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

As the agency wades toward spelling out rules, it considers a ‘competency-based approach’ FDA 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. “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 View All Plans To read the rest of this story subscribe to STAT+. Subscribe 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.