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

npj Digital Medicine 2026 Open access

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Authors: W. Gehin, JC Faivre, JE Bibault, Y. Thiery, S. Deon, E. Desandes, A. Lambert, A. Baudin, M. Schoumacker, P. Eschwege, S. Supiot, T. Perennec
+1 more D. Peiffert
DOI: 10.1038/s41746-026-03073-8
Cited by: 1
References: 40

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.

Fields of Study & Subjects

Artificial Intelligence in Healthcare and Education Pharmacovigilance and Adverse Drug Reactions Explainable Artificial Intelligence (XAI)

Publication details

Journal / source
npj Digital Medicine
Publisher
Springer Science and Business Media LLC
Volume
9
Issue
1
Publication date
28 July 2026
Language
EN