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.
The DHAC will spend much of the meeting hearing public commentary as well as discussing different scenarios relating to a hypothetical “therapy device” built on a large language model with “with unique outputs that mimic a conversation with a human therapist.” The committee will be asked to consider the device for both prescription and over-the-counter contexts; for adults as well as adolescents; and with indications for major depressive disorder and for multiple mental health conditions. The feedback generated from the meeting will help inform the agency’s work on AI.
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