The Regulation of Clinical Artificial Intelligence

AbstractThe regulation of clinical artificial intelligence (AI) poses novel challenges for policy makers worldwide. Existing approaches to assuring the safety and efficacy of AI technologies may suffice for older forms of AI that preceded the development of generative artificial intelligence (GAI). However, the regulation of clinical GAI may require the development of new regulatory paradigms. This article reviews approaches in the United States to regulating pregenerative clinical AI and examines a novel possible approach to GAI regulation. The sooner policy makers in the United States and elsewhere tackle the challenges of regulating clinical AI, the sooner its benefits will be made available to people and patients with acceptable assurances of safety and efficacy.