Lexology November 19, 2025
FDA’s Digital Health Advisors Acknowledge Benefits of Mental Health Chatbots, Urge Caution Around Diagnoses
What is happening: FDA’s Digital Health Advisory Committee met virtually on November 6, 2025 to learn about and discuss generative artificial intelligence (gen AI)–enabled digital mental health devices. The independent advisors appeared to agree that there is value in using gen AI for mental health care, whether as patient-facing chatbots or professional-facing tools. At the same time, there was broad consensus that clear and robust regulatory controls and guidelines on the design, development, testing, authorization, deployment, and monitoring of such devices is critical for adequate risk mitigation.
Presenters and advisors generally agreed on the following guiding principles for this next frontier in digital care:
- “Professional...
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