Tag: early feasibility studies
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EU Stakeholder Perspectives on Early Feasibility Studies for Digital Health
Understanding the Regulatory Context for Digital Health in the European Union Digital health technologies (DHTs) — from mobile apps and wearables to AI-driven decision aids — are transforming how care is delivered. In the EU, these tools face a software-focused regulatory environment under the Medical Device Regulation (MDR) and an evolving AI framework. A growing…
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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…