RegulationFriday, December 5, 2025

FDA advisors scrutinize generative AI tools for psychiatry and digital mental health

Source: HCPLive
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TL;DR

AI-Summarized

HCPLive reports that the U.S. Food and Drug Administration’s Digital Health Advisory Committee has been evaluating how generative AI in mental health apps and chatbots may affect the safety and effectiveness of medical devices, particularly where AI delivers therapeutic content without clinician oversight. In an interview, psychiatrist Hans Eriksson outlines how AI can help personalize treatment by analyzing patient characteristics and population‑level data, but stresses the need for rigorous performance testing and regulatory oversight as AI increasingly mediates psychiatric care.

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This article aggregates reporting from 1 news source. The TL;DR is AI-generated from original reporting. Race to AGI's analysis provides editorial context on implications for AGI development.