FDA 与 CMS 加紧协调，避免各州测试临床 AI 引发监管重叠僵局
STAT+: FDA, CMS scramble to avoid regulatory logjam as more states look to test AI in clinical settings
随着更多州寻求在临床场景中测试 AI，FDA 与 CMS 正幕后协调，以避免州与联邦对临床 AI 的重叠管辖权造成监管僵局、拖慢医疗 AI 落地。州级负责医疗行为与医生执照监管，而无人工监督执行开处方等临床任务的 AI 可能归入 FDA 医疗器械监管范围。
Officials worry that confusion over overlapping jurisdictions could stall health AI adoption
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.
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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.
来源：STAT News · statnews.com