Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study
EFSs remain underused in the EU DHT sector, primarily due to regulatory complexity, fragmentation, and a lack of tailored guidance. A harmonized, DHT-specific EFS framework featuring clearer definitions, standardized processes, and structured dialog between innovators and regulators could accelerate safe, effective, and user-centric digital health innovation. As the MDR and AI Act converge, coordinated regulatory approaches will be critical to balancing innovation, safety, and patient benefit in Europe.
Authors
- Sebastian Kühn (ORCID: https://orcid.org/0000-0002-8031-2973)
- Nicolas Martelli (ORCID: https://orcid.org/0000-0001-5959-231X)
- Ilja Michaelis
- Ornella Tangila Kayembe
- Tom Melvin (ORCID: https://orcid.org/0000-0001-6370-4177)
- Ann McDonnell (ORCID: https://orcid.org/0009-0003-4436-4631)
- Marlen Peseke (ORCID: https://orcid.org/0000-0002-3876-1740)
- Franco Luigi Zurlo
- Majella Geraghty (ORCID: https://orcid.org/0009-0007-9596-410X)
- Zoe Sophie Oftring
Institutions
- Philipps University of Marburg (DE)
- Trinity College Dublin (IE)
- Universitätsklinikum Gießen und Marburg (DE)
- Hôpital Européen (FR)
- Trials Methodology Research Network (IE)
- Bocconi University (IT)
Publication Details
- Journal
- Journal of Medical Internet Research
- Published
- 2025-10-01
- DOI
- https://doi.org/10.2196/77982
- Citations
- 1
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 0.65