FDA digital advisers confront risks of therapy chatbots, weigh possible regulation

November 5, 2025

a model of the regions of the brain

(STAT News) – The meeting comes amid mounting negative reports about conversational artificial intelligence tools

A Food and Drug Administration advisory committee will meet Thursday to explore a topic that’s been taboo during the Trump administration: Regulating artificial intelligence.

The FDA’s Digital Health Advisory Committee (DHAC) will convene to discuss nitty-gritty details around the regulation of therapy chatbots and other mental health devices that use generative AI. The meeting is part of the agency’s ongoing effort to clarify how regulation applies to medical devices based on newer forms of AI, including large language models that produce conversation-like outputs that are not predictable and may misguide users or lead to patient harm. (Read More)