Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.

摘要

Artificial intelligence (AI) is transforming medical imaging and digital health, yet standard pre-market clearances evaluate algorithms under static, idealised conditions. Once deployed, imaging AI can degrade because of scanner drift, acquisition protocol shifts, software updates, and patient demographic variation. Although the US Food and Drug Administration Predetermined Change Control Plan and the EU AI Act introduce lifecycle oversight, clinical institutions lack structured tools to operati