Assessing the Regulation of Medical Artificial Intelligence in Clinical Settings: Considerations for Form, Process, Authority, and Timing

Abstract

The rapid integration of artificial intelligence (AI) into healthcare has introduced a transformative category of technologies known as Medical Artificial Intelligence (MAI). These tools, often approved by the U.S. Food and Drug Administration (FDA), are now used to assist in diagnosis, treatment planning, patient monitoring, and clinical decision-making. However, MAI poses novel regulatory challenges due to its dynamic, adaptive, and sometimes opaque nature. This dissertation critically examines the current regulatory frameworks governing MAI in the United States, focusing on tools used by health professionals in clinical settings. Drawing on legal theory, empirical data, and interdisciplinary analysis, the study explores how MAI fits—or fails to fit—within existing regulatory categories designed for conventional medical devices. It analyzes FDA approval trends, clearance pathways, medical specialties, and manufacturer profiles for over 1,000 FDA-approved AI/ML-enabled devices. The study also investigates gaps in post-market surveillance, algorithmic transparency, and the role of third-party evaluators. Chapters in this dissertation evaluate the scope and limits of current regulatory mechanisms, such as the FDA’s 510(k), De Novo, and PMA pathways, and discuss the involvement of other regulatory bodies including the Federal Trade Commission and Department of Health and Human Services. Particular attention is given to unresolved legal questions, such as liability in AI-induced errors, the classification of MAI as a “system” versus a “device,” and the role of evolving real-world performance in determining regulatory adequacy. Ultimately, this work proposes a tailored regulatory framework that is adaptive, risk-based, and harmonized across international borders. It advocates for collaborative governance involving public agencies, private innovators, and global partners to ensure that regulation keeps pace with technological advancement while protecting patients, supporting clinicians, and promoting innovation.