Bridging the gap: aligning clinical decision support regulation with clinical practice in the era of artificial intelligence.

Abstract

Clinical decision support (CDS) software plays an increasingly central role in health-care delivery, yet the ambiguous interpretations of regulations result in inconsistent application in clinical practice. In this Viewpoint, we trace the evolution of CDS regulation in the USA and discuss how the evolution resulted in ambiguity for health systems. On the one hand, health systems are aware that some CDS software they use fall within regulatory oversight. On the other hand, the current regulatory ambiguity and low-intensity enforcement maintain existing practice. This situation raises questions around regulatory consistency and patient safety, particularly for high-risk CDS software that shapes standard-of-care practices. In response, we propose three key directions centred on radical transparency: public disclosure of CDS software, structured dialogue between industry and the US Food and Drug Administration (FDA), and updates to existing FDA guidance. These steps aim to foster a pragmatic, risk-based approach to CDS software oversight, with the approach aligning regulation with clinical practice.