Attorney Michael H. Cohen speaks on “FDA & Related Legal Issues in Online Health Ventures” at a prominent LA law firm’s Restaurant, Food & Beverage Group on July 9. The talk will focus on legal and regulatory issues such as:
- Corporate practice of medicine / unlicensed practice / scope of practice / board discipline
- FDA issues
- Medical devices
- 510(k) submission
- Mobile medical app review
- Dietary supplements
- Structure/function vs. disease claims
- Product positioning and website review
- Some OTC drugs and homeopathics
- Medical devices
- FTC / claims / substantiation
- HIPAA, privacy and security
- Stark, anti-kickback, fee-splitting
- Other complex, nuanced regulatory issues
Typical clients in this regulatory space include:
- Companies: Technology companies, startups, entrepreneurs, ventures in the health & wellness space (online or brick-and-mortar).
- Clinics/groups/facilities: Medical groups, sleep centers, hospices, clinical laboratories, pharmacies, diagnostic facilities, medical, integrative medicine or multidisciplinary healthcare centers and clinics.
- Individual practitioners: Clinical practitioners (MD, NP, psychologist, chiropractor, acupuncturist, health coach/consultant, etc.).
- California Business & Professions Code, Sections 650 (kickbacks), 2242 (prescribing), 2242.1 (online prescribing), 2290.5 (telemedicine), 4022 (dangerous device), 4024 (dispensing), 4067 (dispensing online).
- California Medical Board, Internet Prescribing—Information for Physicians (Internet prescription); Practicing Medicine Through Telehealth Technology (telemedicine).
- Food, Drug, & Cosmetic Act, Section 201(h) (“medical device” definition).
- FDA, Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications (July 11, 2011); Dietary Supplement Health and Education Act of 1994; Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure of Function of the Body, 65 Fed. Reg. 999 (Jan. 6, 2000); Product Classification database; Warning letter to Biosense Technologies.
- FTC, Dietary Supplements: An Advertising Guide for Industry; Enforcement Policy Statement on Food Advertising; Marketing Your Mobile App: Get It Right From the Start.
- 21 CFR 880.6310(a) (Medical Device Data System).
- Michael H. Cohen, Complementary & Alternative Medicine: Legal Boundaries & Regulatory Perspectives (Johns Hopkins University Press, 1998).
Michael H. Cohen was an associate in the Corporate Department at Davis Polk & Wardwell, served on the faculty of several law schools, and served as Director of Legal Programs at Medical School Division for Research and Education in Complementary and Integrative Medical Therapies and Harvard Medical School Osher Institute. He was also Assistant Professor of Medicine at Harvard Medical School, with a joint appointment as Assistant Adjunct Professor in the Department of Health Policy and Management at the Harvard School of Public Health.
Michael is a thought leader in health care law, pioneering legal strategies and solutions for clients in traditional and emerging healthcare markets. He represents a broad range of healthcare providers, including medical and osteopathic doctors; psychologists, nurses, dentists and other allied health professionals; and complementary and alternative medicine practitioners such as chiropractors, acupuncturists, and massage therapists. His clients include clinical care facilities, dietary supplement companies, healthcare educational institutions, health insurance organizations, medical spas, medical device makers, telemedicine providers, and entrepreneurs in the health, wellness, and lifestyle industries.