On October 21st, Wilson Sonsini is pleased to host the second virtual session in our “Clinical AI and Health Tech: An Inflection Point” Webinar Series.

Clinical AI is moving quickly from pilot to point of care, and the rules that govern it do not sit with any single regulator. Oversight is spread across the U.S. Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), federal data and privacy authorities, the Federal Trade Commission (FTC), and a fast-growing patchwork of state laws, each reaching a different part of how these tools are built, cleared, deployed, and reimbursed.

Following our September 29th session on the FDA's emerging framework for generative AI-enabled medical devices, our Wilson Sonsini Healthcare and FDA Regulatory panel steps back to map the full landscape and provide a high-level tour of the regulatory terrain governing clinical AI:

• who regulates these tools, and where the jurisdictional lines fall among the FDA, CMS, state medical boards, and privacy and consumer-protection authorities;
• how device regulation, the practice of medicine, data and privacy obligations, and reimbursement intersect across a product's life cycle; and
• the federal and state developments most likely to reshape the landscape heading into 2027.

Attendees will leave with a working map of the clinical AI regulatory landscape and a clearer view of where their products and portfolios sit within it.