STAT+: FDA will convene an advisory committee to tackle AI mental health device regulation
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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.\u00a0<\/p>\n
The move suggests the agency may soon tighten its focus on such tools.<\/p>\n
The Nov. 6 meeting of the FDA\u2019s Digital Health Advisory Committee (DHAC) will focus on \u201cGenerative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,\u201d according to a notice published Thursday<\/a> in the Federal Register. The notice says newly released mental health products using AI pose \u201cnovel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.\u201d\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n