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About Mark
Mark Garsombke is a seasoned health care and life sciences attorney who advises providers, manufacturers and technology-driven organizations on data privacy and licensing, regulatory compliance and complex business transactions.
Mark counsels a wide range of clients, including medical device and pharmaceutical companies, health care providers and Fortune 500 organizations, on emerging and evolving legal issues at the intersection of health care, technology and innovation. He provides practical, business-oriented guidance on matters involving data privacy and security, artificial intelligence, FDA regulation, intellectual property licensing and business transactions, helping clients navigate risk while advancing strategic initiatives.
Mark’s practice includes:
- Advising on data privacy and security, including HIPAA compliance and data governance strategies;
- Counseling on FDA regulatory requirements, human subject research and life sciences compliance matters;
- Guiding clients on artificial intelligence and virtual care regulatory considerations;
- Structuring and negotiating data licensing and technology-driven commercial transactions; and
- Providing strategic advice on Anti-Kickback Statute and related fraud and abuse issues.
Previously, Mark served as in-house counsel to a global medical device manufacturer (on secondment) and a large mutual fund company, giving him valuable insight into the operational and strategic considerations facing his clients. He frequently speaks and writes on data privacy, security and FDA-related legal developments.
