Health Care Innovation & Regulatory Compliance

Catalog description

The health care sector features rapid changes in technology, business models, patient needs, and payor requirements. Innovation can create potential risk under legal frameworks that were not designed with a modern health system in mind. While it is important to identify these legal risks, clients often want lawyers to go a step further to design legally-compliant solutions to facilitate innovation. This course will help students learn practical skills to evaluate and manage legal risk for novel or developing health care concepts. These skills may include: evaluating exposure under anti-fraud laws like the Anti-Kickback Statue to scenarios where no safe harbor applies, understanding implications of different uses or transfers of Personal Health Information, understanding the role of coverage policies (Medicare, Medicaid, commercial), and evaluating FDA guidance concerning Software as a Medical Device. For example, students may be asked to write an Advisory Opinion request or other request for guidance from an applicable Federal or State agency regarding an innovative model, or a draft policy memo identifying applicable legal risks and potential.