Becker's Healthcare November 3, 2025
Ella Ruder

The FDA’s Digital Health Advisory Committee will meet Nov. 7 to evaluate whether generative AI tools can be used safely and effectively in mental healthcare. The session marks the committee’s first in nearly a year and comes amid growing use of AI-powered chatbots by patients seeking alternatives to traditional therapy, according to a Nov. 3 report from Politico.

Here are five things to know:

  1. The FDA has not approved any generative AI devices for mental health treatment. However, it has authorized more than 1,200 AI-enabled tools for other clinical purposes.
  1. The committee will hear presentations on clinical trial data, provider and patient considerations, and use...

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Topics: AI (Artificial Intelligence), FDA, Govt Agencies, Mental Health, Provider, Technology
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