{"id":28883,"date":"2026-09-22T08:02:51","date_gmt":"2026-09-22T08:02:51","guid":{"rendered":"https:\/\/quickbirdmedical.com\/?post_type=news&#038;p=28883"},"modified":"2026-09-22T08:06:42","modified_gmt":"2026-09-22T08:06:42","slug":"fda-generative-ai-medical-devices-risk-heuristics","status":"publish","type":"news","link":"https:\/\/quickbirdmedical.com\/en\/news\/fda-generative-ai-medical-devices-risk-heuristics\/","title":{"rendered":"FDA Questions the Disclaimer in Health Apps"},"content":{"rendered":"<p>On August 18, 2026, the FDA issued a <strong>discussion paper on medical devices using generative AI<\/strong>; comments may be submitted until October 19, 2026, under docket number FDA-2026-N-7874. Nothing in it is binding; it is not guidance, but rather a collection of considerations and open questions.<\/p>\n<p>The agency is proposing a two-axis <strong>risk heuristic<\/strong> for discussion:<\/p>\n<p><strong>how far-reaching and autonomous a product&#8217;s actions are<\/strong>\u2014ranging from purely informational output to autonomous behavior\u2014and <strong>how severe the damage would be<\/strong> if one were to rely on incorrect output.<\/p>\n<p>Of interest for patient-facing applications: <strong>The FDA tends to view the line between providing information and guiding action as a continuum<\/strong>, and it is considering whether a phrase such as \u201ctalk to your doctor\u201d actually makes a message less action-oriented. The line of reasoning is interesting: Anyone seeking to mitigate the impact of a message with such a disclaimer faces the same discussion when classifying it under the applicable MDR Rule 11.<\/p>\n<p>With regard to validation, the paper outlines tests against predefined thresholds and clinical confirmation, which does not necessarily require a prospective study in every case. After market authorization, monitoring for performance degradation should then take place.<\/p>\n<p class=\"last-child\">The FDA&#8217;s considerations can be found here: <a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request?utm_source=newsletter-quickbirdmedical\" target=\"_blank\" rel=\"noopener\">https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/considerations-regulation-generative-ai-enabled-medical-devices-discussion-paper-and-request<\/a><\/p>\n","protected":false},"featured_media":0,"template":"","categories":[],"tags":[],"display":[54],"class_list":["post-28883","news","type-news","status-publish","hentry","display-display-on-news-page"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA: Generative AI in Medical Devices \u2014 New 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