THIS WEBSITE USES COOKIES
We use cookies to personalise content, to provide social media features, and to analyse our traffic. By choosing 'allow all cookies', you consent to our cookies.
To find out more, read our privacy policy and cookie policy.

EDiHTA

Day: 6 October 2025

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

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

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

    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)

    DOI

    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.
  • Participate in the EDiHTA survey to shape the future of digital health assessment

    Participate in the EDiHTA survey to shape the future of digital health assessment

    EDiHTA featured at Greece’s 10th National HTA Conference

    The EDiHTA project invites innovators in digital health to take part in a short survey and help shape the development of the EDiHTA toolkit, a practical resource designed to guide developers through the Health Technology Assessment (HTA) process.

    If you are developing a digital health solution at TRL/IML 6 or above, your insights are essential. By contributing, you will help co-create a toolkit that supports digital health innovators in demonstrating the value, safety and impact of their technologies across European healthcare systems. Click the button below to take the survey:

    Take the survey

    This survey forms part of EDiHTA’s mission to build the first flexible and validated HTA framework tailored for digital health technologies. The project brings together leading European partners to support the adoption of evidence-based digital health innovations. Don’t miss the opportunity to share your experience and contribute to the future of digital health innovation in Europe.

  • EDiHTA featured at Greece’s 10th National HTA Conference

    EDiHTA featured at Greece’s 10th National HTA Conference

    EDiHTA featured at Greece’s 10th National HTA Conference

    The EDiHTA project was proud to be featured at the 10th National Health Technology Assessment (HTA) Conference in Greece, a milestone event marking the country’s progress in implementing its national HTA plan with the support of the Greek Ministry of Health, the WHO Regional Office for Europe and the European Commission.

    Representing the consortium, EDiHTA Project Manager Emmanouil Tsiasiotis presented the latest developments of the project, showcasing how EDiHTA contributes to capacity building and strengthens collaboration within the evolving EU HTA ecosystem.

    The conference also provided an excellent opportunity to connect with representatives from the Greek Ministry of Health and other national stakeholders, fostering dialogue on how EDiHTA’s harmonised framework can support future national and cross-border implementation.

    The EDiHTA team is excited to build on this momentum as the project continues to advance towards its goal of a more integrated and evidence-based European HTA landscape.

Receive the latest news

Subscribe to our Newsletter

Stay informed about latest EDiHTA results, conferences, and milestones.