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Operationalizing the EU AI Act in a comprehensive cancer center through an institutional governance framework
W Gehin1, J C Faivre2, J E Bibault3
1Department of Radiation Oncology, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France. w.gehin@nancy.unicancer.fr.
Abstract:
The EU AI Act subjects high-risk clinical AI systems to deployer obligations whose institutional operationalization remains undefined. Drawing on experience at a French comprehensive cancer center, we present a governance framework combining three novel components: a dual-axis model for institutional risk stratification, a five-category AI-related adverse event taxonomy inspired by pharmacovigilance, and structured proficiency testing against simulated AI errors. Successful AI integration depends on institutional readiness, not algorithmic performance.
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