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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study
1
Zitationen
10
Autoren
2025
Jahr
Abstract
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.
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