Kotter Elmar, D'Antonoli Tugba Akinci, Cuocolo Renato, Hierath Monika, Huisman Merel, Klontzas Michail E, Martí-Bonmatí Luis, May Matthias Stefan, Neri Emanuele, Nikolaou Konstantin, Pinto Dos Santos Daniel, Radzina Maija, Shelmerdine Susan Cheng, Bellemo Arianna
Department of Diagnostic and Interventional Radiology, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Insights Imaging. 2025 Feb 13;16(1):33. doi: 10.1186/s13244-025-01905-x.
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.
本声明由欧洲放射学会人工智能工作组制定，确定了欧盟人工智能法案中与医学成像相关的关键政策。它为政策制定者和专业团体提供了具体建议，以有效实施该立法，解决潜在的差距和不确定性。关键领域包括人工智能素养、高风险人工智能系统的分类规则、数据治理、透明度、人工监督、质量管理、部署者义务、监管沙盒、上市后监测、信息共享和市场监管。通过提出可操作的解决方案，该声明突出了欧洲放射学会在支持人工智能法案在该领域的适当应用方面的准备情况，促进清晰度以及人工智能技术的有效整合，以确保其为欧洲患者带来有益且安全的使用。关键相关性声明：随着欧盟人工智能法案即将出台，利益相关者及时就其关键领域提供意见至关重要。本声明就欧盟人工智能法案中影响医学成像的方面提供了专家反馈。要点：人工智能法案将对医学成像领域产生重大影响，塑造人工智能技术的使用和监管方式。欧洲放射学会致力于制定指南和最佳实践，在实施过程中开展合作。本声明就该框架中影响医学成像的方面提供了专家反馈。
