FDA plans advisory committee meeting on AI mental health devices

Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

The Food and Drug Administration will convene experts to discuss challenges around regulating mental health products that use artificial intelligence, as a growing number of companies release chatbots powered by large language models whose output can be unpredictable. 

The move suggests the agency may soon tighten its focus on such tools.

The Nov. 6 meeting of the FDA’s Digital Health Advisory Committee (DHAC) will focus on “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,” according to a notice published Thursday in the Federal Register. The notice says newly released mental health products using AI pose “novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.”