legally operate, a nurse must partner with or work under a licensed physician serving as a medical director or form a management services organization (MSO) that handles the day-to-day operations of the medical spa. At Cohen Healthcare Law Group, we have over 25 years of experience in helping aspiring med spa owners and licensed medical professionals navigate complex healthcare laws, supervision, and corporate structure requirements needed to open a med spa in California. Schedule a consultation with us today to ensure your med spa business stays compliant with California laws. In this post, we explain the legal process, licensing requirements, and ownership rules for nurses who want to open a med spa in California. Can a Nurse Open a Med Spa in California? Many nurses looking to enter the aesthetics industry often ask, “Can a nurse open a med spa in California? ” The answer... - Published: 2025-10-25 - Modified: 2026-01-08 - URL: https://cohenhealthcarelaw.com/durable-power-of-attorney-for-healthcare/ A durable power of attorney for healthcare is an important legal document that allows you to appoint someone you trust to make medical decisions on your behalf if you become unable to do so. It ensures that your healthcare wishes are respected even when you can’t communicate them yourself. Without this document, doctors or family members may make important medical decisions without fully understanding your preferences. For trusted legal guidance backed by over 25 years of experience in FDA and healthcare law, work with Cohen Healthcare Law Group. Our seasoned attorneys can help you draft a legally sound durable power of attorney for healthcare and ensure your medical wishes are fully protected. Contact us today to get started. In this post, we’ll cover what a durable power of attorney for healthcare is, why it’s important, and the key steps to creating one correctly. You’ll also learn about choosing the right healthcare agent, ensuring your document meets state laws, and how to update it as your circumstances change. What Is a Durable Power of Attorney for Healthcare? A durable power of attorney for healthcare is a legal document that authorizes another person, called a health care agent or attorney in fact, to make health care decisions for you when you are unable to act on your own behalf. This document remains in effect even if you become incapacitated or lose the ability to make medical decisions due to illness, injury, or age. The agent you appoint should be someone you trust... - Published: 2025-10-20 - Modified: 2026-01-09 - URL: https://cohenhealthcarelaw.com/laboratory-compliance/ Laboratory compliance is foundational to safe, legal, and credible medical testing operations. Whether you run a diagnostic lab, clinical research facility, or pathology service, failure to meet regulatory standards can result in fines, loss of licensure, or reputational ruin. But achieving medical laboratory compliance efficiently is possible when you align policies, systems, and legal strategy. At Cohen Healthcare Law Group, we have over 25 years of experience in offering compliance and regulatory counsel tailored to labs, clinics, and other healthcare facilities. Contact us today for a consultation! In this post, we’ll break down what laboratory compliance really means, the key laws and standards you must obey, and practical steps to streamline your journey. What Is Laboratory Compliance? Laboratory compliance refers to the process of ensuring that a clinical laboratory or testing facility follows all applicable regulations, industry guidelines, and compliance requirements governing safe and reliable laboratory operations. It’s the foundation of trust, accuracy, and safety in healthcare and research. Through strong lab compliance, organizations demonstrate their ability to comply with regulations set by regulatory agencies such as the FDA and other US government bodies that oversee testing, reporting, and data integrity. A robust compliance program also integrates technology such as a laboratory information management system (LIMS) to streamline lab processes, monitor activities, and ensure records are properly maintained. The use of LIMS helps laboratories achieve compliance more efficiently by automating workflows, tracking samples, managing equipment maintenance and calibration, and generating the necessary evidence for laboratory inspection. This ensures that every... - Published: 2025-10-13 - Modified: 2025-10-15 - URL: https://cohenhealthcarelaw.com/ai-in-healthcare-compliance/ AI in healthcare compliance is transforming how healthcare organizations maintain regulatory standards, reduce risks, and ensure patient safety. By leveraging technologies like machine learning, predictive analytics, and natural language processing, healthcare providers can automate compliance checks, detect potential violations early, and streamline reporting processes. From monitoring billing accuracy to identifying data breaches before they escalate, AI helps compliance teams stay proactive rather than reactive. It also assists in navigating complex laws such as HIPAA and FDA regulations, which often change and require constant vigilance. At Cohen Healthcare Law Group, our experienced experts have over 25 years of experience in giving tailored legal advice on implementing or managing AI in healthcare compliance. Get in touch with us today to learn more about healthcare law services. In this post, we’ll cover what AI in healthcare compliance means and examples of how it’s used. We will also discuss its benefits, challenges, and best practices for implementing AI responsibly. What Is AI in Healthcare Compliance? AI in healthcare compliance refers to the use of artificial intelligence (AI) technologies such as machine learning, natural language processing, and robotic process automation to help healthcare organizations monitor, manage, and maintain regulatory compliance. These AI systems can process vast amounts of healthcare data and medical records to identify patterns, detect anomalies, and flag potential compliance risks faster than traditional methods. In the past, compliance efforts relied heavily on manual reviews and human oversight, which made it difficult to keep up with the evolving regulatory landscape. Traditional compliance methods... - Published: 2025-10-08 - Modified: 2025-10-14 - URL: https://cohenhealthcarelaw.com/keep-your-medical-office-compliance-checklist/ Keeping your medical office compliant with ever-changing healthcare regulations can be challenging, but it’s essential to avoid costly penalties and protect your practice’s reputation. To stay organized, it’s important to keep your medical office compliance checklist up to date and aligned with federal and state requirements. This includes tracking HIPAA privacy standards, adhering to OSHA workplace safety rules, ensuring billing accuracy, following patient consent protocols, and maintaining staff training records. If you need expert legal guidance tailored to your medical practice, the team at Cohen Healthcare Law Group is here for you. With over 25 years of experience in healthcare law, we can help you navigate complex compliance regulations. Contact us today to protect your medical practice. In this post, we’ll outline practical steps to help you manage your compliance checklist effectively. You will also learn common pitfalls to avoid and how to adapt to new healthcare laws as they evolve. Why Should I Keep a Medical Office Compliance Checklist? Keeping your medical office compliance checklist is your first line of defense against costly agency audits, penalties, and reputational damage. In the healthcare industry, regulators expect healthcare organizations and professionals to maintain full OSHA compliance, from workplace safety standards to the proper use of personal protective equipment. A current compliance checklist ensures your medical office meets key OSHA standards such as the bloodborne pathogens standard, the hazard communication standard, and the emergency action plan. These are all designed to protect employees from exposure to hazardous chemicals, radiation areas, and other... - Published: 2025-10-03 - Modified: 2025-10-08 - URL: https://cohenhealthcarelaw.com/oig-compliance-program-guidance/ The OIG compliance program guidance serves as a roadmap for healthcare organizations. It helps them establish effective compliance programs, reduce the risk of fraud and abuse, and maintain integrity in billing and operations. For providers, this guidance is not only about meeting regulatory expectations but also about building a culture of accountability and reducing risks that could lead to costly penalties or investigations. At Cohen Healthcare Law Group, we have over 25 years of experience in helping healthcare providers navigate complex healthcare laws, implement compliance programs, and avoid significant legal risks. Schedule a consultation with us today! In this post, we’ll cover what the OIG compliance program guidance is and why it matters. We will look at the key elements of an effective compliance program. What Is OIG Compliance Program Guidance? The OIG compliance program guidance is a framework developed by the Office of Inspector General (OIG) within the Department of Health and Human Services (HHS) to help healthcare organizations design and implement effective compliance programs. These programs are intended to prevent fraud, waste, and abuse in the healthcare industry while also supporting quality and patient safety. The OIG has issued both general compliance program guidance and industry segment-specific compliance guidance for hospitals, nursing facilities, physician practices, and other healthcare entities. These documents provide policies and procedures, best practices, and compliance considerations tailored to different sectors of the healthcare compliance community. The primary purpose of the OIG’s compliance program guidance is to establish a strong compliance program infrastructure that integrates... - Published: 2025-09-15 - Modified: 2025-10-01 - URL: https://cohenhealthcarelaw.com/additional-protections-researchers-can-include/ When it comes to healthcare research, compliance is not only about meeting the minimum requirements set by regulators. It also involves taking proactive steps to safeguard participants, protect sensitive data, and build trust with oversight bodies. That is why many professionals look for additional protections researchers can include, such as enhanced informed consent, stronger data privacy, independent oversight, ongoing participant support, and regular compliance audits. Need tailored compliance strategies for your healthcare research? Cohen Healthcare Law Group has over 25 years of experience in healthcare law, specializing in guiding researchers, institutions, and healthcare businesses through complex regulatory landscapes. Reach out to us today! This post will explain why additional protections are important for healthcare research compliance. It will also show how these measures reduce legal and regulatory risks and when to seek legal counsel for research compliance. What Are Standard Protections in Research? Standard protections in research are the foundational safeguards that ensure that studies are conducted ethically and responsibly. These typically include informed consent, where participants are fully briefed on the study before agreeing to take part; Institutional Review Board (IRB) approval, which ensures the research design meets ethical and regulatory standards; and measures to maintain confidentiality and subject privacy. While these protections are essential, relying solely on them can leave important gaps. For example, standard protocols may not always account for new digital risks to data confidentiality or evolving privacy concerns under modern regulations. They may also be insufficient for research involving vulnerable populations or highly sensitive topics.... - Published: 2025-09-08 - Modified: 2025-12-31 - URL: https://cohenhealthcarelaw.com/healthcare-defense-attorney/ A healthcare defense attorney is a legal professional who represents healthcare providers, organizations, and businesses when they face investigations, regulatory actions, or lawsuits. These attorneys have deep knowledge of healthcare laws, including HIPAA, fraud and abuse laws, licensing regulations, and compliance standards. At Cohen Healthcare Law Group, we specialize in guiding health and wellness providers through complex legal challenges with skill and care. Contact us today to protect your practice and get trusted legal advice tailored to your needs. This post explains who a healthcare defense attorney is and what they do. It also lets you know why their role is critical for protecting healthcare providers and businesses. What Is a Healthcare Defense Attorney? A healthcare defense attorney is a legal professional who provides legal services to healthcare providers, medical professionals, and healthcare entities facing lawsuits, government investigations, or regulatory challenges. Unlike a medical malpractice attorney, who focuses primarily on defending medical practitioners against negligence claims, healthcare defense attorneys handle a broader scope of healthcare law issues affecting the healthcare industry. They represent healthcare clients such as hospitals, physician groups, surgical centers, home health agencies, pharmaceutical companies, and other healthcare providers. Their role often involves protecting healthcare businesses and medical practices from federal government scrutiny, private insurance companies, or state Medicaid fraud control units under statutes like the False Claims Act, Stark Law, and the Anti-Kickback Statute. By offering extensive experience in healthcare litigation, compliance, and fraud and abuse cases, these attorneys help ensure healthcare professionals can continue to provide... - Published: 2025-09-02 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/healthcare-legal-advice-accelerate-health-wellness/ Healthcare and wellness businesses face complex regulations that can impact growth, compliance, and patient trust. From HIPAA and licensing to contracts and risk management, legal guidance is essential to protect your practice and accelerate success. This post explores why working with a healthcare attorney is critical and offers practical legal tips to safeguard and grow your business. To grow and protect your wellness business, you should work with a healthcare attorney to stay compliant with regulations, draft strong contracts and waivers, and handle licensing and scope-of-practice issues. A healthcare lawyer can also guide you on HIPAA, the Affordable Care Act (ACA), and other laws while helping you reduce risks and build a sustainable business model. Cohen Healthcare Law Group has been in operation for over 25 years. We have a team of expert and trusted healthcare legal advisors dedicated to health and wellness entrepreneurs. Reach out to us today! This post explains the critical role of legal compliance for wellness businesses. It also shows how a healthcare attorney can protect your practice. Furthermore, you’ll learn how you can reduce risks and safeguard operations. Why Legal Advice Is Essential in Healthcare and Wellness Compliance is the foundation of any healthcare business. Federal healthcare programs and agencies, such as the Federal Trade Commission (FTC) and other regulators, require strict adherence to healthcare regulatory rules. With informed consent, risk analyses, and ongoing compliance strategies, legal services ensure that health and wellness companies remain protected while serving clients ethically and effectively. From health coaching and functional medicine to medical devices, dietary supplements, and digital health innovations, healthcare providers, physicians, and mental health providers must navigate complex healthcare law. Without proper legal counsel, health and wellness companies can face lawsuits, fraud and abuse claims, or even violations of the False Claims Act, Stark Law, or the Anti-Kickback Statute. This is why healthcare... - Published: 2025-08-26 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/can-you-take-patient-records-when-leaving-a-medical-practice/ No, you generally cannot take original patient records when leaving a medical practice, as they belong to the practice, not the individual physician. However, you can request copies or access to information for continuity of care if done legally and ethically. This guide explains HIPAA rules, state requirements, and best practices for safely transferring or copying patient records while ensuring compliance and protecting patient privacy. No, you generally cannot take original patient records with you when leaving a medical practice. Patient records are considered the property of the practice or healthcare organization, not the individual physician. However, under HIPAA, you may request copies or access to relevant information for continuity of care, provided you follow proper legal and ethical procedures. If you’re a healthcare provider planning to leave your current practice, make sure you’re fully compliant with HIPAA and other privacy laws. With 25+ years of experience in healthcare law, Cohen Healthcare Law Group helps physicians and practices stay compliant, protect themselves from liability, and ensure smooth transitions. Contact us today! This post will cover HIPAA rules on transferring or copying records when a provider leaves. It will also let you know best practices for maintaining continuity of care without violating HIPAA. Who Owns Patient Records? Ownership of patient records is a complex issue that depends on the laws of the jurisdiction, as well as the agreements between healthcare providers and their organizations. In the United States, the general rule is that the medical practice or healthcare facility owns the physical or electronic patient records, not the individual physician. Even if a physician has treated a patient for years, the records typically remain the property of the practice, hospital, or clinic where the care was delivered. Patients, however, do not “own” the records themselves, but they do have a legal right to access and obtain copies of their health information. Under HIPAA (Health Insurance Portability... - Published: 2025-08-23 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/otc-drug-label-requirements/ Over-the-counter (OTC) drugs must follow strict FDA labeling requirements to ensure consumer safety. Proper labels include active ingredients, uses, dosage instructions, warnings, and manufacturer information. Compliance protects consumers, prevents legal penalties, and safeguards brand reputation. Cohen Healthcare Law Group helps companies navigate OTC drug labeling regulations to ensure full compliance and minimize risk. Over-the-counter (OTC) drugs are medications available without a prescription, intended to treat common health issues such as headaches, allergies, cold symptoms, or digestive discomfort. Under FDA regulations, OTC drug labels must follow a standardized drug facts format that includes active ingredients, purposes, directions, and more. At Cohen Healthcare Law Group, we have over 25 years of experience in helping healthcare and wellness companies ensure full compliance while protecting their business. Our healthcare attorneys can help you navigate OTC drug regulations to safeguard your products and brand. Contact us to work with us today! In this article, we're going to break down the importance of proper labeling for OTC drugs and walk you through the FDA’s specific OTC drug label requirements. What Are OTC Drug Label Requirements? OTC drug label requirements refer to the specific format and content standards that all over-the-counter (OTC) drug products must follow before being marketed to the public. These requirements ensure that the immediate container label, outer packaging, and any accompanying information provide consumers with clear, accurate, and complete details about the drug product’s purpose, uses, dosage, warnings, and ingredients. The applicable OTC drug monograph for each nonprescription drug product sets out what information must appear and in what form. In the United States, the primary regulatory body responsible for overseeing OTC drug regulations is the U. S. Food and Drug Administration (FDA). The FDA enforces labeling provisions under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which apply to all nonprescription drug products, topical... - Published: 2025-08-19 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/health-care-proxy-vs-durable-power-of-attorney/ Understand the differences between a Health Care Proxy and Durable Power of Attorney, and learn why having both ensures your medical and financial wishes are protected. A health care proxy, also called a medical power of attorney, is a legal document that allows you to appoint someone as your "health care agent. " This agent makes medical decisions for you if you become incapacitated or unable to speak for yourself. On the other hand, a Durable Power of Attorney (DPOA) allows you to authorize another person as your “agent” or “attorney-in-fact. ” This person is to make financial and legal decisions on your behalf. The "durable" part means this power continues even if you become mentally or physically incapacitated. With over 25 years of experience, Cohen Healthcare Law Group specializes in healthcare and legal compliance. When you work with us, our experienced attorneys will help you draft or review your health care proxy and durable power of attorney. Contact us now for a consultation. This article will explain the key differences between a health care proxy and a durable power of attorney. It will also discuss when you might need both. What Is a Health Care Proxy? A health care proxy is a legal document that authorizes a trusted person to make medical decisions on your behalf if you're unable to do so. It could be a family member, close friend, or another individual you choose. This situation typically arises when you're incapacitated, such as after a serious accident, during surgery, or in end-of-life care situations. Health care proxies are vital tools in ensuring that your healthcare decisions are respected, especially if you cannot communicate your... - Published: 2025-08-14 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/can-medical-offices-go-corporate/ Medical offices can go corporate, transitioning from physician-owned practices to entities managed by corporations, private equity groups, or healthcare management companies. While this shift can bring financial stability, streamlined operations, and access to advanced technology, it also raises legal and regulatory challenges, including compliance with federal and state laws, physician autonomy, and patient care standards. Experienced healthcare attorneys can guide practices through this complex process, ensuring a smooth, compliant transition that protects both patient care and long-term business viability. Yes, medical offices can go corporate in certain circumstances, depending on state laws. This typically means shifting from a physician-owned, independent practice to a business structure owned or managed by a corporation, often involving outside investors, healthcare management companies, or larger healthcare networks. If you’re considering turning your medical practice into a corporation or navigating the legal rules around corporate ownership in healthcare, Cohen Healthcare Law Group is here for you. We bring over 25 years of experience to the table and can guide you in structuring your business formation to comply with federal and state laws. Contact us today to discuss your next steps. This post explains what going corporate means for medical offices and the laws on corporate practice of medicine. It will also let you know the legal issues that may arise when medical offices go corporate. What Does Going Corporate Mean for Medical Offices? When a medical office “goes corporate,” it transitions from being owned and operated by individual physicians to being part of a larger corporate healthcare entity. These entities can include for-profit corporations, private equity-backed groups, or healthcare management companies that oversee operations, business strategy, and sometimes even staffing and clinical workflows. Typically, solo/independent practices are physician-owned, with full control over patient care decisions, operations, and business management. These practices often focus on personalized patient relationships and local community service. On the other hand, corporate-owned practices are managed by business executives or management firms, often with a focus on efficiency, scalability, and standardized protocols.... - Published: 2025-08-11 - Modified: 2025-09-23 - URL: https://cohenhealthcarelaw.com/fda-and-ftc-legal-boundaries-for-cosmetics/ Navigating the legal boundaries for cosmetics in the U.S. requires understanding the distinct roles of the FDA and FTC. The FDA oversees product safety, labeling, and classification, ensuring cosmetics are not adulterated or misbranded. The FTC regulates advertising and marketing, holding companies accountable for truthful, substantiated claims. Together, these agencies protect consumers and set compliance standards for cosmetic businesses. The FDA regulates the safety and labeling of cosmetics under the Federal Food, Drug, and Cosmetic Act (FDCA). It ensures products are not adulterated or misbranded and monitors whether certain claims transform a cosmetic into a "drug" under the law. On the other hand, the FTC oversees advertising practices, ensuring that cosmetic marketing is truthful, not misleading, and backed by reliable evidence. The FTC can take enforcement action against deceptive or unfair business practices in cosmetic advertising. With over 25 years of experience, our team at Cohen Healthcare Law Group can help you build a legally sound business that is FDA and FTC compliant. Contact us today for legal advice. This post covers why cosmetics companies must understand FDA and FTC roles. It also lets you know how to protect your brand from regulatory action. What is the FDA’s Role in Cosmetics Regulation? The U. S. Food and Drug Administration (FDA) plays an important role in overseeing the safety and labeling of cosmetic products sold in the United States. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA is responsible for ensuring that cosmetics are not adulterated or misbranded and that consumers are not misled by false or deceptive labeling. However, unlike drugs or certain medical devices, cosmetics do not require FDA pre-approval before they reach the market. This places a greater responsibility on manufacturers and distributors to ensure product compliance. Cosmetics, as defined by the FDA, are products intended to be applied to the human body for... - Published: 2025-08-08 - Modified: 2025-09-23 - URL: https://cohenhealthcarelaw.com/fda-warning-letters/ FDA Warning Letters are formal notifications issued when the FDA finds significant regulatory violations in areas like labeling, marketing, or manufacturing practices. While a warning letter itself is not an immediate penalty, ignoring it can lead to severe consequences, including product seizures, injunctions, or loss of approvals. Companies typically have 15 business days to respond with corrective actions. Proactive compliance, quality management systems, internal audits, and employee training are key to preventing future violations. FDA Warning Letters are formal notifications issued by the U. S. Food and Drug Administration (FDA), to individuals or businesses that have violated FDA regulations. These letters typically identify specific violations such as misbranding, marketing unapproved products, improper manufacturing practices, or deceptive claims, and provide the recipient a limited time to respond and correct the issue. At Cohen Healthcare Law Group, FDA compliance is our specialty. For over 25 years, we’ve helped clients respond strategically and effectively to FDA warning letters. Book a consultation with our legal team today! In this post, we’ll break down what FDA warning letters are and why they matter. We will also let you know common reasons companies receive FDA letters and how best to respond to them. What is an FDA Warning Letter? An FDA Warning Letter is an official notification sent by the U. S. Food and Drug Administration to firms or individuals found to be in significant violation of federal law. These letters are considered the agency's principal means of advisory correspondence, used when FDA investigators determine that a company has violated the Federal Food, Drug, and Cosmetic Act (FD&C Act) or related implementing regulations. The purpose of the letter is to inform the recipient of the violations in sufficient detail and to request prompt corrective action to bring the business into compliance. FDA warning letters are different from other types of FDA communications. These include recalls, inspections, and form citations, such as Form 483. Unlike recalls, which are typically voluntary actions... - Published: 2025-07-25 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/aks-safe-harbors/ When it comes to healthcare law, few regulations are as critical and as complex as the Anti-Kickback Statute (AKS). This federal law prohibits the exchange of anything of value to induce or reward referrals of business to federal healthcare programs. When it comes to healthcare law, few regulations are as critical and as complex as the Anti-Kickback Statute (AKS). This federal law prohibits the exchange of anything of value to induce or reward referrals of business to federal healthcare programs. In other words, if a healthcare provider offers or accepts any kind of kickback for patient referrals, they could face steep fines or even jail time. But here's where it gets interesting: AKS Safe Harbors. AKS Safe Harbors are specific exceptions built into the law that protect certain payment and business practices from being treated as illegal kickbacks. These provisions offer legal clarity and protection for healthcare providers, practitioners, and organizations operating within complex business arrangements such as joint ventures, referral networks, or equipment leasing. Whether you're launching a healthcare venture or re-evaluating existing business practices, even minor missteps can lead to major legal consequences. With over 25 years of experience in the industry, you can trust our experienced attorneys at Cohen Healthcare Law Group to help you structure your agreements safely and help you stay AKS compliant. Contact us now! In this article, we will cover the Anti-Kickback Statute (AKS). We will also share how safe harbors work and their role in healthcare companies. What Is the Anti-Kickback Statute (AKS)? The Anti-Kickback Statute (AKS) is a part of federal law aimed at preventing corruption and ensuring integrity in the American healthcare system. Enacted as part of the Social Security Act, the federal Anti-Kickback Statute prohibits anyone from knowingly and... - Published: 2025-07-22 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/what-are-the-legal-risks-involved-with-an-iv-therapy-business/ Doctors, registered nurses and EMTs should review with an experienced healthcare attorney - corporate practice of medicine issues, medical and business practices, and other legal issues before starting or running an IV therapy practice IV hydration therapy has exploded in popularity in recent years. In fact, the global IV hydration therapy market was valued at around $2. 32 billion in 2022 and is projected to expand to approximately $4. 23 billion by 2030, growing at a compound annual growth rate (CAGR) of 8–8. 0%, according to Grand View Research. As demand grows, so does interest from healthcare professionals, especially registered nurses (RNs) who are uniquely positioned to deliver these services safely and effectively. While RNs are well-equipped to safely and effectively administer these treatments, starting an IV hydration business comes with important legal considerations. In many states, RNs cannot independently own or operate a medical practice unless they do so through a legally compliant structure such as a Management Services Organization (MSO) partnered with a licensed physician. With over 25 years of experience, Cohen Healthcare Law Group specializes in helping registered nurses, nurse practitioners, and other healthcare professionals build legally sound and profitable businesses. From creating the right business structure to drafting compliant MSO agreements, our attorneys understand the unique legal landscape surrounding IV therapy and integrative wellness. Schedule a consultation with us today! This post will clearly let you know the various groups of people who can open an IV hydration business. It will also outline steps on starting a mobile IV therapy business. Who Can Open an IV Hydration Business? Because IV therapy involves administering fluids and nutrients directly into the bloodstream, it falls under strict healthcare regulations. Opening an IV hydration business depends... - Published: 2025-07-21 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/are-kickbacks-illegal/ Kickbacks are improper payments or compensation made in exchange for preferential treatment, services, or referrals. They are illegal in many industries, especially in regulated sectors like healthcare, government contracting, real estate, and corporate procurement. Kickbacks are improper payments or compensation made in exchange for preferential treatment, services, or referrals. They are illegal in many industries, especially in regulated sectors like healthcare, government contracting, real estate, and corporate procurement. These arrangements are often disguised as consulting fees, referral bonuses, or profit-sharing. In the U. S. , laws such as the federal Anti-Kickback Statute and the Stark Law specifically prohibit kickbacks in exchange for patient referrals or services covered by federal healthcare programs. Violating these laws can lead to criminal charges, massive fines, exclusion from Medicare/Medicaid, and even prison time. Concerned about fee-splitting or kickback exposure? Cohen Healthcare Law Group has over 25 years of experience in the industry and can help you navigate complex healthcare regulations and structure your business legally. Contact us today to protect your practice! This blog will cover what counts as a kickback and key laws that prohibit kickbacks in the healthcare sector. It will also let you know how kickbacks are detected and prosecuted. What Are Kickbacks in Healthcare? Kickbacks in healthcare refer to illegal payments or incentives offered to healthcare providers, such as physicians or medical facilities, in exchange for patient referrals, the prescribing of certain medications, ordering unnecessary tests, or steering business to specific service providers. These improper compensation arrangements are not only unethical but also violate federal law, particularly when they involve federal healthcare programs like Medicare or Medicaid. In the healthcare industry, kickback schemes can take many forms. A common example includes financial incentives given to... - Published: 2025-07-17 - Modified: 2025-09-23 - URL: https://cohenhealthcarelaw.com/does-stark-law-apply-to-medicaid-patients/ The Stark Law, also known as the Physician Self-Referral Law, is a federal statute that prohibits physicians from referring patients for certain designated health services (DHS) payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, The Stark Law, also known as the Physician Self-Referral Law, is a federal statute that prohibits physicians from referring patients for certain designated health services (DHS) payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies. The law is designed to prevent conflicts of interest, overutilization of healthcare services, and unnecessary costs to federal healthcare programs. Generally, the Stark Law specifically applies to services billed to Medicare, not Medicaid. However, providers should note that other federal and state regulations, such as the federal Anti-Kickback Statute and state-level Medicaid fraud laws, can still apply to Medicaid patient referrals and financial relationships. In many states, similar self-referral laws mirror Stark provisions and do cover Medicaid. At Cohen Healthcare Law Group, we specialize in Anti-Kickback Statute, the Stark Law, fee-splitting, and healthcare regulatory compliance. With over 25 years of experience, our experienced legal team can help you navigate complex laws and avoid costly mistakes. Contact us today! In this blog, you will get a clear explanation of the Stark Law and its intent. Furthermore, you will learn who the Stark Law applies to and how healthcare providers can stay compliant. What Is the Stark Law? Formally known as the Physician Self-Referral Law, the Stark Law is a federal statute under the Social Security Act that prohibits physicians from referring patients to receive certain designated health services (DHS) payable by Medicare from entities with which the physician or their immediate family... - Published: 2025-07-14 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/doctor-not-paying-rent/ A doctor not paying rent for a surgery space, equipment, or medical suite leads to consequences that extend beyond a typical lease default. In addition to potential eviction or legal action, the situation can raise serious regulatory and compliance risks. A doctor not paying rent for a surgery space, equipment, or medical suite leads to consequences that extend beyond a typical lease default. In addition to potential eviction or legal action, the situation can raise serious regulatory and compliance risks. This happens if the lease wasn’t properly structured under laws like the Anti-Kickback Statute (AKS), Stark Law, or corporate practice of medicine (CPOM) restrictions In healthcare, rent can be interpreted as a form of compensation or referral incentive if not properly documented. For landlords, clinics, MSOs (Management Services Organizations), and medical facility owners, a doctor’s failure to pay rent might raise red flags about how the lease was structured in the first place. If the agreement isn’t legally compliant, even well-meaning parties can face fines, investigations, or enforcement actions. With over 25 years of experience, Cohen Healthcare Law Group specializes in structuring legally compliant leases and resolving high-risk healthcare contract issues. When you partner with us, you gain clarity on fee splitting rules and other critical compliance laws. Contact us today to learn how we can support your healthcare business. This blog explores what happens when a doctor fails to pay rent for surgery space and why it’s more than just a landlord-tenant issue. It also highlights the legal and compliance risks involved, especially under healthcare laws like the Anti-Kickback Statute, Stark Law, and corporate practice of medicine rules. What Are the Rent Payment Obligations for Doctors? Typically, doctors who rent surgery space or use specialized equipment within a medical... - Published: 2025-07-10 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/patient-notification-requirements-when-medical-practices-merge-or-are-acquired/ Physicians and medical practices who merge their practices, sell, or acquire a medical practice need to notify their clients about the transaction so they can make informed decisions about their doctors and their medical records. When a medical clinic is sold or merges with another practice, one of the most critical and legally sensitive tasks is transferring patient medical records. These records contain protected health information (PHI) and must be handled with strict compliance with HIPAA and state privacy laws. The process of transferring patient medical records requires a structured protocol, typically involving data encryption, secure health IT systems, written patient notifications, and signed authorizations where necessary. If clinics fail to meet legal and ethical standards, the consequences can be severe, ranging from patient care disruptions to lawsuits, regulatory penalties, and loss of licensure. The safest way to manage medical record transfers during a clinic sale or merger is to seek legal counsel from experts in healthcare law. At Cohen Healthcare Law Group, we have over 25 years experience in offering specialized legal guidance to help healthcare providers maintain HIPAA compliance and avoid regulatory pitfalls. Contact us today! This post will cover your legal obligations when transferring medical records. It will also let you know who can and how to transfer medical documents. When Are Clinics Required to Transfer Medical Records? Clinics are required to transfer medical records in several key situations where continuity of care or legal compliance is at stake. One of the most common scenarios is during a merger, acquisition, or sale of a medical practice. In these cases, patient records must be securely handed over to the new provider to maintain care and comply with HIPAA requirements. Similarly, when a physician... - Published: 2025-07-08 - Modified: 2026-01-19 - URL: https://cohenhealthcarelaw.com/hipaa-compliance-for-pharmacies-violations-and-faqs-2/ Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for violations, and to get answers to HIPAA compliance questions. The Health Insurance Portability and Accountability Act (HIPAA) is a federal law enacted in 1996 to protect patients’ private health information (PHI). HIPAA establishes rules around how healthcare providers, including pharmacies, store, use, and share sensitive health data. Due to their direct access to sensitive data, pharmacies are especially vulnerable to HIPAA violations and enforcement actions. Common examples of pharmacy HIPAA violations include improper disclosure of PHI, failure to secure electronic records, and inadequate staff training. With over 25 years of experience, Cohen Healthcare Law Group specializes in helping healthcare providers, including pharmacies, navigate HIPAA compliance, audits, and legal risks. Contact us today to schedule a consultation. This blog will give a quick overview of HIPAA and its role in healthcare and how it applies to pharmacies. It will then share common examples of pharmacy HIPAA violations. What Is HIPAA? The Health Insurance Portability and Accountability Act (HIPAA) is a federal law enacted in 1996 to protect individuals' health information and ensure patient privacy. Overseen by the U. S. Department of Health and Human Services (HHS) and enforced by the Office for Civil Rights (OCR), HIPAA established national standards for safeguarding Protected Health Information (PHI) across the healthcare system. Two key HIPAA rules are especially relevant to pharmacies: The HIPAA Privacy Rule: This rule regulates how covered entities, such as pharmacies, healthcare providers, health plans, and healthcare clearinghouses, may use and disclose a patient’s protected health information. It ensures that only the minimum amount of information necessary is shared, and... - Published: 2025-07-08 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/healthcare-legal-pitfalls-why-ai-and-web-searches-cant-replace-a-healthcare-attorney/ Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the limitations of relying on AI and online resources for healthcare legal advice. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. Today's video is about healthcare and FDA legal pitfalls. Why AI and web searches can't replace a healthcare attorney. I still have my job, okay? With the increasing availability of online resources and AI tools, it's really tempting for healthcare business to turn to these resources for quick legal answers. The problem is. Legal advice, it ain't that fast and it's a lot of interpretation, so what you get from these resources can fall short. I know people have been like passing around what's the corporate path of medicine in 50 states. It used to be you needed a paralegal and a research assistant and somebody to really go through and get all that detail. If you look at some of these rules that have I don't know, 10 different parts. Certainly reading HIPAA, there's dozens and dozens of gears. Things that you have to do, and they actually require interpretation and implementation and those are things that are very difficult to do unless you have an experienced human eye that knows how to tailorize these things. Tailorize, I even made that up. Tailor these tools for your business. Consent forms. You can get templates, you can get templates before AI. But the thing is, you got to tweak them and you, we go back and forth with the provider, with the healthcare business.... - Published: 2025-07-01 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/why-healthcare-providers-need-more-than-ai-and-web-based-legal-guidance/ Join Michael H. Cohen, founding attorney of Cohen Healthcare Law Group, as he delves into the complexities of healthcare law and the importance of tailored legal guidance. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. Here's why healthcare providers and businesses need more than AI and web-based legal guidance. Admittedly, the regulatory terrain is complex, but that in itself isn't enough. What is important is that every business has really unique nuances, and that's going to affect the interpretation of the legal rules as they're applied to your situation. So, healthcare law is not just one discreet body of law. There's federal law, there's state law, there's statutes, there are regulations. Sometimes there are policy statements by the board. Sometimes there are articles that kind of hint at trends. It's not just the information, but it's about knowing where to look for the information and then figuring out which information actually applies to you. So, imagine that, for example, you're a telehealth provider and you are looking at telehealth law. Maybe you operate in three different states. Maybe you are, in a tri-state area and you can read this stuff. But even lawyers reading this stuff, it's hard to really, it's not written in English. And even if you tell the AI translate in English, it doesn't always translate because law is written in a particular way. And the problem is, if you get it right, great, but if you don't: trouble. And if you do or don't, it really depends on what's in the mind of the person... - Published: 2025-06-26 - Modified: 2025-12-24 - URL: https://cohenhealthcarelaw.com/can-i-own-a-medical-practice-if-i-am-not-a-doctor-an-overview-of-corporate-practice-of-medicine/ We spoke about a series of webinars talking about a trending topic in the legal aspects of corporate medicine, Management Services Organization. And with much anticipation, we bring you – Part II of our MSO webinar. Many assume only licensed physicians can own and operate a healthcare clinic. While this may hold true in some cases, particularly when medical diagnosis and treatment are involved, there are corporate structures and legal strategies that allow non-physicians to own or co-own a clinic, if they do it the right way. This is where compliance with corporate practice of medicine (CPOM) laws, HIPAA rules, and state-specific healthcare regulations becomes important. You must not be a doctor to open a clinic. However, there’s a complex legal framework involved, and failing to follow the rules can lead to serious consequences like fines, license revocation, or even criminal charges. At Cohen Healthcare Law Group, we specialize in helping entrepreneurs and professionals legally structure and operate clinics, even if they’re not doctors. With over 30 years of experience, our team can help you with HIPAA compliance help and much more. Contact us today! This blog will help you know the types of clinics you can open without a medical license. It will also break down the steps involved in opening a clinic without being a doctor in California. Who Can Open a Clinic in California? Under California law, not just anyone can open a medical clinic. Only certain individuals and entities are legally allowed to own or operate a clinic, especially when the services offered involve direct medical care or clinical decisions. Licensed medical professionals such as MDs, DOs, chiropractors, and dentists are authorized to own and operate a medical practice, as they have... - Published: 2025-06-24 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/what-is-an-mso-msa-and-how-does-an-mso-msa-benefit-my-med-spa/ A MSO helps separate the medical side of a med spa from the business side of the med spa. A properly drafted MSA helps clarify the roles of the MSO and federal and state compliance issues. Med spas are booming across the U. S. , blending aesthetic beauty treatments with medical-grade services like Botox, fillers, and laser therapy. With demand soaring, many entrepreneurs and non-physicians are eager to enter the market. However, state laws often prohibit non-doctors from owning or directly operating medical practices. That’s where Management Services Organizations (MSOs) come in. An MSO is a separate business entity that handles non-clinical operations such as staffing, marketing, billing, and office management, while the medical side must remain fully under the control of a licensed healthcare professional. If you're looking to build or grow your med spa business while staying fully compliant with healthcare laws, our team at Cohen Healthcare Law Group offers the legal experience you need. With over 30 years of experience, we specialize in helping entrepreneurs and physicians navigate complex MSO structures, medical spa compliance, and regulatory strategy. Contact us today! This post explains what an MSO is and how it operates. It also highlights the core rules MSOs must follow, and points you to trusted legal experts who can help you set up or scale your med spa the right way. What Is an MSO in Healthcare? A Management Services Organization, or MSO, is a separate business entity that provides non-clinical management services to healthcare practices. The MSO does not participate in medical procedures or clinical practice, nor does it make medical decisions. Instead, it operates on the business side of a healthcare venture, enabling licensed physicians, nurse practitioners, and physician assistants to... - Published: 2025-06-22 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/the-risks-of-relying-on-generic-legal-information-in-healthcare-why-an-fda-attorney-is-essential/ In this video, Michael H. Cohen, the founding attorney of Cohen Healthcare Law Group, discusses the significant risks associated with depending on generic legal information in the healthcare sector. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today's video, we'll talk about the risks of relying on generic legal information in healthcare. Why an FDA or healthcare attorney for that matter is essential. So, what do you mean by generic? Generic meaning you can use a search, you can use a prompt, and you just get an answer. Why is that just not going to be enough? What is the meaning of life? I guess there are a lot of answers to that, but I'm still searching and, sorry, I'm just not satisfied by what's on the web, but that's because the question is really much broader than some generic, generalized answer. You have to find an answer that's really built for you that addresses your case, your situation, your matter, your business. And already today a lot of companies are getting in trouble. Because they're using, for example, generic advertising, generic marketing. So, for example, a clinic offering alternative therapies was using these broad claims that they got online, but those ads didn't meet FTC and FDA standards, and when these agencies looked at them, they got fined. So those standards are a matter of interpretation and they're not just about the rules. If they'd had every single claim reviewed, they would've gotten the benefit, not only of avoiding getting hauled up on a sling by the regulators, but... - Published: 2025-06-19 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/compliance-issues-for-durable-medical-equipment-companies/ Durable medical equipment companies need to review the Anti-Kickback Statute, Stark Law, HIPAA, CMS requirements, and other federal and state requirements before marketing their business. Durable Medical Equipment (DME) refers to medically necessary devices intended for repeated use, often prescribed by physicians and reimbursed by Medicare, Medicaid, or private insurers. Because DME plays a direct role in patient treatment, and often involves federal reimbursement, the industry is tightly regulated. The DME industry is governed by a complex web of federal and state regulations, and failing to comply isn’t just a bureaucratic misstep. This is because failing to comply can lead to shutting your business down entirely. From FDA oversight to CMS supplier standards, billing compliance, and fraud laws, every stage of your product’s lifecycle is under scrutiny. Our attorneys at Cohen Healthcare Law Group specialize in helping medical device manufacturers navigate FDA regulations. With over 30 years of experience, we are here to guide you through medical devices regulations, avoiding billing and marketing missteps, and building legally sound operations. Contact us now! This blog will break down what counts as Durable Medical Equipment (DME) and why legal and regulatory compliance is critical for every DME company. We will also share the key compliance areas you need to know. What Is Durable Medical Equipment (DME)? Durable Medical Equipment (DME) refers to medical devices designed for long-term use, prescribed by a licensed healthcare provider to aid in a patient’s daily activities or treatment plan. DME must meet some specific criteria, such as being durable, used for a medical purpose, not typically useful to someone who isn’t sick or injured, and appropriate for home use. Common examples of... - Published: 2025-06-15 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/why-healthcare-businesses-must-rely-on-experienced-healthcare-attorneys-not-the-internet-or-ai-risks-and-rewards/ Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, discusses why businesses in the health and wellness sector should consult a healthcare attorney rather than relying on the internet or AI for legal and regulatory advice. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. Today's topic, which is relevant now might be different in the year 3,500, but right now, why do you need a healthcare attorney, not the internet or AI? Why do you need someone like us? And there's no chip in my brain. It's just human knowhow. What do we do in a time when information is just to click away? It can be very tempting to rely on web searches or AI for answers to legal and regulatory questions, even in healthcare, which is a lot more abstruse and esoteric than general business law. But when it comes to complex healthcare and FDA regulations, one thing that really counts is expertise and experience. It helps to be a war veteran, if you will, of battles in the industry. The healthcare laws are complicated. They're updated all the time. Online sources can provide a general overview and some citations, but the key is really the interpretation. It's the nuanced industry specific, fact specific, case specific. And the trick is in applying the law to that situation. So, for example, we represented a telehealth company. They relied on a web search. They get some kind of broad patient protection guidelines, but they didn't meet HIPAA standards. And when the business was audited, they were facing heavy fines and penalties and they had to quickly overhaul their... - Published: 2025-06-08 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/clinical-trial-compliance-key-fda-regulations-for-research-organizations/ Clinical trial companies must comply with FDA regulations, informed consent laws, and IRB requirements to ensure ethical and legal compliance. Learn how to navigate 21 CFR Part 50 & 56, manage patient safety protocols, and avoid regulatory penalties when conducting research. The intricate web of clinical trial regulations is meant to safeguard study subjects, assure the ethical conduct of research, and ensure the integrity of the scientific results. Any organization that undertakes the responsibility of conducting clinical studies must comply with the rules and regulations set down by three primary authorities: the Food and Drug Administration (FDA), the Department of Health and Human Services (HHS), and Institutional Review Boards (IRBs). Violating their mandates can have serious repercussions, yielding everything from delay to legal action to outright trial rejection. This article gives an overview of the important regulatory areas that research organizations must be aware of, such as the Food and Drug Administration's 21 Code of Federal Regulations Parts 50 and 56, obligations involving informed consent and institutional review boards, and standards for good clinical practice. It also covers some recent enforcement trends. Understanding FDA Regulations: 21 CFR Part 50 and 21 CFR Part 56 Core requirements for clinical research, as specified by the FDA, are contained in two major regulations. The first is 21 CFR Part 50, which deals with informed consent. The second is 21 CFR Part 56, which governs Institutional Review Boards. In order to start, clinical trials must secure informed consent from every participant and obtain IRB approval. The trials themselves, of course, must adhere to GCP to meet basic regulatory expectations, especially from the FDA. Even with clear regulations, research organizations still encounter frequent issues such as these: Informed consent is not properly obtained. Oversight by the... - Published: 2025-06-08 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/legal-guidance-for-fertility-clinics-compliance-patient-consent-and-data-privacy/ Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the key legal considerations for fertility clinics. Learn about the importance of comprehensive patient consent forms, data privacy measures in compliance with HIPAA, and specific regulations surrounding reproductive technologies under FDA law. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. Today, let's talk about fertility clinics. Fertility clinics are just one example of a specialized kind of center that's going to be regulated in healthcare. It could be an addiction center, it could be a health and wellness clinic. Could be IV hydration, sleep medicine, women's health, men's health, sports medicine. So today, fertility clinic. So very similar issues. First of all, comprehensive patient consent form. And we helped one such clinic develop a detailed consent form and the idea was to prevent them from being burned, for having something that was too thin and didn't really describe the risk and benefits adequately. Secondly, data privacy. HIPAA is always something to think about in healthcare. So, you want to think about policies, procedures, data protection, IT policies, backup, encryption, appointing privacy and safety officers, the full suite of privacy and safety compliance. And third, there might be specific rules applicable to reproductive technology. For one thing, the therapies could come under scrutiny. There are, you're talking about products now suddenly are in the realm of FDA law and it can govern what the product is. Is it a medical device? Is that a supplement? Is it something cosmetic? Or is it a combination product or is it a new drug or a biological? How strictly are these things regulated? So, finding the right FDA... - Published: 2025-06-01 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/navigating-fdas-cgmp-standards-for-dietary-supplement-manufacturers/ Ensure your dietary supplement business stays FDA-compliant with this in-depth guide to cGMP standards under 21 CFR Part 111. Learn about ingredient testing, recordkeeping, quality control, and FDA enforcement actions to avoid penalties, recalls, and warning letters. It is very important for dietary supplement manufacturers to understand FDA regulations and comply with them. The Current Good Manufacturing Practices (cGMPs) are the FDA minimum requirements that a manufacturer must meet to produce a dietary supplement. The cGMPs are found in 21 CFR Part 111. These regulations were implemented to protect you, the consumer, so that you can have some assurance that the product you are taking has actually been manufactured in a consistent manner and that it has been properly labeled. These regulations also give you some peace of mind that the product does not contain any undeclared contaminants or adulterants. So, what are cGMPs when it comes to dietary supplements? The FDA's regulations under 21 CFR Part 111 cover the entire life cycle of a supplement, from manufacture and packaging to labeling, holding, and distribution. If you're looking for the full regulatory text, it's available online. The great goal is the consistent, controlled production of a supplement; its accurate labeling; and the absence, in the supplement, of any harmful contaminants or improper ingredients. A robust quality control program is one of the cornerstones of cGMP compliance. It is not enough for a manufacturer to have quality control. The manufacturer must develop written procedures for overseeing quality at every stage of production and must follow those procedures. Quality control begins with the testing of raw ingredients, which are tested for identity, potency, and purity. The quality control program requires that detailed batch records be kept. The program also... - Published: 2025-05-22 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/mobile-health-apps-legal-compliance-essentials-for-fda-and-ftc-standards/ Mobile health apps must comply with FDA regulations, HIPAA privacy laws, and FTC advertising guidelines to avoid enforcement actions. Learn how to determine if your app is a medical device, manage patient data securely, and market legally under federal and state laws. Apps that provide services such as telemedicine, fitness tracking, remote monitoring, and medication reminders are rapidly expanding within the burgeoning mobile health (mHealth) industry. But with this growth comes an increase in regulatory scrutiny. Developers, healthcare providers, and startups in this space need to be on guard because the law is looking much more closely at the nascent mHealth industry. And a lot of the apps we're developing are now being classified as medical devices, with some of us on the borderline of telemedicine. This manual will take you through the basic legal factors involved in mobile health apps. It will help you figure out if your app is regulated by the FDA, how to manage patient data in a way that meets the requirements of HIPAA, and how to ensure that your app's advertising practices are in line with FTC guidelines. You will also learn about state laws—in particular, telehealth and privacy laws—that may impact the operation of your app. 1. Determining If Your App Needs FDA Approval When a mobile health app meets the definition of a medical device according to 21 CFR 801, the FDA gets involved. If your app is intended to diagnose, treat, or prevent a disease or health condition, it likely comes under FDA oversight. Apps that are concerned only with general wellness or non-medical functions are usually not directed by the FDA. For instance, an application that measures blood pressure and works together with a medical device or one that employs AI to... - Published: 2025-05-18 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/recent-dietary-supplement-fda-alerts-and-warning-letters/ The Food and Drug Administration regulates dietary supplements by sending out warning letters and enforcing those letters. FDA also provides guidance in many forms, including alerts and notices. The FDA has the authority to regulate dietary supplements pursuant to the federal Food, Drug, and Cosmetic Act and other laws. FDA provides guidance documents to help the developers of dietary supplements understand their compliance requirements. These guidance documents include the following: Current Good Manufacturing Practice (CGMP) New Dietary Ingredients Warning Letters & Safety Information Labeling and Claims Adverse Events Reporting and Recordkeeping General Compliance and Inspection Information for Industry Special Issues/Miscellaneous Items Archived Items of Interest We’ve discussed some of the key compliance requirements for dietary supplements previously. We also have a video presentation on the compliance requirements for dietary supplements. In this article, we discuss a few additional compliance issues. Navigating FDA and Healthcare Laws for Dietary Supplements: Compliance Made Clear Learn essential FDA and healthcare compliance requirements for dietary supplements, including labeling, marketing claims, and manufacturing practices. Insights from Cohen Healthcare Law Group. Dietary Supplement Compliance: Labeling, Marketing, and Manufacturing Strategies for Success In this video, Michael discusses the importance of making assertive yet compliant claims, adhering to good manufacturing practices, and ensuring ingredient safety to avoid FDA warnings. FDA oversight of dietary supplements The FDA coordinates its oversight of dietary supplements with the Human Foods Program’s Office of Food Chemical Safety, Dietary Supplements, and Innovation. FDA regulates the dietary ingredients for dietary supplements and the finished dietary supplement products. FDA’s oversight of dietary supplements differs from its oversight of "conventional" foods and drug products. Based on the Dietary Supplement Health and Education Act of 1994 (DSHEA),... - Published: 2025-05-15 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/risk-management-and-compliance-for-direct-to-consumer-genetic-testing-companies/ Direct-to-consumer genetic testing companies must navigate complex FDA regulations, HIPAA compliance, and state laws to avoid enforcement actions. Learn how to structure your business legally, manage genetic data privacy, and ensure truthful marketing claims to prevent regulatory fines and lawsuits. The DTC genetic testing industry has experienced rapid growth and now finds itself in a climate of intensified scrutiny from federal and state regulators. Numerous companies that offer DNA-based health insights, ancestry results, or genetic predisposition information are feeling the heat and being forced to ensure that their operations are in line with an increasingly fragmented federal and state regulatory scheme. It is no easy task. These companies risk enforcement actions from the FDA, penalties for lapses in data privacy, and legal exposure for making false or misleading marketing claims. This guide covers the critical legal aspects that DTC genetic testing companies must deal with, such as the following: FDA regulations concerning genetic testing; HIPAA and state privacy laws that concern you and your customers; FTC standards for marketing your product; and regulatory pitfalls that DTC companies commonly fall into. DA Regulations for Genetic Testing: Is Your Product a Medical Device? One of the first inquiries about compliance for DTC genetic testing firms to consider is whether their offering is subject to FDA oversight, specifically, whether it is a medical device. Health-related tests—those that might indicate a person's likelihood of coming down with a specific disease, for example—usually have some federal scrutiny. That can be as light as a product being "cleared" by the FDA through a rather straightforward process for low-risk devices. Genetic tests typically can be divided into three main categories. Medical device tests, which are regulated by the FDA, comprise those that detect genetic markers linked to... - Published: 2025-05-12 - Modified: 2025-08-22 - URL: https://cohenhealthcarelaw.com/fda-guidance-on-studying-and-marketing-medical-devices-part-two/ The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps three and four. In part one of our discussion of FDA premarket submission requirements for medical devices, we discussed the following FDA guideline steps. Step One: Classify Your Device and Understand Applicable Controls Step Two: Select and Prepare the Correct Premarket Submission In this second part, we continue our discussion of step two. We also discuss the following steps: Step Three: Prepare the Appropriate Information for the Premarket Submission Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing Step Two: Select and Prepare the Correct Premarket Submission Information to Consider When Preparing a Premarket Submission The FDA recommends that developers/sponsors of medical devices review the additional premarket submission requirements. Design Controls. “Class II and Class III devices must be designed in accordance with Design Controls under the Quality System Regulation (21 CFR 820. 30). Most class I devices are not subject to Design Controls. ” For additional information on Design Controls, applicants can review the FDA’s Design Control Guidance for Medical Device Manufacturers. Nonclinical Testing. The classification level of the medical device, the operating principles, the technology of the device, and the labeling of the device – all determine what information and testing are necessary to market a medical device. “Nonclinical testing performed in support of a premarket submission for a medical device should comply with the Good Laboratory Practices (GLPs) in 21 CFR 58. ” Consensus Standards. “The FDA encourages the use of FDA-recognized consensus standards in premarket submissions. An integral part of a least-burdensome approach to device... - Published: 2025-05-08 - Modified: 2025-12-03 - URL: https://cohenhealthcarelaw.com/growing-your-business-scaling-legally-and-strategically/ Join us for the final installment of the IV Hydration Webinar series, 'Growing Your Business, Scaling Legally and Strategically.' Learn about common scaling challenges, intellectual property tools, franchising, mergers and acquisitions (M&A), maintaining legal compliance, and the importance of succession planning. TRANSCRIPT Christian Maniquis: Hello and good afternoon everyone. Today is the 30th of April, and we are now on our third and final installment for our IV Hydration Webinar series. The title being, growing Your Business, scaling Legally and Strategically. Our panelist for today and speakers would be Attorney Drew Barnholtz. You guys already know him very well since the very beginning of the series, and I'd like to make an introduction to one of our esteemed attorneys, attorney Fisher James Kinslow. We call him Jim. Jim, you want to take the floor for a bit? Fisher James Kinslow: Thanks, Christian. Yes my name's Jim Kinslow. I'm a California licensed attorney. I've been in healthcare practitioner for about 25 years. My focus has been upon digital health and associated platforms and intellectual property. I've been with Cohen Healthcare Law Group for over a year now, and I look forward to meeting you. Christian Maniquis: Thank you for that quick and detailed introduction, Jim. Again, this webinar is in collaboration with the founder and CEO of the Drip Success Formula, My Queen Dickens and the Thrive and Hive Community. I see that in the participants, there are some familiar names, some of which has been with us since the beginning of the series, and thank you very much for all being here. I'd just like to remind everyone that we do have a question and answer box for you to be able to chip in and ask a little bit more... - Published: 2025-05-08 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/legal-and-compliance-strategies-for-health-coaching-businesses/ Health coaching businesses must comply with state licensing laws, corporate practice of medicine rules, HIPAA, and FTC regulations when offering services. Learn legal strategies to structure your coaching business, protect against unlicensed practice claims, and market services within regulatory guidelines. The health coaching industry is expanding. At this time, it is essential for coaches and wellness entrepreneurs to be aware of the legal landscape. The industry is expanding so quickly that in some states, laws governing health coaching don’t even exist yet. Because the laws are lagging, there’s no clear path to follow, and you know what that leads to—confusion. And operating under a cloud of confusion puts your business at risk. It opens you up to the possibility of being sued and even having to declare bankruptcy. Without a clear direction, this is where a lot of wellness entrepreneurs seem to be headed. This guide covers several of the major compliance problems that health coaches, wellness startups, and coaching platforms seem to have a hard time grasping. Some of the most important ones are outlined here. They are important because ignoring them could lead to serious legal and financial trouble. They are also important because they affect a lot of people, and dumb compliance problems can make you look untrustworthy or lead to the kind of appearance that makes you seem untrustworthy. Do Health Coaches Need a License? Understanding State Laws In the majority of states, you don't need a license to work as a health coach. But depending on the kind of services you offer, especially if they are of a certain kind, you could be violating state laws that require professionals to be licensed. For instance, if you are offering detailed nutrition plans (more than just broad... - Published: 2025-05-05 - Modified: 2025-09-18 - URL: https://cohenhealthcarelaw.com/fda-guidance-on-studying-and-marketing-medical-devices-part-one/ The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two. The FDA provides guidance for manufacturers regarding the steps necessary to obtain FDA approval to market medical devices. Medical products, according to the FDA, are considered medical devices if the medical devices meet the definition of a medical device per Section 201(h) of the Food, Drug, and Cosmetic Act. This definition is as follows: “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes... . ” Developers should determine the intended uses and indications for their product. The marketing of medical devices according to the Federal Food, Drug, and Cosmetics Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299 vary depending on the dangers of the device and the need to reasonable ensure the safety and effectiveness of the device. Marketing Pathways The FDA has different marketing pathways: Premarket Notification... - Published: 2025-05-01 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/advertising-compliance-for-medical-devices-ftc-and-fda-requirements/ The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of their making. The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) finely regulate the promotion compliance of medical devices—both in terms of the claims made and in the manner of their making. The upshot is that promotional claims about medical devices, including advertising, must be truthful and not misleading. To achieve this, the FDA and the FTC have established a series of very clear guidelines, and they have also set forth some basic, mostly "common sense" rules that any entity promoting a medical device would be wise to follow. This document is your essential guide to, and entryway into, the world of promotional compliance for medical devices. Understanding FDA Regulations for Medical Device Labeling and Promotional Claims: The Food and Drug Administration supervises the medical device promotional world, ensuring that claims made therein are truthful and based on solid evidence. They cover a lot of ground. The world of medical devices is not a small one, with hundreds of thousands of individual items that need to be carefully and clearly labeled. "Labeling" is a gigantic umbrella that covers any and all materials used to explain or promote the device. That means everything from brochures to website content to instructions. For a look at their comprehensive requirement list, hit up their webpage. Scientific evidence must back medical claims. If a device manufacturer claims that the device can diagnose or treat a condition, there must be clinical data to back this up. Promoting a device for unapproved or off-label use is... - Published: 2025-04-22 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/healthcare-mergers-and-acquisitions-legal-considerations-for-providers/ Explore essential legal considerations for healthcare mergers and acquisitions, covering due diligence, regulatory compliance, and structuring agreements. Insights from Cohen Healthcare Law Group. Explore essential legal considerations for healthcare mergers and acquisitions, covering due diligence, regulatory compliance, and structuring agreements, with insights from Cohen Healthcare Law Group. In the healthcare sector, M&A is a complicated business that calls for detailed planning and careful attentiveness to the regulatory landscape if it's to have any hope of achieving a successful outcome. This guide tackles the crucial aspects of M&A law that healthcare providers need to be aware of and pay heed to—due diligence, for starters, which is now more vital than ever because of the increased risk of governmental enforcement actions. After that, we move on to the necessity of securing the myriad of required regulatory approvals, a process that constitutes a "deal killer" for many transactions. Finally, we consider various ways that agreements can be structured to keep risks to a minimum while also maximizing the benefits that the transaction is supposed to produce. It is very important to carry out detailed due diligence during mergers and acquisitions in the healthcare sector, which involves a comprehensive evaluation not just of the target company's financial situation but also of its legal past and regulatory adherence. Financial due diligence looks at the real financial picture of the company; in healthcare M&A, operational due diligence is just as critical for getting a handle on the company's true condition. Both types require very thorough, very detailed examinations of the target company. A good online resource for diving deeper into financial due diligence exists here. Healthcare mergers and acquisitions... - Published: 2025-04-15 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/medical-spa-ownership-structures-navigating-legal-and-compliance-challenges/ Discover legal compliance strategies for medical spa ownership, covering corporate practice of medicine, MSO structures, and physician partnerships. Insights from Cohen Healthcare Law Group. Aesthetic and wellness treatments are the specialties of medical spas. However, they're often provided in a regulatory grey area. The reason? Many of the services offered in a medical spa setting can be considered medical procedures, and state laws vary widely on what can be done by whom in a medical setting. This guide serves two key purposes. First, it's a primer on the legal dos and don'ts for medical spa operators. Second, it's a resource for would-be operators to understand the legal landscape before they leap into this high-risk, high-reward business. Compliance Considerations in Medical Spa Ownership A compliant med spa requires ownership, management, and medical oversight that fully understand and follow the rules and regulations. Navigating CPOM Restrictions for Medical Spas Numerous states have taken it upon themselves to enforce the CPOM laws. These ensure that only licensed medical professionals own or control medical practices. These laws hit medical spas hard, though, ensuring they can't be structured around non-physician investors. What do these laws mean in practice? They mean that if you're a non-physician, you can invest in a medical spa (or any sort of medical practice, for that matter), but you can't run it. The laws vary quite a bit from state to state. For specifics, it would be best to check out the 50-state guide at the link above. In CPOM states, owning a med spa requires licensed physicians or some form of medical corporation to do so. Remember, in CPOM states, non-medical business partners can... - Published: 2025-04-01 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/telehealth-platforms-and-hipaa-data-privacy-compliance-for-remote-services/ Explore essential HIPAA compliance guidelines for telehealth platforms, covering data security, privacy requirements, and best practices for protecting patient information. Insights from Cohen Healthcare Law Group. With the expansion of the telehealth service, ensuring the privacy of its data and compliance with all relevant laws has become a top priority for healthcare providers. Telehealth platforms must put in place robust security measures to protect patient information and avoid fines for regulatory noncompliance. This guide looks at the compliance requirements most relevant to telehealth, with a sharp focus on ensuring that health data remains secure and private—because the side effects of not doing so can harm all the parties involved. Understanding HIPAA’s Privacy and Security Rules for Telehealth The very clear instructions entailed in HIPAA's Privacy and Security Rules detail precisely how telehealth providers must manage protected health information (PHI). To remain on the right side of the law and to maintain the trust of the patients you serve, it is crucial that you follow these rules to the letter. The HIPAA Privacy Rule governs the use and disclosure of a patient's protected health information by telehealth providers. When we say "govern," we mean it in the most practical sense. Telehealth providers must follow the Privacy Rule. They must also—the phrase we used above for the most part says this well—keep in mind what the Privacy Rule allows and requires when they use and share a patient's PHI with a telehealth service. A good place to start to get the full picture is the HHS website. To protect electronic PHI (ePHI), the Security Rule of HIPAA demands that specific safeguards be established. These safeguards are: Safeguards of... - Published: 2025-03-22 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/legal-considerations-for-home-health-agencies-compliance-and-risk-management/ From compliance programs and proper licensing to thorough documentation, learn how to mitigate risks and navigate the complex regulatory landscape to ensure your home health agency operates smoothly and efficiently. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today's video, we'll talk about some legal considerations for home health agencies. So like everybody else in healthcare, home health agencies face a lot of regulations. They need to be understood and they've got legal risks and everything needs to be managed. So first, a home health agencies should implement comprehensive compliance program. We help the home health agency to develop policies and training to meet a slew of regulatory requirements and help them reduce their risk of audit. Second, it's really important to ensure that the staff is properly licensed. Do background checks. We've helped with hiring processes, employment law, to make sure that the caregivers met the state standards so that they could be, obviously, better workers. And third: thorough documentation. Poor documentation can lead to bad results in lawsuits, so we help with record keeping protocols to facilitate compliance. Without legal guidance, home health agency is really exposed to the regulators. They're at their mercy. So you want to have all these planks in place to protect your home healthcare agency's future. If you'd like to dive deeper into any of the topics we've talked about today, reach out to us. Click below. We'd love to talk to you. We look forward to it. Testimonials - Published: 2025-03-22 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/compliance-in-value-based-care-legal-strategies-for-healthcare-providers/ Learn essential compliance strategies for value-based care, covering regulatory requirements, Anti-Kickback Statute, Stark Law, and risk mitigation for healthcare providers. Insights from Cohen Healthcare Law Group. Care that is reimbursed on a value basis is intended to do three things: improve the outcomes for patients, cut back on the costs associated with their healthcare, and link provider payment to the kind of care they give. High-quality care is what we should expect as a matter of course; low-cost, high-quality care is distinctively American and should be the unfailing goal of our system. But navigating the complex landscape of laws that govern our healthcare system without running off the road requires paying very close attention to a few guiding strategies. Those strategies can help keep you on the road, can keep your venture in good shape. Key Compliance Requirements for Value-Based Care Models When you are structuring care models that provide for their value, you absolutely must make sure you're complying with both federal and state regulations. Otherwise, you're courting disaster, as many of the recent healthcare enforcement actions show. Even the forthright federal prosecutors responsible for those actions would concede that knowing the law is half the battle. Healthcare stakeholders must adopt legal strategies that align with the multitude of federal and state regulations that apply to value-based care models. Structuring Value-Based Agreements to Meet Anti-Kickback Safe Harbors The Anti-Kickback Statute forbids any type of payment in return for patient referrals. Yet, recent updates to the regulations have carved out safe harbor protections for certain value-based care models. These safe harbors are meant for coordinated care arrangements involving shared financial risk and performance-based incentives. For compliance,... - Published: 2025-03-15 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/legal-strategies-for-health-coaches-ensuring-compliance-and-building-trust/ Learn about defining your scope of practice, developing effective disclaimers, ensuring detailed informed consent, and navigating complex multi-state licensing regulations. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. Health coaches and health coaching businesses, what do you need to know from a legal perspective? Obviously lots of health coaches out there, health coaches, health coaching, multi-state businesses, everybody loves a coach, right? But what are the legal risks and what do you need to think about? So first of all, define your scope of practice. We worked recently with a health coach who was developing disclaimers, and there's some standard disclaimers. This doesn't replace medical services, warranties, but you want this stuff in there to protect yourself. Informed consent. The consent form has to be detailed, not just this generic, boilerplate thing. There are things that we know to put in, want to talk about the treatment, the risk, the alternatives, very specifically to mitigate the risk that someone could say failed informed consent. Third, licensing, huge area. You know, some states talk about coaching. Some states talk about medicine, psychology. They vary how much they say, what level of detail, what's prescribed, what's allowed. Sometimes nothing said at all. You need a lot of interpretation, and the rules are a patchwork across states. So it's important to find a healthcare attorney that's very experienced working with the healthcare coaching industry to give legal advice for the coaching business or practice. If you'd like to dive deeper into any of the topics... - Published: 2025-03-15 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/understanding-the-stark-law-compliance-essentials-for-healthcare-practices/ Learn the key compliance requirements for the Stark Law, covering prohibited self-referrals, permissible exceptions, and risk mitigation strategies for healthcare practices. Insights from Cohen Healthcare Law Group. The Physician Self-Referral Law, more commonly known as the Stark Law, is very important in keeping our healthcare system as conflict-free as possible. It states that if you are a physician and you have a patient who is on Medicare, you cannot refer that patient to any entity for "designated health services" (DHS) if you have a financial interest in the entity to which you are referring. Prohibited Self-Referrals and Financial Relationships Doctors cannot refer patients covered by Medicare to places where they or their immediate family members have a financial interest. They sure can't do it legally. And yet the Department of Justice (DOJ) and Department of Health and Human Services (HHS) continue to bring cases against doctors, alleging that they have done just this. Services to which doctors can't refer under these conditions are called designated health services (DHS). They include inpatient and outpatient hospital care; imaging; lab tests; and services that involve physical therapy and durable medical equipment. The Stark Law covers financial relationships that include not just direct ownership but also compensation arrangements of various kinds, such as payment for services, office leasing, or other financial arrangements that tie together physicians and DHS providers. If a Stark Law violation is uncovered, the penalties can be steep, running as high as unfathomable fines and the kick to a medical practice that could easily put it out of business: being excluded from Medicare. And repayment of claims found to be in violation can also result in a hefty... - Published: 2025-03-08 - Modified: 2025-10-30 - URL: https://cohenhealthcarelaw.com/anti-kickback-statute-compliance-for-healthcare-providers-and-facilities/ Learn essential Anti-Kickback Statute compliance strategies for healthcare providers and facilities, including safe harbor provisions and risk management tips. Insights from Cohen Healthcare Law Group. The federal Anti-Kickback Statute (AKS) is a vital regulation that healthcare service providers and facilities must follow to maintain ethical financial relationships and steer clear of really bad legal outcomes. This statute makes it crystal clear that you can't offer, pay, solicit, or receive anything of value in exchange for referrals that involve federal healthcare programs. You can imagine why folks in the healthcare business would be concerned about this law (and about violating it, of course). Understanding the Anti-Kickback Statute and Its Scope The AKS casts a wide net over all kinds of remuneration that might be given or received in exchange for healthcare referrals. They cover cash, gifts, and a whole range of other benefits that might serve as bait. The law obviously targets bad behavior—hospitals buying up doctors to ensure a steady supply of patients, for instance—but risk-averse healthcare providers might take the absence of specific legal safe harbors to mean that they ought to avoid almost any kind of profitable interaction with a referral source. Not complying with the rules can get you into a lot of trouble. If the law is broken, the violators can serve up to five years in jail, pay eye-popping fines, and be banned from all sorts of federal programs. But it’s crucial to understand what the rules do and don’t allow, and to get clear on the difference between the AKS and the Stark Law. The latter isn’t in our purview, but a case study associated with it makes the... - Published: 2025-03-05 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/what-is-emergency-use-authorization/ Medical manufacturers and medical practitioners need to understand the FDA rules for developing and prescribing emergency use authorization vaccines and medical devices during pandemics and other healthcare emergencies. The Federal Drug Administration uses “Emergency Use Authorization (EUA)” to “help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases. ” The FDA uses medical countermeasures (MCMs) when public health emergencies require more aggressive procedures to protect the public from harm – such as during the COVID-19 pandemic. COVID-19 Vaccination Requirements and Laws The US Centers for Disease Control and Prevention has clinical care guidelines for the three vaccines that have been approved – the two mRNA vaccines and the Jansen vaccine. How does the EAU authority process work? According to the FDA, “A determination under section 319 of the Public Health Service Act that a public health emergency exists does not enable FDA to issue Emergency Use Authorizations. A separate determination and declaration are needed under section 564 of the Federal Food, Drug, and Cosmetic Act to enable FDA to issue Emergency Use Authorizations, provided other statutory criteria are met. ” The FDA cannot issue an EUA under section 564 of the FD&C Act unless one of the four following determinations occurs “The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency. The Department of Health and Human Services (HHS) Secretary issues a determination of a public health emergency or significant potential for a public health emergency. The DHS Secretary issues a material threat... - Published: 2025-03-01 - Modified: 2025-10-31 - URL: https://cohenhealthcarelaw.com/legal-guidelines-for-functional-medicine-practices-navigating-regulations-and-compliance/ Explore key legal and compliance guidelines for functional medicine practices, covering scope of practice, informed consent, and multistate licensing. Insights from Cohen Healthcare Law Group. As more individuals pursue personalized, holistic healthcare, the functional medicine field is gaining traction. Yet providing care in this evolving space can come with legal complexities. This is primarily because the laws that govern healthcare in the U. S. are made at both the federal and state levels. While federally set standards, such as those found in the Affordable Care Act, apply to all states, much of the functional medicine legal landscape is painted with the brush of state law. And here the picture can vary widely. Both the laws in different states and the informed consent decisions that different groups of practitioners make can—and do—lead to different legal outcomes. Understanding Scope of Practice Regulations Every state has individual laws that define what services healthcare providers can offer based on their credentials. These scope-of-practice laws tell us what kind of procedures and treatments professionals like naturopathic doctors, nurse practitioners, and physicians are allowed to perform. It's essential to work within the legal confines of your license. Practicing outside your authorized scope—like a prescriptive authority, for example—can land you in serious trouble: fines, for one thing; and suspension or even revocation of your license, for another. Even if you're trying to do the right thing by documenting your qualifications to practice in a "specialty" area, you could still end up with a black mark on your record—like a naturopathic doctor in limited-prescriptive-authority state recently did, when he was found to have prescribed a controlled substance—if you haven't really got the legal... - Published: 2025-02-22 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/compliant-marketing-and-product-safety-for-cosmetics-companies-legal-must-haves/ Join Michael H. Cohen, founding attorney at Cohen Healthcare Law Group, as he discusses the intricacies of FDA regulations and marketing challenges faced by cosmetic companies. Hi, I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today's video, I'll talk about some marketing and FDA related issues for cosmetic companies. Cosmetics companies FDA regulations. Their claims are a lot more limited than you can use for dietary supplements. Many companies are confused about this. Again, it's a trouble with FDA. So let's talk about this. But first I'm going to talk about product testing. Product testing is really important because the FDA does have standards there and it's not all about the claims. So you have to make sure that you're ticking off the boxes on the safety side. Now back to claims. The advertising claims have to be substantiated. So if you make claims that are just kind of wild and there's no scientific basis for them, you're going to get flagged. And there's certain standards that FDA and FTC have for marketing claims. And you want to be on top of that and get legal advice. So your claims are going to pass through without undue trouble. And, there are lots and lots of FDA regulations. Again, it's not like you can just throw something on the market. We have attorneys that I've done a deep, deep dive with FDA regulations and they can take you through all these aspects, not just what you'll get from a vendor who helps you figure out what goes on the... - Published: 2025-02-20 - Modified: 2025-12-03 - URL: https://cohenhealthcarelaw.com/how-to-use-the-mso-structure-to-build-your-medical-spa/ Join us for an insightful webinar on "How to Use the MSO Structure to Build Your Medical Spa," where you will you’ll learn how we structure a medical spa for licensed healthcare providers, such as Physicians, Nurses, Physician Assistants, and others. We’ll talk about compliance hot spots and some strategies to mitigate legal risk TRANSCRIPT Good morning. In the next half hour or so, you’ll learn how we structure a medical spa for licensed healthcare providers, such as Physicians, Nurses, Physician Assistants, and others. We’ll talk about compliance hot spots and some strategies to mitigate legal risk. And by the way, we’ll have a recording of this Webinar available, so you’re welcome notes, but you’ll also have a recording. We’re going to cover these three main topics: First, what is an MSO and why do you need one? Second, who owns and who is in charge of the medical spa? If you have various providers working together, such as MD, NP, RN, and PA, who can own what, who has to supervise what and how, and who is responsible for what? Third, how do you grow the medical spa brand and structure? How do you pay people and for what roles? So, buckle your seat belt, turn off distractions and get ready to take notes. Our team has helped hundreds of healthcare professionals—from first-time entrepreneurs to experienced clinicians. By being proactive about their legal strategy, these clients have avoided regulatory trouble and have built local medical spas and national brands that have flourished in the marketplace. First: what is an MSO and why do you need one? MSO stands for Medical Services Organization. The reason medical spas typically use an MSO structure is in order to separate the clinical side of the medical spa from the business, operational side. The clinical side is run... - Published: 2025-02-15 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/compliance-tips-for-nutritional-supplement-companies-navigating-fda-and-ftc-regulations/ Learn essential compliance tips for nutritional supplement companies to meet FDA and FTC standards, covering labeling, health claims, and risk mitigation strategies. Insights from Cohen Healthcare Law Group. Nutritional supplements are becoming big business, but sellers of these products must follow the law if they wish to operate without interference. The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) regulate the marketing of nutritional supplements. The two agencies have a set of rules, laws, and guidelines that they expect those in the business of selling supplements to follow. This article is an overview of what those rules are and what happens if you don't follow them. Key Compliance Requirements for Nutritional Supplement Companies The dietary supplement industry has unique regulatory issues because of the stringent FDA and FTC standards it must meet. This document outlines essential steps necessary for maintaining compliance in this complex, paper-based realm. 1. Adhering to FDA Labeling and Ingredient Disclosure Requirements All labels on dietary supplements must be accurate and complete, according to the FDA. This ensures that consumers know what is in a product and how it is supposed to function. Accurate Ingredient Labeling: The FDA requires that all ingredient lists on supplement labels be in descending order by weight. For clarity, each ingredient must be identified with its common name. Supplement Facts Panel: Every product that is a supplement must contain a Supplement Facts panel. This panel tells you the serving size for the product, the amount per serving, and the % Daily Value for each nutrient, if they have established a value. The panel's presence is about more than just following rules; it's about helping consumers make choices.... - Published: 2025-02-01 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/marketing-cosmetics-safely-fda-compliance-tips-for-cosmetic-companies/ Discover key FDA compliance tips for cosmetic companies, including labeling, claims, and ingredient safety to avoid regulatory issues. Insights from Cohen Healthcare Law Group. The cosmetics industry is highly competitive, with new products constantly entering the market. However, cosmetics companies must comply with FDA regulations to avoid enforcement actions related to misbranding, unsafe ingredients, and misleading claims. This guide covers essential FDA compliance tips to help cosmetic companies market their products safely and legally. Key FDA Compliance Requirements for Cosmetic Companies FDA compliance in cosmetics focuses on proper labeling, avoiding drug claims, and ensuring ingredient safety. Below are essential steps for staying compliant and protecting your brand. 1. Proper Labeling for Cosmetic Products Accurate labeling is a critical compliance area for cosmetics companies. Improper labeling can result in products being classified as “misbranded,” leading to enforcement actions from the FDA. Statement of Identity: Every cosmetic product label must include a statement of identity that clearly describes the nature of the product. This helps consumers understand what they are purchasing. See FDA’s full labeling guidelines. Ingredient List: Cosmetics labels must list all ingredients in descending order of predominance. Ingredients must be listed by their common names to ensure transparency for consumers and avoid misbranding. Warning Labels: Certain cosmetic products, like those containing alpha hydroxy acids (AHAs), may require warning labels about potential risks. Label warnings help educate consumers on safe use. Case Study: A cosmetics company received a warning letter for failing to include an ingredient list on its product packaging. By updating labels to meet FDA guidelines, the company avoided further enforcement actions. See a guide on cosmetics labeling. Key Action: Ensure all cosmetic... - Published: 2025-01-22 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/coaching-and-counseling-across-state-lines-legal-compliance-for-multistate-wellness-businesses/ Learn key legal compliance essentials for providing coaching and counseling services across state lines, including licensing, scope of practice, and patient privacy regulations. Insights from Cohen Healthcare Law Group. As coaching and wellness counseling become more popular, many wellness professionals are offering their services across state lines, often through telehealth or virtual sessions. However, providing services across state borders introduces complex legal and regulatory considerations, including licensing, scope of practice, and patient privacy laws. This guide provides essential legal tips for compliance in multistate coaching and counseling services. Key Compliance Considerations for Multistate Coaching and Counseling When offering coaching and counseling services in multiple states, it is crucial to understand state-specific regulations, particularly licensing and scope of practice limitations. Below are important compliance steps for managing a multistate wellness practice. 1. Determining Licensing Requirements for Cross-State Coaching and Counseling Licensing laws vary significantly by state and often depend on the type of service provided. Licensed counseling or therapy requires a state-specific license, while coaching is generally less regulated but still subject to state laws. Licensing for Mental Health Professionals: Mental health counselors, therapists, and psychologists typically must be licensed in the state where the client resides. Exemptions for Coaching: Coaching services that focus on personal development rather than mental health may not require a license in most states. However, some states may regulate certain coaching activities if they overlap with licensed therapy practices. Interstate Licensure Compacts: Certain professions, like counseling and psychology, are exploring licensure compacts that facilitate cross-state practice. The Psychology Interjurisdictional Compact (PSYPACT) allows psychologists to provide telepsychology services across participating states. Example: A psychologist used PSYPACT to offer telepsychology services in multiple states, ensuring compliance without... - Published: 2025-01-15 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/functional-and-integrative-medicine-compliance-essentials-for-your-practice/ Explore key compliance essentials for functional and integrative medicine practices, including licensing, scope of practice, and patient privacy requirements. Insights from Cohen Healthcare Law Group. Functional and integrative medicine practices offer holistic care and personalized treatment plans, focusing on patient-centered approaches. However, compliance is crucial, particularly because these practices operate at the intersection of traditional and alternative medicine. From licensing to scope of practice, this guide explores compliance essentials that integrative and functional medicine practitioners need to know to avoid regulatory risks and operate legally. Key Compliance Considerations for Functional and Integrative Medicine Practices Functional and integrative medicine practices face unique regulatory requirements, including licensing, patient privacy, and advertising standards. Below are essential compliance steps to help these practices operate within legal boundaries. 1. Ensuring Proper Licensing for Functional and Integrative Medicine Providers Licensing for functional and integrative medicine providers varies by state and may require additional or specific credentials, depending on the types of treatments offered. State Licensing Requirements: Each state has unique licensing requirements that vary based on the practitioner’s background, whether they are MDs, DOs, NDs, or other healthcare professionals. See the list of state-specific licensing boards. Additional Certifications for Alternative Therapies: Practitioners offering alternative therapies, such as acupuncture or naturopathy, may need additional certifications. Some states require separate licenses for non-traditional treatments. Research your state’s licensing requirements carefully. Interstate Practice Considerations: Functional and integrative medicine practitioners looking to provide telemedicine or cross-border care should verify licensing requirements for each state they plan to serve. Certain states may require practitioners to hold an in-state license for telemedicine services. For more on telemedicine licensing, see the IMLC website. Example: A naturopathic doctor offering... - Published: 2025-01-08 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/the-complete-guide-to-healthcare-provider-and-facility-licensing-and-accreditation/ Learn about essential licensing and accreditation requirements for healthcare providers and facilities, including key differences and compliance strategies. Insights from Cohen Healthcare Law Group. Healthcare providers and facilities are subject to a wide array of licensing and accreditation requirements that vary by state and specialty. Licensing ensures that providers and facilities meet minimum standards for safety and quality, while accreditation often represents a higher level of excellence. Understanding these requirements is essential to avoid costly penalties and ensure high-quality patient care. This guide provides a comprehensive overview of licensing and accreditation essentials for healthcare providers and facilities. Key Licensing and Accreditation Requirements Licensing and accreditation requirements cover different aspects of healthcare practice. Licensing is mandatory, whereas accreditation is often voluntary but can enhance credibility. Here are the primary areas to consider for healthcare providers and facilities. 1. Licensing Healthcare Providers: Ensuring Compliance with State Regulations Healthcare providers, including physicians, nurses, and therapists, must be licensed to practice in each state where they operate. Licensing boards ensure that professionals meet the standards necessary for patient safety and quality care. State Licensing Boards: Each state has specific licensing boards responsible for credentialing healthcare providers, including medical, nursing, and allied health boards. Continuing Education and Renewals: Most states require providers to complete continuing education credits to maintain their licenses. Renewal periods and continuing education requirements vary by profession and state. Interstate Licensing Compacts: Certain professions, like medicine and nursing, participate in interstate compacts allowing providers to practice in multiple states. For more information on the Nurse Licensure Compact, visit this site. Example: A nurse practitioner used the Nurse Licensure Compact (NLC) to practice in several states without... - Published: 2025-01-01 - Modified: 2025-11-04 - URL: https://cohenhealthcarelaw.com/how-biotech-companies-can-legally-navigate-fda-ip-and-clinical-trials/ Learn about regulatory planning for FDA approval, essential intellectual property protection steps, and meeting the high standards for clinical trials. Discover how proactive legal advice can safeguard your innovations and streamline your path to market success. Hi, I'm Michael H. Cohen, I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today's video, we'll talk about how biotech companies can navigate FDA IP and clinical trials, lots of topics very quickly. So, biotech and life science companies face a maze of regulatory hurdles, from FDA compliance to intellectual property challenges. Let's explore a couple of strategies to help get through some of these obstacles. So first, regulatory planning is critical. By developing a roadmap for FDA approval early on, companies can avoid costly setbacks later. We work with a biotech startup that initially had overlooked some of the key FDA requirements. With strategic planning and legal input, they streamline their process, saving time and resources later in their negotiations with FDA. On another front, IP protection is obviously critical. Patents, trademarks, trade secrets, they safeguard innovations. We had a client who was at risk of losing a key innovation to a competitor until they filed for a patent. So, getting your IP early on prevents competitors from infringing on your own research. And last, clinical trials, they have to meet a ton of legal and ethical standards. We advised a life sciences firm conducting trials on a new therapy, ensuring that they were able to comply with IRB regulations. Get through the IRB and meet the ethical standards. And this helped them stay compliant. They got to get their trials through, and they also... - Published: 2024-12-22 - Modified: 2025-10-29 - URL: https://cohenhealthcarelaw.com/how-to-structure-your-medical-spa-with-professional-medical-corporations-and-msos/ Learn how to legally structure your medical spa using Professional Medical Corporations (PMCs) and Management Services Organizations (MSOs) to ensure compliance. Insights from Cohen Healthcare Law Group. The rapid growth of the medical spa industry has led to an increase in regulatory scrutiny. Structuring a medical spa within compliant ownership models—such as Professional Medical Corporations (PMCs) and Management Services Organizations (MSOs)—is essential for legal operation. This guide explains how to legally structure a medical spa, including key considerations for ownership, control, and state-specific regulations. Key Components of Structuring a Medical Spa Structuring a compliant medical spa involves understanding scope-of-practice laws, corporate structure options, and management agreements. Below are practical strategies to ensure your medical spa aligns with state laws and operates within a legal framework. 1. Understanding the Corporate Practice of Medicine (CPOM) Doctrine The Corporate Practice of Medicine (CPOM) doctrine restricts non-licensed individuals and entities from owning or controlling medical practices in many states. For medical spas, this means only licensed professionals can own and operate medical services. CPOM Restrictions and State Variations: Each state has specific CPOM rules dictating who can own and control a medical spa. California, for example, enforces strict CPOM laws requiring licensed medical professionals to hold majority ownership. See California's CPOM laws. Physician Ownership and Oversight: Medical procedures offered at medical spas, such as injectables and IV hydration, are considered medical services in many states. This means a physician or similarly licensed professional must oversee and potentially own the medical aspect of the spa to comply with CPOM rules. Avoiding CPOM Violations: Non-licensed business owners can face penalties if they control or influence medical decisions in a CPOM-regulated state. It’s essential... - Published: 2024-12-15 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/building-a-legally-sound-anti-aging-and-functional-medicine-business/ This episode covers key strategies for managing legal risks, including the importance of clear patient consent forms, compliance in marketing and advertising, and consulting healthcare attorneys familiar with state-specific regulations. I'm Michael H. Cohen. I'm founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness. In today's video, I'll talk about navigating legal boundaries for anti aging and functional medicine practices. I love anti aging and functional medicine. I use it myself, and I'm aware that these practices and businesses are in a constantly evolving legal landscape, from complex to complex. regulations to innovative treatments, providers and businesses face unique challenges. And Today I'm going to talk about three strategies to help manage legal risk. First of all, developing clear patient consent forms is essential. Consent forms should outline the scope and nature of treatments, ensuring that patients understand anything that's super risky or even experimental. Recently we had this clinic offering hormone therapy, and they sought our guidance to refine their consent process. And what we did is really help them detail the risks and benefits and the alternatives so the clinic could help the patients make better informed choices while reducing liability risk. of poor informed consent. Second, compliance in marketing and advertising is crucial. Many anti aging services and functional medicine practices tread this line with claims. One provider was using stem cell therapy, and they came to us to review advertising materials, ensuring that these met FDA and FTC guidelines. And what we had to do is really look at every claim against previous enforcement letters in the area to ensure that they didn't cross a... - Published: 2024-12-15 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/medical-spas-and-aesthetic-clinics-key-legal-insights-for-safe-and-compliant-operations/ The popularity of medical spas has soared, offering clients advanced treatments like IV hydration, injectables, and aesthetic enhancements. However, medical spas operate within a highly regulated landscape. The popularity of medical spas has soared, offering clients advanced treatments like IV hydration, injectables, and aesthetic enhancements. However, medical spas operate within a highly regulated landscape. Compliance with scope-of-practice laws, corporate structure regulations, and advertising standards is essential to avoid enforcement actions. This guide provides key legal insights to help medical spas operate safely and legally, balancing innovation with compliance. Key Legal Considerations for Medical Spa Compliance Medical spas face distinct regulatory requirements, especially when it comes to ownership, licensing, and patient safety. Below are practical tips to help your medical spa remain compliant and thrive in this competitive industry. 1. Understanding Scope of Practice for Medical Spa Treatments The scope of practice for services like IV hydration and injectables varies by state, with strict regulations regarding who can administer certain treatments. Compliance with these rules is essential for safe, legal operations. Licensed Medical Professionals: Most states require that medical procedures like injectables and IV hydration be performed or supervised by licensed medical professionals, such as physicians, nurse practitioners, or physician assistants. Check your state’s specific scope-of-practice laws to ensure compliance. Delegation and Supervision: In states where delegation is allowed, ensure that appropriate supervision is provided and that staff are trained for each service offered. Some treatments may require direct physician oversight, especially when IV therapy or prescription-based injectables are involved. Liability Considerations: Medical spas should carry liability insurance that covers treatments offered. Non-compliance with scope of practice can lead to disciplinary actions, fines, or potential malpractice claims. Example:... - Published: 2024-12-08 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/3-legal-keys-to-know-when-starting-an-iv-hydration-clinic-or-medical-spa/ Are you planning to start an IV Hydration Clinic or Medical Spa in Florida or perhaps expand across multiple states? In today’s video, we break down the essential legal foundations you need to know to start an IV hydration clinic, specifically using Florida as a case study. Hi there, are you wanting to start an IV Hydration clinic or a Medical Spa, maybe you wanted to be multi-state or let’s just take one state to showcase, let’s just say, Florida. What are the legal basics that you would need to know? Well, here’s first one. At the moment, there is no single Florida agency that directly and unambiguously regulates IV hydration clinics. The legislature just hasn’t gotten that far. But, that doesn’t mean that an IV hydration clinic is not subject to a host of other existing legal rules. So, for example, think about who’s providing the therapy? Let’s just say it’s a nurse practitioner. Let’s just say the client use a nurse practitioner. So, can you start this IV hydration clinic autonomously? This is actually two different questions. In Florida, the scope of autonomous nursing practice is limited to primary care areas like internal medicine, family practice, pediatrics, geriatrics. The board of nursing has not really further defined the scope of nursing practice to include (or not include) IV hydration clinics. So, our recommendation right now if you’re going to use a nurse practitioner, then the nurse practitioner should have a relationship with a supervising physician in Florida. Now, in some states, this is a collaborative physician, the scope of practice varies by state. And the next question is whether you need what’s called a good faith exam. Currently, Florida does not have this requirement of initial evaluations. But we recommend it because it’s best practice,... - Published: 2024-12-08 - Modified: 2025-10-28 - URL: https://cohenhealthcarelaw.com/telemedicine-across-state-lines-essential-legal-tips-for-compliance/ Explore essential legal tips for telemedicine compliance across state lines, including licensing, patient privacy, and prescribing standards. Insights from Cohen Healthcare Law Group. As telemedicine expands, many healthcare providers are navigating how to legally deliver services across state lines. However, telemedicine involves state-specific regulations, requiring compliance with varying standards for licensing, privacy, and patient consent. This guide provides essential legal insights to help telemedicine providers operate across state lines while managing regulatory risks. Key Legal Tips for Telemedicine Compliance Across States To operate legally across state lines, telemedicine providers must address licensing requirements, patient privacy, and prescribing standards. Below are strategies to ensure compliance while delivering care remotely. 1. Meeting State Licensing Requirements for Multistate Telemedicine Practice Licensing requirements vary widely by state, and telemedicine providers must often hold a license in the state where the patient resides. Failing to meet these standards can lead to fines and disciplinary action. State Licensing Rules: Most states require telemedicine providers to hold an active medical license in the state where the patient is located. Some states participate in the Interstate Medical Licensure Compact (IMLC), which streamlines multistate licensure for physicians. For more information, visit the IMLC website. Provider-Specific Licensing: Requirements may vary for different providers, such as nurse practitioners or physician assistants. These providers should review their profession-specific licensing requirements to ensure compliance across states. Telemedicine Compact Participation: For eligible physicians, joining the IMLC can ease the process of obtaining multistate licenses. This compact allows participating physicians to expand their reach legally with less administrative burden. Case Study: A physician licensed in Texas used the IMLC to expand telemedicine services into multiple states, ensuring legal... - Published: 2024-12-01 - Modified: 2026-06-04 - URL: https://cohenhealthcarelaw.com/what-legal-protections-do-i-need-in-a-contract-manufacturing-agreement-for-dietary-supplements/ In today’s video, we’ll explore the critical legal protections you need in a Contract Manufacturing Agreement (CMA) for dietary supplements. If you’re partnering with a manufacturer to produce and label your dietary supplements, having the right legal safeguards is essential. Hi, I’m Michael H Cohen, founding attorney of Cohen Healthcare Law Group. Today, we’re going to address a very specialized topic, and that is what legal protections do you need in a Contract Manufacturing Agreement for Dietary Supplements? We’re talking about when you hire somebody and they’re going to make the dietary supplements and label them for you. First of all, the Manufacturer, the one actually making the supplements, they have to take legal responsibility for making sure that those supplements comply with applicable laws and regulations. They have the factory; they’re doing the batch production. So, you want them to take legal responsibility. They have to have a whole slew of quality control measures and those are things that we specify in the contract. They have to follow Good Manufacturing Practices, it’s very detailed. As the Client, the one contracting for the supplements, you want to provide the specs. So, you want to say what goes in the supplements. The second really important point is confidentiality. Your contract manufacturing agreement has to protect your information, your proprietary information about what goes in the supplements. And third, more broadly, intellectual property. So, who owns what at the end of the day? Let’s say these supplements become really popular, how do the profits get distributed? Ideally, you just pay the manufacturer to do what it does, and you get the profits. But what if something unusual happens, say that they discover that they have a meeting together and one or the... - Published: 2024-11-22 - Modified: 2025-08-24 - URL: https://cohenhealthcarelaw.com/fdas-discussion-of-disease-awareness-and-prescription-drug-communications-on-television-evidence-for-conflation-and-misleading-product-impressions/ The FDA’s Center for Drug Evaluation and Research conducted a study examining the relationship between disease communications and prescription drug advertising. The results are discussed The Food and Drug Administration regulates which drugs are approved for manufacture, distribution, sale, and use in America. The FDA’s Center for Drug Evaluation and Research (CDER) reviews many aspects of drug safety including clinical trials and the marketing and promotion of drugs. CDER’s work isn’t limited to medications. CDER’s general duties include: “Overseeing prescription drugs, generic drugs, biosimilars, and over-the-counter drugs. Using science and data to ensure drug safety, quality, and efficacy. Streamline the drug development process and ensure drugs are safe and effective. Providing drug information for consumers and patients, health care providers and professionals, industry, and more Making recommendations to update drug labeling. Providing drug information for consumers and patients, health care providers and professionals, industry, and more. Making recommendations to update drug labeling. ” Many products that consumers use that qualify as drugs include such products as fluoride toothpaste, dandruff shampoos, sunscreens, and antiperspirants. What is conflation? The FDA writes that pharmaceutical companies that promote new drugs “may release disease awareness communications about the disease a new drug is intended to treat. ” Generally, communications about diseases explain the signs and symptoms of the underlying medical disorder, what happens if that disorder isn’t treated, and a recommendation to consumers that consumers should consult with the healthcare provider about what treatments to use. The information in these general disease communications may not be consistent with the information in advertisements for the drugs that treat the condition. This various/ confusion is called “conflation. ” Conflation can cause consumers... - Published: 2024-11-15 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/4-things-to-know-when-naming-a-california-professional-medical-corporation/ In today’s video, we’ll explore the essential steps and legal guidelines for naming a Professional Medical Corporation (PMC) in California. Hi, I’m Michael H Cohen, founding attorney of Cohen Healthcare Law Group. In today’s video, we’ll talk about what you need to put in a name in a California Professional Medical Corporation. , affectionally known as a “PMC. ” The rules in California are very specific: You need this Professional Designation that is a professional corporation. Words like "Professional Corporation," "P. C. ," or "Prof. Corp. " So, for example, our law firm “Cohen Healthcare Law Group, PC” There are certain permitted words, and the words really should indicate the specific profession or type of services. For example, "Dermatological Practice" or “IV Hydration Clinic” or “Medical Spa. ” The name have to be distinct from other names of similar entities in California, so that the consumer is not confused. Typically, you want to include the physician’s name. For one, it’s common practice. And secondly, it helps with the branding and the recognition especially if it’s a well-known doc. There might be other very specific medical board or department of public health regulations depending on the exact type of practice, or company, or clinic. So, you will want to check with us but these are the general rules. Another point is that if you got a corporation that say has a 51% MD owner, a 49% Nurse, you might want to put the physician’s name in the title so that nobody gets confused about the ownership of the corporation. Now, a lot of these rules are common sense, and you have... - Published: 2024-11-15 - Modified: 2025-08-24 - URL: https://cohenhealthcarelaw.com/how-do-nursing-and-emt-licenses-and-certifications-differ/ Generally, nurses must obtain their state nursing license by having the proper degree(s) and passing a state nursing exam. Nurses can be certified in specialties. EMTs must obtain their certification before obtaining their license. In this article, we discussed how licensing and certifications differ for other healthcare professions. Licensing and certification requirements for nurses The license requirements for nurses parallel those for doctors but there are differences. Licensing for nurses Generally, nurses must graduate from an accredited nursing program before they can apply for a nursing license. A nurse who graduates from an accredited nursing program obtains their license to practice in a specific state by passing the National Council Licensure Examination (NCLEX). The examination is administered by the National Council of State Boards of Nursing. The nursing license permits the nurse the right to start their nursing career – or permit nurses to practice in a new state if the nurse already has a license in another state. State nursing boards also enforce nursing regulations. The enforcement can include a revocation for certain violations. Our healthcare lawyers advise nurses about what medical laws and regulations apply to their nursing practice such as what level of supervision is required for their services and when nurses can have an interest in a medical practice. Certifications for nurses There are two types of nursing certificates - board specialization and continuing education. Many nurses seek to enhance their credentials by obtaining nursing certificates for various specialties. Some of the nursing organizations that provide these certifications include: The American Association of Critical-Care Nurses (AACN) The American Association of Nurse Practitioners (AANP) The American Nurses Credentialing Center (ANCC) Generally, the certification requirements for the different nursing specialties include having... - Published: 2024-11-01 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/does-a-professional-medical-corporation-prevent-liability/ In today's video, we're going to talk about whether owning and operating a professional medical corporation actually protects the physician or other clinician against liability. In today's video, we're going to talk about whether owning and operating a professional medical corporation actually protects the physician or other clinician against liability. So, the same question could be asked of a professional nursing corporation, professional physician assistant corporation, professional Chiropractic acupuncture corporation, and so on. Hi everyone. I am still Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients like you navigate the complex terrain of healthcare and FDA law so you can launch, grow, and scale your healthcare business. Generally, one of the purposes of any corporation is to limit professional liability and transfer that risk to the entity. So, in broad terms, when the professional medical corporation gets sued, that liability is supposed to accrue to the corporation, not the individual. Now, there's one really significant exception that's known as piercing the corporate veil. Ouch. If corporation is really a sham, if it doesn't follow corporate formalities like having a board of directors and regular meetings minutes, or is seriously undercapitalized, then yes, it's possible that the limited liability protection can be pierced, punctured. The other important caveat is that if there is a malpractice lawsuit against the physician who's head of the professional medical corporation, or against any clinical staff that the physician is responsible for supervising, or for example, there might even be a claim of malpractice based on negligent supervision by the physician. Then, staff or the physician could be held personally liable, and the corporation... - Published: 2024-10-22 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-an-mso-switch-medical-directors/ In today's video, we'll talk about the role of the medical director in a med spa, or an IV hydration clinic, or integrative medicine center wellness clinic. What happens when a healthcare venture tries to swap out one medical director and swap in another? In today's video, we'll talk about the role of the medical director in a med spa, or an IV hydration clinic, or integrative medicine center wellness clinic. What happens when a healthcare venture tries to swap out one medical director and swap in another? So, in our hypothetical today, Mary sue, managing member of an LLC that operates an MSO for medical spa, presents us with an oddball situation. And these oddball situations come up all the time with twists and turns. So, Mary sue had created a so called friendly professional medical corporation. Friendly, meaning that the MSO controls the hiring and firing of a medical doctor in charge of the professional medical corporation. Now, some state enforce a strong Corporate Practice of Medicine prohibition. This is a no. The medical board is not friendly. And they say that the MSO can't control the hiring and firing of medical doctors. No way, no how. But Mary sue was in a presumably weak corporate practice medicine state or no corporate practice of medicine state. So, she simply hired a new medical director and transferred to this new MD the shares of the old medical director. And having made this move, Mary sue came to us after the fact for legal advice. Well, this took a bit of unwinding. So, as mentioned, the very first question is whether the so-called friendly PC model or the MSO calls the shots of who controls the professional medical corporation will even pass muster in... - Published: 2024-10-15 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/good-faith-exams/ So, one of our clients was asking about the good faith exam. Now, does this need to be an actual conversation between the MD and the patient? Or can the patient simply complete the medical questionnaire, sign that they're responsible for everything, for talking to the primary care doctor about any iv hydration treatments that they're receiving? So, one of our clients was asking about the good faith exam. Now, does this need to be an actual conversation between the MD and the patient? Or can the patient simply complete the medical questionnaire, sign that they're responsible for everything, for talking to the primary care doctor about any iv hydration treatments that they're receiving? Hi, I'm Michael H. Cohen. I am indeed founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients, just like you, navigate the complex terrain of healthcare and FDA law so you can grow, launch, scale your healthcare business. Now, a good faith exam, as you probably know, is a standard medical exam performed by a physician according to the professional standard of care. And we typically recommend conducting an in-person exam, at least at the beginning, so the physician can see the patient and discuss in real time. It's a risk management technique. It depends, really, on state law, and states are all over the map. But that's the fundamental just good practice. The exam should be done at least once a year, more if indicated. So, if a patient just had surgery, they have problems with their medication, they've revamped their dietary supplements, they had an accident, they're pregnant, then obviously, more exams are required. Medical boards do pursue practitioners in IV hydration clinics for failing to meet this hurdle. So again, it's good risk management. But we will give tailored advice to you. We look forward to talking... - Published: 2024-10-11 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-an-mso-get-paid-more-than-fair-market-value/ In this video, we're going to talk about the MSO and whether it is possible to transfer all the money from the professional medical corporation or practice actually to the MSO. It's like MSO fee. In this video, we're going to talk about the MSO and whether it is possible to transfer all the money from the professional medical corporation or practice actually to the MSO. It's like MSO fee. Hi, I'm Michael H. Cohen. I'm founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients like you navigate the complex terrain of healthcare and FDA law so you can grow, launch, scale your healthcare business. So, the answer is no. You cannot simply transfer, like all of the funds from a medical practice to an MSO. California laws require that the percentage that's paid to the MSO represent fair market value for the MSO services. Now, there's no bright line rule for what is and is not fair market value, but there are appraisers in this industry, people who could give you a valuation opinion. As a law firm, we don't provide opinions about valuation, but we do have kind of a general rule of thumb. So, if the MSO's fee is really high, people assign different percentages. Some say 50, 60, 75%. The point is, at some point, it tips the balance toward looking like there's so much control by the MSO that it's a corporate practice of medicine problem. Please note that the fees, how they calculated, should be fixed in the agreement. And they shouldn't just wobble up and down, you know, based on circumstances, because that would be a kickback. Unless they represent the fair market value of... - Published: 2024-09-23 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/starting-up-a-second-medical-corporation/ Sally, a licensed MD, is looking to open a second medical practice across the hall from her main practice so that she can focus on niche medical procedures, such as aesthetic medicine procedures. Sally, a licensed MD, is looking to open a second medical practice across the hall from her main practice so that she can focus on niche medical procedures, such as aesthetic medicine procedures. Now, the procedures, you know, might be billed to insurance, and they could also be, you know, regular medical procedures, but the main practice is on a cash basis. So, you know, what should Sally do? Hi, I'm Michael H. Cohen, founding attorney of Cohen Healthcare Law group. We help healthcare industry clients like you navigate the complex terrain of healthcare and FDA law so you can grow, launch, scale your healthcare business. And here there might be some logic to having two separate medical practices. However, you know this immediately. We have two different entities. You've got stark self-referral as well as anti-kickback issues. And there's the additional variable of having one cash practice and one based on insurance. So, you know, we got to just comb through the issues. And there are a bunch of exceptions to the self-referral laws, such as referrals within a group practice and a very nuanced. So, we've covered them elsewhere. But in general, the insurance piece has to be navigated pretty well so that Sally can ensure, for example, that nothing in her agreements with insurers prohibits her from billing patients on a cash basis and part of a practice, even if under the rubric of a separate medical corporation. And the referrals from one end to another, you... - Published: 2024-09-10 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-a-paramedic-own-and-operate-an-iv-hydration-business/ Today's question is: Can a paramedic own and operate an IV hydration clinic? Today's question is: Can a paramedic own and operate an IV hydration clinic? Glad you asked that question. Hey, I'm Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. We help you navigate healthcare and FDA laws so you can grow your healthcare venture. Call us with any questions. We're here to grow your health care business. Now here from the wild, a question of who can own and operate an IV hydration business really varies by state and by professional. And as well, owning is different from providing services or operating the business. So that's even different because that could be management. So, the first thing to do is to look at the legal definition of paramedic scope of practice in a given state. And this means looking at the licensing statute. Oftentimes, the licensing statute will give the paramedic legal authority to administer IV in an emergency situation. Now, an IV hydration clinic doesn't exist for emergencies. It's for general wellness. And so, regulators here could see some kind of line crossing into unlicensed practice in medicine. So generally, no go. Recently, we researched a statute that allows paramedics to administer IV hydration in non-emergency situations, for example, in urgent care clinics. Now, that's urgent, but maybe not an emergency, but the statute that we're talking about limited the paramedic to providing IV hydration during their official duties. Now, what is official duties mean? We asked the local state board, and of course, we got no response.... - Published: 2024-09-01 - Modified: 2025-08-28 - URL: https://cohenhealthcarelaw.com/what-does-a-medical-compliance-officer-do/ A medical compliance officer should work with a healthcare lawyer to understand the federal and state laws and regulations that govern the medical compliance officer’s medical practice or medical company. According to MedTrainer, a health business company, a Healthcare Compliance Officer’s (HCO) job is to understand the laws, regulations, and medical standards that govern medical practices and any company that works in the healthcare profession. Every physician’s office, medical group, medspa, or any other healthcare provider – and any medical business - must understand what federal, state, and local laws and medical standards their healthcare company must follow. Many healthcare practices and companies hire an individual person to serve as an HCO – either on a full-time or a part-time practice. Some healthcare practices and companies also have a compliance committee. HCOs should consult with an experienced healthcare lawyer who understands the applicable laws and advise healthcare businesses about the steps and options for coming into compliance. What are the duties of a healthcare compliance officer? HCOs help develop, implement, and review compliance protocols to help each member of the practice understand their legal and ethical obligations. A starting point for HCOs is to review, understand, and use the compliance program guidance provided by the Officer of Inspector General (OIG) for the US Department of Health and Human Services (US HHS). The OIG’s compliance program recommends that HCOs focus on the following seven compliance techniques: Written policies and procedures. Healthcare practices and companies should have written standards and policies that the members of the medical company should have, review, understand, and implement. Compliance leadership and oversight. The healthcare practice/company should appoint a lead healthcare compliance officer who has the responsibility... - Published: 2024-08-23 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-a-physician-pass-through-marketing-fees-to-the-mso/ In today's video, George is a marketing professional who does SEO and digital marketing in house for physicians and health and wellness businesses. George is wondering whether it's okay for medical practices to pay his fee through the management company or MSO, or directly from the professional medical corporation. Hi, everyone. In today's video, George is a marketing professional who does SEO and digital marketing in house for physicians and health and wellness businesses. George is wondering whether it's okay for medical practices to pay his fee through the management company or MSO, or directly from the professional medical corporation. Hi, I'm Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients, just like you, navigate the complex terrain of healthcare and FDA law so you can grow, launch, scale your healthcare business. George has an odd question. So, the fees are owed by the physician to George. So ideally, they would be paid by the physician or the MD's professional medical corporation to the marketing company. George's company. That's the cleanest way to do it. However, you know, marketing is something normally done by the MSO. So, it would not be unusual for the MSO to hire someone like George and then charge a marketing fee to the professional medical corporation. So that's how the fees will flow. But the main consideration is how the marketing fee is structured. So, while it's common for MSOs to subcontract marketing services to a third-party marketing company like George, wherever services are provided in the healthcare industry and marketing, we recommend that the marketing fees be charged at fair market value and usually at a flat fee. If more than fair market value is given or received for marketing services, it sets up anti-kickback problem. Because... - Published: 2024-08-16 - Modified: 2025-08-28 - URL: https://cohenhealthcarelaw.com/how-mergers-and-acquisitions-affect-employees/ Medical practices and companies who merge with or acquire another practice or company need to understand and plan for how the transaction affects the rights, benefits, and concerns of their employees Mergers (the consolidations of two companies) and acquisitions (the purchase of one business by another business) affect the employees of both companies in many ways. Medical practices and medical companies need to understand how mergers and acquisitions affect the employees from many different vantage points starting with who stays and who may be let go, the workload of the employees after the merger or acquisition, employee benefits, and the overall morale of the new single entity. According to an M & A software company based in Chicago, some of the employee considerations the new company must consider are: The effect on the employees of each medical practice or business The new management will need to review the following employee concerns which include advantages and disadvantages for the new practice and the employees: The roles of the employees. Some employees may be let go. Some jobs will have been performed by the same employees in each venture. For example, if two medical practices merge, each practice may have had its own billing clerks, receptions, managers, and compliance personnel. When the companies merge or one is acquired, decisions need to be made about which employees might be discharged, what each employee might do that the employee did before the new company was formed, and what new duties each employee may have. The owners of the companies involved in the merger or acquisition might offer severance packages to help employees decide who leaves the company rather than just having the new owners fire... - Published: 2024-08-16 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-the-mso-charge-a-variable-digital-marketing-fee/ In this video, we answer an MSO question, so can the MSO have a digital marketing fee as its expense, and can the fee be variable? In this video, we answer an MSO question, so can the MSO have a digital marketing fee as its expense, and can the fee be variable? Hi, I'm Michael H. Cohen, founding attorney, Cohen Healthcare Law Group. We help healthcare clients, just like you, grow and scale your business by navigating the complex arena of healthcare law. So, sometimes we recommend that the MSO seek reimbursement from the practice. For the MSO it’s hard advertising costs like Google Ads, Facebook ads and similar costs, and this is a risk mitigation practice just for the advertising to help against anti-kickback concerns. But it's really variation of the idea that marketing efforts are best compensated by a flat fee, whereas, for example, the broader administration, management and execution of these tasks can have a variable fee in many states like California, as long as that fees commensurate with fair market value and the level of service. I went a little fast on this, but there's much more on our blog. Appreciate you watching. Please let us know if you have any questions. We're with you on your journey to business success. Testimonials - Published: 2024-08-01 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/complying-with-hipaa-de-identification-standards/ In this short video, we're going to talk about how one of our clients is planning to do a clinical study, and they want to share the participant data with a third party for analysis. In a short video, we're going to talk about how one of our clients is planning to do a clinical study, and they want to share the participant data with a third party for analysis. Now, how do they do that with HIPAA? They have to share the data on a blind basis. Let's explain. Hi, I'm Michael H. Cohen, founding attorney, Cohen Healthcare Law Group. And our job is to help healthcare industry clients like you navigate the complex and often mystifying terrain of healthcare and FDA law, including HIPAA, so you can grow your healthcare venture. So, yeah, it's good to comply with HIPAA. Specifically, here, there are very specific de-identification standards which are going to require you to strip away certain categories of personally identifiable information from records before releasing them to a third party. And this is the method. It's kind of a safe harbor under HIPAA. HIPAA is excruciatingly detailed, and we can help you get through the de identification agreement and some of these basics along your way. We look forward to working with you. Please give us a call, and we wish you the best on your continuing journey toward business. Testimonials - Published: 2024-07-15 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/should-nps-pas-and-mds-be-1099-or-employees/ In today's video, we'll discuss whether nurse practitioners and physician assistants can be 1099 contractors in a medical practice in California. In today's video, we'll discuss whether nurse practitioners and physician assistants can be 1099 contractors in a medical practice in California. Hi, I'm Michael H. Cohen. I'm founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients like you navigate the complex terrain of healthcare and FDA law so you can grow, launch, scale your healthcare business. So generally, it's almost always legally safer in a highly regulated, highly litigious environment such as California or similar states for a practice, a medical practice to pay its clinical service providers as W2 employees. In general, depending on the state, penalties can be very high for misclassifying employees as independent contractors. Classifying nurse practitioners and physician assistants as employees can bring several risk mitigation benefits. Secondly, mitigates the risk of a disgruntled worker leaving the practice and then finger pointing at the practice on, you know, the behest of a plaintiff's attorney saying that they were illegally misclassified as 1099 when they should have been a W2 and received salary and employment benefits. Now, of course, contractors can be more profitable and healthcare startups weigh the legal risk against the business advantages. So, some healthcare entities do assume the risk of misclassification. I mean, I wouldn't push it too far, but they do pay workers on a 1099 basis. But they should know that the control test is what normally applies. So, the more control the healthcare business has over the worker, the more likely the worker is going to... - Published: 2024-04-22 - Modified: 2025-08-25 - URL: https://cohenhealthcarelaw.com/understanding-the-different-types-of-nursing-jobs-and-corresponding-compliance-issues-part-one/ The nursing profession includes many different levels of jobs based on a nurse’s education and job duties. All nurses are affected by federal and state laws and regulations that need to be understood. There are many different types of nursing professions. Each different type has specific academic and licensing qualifications. There are numerous federal and state regulations that govern nursing practices generally and each type of nursing profession specifically. We’ve previously discussed many of the different types of compliance issues that nurses need to consider. This sequence of articles (there will be two additional parts) begins with identifying the different types of nursing jobs. We’ll also discuss the different types of nursing business opportunities. We’ll then discuss some of the leading concerns that nurses (all nurses and nurses with specific specialties) need to review with an experienced healthcare lawyer. We’ll finish by explaining how a Managed Service Organization (MSO) can help address some of these compliance issues. Here's a recap of some of our more recent nursing profession compliance articles: 7 Reasons Why Nurses Lose Their License Nurse Entrepreneur: How to Tackle Legal Challenges of Owning a Medical Spa or other Healthcare Business Nurse Practitioner Telehealth Functional Medicine vs. Coaching (Laws & Legal) Can an ND Supervise Nurse IV Injections? Medical Spa Laws Detail Physician vs. Nurse Authority California Assembly Bill (AB)-890 and Two New Nurse Practitioner Categories Do California Nurses Need a Collaborating Physician? California’s New Scope of Practice Law for Nurse Practitioners - Part One California’s New Scope of Practice Law for Nurse Practitioners - Part Two How to Use a Management Services Organization for Profit if you're a Doctor, Nurse, or Entrepreneur What are the different types of nursing practices?... - Published: 2024-03-22 - Modified: 2025-08-26 - URL: https://cohenhealthcarelaw.com/msos-and-compliance-issues-for-anti-aging-aesthetic-clinics/ The doctors and owners of anti-aging medical practices need to understand what procedures and treatments require FDA approval, who can perform the procedures, and many other compliance issues. An MSO can help address some of these compliance issues. Anti-Aging Aesthetic Clinics offer various health-related services, often through a medical spa. Numerous federal and state healthcare laws regulate several aspects of these clinics, including: Who is authorized to provide these services? Whether the services provided are classified as medical services. Whether those performing the services may breach unauthorized practice of medicine laws. Whether ownership interests constitute the corporate practice of medicine. Whether FDA approval is required for any drugs, devices, or procedures. The legality of referral arrangements between clinic owners and collaborating doctors. Many other related issues. In this article, we delve into the services offered by anti-aging clinics, highlight key legal compliance concerns, and explore how a Managed Service Organization (MSO) can be employed to address some of these compliance issues. What is Anti-Aging? As previously discussed, the more medical term for anti-aging medicine is biogerontology. Anti-aging medicine "focuses on diagnosing, understanding, preventing, and attempting to cure certain age-related impairments. " Many doctors, physician practices, and healthcare companies in the anti-aging field promote their products and services as capable of extending someone's life. As with all medical practices, federal and state regulations govern the claims made regarding what products and services can achieve for a patient and the accuracy of promises made to patients. This includes regulations from the FDA and FTC, as well as local and state regulations. LEGAL RISK ISSUES IN REGENERATIVE MEDICINE AND ANTI-AGING MEDICINE As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As... - Published: 2024-03-22 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/can-the-mso-management-fee-be-more-than-90-of-the-revenue-of-the-medical-practice/ The anti-kickback laws require these fees to be fair market value and not take into consideration the referral of any patients that might come from the MSO to the medical practice. The anti-kickback laws require these fees to be fair market value and not take into consideration the referral of any patients that might come from the MSO to the medical practice. It so happens these days that a lot of MSOs will provide marketing services for the medical practice. And depending on your state law, it could open the door to interpretations that there are patient referrals and that part of that fee may be in consideration for the volume or value of the patient referrals. There’s no one answer, what is fair market value? 90%, just kind of my gut reaction to it, is that’s way too high for a management company to be charging. And I always tell clients, at the end of the day, put yourself in the position where you’re defending this fee, and if you’re in court and you see the person up there in the black robes and you’re trying to justify this fee, it might look a little strange that the lion’s share of the practice is going to a lay business, the management company. And so that would raise a number of alarm bells to most judges, to most enforcement agencies out there. Testimonials - Published: 2024-03-08 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/what-can-a-nursing-corporation-in-california-be-used-for/ The Medical Board has issued a number of different opinions that the medical spa must be a medical corporation, not a nursing corporation. I just want to make extra clear that in California, the Medical Board has issued a number of different opinions that the medical spa must be a medical corporation, not a nursing corporation. I can’t tell you how many times people have formed a nursing corporation, and then we have to unwind everything and fix it, and it gets expensive to do that. So to the extent any of you are on the verge of forming an entity, it would be a medical corporation in California, not a nursing. Testimonials - Published: 2024-03-08 - Modified: 2026-01-19 - URL: https://cohenhealthcarelaw.com/hipaa-compliance-for-pharmacies-violations-and-faqs/ Pharmacies should consult with experienced healthcare lawyers to understand what conduct may qualify as a HIPAA violation, the penalties for violations, and to get answers to HIPAA compliance questions. This is our second article about what pharmacies should know about complying with HIPAA. In the first part, we discussed which HIPAA rules apply to pharmacies, as well as the best practices for pharmacies to demonstrate HIPAA compliance. This article provides examples of HIPAA violations and the potential consequences of violations. This article also answers FAQs about pharmacies and HIPAA compliance. GOT HIPAA? GET HIPAA? JOYCE EXPLAINS WHY AND HOW Interview with an expert in healthcare privacy and security, both on the federal side with HIPAA, and the state side, especially California law. What conduct by a pharmacy is considered a violation of HIPAA? A few examples of HIPAA privacy violations include disposing of Patient Health Information (PHI) in the trash instead of shredding it, leaving prescription information in areas that can be accessed by the public, and disclosing any prescription information to third parties without patient’s consent. HIPAA violations include the following: Unauthorized access. This includes intentionally or accidentally accessing patient health information – without patient authorization or a legitimate need – thus violating the patient’s privacy rights. Improper disposal. Pharmacies may be cited for HIPAA violations if they improperly or incompletely dispose of patient records, medication information, or prescription labels that potentially expose sensitive data to people who are not authorized to see the information. Inadequate Physical Security. This type of violation includes the failure of the pharmacy to develop and implement physical safeguards to protect Patient Health Information. Improper handling of prescriptions. Pharmacies may violate HIPAA if... - Published: 2024-03-02 - Modified: 2025-12-09 - URL: https://cohenhealthcarelaw.com/should-the-mso-be-an-s-corp-and-the-medical-practice-be-a-c-corp-or-vice-versa/ We always recommend getting a CPA involved to help determine what tax election you should make and so that would be the answer to that one. It really depends on revenue projections and things like that. The S-Corp C-Corp distinction is a tax distinction. Under the IRS, you have the ability to do an S election or remain a C-Corp, and C-Corp is double taxation on the corporate level, and the individual S-Corp is on the individual only. It’s a pass-through. We always recommend getting a CPA involved to help determine what tax election you should make and so that would be the answer to that one. It really depends on revenue projections and things like that. Testimonials ## Employees