FDA, CMS Scramble Over State-Federal AI Rules — SkimNews
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- FDA and CMS are scrambling behind the scenes to avert a regulatory logjam as more states look to test AI in clinical settings.
- Trump administration has sought to reduce regulatory burdens on companies developing health AI and created new ways to pay for the technology.
- State medical regulators regulate the practice of medicine and license doctors and other clinicians, creating a separate layer of oversight for clinical AI.
- FDA regulates medical devices and would likely gain jurisdiction over AI products that perform clinical tasks, including writing prescriptions, without human supervision.
Why it matters: The immediate stake for health-AI developers is whether federal and state rules can coexist: two regulators, FDA and CMS, are trying to head off a logjam while states look to test clinical AI. The dividing line is human supervision, because unsupervised tools that write prescriptions would likely fall under FDA device regulation, adding federal oversight to state medical-practice rules.
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