Federal health officials are navigating jurisdictional disputes with states as local authorities explore the clinical application of artificial intelligence. While the Trump administration established novel payment mechanisms to assist health AI developers, overlapping federal and state oversight continues to hinder progress. Regulatory confusion specifically targets autonomous tools that perform clinical tasks like writing prescriptions, since states oversee medical practice while the Food and Drug Administration regulates medical devices.
Key points
Dual oversight from federal medical device regulators and state medical licensing authori…: Dual oversight from federal medical device regulators and state medical licensing authorities creates obstacles for clinical artificial intelligence.
Efforts by federal administrations to reduce regulatory burdens are complicated by state-…: Efforts by federal administrations to reduce regulatory burdens are complicated by state-level jurisdiction over clinical practice.
Independent tools operating without human oversight challenge the established boundaries…: Independent tools operating without human oversight challenge the established boundaries between medical devices and medical practice regulation.
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Health officials hoping to boost adoption of artificial intelligence in health care have been moving behind the scenes to address brewing conflict between states and the federal government over the technology.
The Trump administration has sought to alleviate regulatory burden on companies developing health AI and created new ways to pay for the technology. But there remains a key problem: The federal government and states have overlapping jurisdiction over AI that performs clinical work, like writing prescriptions.
States regulate the practice of medicine and issue licenses to doctors and other clinicians. If AI performs these tasks without human supervision, that would likely push those products into the jurisdiction of the Food and Drug Administration, which regulates medical devices.
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