Can an RN Start an IV Hydration 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 [...]

How to Transfer Medical Records Between Doctors Safely

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 [...]

MSO Rules for Med Spas

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.

Durable Medical Equipment Compliance

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.

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, [...]

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, [...]

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 [...]

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.

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.

California’s “Physicians Make Decisions Act” Regulates the Use of AI in Insurance Decisions

California’s “Physicians Make Decisions Act,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.

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.

Operating Multistate Telemedicine Practices: Compliance Tips for Physicians

Explore compliance tips for operating multistate telemedicine practices, covering licensure, patient consent, and data privacy standards. Insights from Cohen Healthcare Law Group.

Nurse Practitioner Practice Authority

Doctors and nurses in California and many other states can provide certain medical procedures if those standard procedures are set forth in a practice agreement/collaborative agreement.

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 [...]

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 Compliance and Laser Treatments – Part Two

Laser technology is being used for many different types of medical treatments including surgery, dermatology, eye care, and dental care. Medical providers need to understand the healthcare [...]

Healthcare Compliance and Laser Treatments – Part One

Laser technology is being used for many different types of medical treatments including surgery, dermatology, eye care, and dental care. Medical providers need to understand the healthcare [...]

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 [...]

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.

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. [...]

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 [...]

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.

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 [...]

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.

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.

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.

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 [...]

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 [...]

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.

Top Strategies for HIPAA Compliance Every Healthcare Business Needs to Know

Discover essential strategies for HIPAA compliance that every healthcare business needs to implement, covering patient data protection, risk management, and best practices. Insights from Cohen [...]

FDA’s 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

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 [...]

How do healthcare certification, accreditation, and licensing differ?

Healthcare licenses generally require that applicants have specific educational degrees and pass appropriate exams. Certifications generally confirm an individual has specialized knowledge. [...]

Corporate Integrity Agreements and Exclusions from Medicare and Medicaid

Healthcare practitioners and healthcare entities can enter into corporate integrity agreements with the OIG (of HHS) to ensure compliance in return for continued participation in federal [...]

Modernizing the New Drugs Regulatory Program

The Center for Drug Evaluation (CDER), in 2017, developed an initiative to modernize CDER’s New Drugs Regulatory Program (NDRP). The initiative focuses on scientific leadership, benefit-risk [...]

Compliance Requirements for the Ryan Haight Online Pharmacy Consumer Protection Act of 2008

The Ryan Haight Online Pharmacy Protection Act of 2008 regulates how pharmacists can dispense certain controlled substances and how practitioners should comply.