'Artificial intelligence for health insurance: A proposed framework for FDA oversight' by Renee Sirbu, Jessica Morley and Luciano Floridi comments
Despite mounting enthusiasm regarding the introduction of artificial intelligence (AI) software as a medical device (SaMD) to clinical care and, consequently, the development of a new regulatory proposal for the federal oversight of AI/ML medical devices, little attention has been paid to the oversight of AI tools used by large insurers. The U.S. Food and Drug Administration (FDA) has advanced an “Action Plan” for clinical AI (CAI) governance. However, the U.S. healthcare system remains threatened by the unregulated application of insurance AI (IAI). In this article, we use IAI tools in the Medicare Advantage (MA) prior authorization pathway as an illustrative case to argue that these technologies require further regulatory attention by the FDA. Specifically, we propose a redefinition of “medical device” under the 21st Century Cures Act as necessarily inclusive of IAI and advance an actionable framework for FDA oversight in the approval of IAI tools for deployment by large healthcare insurers.
