FDA, CMS Move to Avert State AI Rule Clash — SkimNews
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- FDA and CMS are moving behind the scenes to address a brewing conflict between federal officials and states over health AI as more states consider testing it in clinical settings.
- Trump administration has sought to reduce the regulatory burden on companies developing health AI.
- Trump administration has also created new ways to pay for health-AI technology.
- Federal government and states have overlapping jurisdiction over AI that performs clinical work, including writing prescriptions.
- States regulate the practice of medicine and issue licenses to doctors and other clinicians.
- FDA regulates medical devices, and AI that performs clinical tasks such as writing prescriptions without human supervision would likely fall within its jurisdiction.
Why it matters: For companies developing health AI, the material issue is a two-track regulatory burden: FDA jurisdiction over unsupervised clinical tools and state control over medical practice and clinician licensing. Resolving that overlap is what stands between broader state testing and the regulatory logjam described by officials.
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