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FDA and CMS work to resolve state federal conflict over health AI regulation

Federal health officials are coordinating behind the scenes to manage jurisdictional conflicts between states and the government regarding artificial intelligence in clinical settings.

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

Overlapping authority creates regulatory tension

States currently regulate medical practice and issue licenses to clinicians. If AI performs tasks like writing prescriptions without human supervision, those products fall under FDA jurisdiction. This overlap between state licensing and federal device regulation has created a potential logjam for developers.

Administration seeks to ease burdens

The Trump administration has introduced new payment methods to support the technology. Officials also aim to reduce regulatory burdens on companies building health AI tools. These efforts come as more states look to test artificial intelligence in their clinical environments.

Adoption faces structural hurdles

Health officials hope these changes will boost adoption of the technology across the sector. The conflict remains unresolved despite behind-the-scenes movements by federal agencies. Developers must navigate both state licenses and federal approvals to launch clinical AI products.

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