Artificial intelligence (AI)-enabled mental health products, including chatbots, digital companions, and coaching tools, are attracting increased attention from regulators, policymakers, and courts. Building on Wilson Sonsini’s previous alert, Legal Framework for AI in Mental Healthcare, this advisory discusses recent regulatory and litigation developments affecting these products, including new state laws on AI disclosure and crisis-response protocols, the U.S. Food and Drug Administration’s (FDA) evolving framework for generative AI-enabled devices, Federal Trade Commission (FTC) oversight of health-related claims, and health privacy considerations spanning HIPAA, 42 C.F.R. Part 2, and state consumer health data laws. It also addresses state-law liability exposure and outlines design and governance practices companies can consider before and after launch.
Read the advisory here.