The history of state preemption and medical device regulation: lessons for artificial intelligence oversight.

Abstract

Rapid expansion of artificial intelligence (AI) in health care has outpaced the United States' fragmented regulatory structure, which currently relies on overlapping albeit incomplete federal oversight from multiple agencies. In the absence of clear federal product standards, some states have advanced broad and inconsistent regulatory schemes that often sweep AI-enabled medical devices into consumer-protection frameworks not designed for clinically used technologies. These state-level requiremen