Becker's Healthcare November 10, 2025
Ella Ruder

The FDA’s Digital Health Advisory Committee met to address generative AI in patient-facing mental health applications, building on prior 2024 discussions on broader AI-enabled medical devices.

Here are nine things to know, according to a Nov. 6 report from the agency:

  1. The committee meeting focused on generative AI-enabled digital mental health medical devices — such as “AI therapists” — that may diagnose or treat psychiatric conditions.
  1. Nearly 58 million adults in the U.S. have been diagnosed with mental illness. The percentage of patients with mental health diagnoses jumped 39.8% from 2019 to 2023, according to the report.
  1. Most AI-powered mental health tools available are not regulated by the FDA and many are marketed...

Today's Sponsors

Venturous
ZeOmega

Today's Sponsor

Venturous

Continue Reading

 
Topics: AI (Artificial Intelligence), Digital Health, FDA, Govt Agencies, Mental Health, Provider, Technology
Related Articles:
AI Model FDA-Cleared to Triage 14 Conditions
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 2)
FDA Updates Two Digital Health Final Guidance Documents
FDA in Flux — January 2026 Newsletter
The Promise And Perils Of FDA’s New ‘Plausible Mechanism’ Pathway (Part 1)

Share Article