FDA’s Digital Health Advisory Committee Weighs Guardrails for Generative AI in Mental Health Devices

On November 6, 2025, the U.S. Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) convened for the second time since its inception to explore the regulatory pathways, opportunities, and concerns related to generative AI (GenAI) in digital mental health medical devices. We analyzed the DHAC’s first meeting here. While these technologies, ranging from GenAI-based therapy chatbots to diagnostic tools, are emerging as potential solutions to the mental health access crisis,…
By: Hogan Lovells