Michael H. Cohen

Healthcare Corporate and Commercial

• Advised physicians, dentists, podiatrists, and other licensed healthcare professionals in a wide range of commercial arrangements, including mergers and acquisitions, affiliations, recruitment arrangements, and other types of clinical integration transactions across numerous medical and surgical specialties.
• Advised digital and mobile health entrepreneurs on fundamental regulatory and business structural issues.
• Drafted and negotiated complex commercial contracts among and between healthcare providers and pharmaceutical and medical device manufacturers.
• Drafted and negotiated a wide range of healthcare-related contracts, including physician employment agreements, buy-sell agreements, operating agreements, vendor contracts, and joint venture agreements.
• Negotiated contracts between healthcare providers, insurers, and suppliers, ensuring compliance with regulatory requirements.

Healthcare Data Privacy and Security

• Advised healthcare providers, business associates, and health technology companies on the interpretation of HIPAA and HITECH regulations.
• Coordinated data breach responses involving protected health information subject to HIPAA and personally identifiable information subject to state breach law.
• Drafted and negotiated Business Associate Agreements for healthcare providers, technology companies, and other covered entities and business associates.

Anti-Kickback Statute and Stark Law Compliance

• Advised healthcare providers, facilities, and ventures on Anti-Kickback Statute and Stark Law compliance, including structuring physician compensation arrangements, referral relationships, employment agreements, and ancillary service arrangements to comply with applicable safe harbors and exceptions.
• Counseled healthcare entities on fraud and abuse risk assessment and mitigation, including review of existing business arrangements for compliance with federal and state fraud and abuse laws.

Corporate Practice of Medicine and MSO Structuring

• Counseled healthcare providers, management companies, and investors on corporate practice of medicine laws across multiple states, including designing compliant business structures, drafting MSO agreements, advising on permissible management fee arrangements, and resolving regulatory compliance issues for physician practices, medical spas, telemedicine ventures, and other healthcare businesses.
• Drafted and negotiated management agreements and administrative services agreements for national MSOs and their affiliated healthcare providers.

Telemedicine and Digital and Mobile Health

• Advised telemedicine companies, digital and mobile health startups, and online wellness platforms on regulatory compliance across multiple states, including corporate practice of medicine, medical licensure, prescribing authority, and billing requirements.
• Counseled mobile medical application developers, wearable technology ventures, augmented and virtual reality health companies, and other health technology businesses on FDA, FTC, and state regulatory requirements.

Emerging Healthcare Modalities

• Counseled a broad range of emerging and non-traditional healthcare businesses and practitioners, including integrative and functional medicine centers, anti-aging and regenerative medicine providers, stem cell therapy practices, IV hydration clinics, medical cannabis providers, addiction and behavioral health treatment facilities, and other technology-enabled and emerging healthcare businesses on regulatory compliance, corporate structure, licensing, and business formation.
• Advised aesthetic medicine providers, medical spas, and related healthcare businesses on corporate practice of medicine compliance, fee-splitting restrictions, licensing requirements, and regulatory matters across multiple states.
• Counseled healthcare practitioners providing complementary, alternative, and integrative therapies — including acupuncture, chiropractic, naturopathic, homeopathic, and other modalities — on regulatory requirements, scope of practice issues, and patient care standards.

FDA and FTC Regulatory Matters

• Advised manufacturers, distributors, and marketers of dietary supplements, nutraceuticals, vitamins, minerals, herbs, and functional foods on FDA and FTC regulatory requirements, including claims substantiation, structure-function claims, labeling compliance, good manufacturing practice requirements, and enforcement risk.
• Counseled manufacturers and marketers of cosmetics, OTC drugs, homeopathic products, and medical devices on FDA classification, labeling, marketing, and regulatory compliance.
• Advised healthcare companies and practitioners on FTC advertising standards and enforcement risks applicable to health product and service marketing claims.
• Counseled on informed consent requirements, off-label use and promotion, and permissible communication of scientific information in connection with medical treatments and therapeutic products.
• Advised companies on contract manufacturing arrangements for dietary supplements, cosmetics, and medical products, including regulatory compliance and quality agreements.

Healthcare Regulatory Compliance

• Advised healthcare organizations on regulatory compliance matters, including fraud and abuse laws, patient privacy regulations, and state and federal healthcare regulatory requirements.
• Conducted compliance reviews and regulatory analysis to identify and mitigate legal risks with respect to core healthcare laws and regulations, including the Anti-Kickback Statute, Stark Law, HIPAA, and the Corporate Practice of Medicine.

Academic and Research Contributions to Healthcare Law

• Pioneered and taught Complementary and Alternative Medicine: Health Law and Policy at the Harvard T.H. Chan School of Public Health.
• Developed policies and procedures for integrative medicine across 14 Harvard-affiliated hospitals as faculty member at Harvard Medical School and Harvard T.H. Chan School of Public Health.
• Principal Investigator, NIH/National Library of Medicine: Legal and Social Barriers to Alternative Therapies.
• Principal Investigator, The Greenwall Foundation: Pediatric Use of Complementary Therapies by Parents: Ethical and Policy Choices.
• Principal Investigator, American Specialty Health Plan: Credentialing Practices, Malpractice Liability Policies, and Guidelines Governing Recommendations Involving Dietary Supplements.
• Published six books and more than 100 peer-reviewed articles in medical, legal, and professional journals.
• Delivered more than 100 invited lectures at professional conferences and academic institutions nationally and internationally.
• Consultant, Institute of Medicine, National Academy of Sciences, Committee on Complementary and Alternative Medicine Use by the American Public.
• Consultant, M.D. Anderson Cancer Center Integrative Medicine Program / National Cancer Institute.
• Consultant, Ministry of Science and Research of North Rhine-Westphalia, Germany: Governmental Regulations for Traditional Chinese Herbal Medicine.
• Faculty, The Leadership Program in Integrative Healthcare, Duke University.
• Fortieth Anniversary Senior Fellow, Center for the Study of World Religions, Harvard Divinity School.