Heather Siegelheim is a member of the firm's Health Law Practice Group. Her practice includes advising health care providers, retail and specialty pharmacies, wholesale drug distributors, and prescription drug and device manufacturers on compliance with federal and state laws and regulations in a variety of regulatory and transactional matters. Heather has experience with the following issues:
- Analysis of various arrangements between and among health care providers, manufacturers, and other entities for compliance with fraud and abuse laws, including the Federal Anti-Kickback Statute, Stark Law, False Claims Act, and state anti-kickback and self-referral laws.
- Compliance with state and federal privacy laws, including the HIPAA Privacy, Security, and Breach Notification Rules.
- Compliance with state and federal transparency reporting requirements, including the Sunshine Act provisions of the Patient Protection and Affordable Care Act and state marketing disclosures and gift prohibition laws.
- Compliance with the Food, Drug and Cosmetic Act and other federal and state laws and regulations, government guidance, and industry codes related to pharmaceutical drugs and devices.
- Compliance with FDA and HHS regulations related to clinical trial contracting and research activities.
- Defending health care providers and entities against regulatory complaints and investigations.
Heather's previous experience included general civil and commercial litigation, where she defended individuals and companies in various personal injury, product liability, professional liability, class action and other business litigation matters.
Education and Honors
- Seton Hall University School of Law (J.D., 2009)
- University of Michigan (B.A., 2006)
- New York
- New Jersey
- U.S. District Court, District of New Jersey
- Selected for inclusion in New Jersey Super Lawyers® - Rising Stars (2017: Business/Corporate)