STAT+: FDA, CMS scramble to avoid regulatory logjam as more states look to test AI in clinical settings

Officials worry that confusion over overlapping jurisdictions could stall health AI adoption Sarah Silbiger/Getty Images 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. Health officials hoping to boost adoption of artificial intelligence in health care have been moving behind the scenes to address brewing conflict between states and the federal government over the technology. The Trump administration has sought to alleviate regulatory burden on companies developing health AI and created new ways to pay for the technology. But there remains a key problem: The federal government and states have overlapping jurisdiction over AI that performs clinical work, like writing prescriptions. States regulate the practice of medicine and issue licenses to doctors and other clinicians. If AI performs these tasks without human supervision, that would likely push those products into the jurisdiction of the Food and Drug Administration, which regulates medical devices. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. 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.