Michael H. Cohen

For more than four decades, Michael H. Cohen has advised healthcare providers, entrepreneurs, and organizations on navigating complex regulatory frameworks, structuring compliant business models, and managing legal risk in a rapidly evolving healthcare landscape. His practice focuses on helping clients align innovation with regulatory requirements across a wide range of healthcare and life sciences sectors.

Michael works with healthcare professionals, startups, and established companies on transactional, compliance, and strategic matters involving healthcare delivery, technology, and emerging modalities. He brings a practical understanding of how regulatory structures impact business operations, informed by decades of experience counseling clients and resolving high-stakes disputes.

In addition to his legal practice, Michael has served in academic and research roles that shaped national conversations around healthcare law and policy. He held faculty appointments at Harvard Medical School and the Harvard T.H. Chan School of Public Health, where he developed policies and procedures for integrative medicine across multiple affiliated hospitals and led interdisciplinary research initiatives supported by national grant funding. His work has addressed legal and ethical considerations in healthcare innovation, complementary and alternative medicine, and patient care delivery.

Michael has authored multiple books and more than 100 articles published in peer-reviewed medical journals and leading legal publications. He also has delivered lectures at academic institutions and professional conferences throughout the United States and internationally.

Independent of Offit Kurman, Michael also serves as a healthcare arbitrator and mediator through Healthcare ADR Inc., on the panels of the American Arbitration Association (AAA), the World Intellectual Property Organization (WIPO), the American Health Lawyers Association (AHLA) Dispute Resolution Service, and National Arbitration and Mediation (NAM). As an attorney who arbitrates complex, multi-million-dollar healthcare legal disputes, Michael understands firsthand how regulatory and structural vulnerabilities can translate into litigation, giving the transactional and compliance counsel he helps bring to clients a dimension that few regulatory attorneys can offer.

Areas of Focus:

• Healthcare Corporate and Commercial
  Advises healthcare providers and organizations on healthcare transactions, including mergers and acquisitions, affiliations, and clinical integration arrangements. Counsels clients on healthcare contracts and regulatory compliance involving physician employment agreements, joint ventures, and vendor relationships, with a focus on aligning business objectives with healthcare regulatory requirements.
• Healthcare Data Privacy and Security
  Counsels healthcare providers, business associates, and health technology companies on HIPAA compliance, HITECH requirements, and healthcare data privacy laws. Advises on data breach response, risk mitigation, and Business Associate Agreements to ensure regulatory compliance and protection of sensitive health information.
• Anti-Kickback Statute and Stark Law Compliance
  Advises healthcare organizations on fraud and abuse laws, including the Anti-Kickback Statute and Stark Law. Structures physician compensation and referral arrangements to meet regulatory safe harbors and exceptions, while conducting compliance reviews to mitigate enforcement risk.
• Corporate Practice of Medicine and MSO Structuring
  Guides healthcare providers, investors, and management services organizations (MSOs) on corporate practice of medicine laws and compliant business structuring. Drafts and negotiates MSO agreements and management arrangements across multiple states, supporting regulatory compliance and operational efficiency.
• Telemedicine and Digital and Mobile Health
  Advises telemedicine companies and digital health platforms on multi-state regulatory compliance, including licensure, prescribing, and reimbursement requirements. Counsels health technology developers on FDA, FTC, and state regulatory frameworks impacting digital health and innovation.
• Emerging Healthcare Modalities
  Counsels emerging healthcare businesses including integrative medicine, medical spas, and telehealth venture, on regulatory compliance, licensing, and corporate structure. Advises on healthcare innovation in areas such as regenerative medicine, wellness services, and non-traditional care delivery models.
• FDA and FTC Regulatory Matters
  Advises life sciences and consumer health companies on FDA and FTC regulatory compliance, including labeling, marketing, and claims substantiation. Counsels on advertising standards, product classification, and enforcement risk across pharmaceuticals, medical devices, and dietary supplements.
• Healthcare Regulatory Compliance
  Provides healthcare regulatory counsel on federal and state laws, including HIPAA, Stark Law, and Anti-Kickback requirements. Conducts compliance assessments and risk analyses to help healthcare organizations identify vulnerabilities and maintain regulatory compliance.
• Academic and Research Contributions to Healthcare Law
  Brings a strong foundation in healthcare law and policy through academic research, publications, and teaching. Contributed to national and international discussions on healthcare regulation and innovation through peer-reviewed scholarship, grant-funded research, and presentations at leading academic and professional institutions.