Evaluation and Regulation of Artificial Intelligence Medical Devices for Clinical Decision Support

Artificial intelligence (AI) methods were first developed nearly seven decades ago. Only in recent years have they demonstrated their potential to improve clinical care at the bedside. AI systems are now capable of interpreting, predicting, and even generating important medical information. AI medical devices share many similarities with traditional medical devices but also diverge from them in important ways. Despite widespread optimism and enthusiasm surrounding the use of such devices to improve care processes, patient outcomes, and the healthcare experience for patients, caregivers, and clinicians alike, little evidence exists so far for their effectiveness in practice. Even less is known about the safety or equity of AI medical devices. As with any new technology, this exciting time is accompanied by appropriate questions regarding if, how much, when, and who such AI systems really help. Different stakeholders, ranging from patients to clinicians to industry device developers, may have divergent preferences or assessments of risk and benefits, warranting an informed public discussion to guide emerging regulatory efforts. This review summarizes the rapidly evolving recent efforts and evidence related to the regulation and evaluation of AI medical devices and highlights opportunities for future work to ensure their effectiveness, safety, and equity.