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. 2025 Feb 13;16(1):33.
doi: 10.1186/s13244-025-01905-x.

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

Elmar Kotter  1   2 , Tugba Akinci D'Antonoli  3 , Renato Cuocolo  4 , Monika Hierath  5 , Merel Huisman  6 , Michail E Klontzas  7 , Luis Martí-Bonmatí  8 , Matthias Stefan May  9 , Emanuele Neri  10 , Konstantin Nikolaou  11 , Daniel Pinto Dos Santos  12   13 , Maija Radzina  14   15 , Susan Cheng Shelmerdine  16   17   18 , Arianna Bellemo  5 ; European Society of Radiology (ESR)
Affiliations

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

Elmar Kotter et al. Insights Imaging. .

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.

Keywords: AI literacy; Artificial intelligence; Human oversight; Implementation; Regulation.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: E.K.: Potential declarations: Speaker for Siemens Healthineers; Speaker for Bayer; Speaker for abbvie; Consultant to SHS investment; Shareholder G-Holding, Paris; Shareholder contextflow, Vienna; Immediate Past-President EuSoMII (European Society of Medical Imaging Informatics). Mo.H. is employed by the ESR. Me.H. Speakers honoraria from industry; incidental paid consulting (Capvision); support for attending meetings and/or travel from scientific societies; EuSoMII Board member, ESR eHealth & Informatics Subcommittee member, ECR Imaging Informatics/Artificial Intelligence and Machine Learning Chairperson 2025, committee member with FMS (Dutch), and Radiology: Artificial Intelligence associate editor and trainee editorial board advisory panel (all unpaid). L.M.B. was the Editor-in-Chief of Insights into Imaging at the time of submission. He has not taken part in the review or selection process of this article. M.M. received honoraries via the speakers bureau of Siemens Healthineers AG, Bayer AG and Brainlab AG within the last two years for other topics. S.C.S.: Cofounder of a private company (Anubix Ltd) providing postmortem reporting services. Non-financial research collaborations with Gleamer and Milvue (AI vendors). A.B. is employed by the ESR. The remaining authors declare no conflicts of interest.

Figures

Fig. 1
Fig. 1
AI Act risk level classification
See this image and copyright information in PMC

References

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    1. European Society of Radiology (ESR) (2020) ESR statement in response to European Commission White Paper on artificial intelligence—a European approach to excellence and trust. Available via https://www.myesr.org/app/uploads/2023/08/esr_statement_for_public_consu.... Accessed 22 Aug 2024
    1. European Society of Radiology (ESR). Stakeholder Joint Statement on Access to Innovative Healthcare under the Artificial Intelligence Act (AI Act). Available via https://www.myesr.org/esr-co-signs-joint-healthcare-statement-on-the-eu-.... Accessed 22 Aug 2024
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