Tag: regulatory framework
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies
Why Early Feasibility Studies Matter for Digital Health Technologies in Europe Digital health technologies (DHTs)—including mobile apps, telemedicine platforms, wearables, and software-based clinical decision aids—are increasingly regulated as medical devices when their intended use involves diagnosis, prevention, or treatment. With rising expectations for robust clinical evidence and iterative software updates, early feasibility studies (EFSs) emerge…
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Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: A Qualitative Interview Study
Introduction Digital health technologies (DHTs) span mobile apps, telemedicine, wearables, and software for clinical decision support. As regulation and validation evolve, early feasibility studies (EFSs) have emerged as a potential way to gather real-world, human-centered data early in development. This article summarizes stakeholder insights from a qualitative study conducted across EU digital health companies and…