The introduction of artificial intelligence (AI) into medical devices, decision support, and clinical practice is not new, with a particular uptick in investment and deployment within the past decade. Regulators (eg, the US Food and Drug Administration, the European Medicines Agency, and the National Medical Products Administration), intergovernmental organizations (eg, the World Health Organization), civil society groups, institutional review boards at hospitals, and others have worked hard to define the scope of what AI applications should require review and approval, implementing rules in a fast-changing terrain with mixed results.