{"id":149620,"date":"2025-09-11T19:03:08","date_gmt":"2025-09-11T19:03:08","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/149620\/"},"modified":"2025-09-11T19:03:08","modified_gmt":"2025-09-11T19:03:08","slug":"fda-plans-advisory-committee-meeting-on-ai-mental-health-devices","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/149620\/","title":{"rendered":"FDA plans advisory committee meeting on AI mental health devices"},"content":{"rendered":"<p class=\"author-bio\">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\u2019s promise. He\u2019s also the co-author of the free, twice weekly <a href=\"https:\/\/www.statnews.com\/signup\/health-tech\/\" rel=\"nofollow noopener\" target=\"_blank\">STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.<\/p>\n<p>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<p>The move suggests the agency may soon tighten its focus on such tools.<\/p>\n<p>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 <a href=\"https:\/\/public-inspection.federalregister.gov\/2025-17651.pdf\" target=\"_blank\" rel=\"noopener nofollow\">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<p class=\"restricted-text\">STAT+ Exclusive Story<\/p>\n<p class=\"restricted-login\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t<img decoding=\"async\" class=\"restricted-content-breaker-bg\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2025\/07\/stat-plus-breaker-bg.png\" alt=\"STAT+\"\/><\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" rel=\"nofollow noopener\" target=\"_blank\"><br \/>\n\t\t\t\t\t\t<img decoding=\"async\" class=\"stat-plus-logo\" src=\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/stat-plus-logo-white.svg\" alt=\"STAT+\"\/><br \/>\n\t\t\t\t\t<\/a><\/p>\n<p>\t\t\t\tThis article is exclusive to STAT+ subscribers<br \/>\n\t\t\t\tUnlock this article \u2014 and get additional analysis of the technologies disrupting health care \u2014 by subscribing to STAT+.<\/p>\n<p class=\"restricted-content-breaker-wrapper-cta mobile\">Already have an account? <a href=\"https:\/\/www.statnews.com\/login\/\" data-stat-login=\"\" data-stat-paywall-cta=\"breaker login cta mobile\" rel=\"nofollow noopener\" target=\"_blank\">Log in<\/a><\/p>\n<p>\t\t\t\t\t\tIndividual plans<\/p>\n<p>\t\t\t\t\t\tGroup plans<\/p>\n<p>\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button view-all\" data-stat-paywall-cta=\"breaker view all plans\" aria-label=\"View All Plans\" rel=\"nofollow noopener\" target=\"_blank\">View All Plans<\/a><\/p>\n<p class=\"restricted-content-text\">\n\t\t\t\t\t\tTo read the rest of this story subscribe to STAT+.\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t<a href=\"https:\/\/www.statnews.com\/stat-plus\/\" class=\"stat-button restricted-button\" data-stat-paywall-cta=\"breaker subscribe cta 1\" rel=\"nofollow noopener\" target=\"_blank\">Subscribe<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics.&hellip;\n","protected":false},"author":2,"featured_media":149621,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[60],"tags":[246,97,37583,259,260,248],"class_list":{"0":"post-149620","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-mental-health","8":"tag-fda","9":"tag-health","10":"tag-health-tech","11":"tag-mental-health","12":"tag-mentalhealth","13":"tag-stat"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/149620","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=149620"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/149620\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/149621"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=149620"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=149620"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=149620"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}