Healthcare & FDA Law Blog

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.

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.

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.

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.

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 upshot is that promotional claims about medical devices, including advertising, must be truthful and not misleading. To achieve this, the FDA [...]

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.

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