The ECR highlighted the growing discussions on how to comply with the new European AI Act, both from the perspective of AI developers and deployers in radiology. Multiple presentations and panel discussions addressed this crucial topic.
Recently, the European Society of Radiology (ESR) AI Working Group released recommendations for applying the AI Act in radiology. Key focus 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.
These recommendations aim to guide policymakers and radiology professionals in integrating AI safely and effectively while ensuring compliance with EU regulations. Read the whole paper to improve your understanding of the implications of the AI Act.
Want an easier read? Check out our blog on the EU AI Act on the requirements for healthcare organizations.
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Guiding AI in radiology: ESR’s recommendations for effective implementation of the European AI Act
Insights into Imaging, 2025
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.