Policy Details

Digital Health Advisory Committee – Nov 6, 2025 Meeting (Generative AI-Enabled Digital Mental Health Devices)

Summary

U.S. Food and Drug Administration announced a Digital Health Advisory Committee meeting focused on generative‑AI digital mental‑health devices, opening a public docket and inviting expert input on benefits, risks, evidence, and oversight priorities.

Healthcare Implications

Signals near‑term policy attention; developers and clinicians can submit comments, preview evidence expectations, and anticipate future guidance affecting evaluation and post‑market monitoring of mental‑health AI tools.

Impact Level

Low

Keywords

Clinical Quality & Efficacy; Safety & Risk

Stakeholders

Regulators & Government; Providers & Health Systems; Patients & Public; Developers & Vendors