The History of State Preemption and Medical Device Regulation: Lessons for Artificial Intelligence Oversight
Senior Policy Advisor Larry Bucshon co-authored an article for Health Affairs Scholar examining the regulatory framework for artificial intelligence (AI) in healthcare settings and looking to the history of medical device regulation to propose solutions to the current fragmented landscape. As AI tools become more and more embedded in everyday operations, from administrative work to diagnostic tasks, federal regulations have not kept up, resulting in various rules across various agencies – U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS) and Federal Trade Commission (FTC), to name a few. Absent a uniform federal standard, state legislatures have also stepped in, passing laws on data privacy, use restrictions and more. All of this means headaches for AI users and developers, who must contend with a dizzying list of regulations that can change drastically simply by crossing state lines.
In his article, Mr. Bucshon turns to the past, reviewing the history of medical device regulations that led to the enactment of the 1976 Medical Device Amendments granting the FDA jurisdiction over medical devices and preempting state efforts to do the same. He explains that the same issues then, most notably the encroachment of consumer protection approaches not designed for clinical use technologies, can be seen today, and contends that what the industry needs now is a similar preemption clause for healthcare-related AI as part of consistent federal oversight. The authors call for grounded yet flexible rules that focus on FDA's expertise while still allowing for future innovation and respecting states' rights to regulate certain aspects of medical practice.