FDA and CMS officials are working to prevent a regulatory conflict. States and the federal government both oversee clinical AI. States regulate medical practice and clinician licensing. AI performing clinical tasks without supervision may fall under FDA device rules. The Trump administration eased regulatory burdens for health AI developers. Confusion over jurisdiction could stall AI adoption in health care. Officials are addressing the issue behind the scenes.
What changed
States and the federal government had overlapping jurisdiction over clinical AI without coordination.
What it unlocks
Avoiding regulatory conflicts that could stall health AI adoption in clinical settings.
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