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:
The committee meeting focused on generative AI-enabled digital mental health medical devices — such as “AI therapists” — that may diagnose or treat psychiatric conditions.
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.
Most AI-powered mental health tools available are not regulated by the FDA and many are marketed as wellness apps, not medical devices.
As of the meeting date, the FDA had authorized no AI-enabled medical devices for mental health use, though more than 1,200 AI-enabled devices have been approved in other areas.
Generative AI mental health devices pose novel risk, including hallucinations, biased content or symptom worsening, especially without human oversights.
Devices can be approved via premarket approval, 510(k) or de novo pathways, depending on risk. Digital therapeutics and diagnostics typically are prescription devices.
Evaluating performance requires rigorous testing, especially for chatbot-like products. Postmarket monitoring for misuse is critical to safety.
The FDA is exploring Predetermined Change Control Panels to allow safer updates to adaptive AI models without full re-review, while maintaining guardrails.
The FDA asked the committee for guidance on best practices for evidence, trial design, over-the-counter use, integration of diagnostics and therapeutics, and safety risks for children.