FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine

Abstract

Importance Advances in artificial intelligence (AI) must be matched by efforts to better understand and evaluate how AI performs across health care and biomedicine as well as develop appropriate regulatory frameworks. This Special Communication reviews the history of the US Food and Drug Administration's (FDA) regulation of AI; presents potential uses of AI in medical product development, clinical research, and clinical care; and presents concepts that merit consideration as the regulatory system adapts to AI's unique challenges. Observations The FDA has authorized almost 1000 AI-enabled medical devices and has received hundreds of regulatory submissions for drugs that used AI in their discovery and development. Health AI regulation needs to be coordinated across all regulated industries, the US government, and with international organizations. Regulators will need to advance flexible mechanisms to keep up with the pace of change in AI across biomedicine and health care. Sponsors need to be transparent about and regulators need proficiency in evaluating the use of AI in premarket development. A life cycle management approach incorporating recurrent local postmarket performance monitoring should be central to health AI development. Special mechanisms to evaluate large language models and their uses are needed. Approaches are necessary to balance the needs of the entire spectrum of health ecosystem interests, from large firms to start-ups. The evaluation and regulatory system w…