FDA and CMS scramble to avoid regulatory logjam as more states test AI in clinical settings

The FDA and the Centers for Medicare and Medicaid Services are working behind the scenes to head off a regulatory conflict with states over the use of artificial intelligence in clinical settings, according to STAT News.

As reported, a growing number of states are pursuing their own frameworks to test AI tools in health care, including proposals for state-level sandboxes that would allow clinicians to trial AI systems under local oversight rather than waiting on federal clearance. STAT News reports that this state-level momentum is running into existing federal rules governing medical devices and software, creating the prospect of overlapping or conflicting requirements for the same AI tools.

Federal officials are reportedly trying to get ahead of this friction before it hardens into open disputes between Washington and individual statehouses. STAT News describes coordination efforts aimed at clarifying which agency, or level of government, has authority over which parts of the AI deployment pipeline, from initial testing to clinical use.

The report frames the stakes as significant for how quickly, and under what safeguards, AI tools reach patients and clinicians. Unresolved jurisdictional questions could slow adoption in some states while allowing faster, less uniform rollout in others, depending on how the sandboxes are structured and how federal agencies ultimately respond to them.