Digital health companies are subject to a complex web of healthcare regulations. Both seasoned health-tech stakeholders and newcomers must be able to spot potential regulatory issues impacting their business and develop a forward-thinking and nuanced legal strategy that considers enforcement risks alongside the company’s stage, goals, and risk tolerance.
The first session in this webinar series will guide digital health founders, executives, innovators, and general counsel through an overview of the laws that apply to digital health companies, including:
Adam Pilkington
apilkington@wsgr.comAndrea Linna is a partner at Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s digital health industry group and its healthcare practice. With more than a decade dedicated to healthcare law, Andrea exclusively represents digital health and healthcare IT clients, from emerging companies to established industry players, investors, and healthcare systems. Andrea guides her clients through the patchwork of federal and state laws that apply to digital health companies, addressing issues such as corporate practice of medicine, Stark Law compliance, Anti-Kickback Statute considerations, fee splitting, billing Medicare and Medicaid, contracting with commercial payors, value-based care arrangements, artificial intelligence, remote patient monitoring, online prescribing, scope of practice, and licensing requirements.
Shawn has almost a decade of in-house experience from a variety of healthcare and digital health settings, where he helped companies understand and operationalize healthcare regulatory requirements.
Haley Bavasi is a partner in the Seattle office of Wilson Sonsini Goodrich & Rosati, where she focuses primarily on advising digital health companies across a range of privacy, transactional, research, and healthcare regulatory issues. In particular, Haley leverages her expertise in the Health Insurance Portability and Accountability Act (HIPAA), the U.S. federal health-privacy law, to provide early-stage companies with practical day-to-day counseling, as well advise as in the context of complex commercial transactions, M&A, and go-to-market strategy. Haley’s extensive experience with a wide range of cutting-edge digital health companies provides her with valuable market insights she leverages for her clients.
Eva Yin, Ph.D., M.P.H., is a partner in Wilson Sonsini Goodrich & Rosati’s FDA regulatory, healthcare, and consumer products practice. Her practice includes conducting FDA and healthcare regulatory due diligence for corporate transactions; providing legal counsel to manufacturers regarding FDA approval/clearance for various products—including medical devices, mobile apps, and drugs, FDA compliance, regulation of promotional materials and labeling, and manufacturer compliance under federal and state healthcare laws, e.g., the federal Anti-Kickback Statute (AKS), False Claims Act (FCA), Sunshine Act, state licensing laws, corporate practice of medicine, etc.; reviewing contracts and compliance policies for manufacturers; and providing legal analysis and risk assessment of business models and fee arrangements involving patient assistance programs, healthcare professionals, or hospitals/clinics under federal and state healthcare laws and regulations.