Healthcare Law

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 [...]

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 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, [...]

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, [...]

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 [...]

The Food and Drug Administration has numerous guidance articles about premarket submissions for the developers of medical devices. We discuss steps one and two.

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,” effective January 1, 2025, requires human oversight of the use of artificial intelligence in medical treatments and decisions.

Discover legal compliance strategies for medical spa ownership, covering corporate practice of medicine, MSO structures, and physician partnerships. Insights from Cohen Healthcare Law Group.

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