Operationalizing the EU AI Act in a comprehensive cancer center through an institutional governance framework

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.