Navigating US Regulation of Artificial Intelligence in Medicine—A Primer for Physicians

Abstract

Artificial intelligence and clinical software solutions are augmenting patient care, optimizing clinical workflows, and altering health care organization operations. The regulation and oversight mechanisms under development for this wave of digital innovation will set the precedent for health care and play a key role in shaping the future of digital health. It is critical for the physician voice to be active in both policy making and product development to ensure that clinical outcomes and the needs of patients are prominently represented. With digital technology rapidly changing health care, it can be difficult for practicing physicians to participate in the future while simultaneously tending to their clinical duties. We aim to ease this cognitive burden by providing physicians a primer for current regulation of software and artificial intelligence by the Food and Drug Administration. Regulation and oversight will greatly benefit from physicians primed to add their knowledge and patient-first values to the future of digital technology.