Can You Take Patient Records When Leaving a Medical Practice?
August 26, 2025
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 [...]
What Are the OTC Drug Label Requirements?
August 23, 2025
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 [...]
Health Care Proxy vs Durable Power of Attorney
August 19, 2025
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.
Can Medical Offices Go Corporate?
August 14, 2025
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 [...]
FDA and FTC Legal Boundaries for Cosmetics
August 11, 2025
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, [...]
What Are FDA Warning Letters and How Do They Impact You?
August 8, 2025
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 [...]
Corporate Practice of Medicine
August 3, 2025
The Corporate Practice of Medicine (CPOM) is a legal doctrine that prohibits corporations and non-physicians from owning or controlling medical practices. Its purpose is to preserve physician [...]
AKS Safe Harbors
July 25, 2025
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 [...]
Can an RN Start an IV Hydration Business?
July 22, 2025
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 [...]
Are Kickbacks Illegal?
July 21, 2025
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, [...]
Does Stark Law Apply to Medicaid Patients?
July 17, 2025
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 [...]
Doctor Not Paying Rent for Surgery
July 14, 2025
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 [...]
How to Transfer Medical Records Between Doctors Safely
July 10, 2025
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 [...]
Examples of Pharmacy HIPAA Violations
July 8, 2025
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 [...]
Can I Open a Clinic Without Being a Doctor?
June 26, 2025
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 [...]
MSO Rules for Med Spas
June 24, 2025
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 [...]
Durable Medical Equipment Compliance
June 19, 2025
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.
Marketing Stem Cell Therapies as a Chiropractor: FDA & Legal Pitfalls to Avoid
June 15, 2025
Chiropractors marketing stem cell therapies face FDA and FTC enforcement risks due to unapproved treatments and misleading advertising claims. Learn how to avoid regulatory penalties, structure legal [...]
Clinical Trial Compliance Key FDA Regulations for Research Organizations
June 8, 2025
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 [...]
Navigating FDA’s cGMP Standards for Dietary Supplement Manufacturers
June 1, 2025
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 [...]
Mobile Health Apps Legal Compliance Essentials for FDA and FTC Standards
May 22, 2025
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 [...]
Recent Dietary Supplement FDA Alerts and Warning Letters
May 18, 2025
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 [...]
Risk Management and Compliance for Direct-to-Consumer Genetic Testing Companies
May 15, 2025
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 [...]
FDA Guidance on Studying and Marketing Medical Devices – Part Two
May 12, 2025
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps three and four.
Legal and Compliance Strategies for Health Coaching Businesses
May 8, 2025
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
May 5, 2025
The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.
Advertising Compliance for Medical Devices: FTC and FDA Requirements
May 1, 2025
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 [...]
Healthcare Mergers and Acquisitions: Legal Considerations for Providers
April 22, 2025
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
April 18, 2025
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
April 15, 2025
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
April 8, 2025
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
April 5, 2025
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
April 1, 2025
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.
Compliance in Value-Based Care: Legal Strategies for Healthcare Providers
March 22, 2025
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.
Healthcare Compliance and Laser Treatments – Part Two
March 18, 2025
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 [...]
Understanding the Stark Law: Compliance Essentials for Healthcare Practices
March 15, 2025
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.
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