EDiHTA publishes its first scientific paper on stakeholder perspectives in digital health assessment

October 6, 2025

The EDiHTA consortium is proud to announce the publication of its first scientific paper, marking an important milestone in the project’s research and dissemination efforts. The article, titled “Shaping the Future of DHT Assessment: Insights on Industry Challenges, Developer Needs, and a Harmonized, European HTA Framework”, was published in the Journal of Market Access & Health Policy as part of the consortium’s work on identifying stakeholder challenges and needs.

The paper was authored by the EDiHTA partners Fruzsina Mezei, Emmanouil Tsiasiotis, Michele Basile, Ilaria Sciomenta, Elena Maria Calosci, Debora Antonini, Adam Lukacs, Rossella Di Bidino, Americo Cicchetti and Dario Sacchini.

The paper captures key barriers and enablers faced by digital health developers across Europe and offers priorities for a more coherent, harmonised approach to HTA. These insights directly inform EDiHTA’s work to design a flexible, validated HTA framework and the forthcoming EDiHTA toolkit for developers.

Read the paper: MDPI — Journal of Market Access & Health Policy (DOI: 10.3390/jmahp13030046)

Abstract:

Introduction: Market access, pricing, and reimbursement of digital health technologies (DHTs) in Europe are significantly challenged by regulatory fragmentation and various assessment methodologies. Understanding the challenges and priorities of technology developers is essential for developing effective and relevant policy responses. This study explores perceived barriers and developer-driven priorities to inform the development of a harmonized health technology assessment (HTA) framework under the EDiHTA project. Methods: A mixed-methods approach was adopted, including a scoping review to identify key challenges, a survey of 20 DHT developers, and interviews and focus groups with 29 industry representatives from startups to multinational companies across 10 European countries during 2024. Results: Key challenges included a lack of transparency in reimbursement processes, fragmented HTA requirements, and misalignment between traditional evidence models and the agile development of DHTs. Developers highlighted the need to integrate real-world evidence, consider usability and implementation factors, and provide structured, lifecycle-based guidance. Financial barriers and procedural burdens were particularly significant for small and medium-sized enterprises. Conclusions: These findings highlight the need for an HTA framework that reflects the iterative nature of digital development, integrates real-world evidence, and reduces uncertainty for developers. The EDiHTA project aims to respond to these challenges by building a harmonized and flexible approach that aligns with the goals of the European HTA Regulation.

EDiHTA publishes its first scientific paper on stakeholder perspectives in digital health assessment

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