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Authors
Welzel, Cindy
Ostermann, Max
Smith, Hannah Louise
Minssen, Timo
Kirsten, Toralf
Gilbert, Stephen
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Funding
Funding for this research was provided by:
Bundesministerium für Bildung und Forschung (16KISA100K, 16KISA100K, 16KISA100K)
HORIZON EUROPE European Research Council (101094218, 101094218)
Novo Nordisk Fonden (NNF23SA0087056, NNF23SA0087056)
European Union Classica (101057321)
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Article History
Received: 7 April 2025
Accepted: 11 August 2025
First Online: 30 August 2025
Competing interests
: S.G. declares a nonfinancial interest as an 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. S.G. declares the following competing financial interests: he has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd., Flo Ltd, ICURA ApS, Rock Health Inc., Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, DG SANTE, Prova Health Ltd, haleon plc and Ada Health GmbH and holds share options in Ada Health GmbH. S.G. is a News and Views Editor for npj Digital Medicine but is not part of a peer review process or decision making of this manuscript. S.G. played no role in the internal review or decision to publish this article. T.M. serves as a Member of various WHO Committees in Medical AI & Ethics. Outside the submitted work, he also served as an expert advisor to the European Commission’s Joint Research Service, Microsoft, Daiki, a company engaged in AI compliance and governance; and as a Senior Advisor at the law firm X officio Advokat AB. Authors C.W., M.O., H.L.S. and T.K. declare no Non-Financial Interests and no Competing Financial Interests.
