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 [...]