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Article History

Received: 12 July 2024

Accepted: 15 January 2025

First Online: 6 February 2025

Competing interests

: F.R.: Occasional travel and accommodation costs to CORE–MD meetings were supported within the EU Horizon 2020 grant budget (2022-204); senior associate editor European Heart Journal, Cardiovascular Imaging. E.B.: external collaborative expert at the European Medicine Agency between 2023 and 2024 (unpaid collaboration); Occasional travel and accommodation costs to CORE–MD meetings were supported within the EU Horizon 2020 grant budget (2022-204). N.B.: Honorarium for presentation at Great Wall Cardiac Congress; ESC paid Article Processing Costs for one article in the European Heart Journal – Digital Health; Heart Rhythm Society paid travel costs for presentation at HRX; ESC Vice-chair Digital Health Committee; Editor-in-Chief of European Heart Journal – Digital Health. E.C.: Research contract with Luxottica S.p.A, Payment to my institution; Research contract with Croce Rossa Italiana, Payment to my institution; Project evaluator for the Autonomous Province of Trento, Italy; Honoraria for presentations from Dynamicom Education Srl, Summeet Srl, AIM Italy S.r.l.; Member of the Regulatory Affairs committee of the European Society of Cardiology. R.D.: minority shareholder in myocardium.AI; Consulting fees were paid directly to him. The company develops AI products for cardiac MR image analysis and is in the process of applying for regulatory approval. S.G.: German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) through the European Union-financed NextGenerationEU programme under grant number 16KISA100K, project PATH—‘Personal Mastery of Health and Wellness Data’. The European Commission under the Horizon Europe Programme, as part of the projects CYMEDSEC (101094218) and ASSESS-DHT (101137347). S.G. has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd.; Flo Ltd, Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, Ada Health GmbH, and he holds share options in Ada Health GmbH. Support and honoraria for TK Health Economics Forum at MEDICA. Advisory Group member of the EY-coordinated ‘Study on Regulatory Governance and Innovation in the Field of Medical Devices’ conducted on behalf of the DG SANTE of the European Commission. Share options in Ada Health GmbH. S.G. is a News and Views Editor for npj Digital Medicine. S.G. played no role in the internal review or decision to publish this article. G.M.: Occasional travel and accommodation costs to CORE–MD meetings were supported within the EU Horizon 2020 grant budget (2022-204). Health Products Regulatory Authority, Source of employment. G.O.: Health Products Regulatory Authority, Source of employment. J.B.R.: none. B.V.: Berrow Foundation Lord Florey scholarship. A.G.: Chair, Regulatory Affairs Committee, Biomedical Alliance in Europe.