A 2025 study published in the Journal of Market Access & Health Policy explores the evolving role of digital health technologies in shaping patient experiences and healthcare delivery. The authors used a mixed-methods approach including a survey of 20 Digital Health Technology developers, and qualitative research with 29 industry representatives from startups to multinational companies across 10 European countries in 2024.
Developers identified major challenges including lack of transparency in reimbursement processes, fragmented Health Technology Assessment (HTA) requirements across countries, and misalignment between traditional evidence models and agile Digital Health Technology development. Critical needs included integrating real-world evidence, considering usability and implementation factors, and providing structured lifecycle-based guidance. Small and medium-sized enterprises faced particularly significant financial and procedural barriers.
The findings demonstrate the need for an Health Technology Assessment framework that accommodates the iterative nature of digital innovation, incorporates real-world evidence, and reduces regulatory uncertainty. The EDiHTA project aims to address these challenges through a harmonized, flexible approach aligned with European Health Technology Assessment Regulation goals.
Citation
Mezei, F.; Tsiasiotis, E.; Basile, M.; Sciomenta, I.; Calosci, E.M.; Antonini, D.; Lukacs, A.; Di Bidino, R.; Cicchetti, A.; Sacchini, D. Shaping the Future of DHT Assessment: Insights on Industry Challenges, Developer Needs, and a Harmonized, European HTA Framework. J. Mark. Access Health Policy 2025, 13, 46. https://doi.org/10.3390/jmahp13030046
Read more at this link on the Journal of Market Access & Health Policy
Summary by Deger Kesimoglu, volunteer for the Alliance for Pulmonary Hypertension
