FDA digital health leader promises generative AI regulatory guidance is coming | STAT

FDA By Mario Aguilar Aug. 24, 2026 Health Tech Correspondent Mario Aguilar [email protected] 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’s also the co-author of the free, twice weekly STAT Health Tech newsletter . You can reach Mario on Signal at mariojoze.13. The Food and Drug Administration says it is developing a plan for how to regulate medical devices that use generative artificial intelligence. The FDA will eventually release documents spelling out agency policies regarding the technology, Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT. Advertisement “Our goal is formal policy guidance,” he said in an interview. “The ecosystem is expecting clarity. We seek to provide that clarity, and I’ll 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.” STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Individual plans Group plans Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Artificial intelligence , FDA , health tech , Medical devices , Policy , STAT+ Submit a correction request Reprints Mario Aguilar Health Tech Correspondent 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’s also the co-author of the free, twice weekly STAT Health Tech newsletter . You can reach Mario on Signal at mariojoze.13.