{"id":149179,"date":"2026-08-24T08:57:11","date_gmt":"2026-08-24T08:57:11","guid":{"rendered":"https:\/\/www.europesays.com\/ai\/149179\/"},"modified":"2026-08-24T08:57:11","modified_gmt":"2026-08-24T08:57:11","slug":"fda-digital-health-leader-promises-generative-ai-regulatory-guidance-is-coming","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ai\/149179\/","title":{"rendered":"FDA digital health leader promises generative AI regulatory guidance is coming"},"content":{"rendered":"

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He\u2019s also the co-author of the free, twice weekly STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.<\/p>\n

The Food and Drug Administration says it is developing a plan for how to regulate medical devices that use generative artificial intelligence.<\/p>\n

The FDA will eventually release documents spelling out agency policies regarding the technology, Rick Abramson, director of the agency\u2019s Digital Health Center of Excellence, told STAT.<\/p>\n

\u201cOur goal is formal policy guidance,\u201d he said in an interview. \u201cThe ecosystem is expecting clarity. We seek to provide that clarity, and I\u2019ll also throw in that I think the ecosystem can expect not only broad guidance on the overall topic of generative AI, but also some more narrowly constructed specialty guidance on particular generative AI topics of special interest or special complexity.\u201d<\/p>\n

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