Guiding AI in radiology: ESR’s recommendations for effective implementation of the European AI Act

Abstract

Abstract This statement has been produced within the European Society of Radiology AI Working Group and identifies the key policies of the EU AI Act as they pertain to medical imaging. It offers specific recommendations to policymakers and the professional community for the effective implementation of the legislation, addressing potential gaps and uncertainties. Key areas include AI literacy, classification rules for high-risk AI systems, data governance, transparency, human oversight, quality management, deployer obligations, regulatory sandboxes, post-market monitoring, information sharing, and market surveillance. By proposing actionable solutions, the statement highlights ESR’s readiness in supporting appropriate application of the AI Act in the field, promoting clarity and the effective integration of AI technologies to ensure their impactful and safe use for the benefit of Europe’s patients. Critical relevance statement With the impending arrival of the EU AI Act, it is critical for stakeholders to provide timely input on its key areas. This statement offers expert feedback on the aspects of the EU AI Act that will affect medical imaging. Key Points The AI Act will significantly impact the field of medical imaging, shaping how AI technologies are used and regulated. The ESR is committed to develop guidelines and best practices, collaborating on the implementation process. This statement offers expert feedback on the aspects of the framework that will affect medical imaging. Graphical Abstract

Keywords

• Artificial intelligence
• Regulation
• Implementation
• AI literacy
• Human oversight