Diverging regulatory DNA in adaptive medical AI: US agility and EU accountability in lifecycle governance.

Abstract

Medical artificial intelligence (AI) is transitioning from static, rule-based systems into adaptive models capable of continuous learning and iterative refinement. Such adaptivity expands the utility and performance of clinical AI systems across diverse patient populations and real-world conditions. However, these properties challenge regulatory paradigms originally designed for fixed-function medical devices. Although the United States and the European Union share goals of ensuring safety, acco