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This paper is in the following e-collection/theme issue:

Policy and Policy Proposals (305) Ethics, Privacy, and Legal Issues (787) E-Health Policy and Health Systems Innovation (505) Design and Usability of Medical Devices (208) Business and Entrepreneurship in eHealth (67) Digital Health Reporting Standards, Quality and Transparency in e-Research (207) Regulatory Issues and Medical Device Certification (11)

Published on in Vol 27 (2025)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/77982, first published .
Diverse group discussing health insurance options with a laptop showing a heart monitor.

Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study

Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study

Authors of this article:

Marlen Peseke1 Author Orcid Image ;   Ilja Michaelis1 Author Orcid Image ;   Ornella Tangila Kayembe2 Author Orcid Image ;   Majella Geraghty3, 4 Author Orcid Image ;   Ali McDonnell3 Author Orcid Image ;   Franco Luigi Zurlo5 Author Orcid Image ;   Zoe Sophie Oftring1 Author Orcid Image ;   Nicolas Martelli2 Author Orcid Image ;   Tom Melvin3, 4 Author Orcid Image ;   Sebastian Kuhn1 Author Orcid Image
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Journals

  1. Servy H, Braithwaite B, Kiltz U, van Tubergen A, Studenic P, Voshaar M, Wiek D, Tropé S, Burmester G, Venerito V, Gossec L. Artificial intelligence in healthcare faces regulatory challenges: balancing innovation with human oversight. EULAR Rheumatology Open 2026;2(1):283 View
  2. . AI Medical Device Safety: Scoping Review with ☸️SAIMSARA. SAIMSARA Journal 2026;1(3) View
  3. Banks H, Buzelli M, Tangila Kayembe O, Martelli N, Geraghty M, Callea G. Pre-market clinical investigation approval pathways and the role of Early Feasibility Studies for medical devices: a scoping review to guide EU policy. Expert Review of Medical Devices 2026:1 View