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EDiHTA

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  • EDiHTA publishes its second scientific paper on harmonising Digital HTA in Europe

    EDiHTA publishes its second scientific paper on harmonising Digital HTA in Europe

    EDiHTA publishes its second scientific paper on harmonising Digital HTA in Europe

    EDiHTA partners have published a new peer-reviewed scientific article addressing one of the project’s core challenges: the lack of harmonised Health Technology Assessment methods for evaluating digital health technologies across Europe.

    The article, titled “Toward a Harmonized Health Technology Assessment Framework for Digital Health Technologies in Europe,” is authored by Emmanouil Tsiasiotis, Fruzsina Mezei, Rossella Di Bidino, Michele Basile, Livio Battaglia, Valentina Strammiello, Kristian Kidholm, PhD, Wija Oortwijn, Americo Cicchetti, Dario Sacchini, and draws directly on research conducted within the  EDiHTA project.

    Read the paper: Value in Health | ISPOR (DOI: https://doi.org/10.1016/j.jval.2025.12.004)

    DOI

    Abstract

    Objectives

    The increasing use of digital health technologies (DHTs) in Europe presents opportunities and challenges. Although DHTs could enhance care delivery and health outcomes, existing health technology assessment (HTA) methods often lack flexibility to address their diverse, fast-evolving nature. This article explores the perspectives of 5 stakeholder groups—policy makers, HTA agencies, technology developers, healthcare providers, and patients—regarding the development of a harmonized HTA framework for DHTs within the Horizon Europe funded European Digital Health Technology Assessment (EDiHTA) project.

    Methods

    Findings are drawn from mixed-method research, including stakeholder surveys, interviews and focus groups with 97 stakeholders across European countries. The analysis of the data was performed per each stakeholder group through thematic analysis to identify points of consensus before identifying needs and requirements across stakeholders, relevant to the development of EDiHTA, using the Innovation Health Technology Assessment Methods framework.

    Results

    Results from 8 focus groups and more than 45 interviews are presented concentrating on 5 main themes. The emerging themes focus on the need for harmonization of HTA methods related to DHTs, the current characteristics of DHTs that are most highly valued, the importance of multistakeholder collaboration, the principles of a concept design for EDiHTA framework, and the discussion on the most relevant domains and criteria to be considered.

    Conclusions

    Stakeholders agreed that a harmonized HTA framework is needed; however, differences persist regarding timing and flexibility of evaluation, evidence types, and stakeholder involvement. The EDiHTA project will address differences through framework piloting, supported by multistakeholder workshops and expert advisory groups.
  • EDiHTA prepares for its open piloting phase in 2026

    EDiHTA prepares for its open piloting phase in 2026

    EDiHTA prepares for its open piloting phase in 2026

    EDiHTA is preparing for an upcoming piloting phase that will test and refine the project’s framework for the assessment of digital health technologies (DHTs) in Europe.

    An open pilot for developers in early 2026

    In early 2026, the EDiHTA consortium will invite digital health technology developers, including SMEs and larger companies, to participate in an open pilot. Participants will be able to propose their technologies as use cases and provide structured feedback on the framework and supporting materials.

    This piloting phase is designed to:

    • validate the framework’s usability and relevance across different types of DHTs,

    • test the practicality of evidence requirements and assessment steps,

    • strengthen co-creation with industry stakeholders,

    • support refinement of the framework and guidance materials ahead of broader uptake.

    Expressions of interest

    Expressions of interest are expected to open in January 2026. Further information on participation criteria, timelines and submission steps will be shared in the new year.

    Stay connected for updates as EDiHTA moves into this important next phase of framework development.

  • Recap: EDiHTA at the EPF Congress 2025: advancing patient involvement in Digital HTA

    Recap: EDiHTA at the EPF Congress 2025: advancing patient involvement in Digital HTA

    Recap: EDiHTA at the EPF Congress 2025: advancing patient involvement in Digital HTA

    The EDiHTA project was represented at the European Patients’ Forum (EPF) Congress, held in Brussels on 26–27 November 2025. Over two days, the Congress focused on strengthening patient involvement in European health systems, with discussions exploring current challenges, emerging priorities and practical approaches to embed patient perspectives in healthcare design and decision-making.

    Bianca Pop, Project Officer at the European Patients’ Forum, highlighted the value of collaboration for patient-centred innovation:

    The EPF Congress brought together patients, policymakers, healthcare professionals, researchers and industry representatives to promote collaboration in shaping Europe’s healthcare future. The exchanges highlighted that joint efforts are essential to ensure healthcare innovations address real patient needs.

    Bianca Pop

    | EPF

    Patient involvement as a core pillar of EDiHTA

    Patient involvement is central to EDiHTA’s approach to developing a European framework for assessing digital health technologies. Through the project’s Patient Advisory Group, patient priorities, lived experiences and real-world use considerations are integrated into the framework development process, helping ensure that assessment approaches reflect what matters to those who will ultimately use and benefit from digital tools in health and care.

    At the Congress, EPF, in partnership with the European Health Management Association (EHMA), presented a poster highlighting how patients contribute to EDiHTA’s work and how patient input supports the project’s goal of advancing more person-centred, trustworthy and usable digital health technologies.

    Reflecting on this contribution, Bianca Pop added:

    As part of the EDiHTA project, the Patient Advisory Group has played a key role, offering insights that guarantee digital health technologies are patient-centred and aligned with day-to-day patient care. We remain committed to advancing these efforts, ensuring the patient perspective is integrated at every stage of the project.

    Bianca Pop

    | EPF

    Alexis Strader, Director of Policy and Research at EHMA, also emphasised the value of the Congress as a forum for exchange across communities working on patient involvement and innovation:

    The Congress provided a valuable opportunity to engage with stakeholders working at the intersection of patient involvement, innovation and healthcare. Discussions confirmed strong interest in approaches that support the responsible use of digital health technologies and patient-centred perspectives.

    Alexis Strader

    | EHMA

    Looking ahead

    Insights and exchanges from the EPF Congress will feed into EDiHTA’s ongoing work, reinforcing the project’s commitment to meaningful patient involvement and supporting efforts to embed patient perspectives consistently across the development of the Digital HTA framework.

  • EDiHTA featured at EU Health Policy Platform Live Webinar on digital health transformation

    EDiHTA featured at EU Health Policy Platform Live Webinar on digital health transformation

    EDiHTA featured at EU Health Policy Platform Live Webinar on digital health transformation

    EDiHTA will be presented at the upcoming EU Health Policy Platform (EUHPP) Live Webinar organised by the European Commission in collaboration with HIMSS: “Driving Digital Health Transformation – Insights from the HIMSS European Projects”. The session takes place on Thursday, 11 December 2025 (14:00–15:30 CET, Brussels time) and will explore how EU-funded initiatives contribute to advancing digital health transformation across Member States.

    EDiHTA will be represented by Emmanoil Tsiasiotis, EDiHTA’s Project Manager, who will present EDiHTA’s work on developing a flexible, stakeholder-driven framework for the assessment of digital health technologies. His contribution will highlight how the project supports more consistent, transparent and inclusive approaches to evaluating digital health solutions across Europe.

    The webinar will also introduce the European Projects Insight Report 2025, prepared through the HIMSS European Projects Initiative. The report brings together twelve EU-funded projects and a multi-stakeholder Advisory Board, distilling more than 160 recommendations aimed at improving coordination across initiatives and supporting long-term sustainability of digital health innovation in Europe.

    We look forward to taking part in this exchange alongside other EU-funded projects and to sharing EDiHTA’s experience with the EUHPP community.

    Useful Links:

    HIMSS, the Healthcare Information and Management Systems Society, is a global non-profit organisation working to advance the use of information and technology in health systems. 

  • Poster presentation: EDiHTA introduces its digital HTA framework at EPF Congress 2025

    Poster presentation: EDiHTA introduces its digital HTA framework at EPF Congress 2025

    Poster presentation: EDiHTA introduces its digital HTA framework at EPF Congress 2025

    The EDiHTA project will be highlighted at the European Patients’ Forum (EPF) Congress 2025, taking place on 26–27 November in Brussels. The Congress brings together patient organisations, policymakers, healthcare professionals, researchers and industry representatives to strengthen the role of patients in shaping Europe’s healthcare future.

    As part of the programme, Alexis Strader, Director of Policy and Research at the European Health Management Association (EHMA), will present a poster showcasing EDiHTA’s work on developing a flexible, ethical and inclusive European framework for assessing digital health technologies. The poster reflects the project’s commitment to ensuring that emerging digital tools, such as AI systems, telemedicine platforms and connected medical devices, are evaluated in ways that are meaningful, transparent and aligned with real healthcare needs.

    A central component of this work is the EDiHTA Patient Advisory Group, composed of patient representatives from nine European countries and diverse disease areas. Their insights and lived experiences play a vital role in shaping the project’s approach, ensuring that patient perspectives guide how digital technologies are assessed and implemented.

    By combining collaboration, ethical considerations and strong patient engagement, EDiHTA is helping to build a more inclusive, trustworthy and people-centred digital health ecosystem for Europe.

     

    Learn more about EDiHTA’s patient involvement: Patients – EDiHTA

    Learn more about the EPF Congress: https://epfcongress.eu

  • EDiHTA to be presented at the European Patients’ Forum Congress 2025

    EDiHTA to be presented at the European Patients’ Forum Congress 2025

    EDiHTA joins the first EPF Members’ Circle

    The EDiHTA project will be featured at the European Patients’ Forum (EPF) Congress 2025, taking place on 26–27 November 2025 in Brussels. The EPF Congress is one of Europe’s key events for advancing patient leadership, bringing together patient organisations, policymakers, healthcare professionals, researchers and industry representatives to strengthen the role of patients in shaping the future of healthcare.

    On 26 November, Alexis Strader, Director of Policy and Research at the European Health Management Association (EHMA), will present a poster showcasing EDiHTA’s work on developing a European framework for the ethical and inclusive assessment of digital health technologies.

    The EDiHTA framework aims to improve how digital health tools, such as AI, telemedicine and medical devices, are evaluated and adopted across Europe, ensuring that innovation remains fair, transparent and centred on real healthcare needs.

    A core part of this effort is the EDiHTA Patient Advisory Group, which includes representatives from nine European countries and diverse disease areas. The group plays a crucial role in ensuring that patient experiences and expectations directly inform how digital technologies are assessed and implemented.

    By combining collaboration, ethics and patient engagement, EDiHTA contributes to building a more inclusive, trustworthy and patient-centred digital health ecosystem in Europe.

    Learn more about EDiHTA’s patient involvement and visit the EPF Congress website for programme details and registration information.

     

    The European Patients’ Forum is a key partner in the EDiHTA project, contributing its expertise in patient engagement and advocacy to ensure that patient voices are central to the development of the European framework for digital health technology assessment.

  • EDiHTA joins the first EPF Members’ Circle

    EDiHTA joins the first EPF Members’ Circle

    EDiHTA joins the first EPF Members’ Circle

    We were delighted to participate in the first session of the European Patients’ Forum (EPF) Members’ Circle, a dedicated platform for open dialogue and knowledge exchange within the EPF community.

    The session brought together over 20 patients and patient representatives from across Europe to explore EDiHTA’s mission and progress, presented by our Project Manager, Emmanouil Tsiasiotis and our partners from the Norwegian Centre for E-health Research. Together, we discussed key policy insights from EDiHTA on data protection, cybersecurity and the European Health Data Space (EHDS), focusing on how these developments affect patients’ rights and the assessment of digital health technologies.

    The conversation highlighted the growing role of patients in shaping digital health policy and evaluation frameworks, emphasising collaboration and transparency as essential elements in advancing trustworthy digital health innovation. This first session marks the beginning of a three-part Members’ Circle series with the two additional sessions to follow in 2026, continuing the exchange between patient organisations, researchers and policymakers.

     

    We extend our gratitude to the European Patients’ Forum for hosting this insightful session and to all participants for their valuable contributions and engagement. Stay tuned for updates on the next sessions of the Members’ Circle and follow EPF’s updates.

  • European Projects Insight Report: Showcasing the power of EU-Funded digital health collaboration

    European Projects Insight Report: Showcasing the power of EU-Funded digital health collaboration

    EDiHTA consortium charts the path forward at its 4th General Assembly in Barcelona

    We are delighted to share that the European Projects Insight Report has been officially published on the HIMSS website. Developed as part of the HIMSS European Projects Initiative 2025, the report captures the strategic direction, systemic challenges and transformative potential of 12 EU-funded digital health initiatives, including EDiHTA.

    The report was created by a cross-sectoral Advisory Board comprising experts from HIMSS, the European Commission, national health ministries, patient organisations, academia, health tech and international organisations such as the OECD. Through a multi-phase collaborative process, the Advisory Board reviewed project materials and presentations, contributing more than 160 recommendations, including 82 project-specific insights tailored to each participating initiative.

    The 12 projects featured, CYLCOMED, EDiHTA, ENTRUST, FLUTE, Gravitate-Health, IDERHA, MedSecurance, NEMECYS, ONCOVALUE, SHAIPED, TRUMPET and XiA, represent the diversity and innovation driving Europe’s digital health transformation. The report highlights key lessons and practical recommendations to enhance policy alignment, stakeholder engagement, data governance, interoperability, and sustainability across EU-funded initiatives.

    As a member of this collaborative effort, EDiHTA is proud to contribute to advancing digital health solutions that improve patient outcomes, foster innovation, and support the digital transformation of healthcare systems across Europe.

    Download the European Projects Insight Report

    Read more:

  • EDiHTA consortium charts the path forward at its 4th General Assembly in Barcelona

    EDiHTA consortium charts the path forward at its 4th General Assembly in Barcelona

    EDiHTA consortium charts the path forward at its 4th General Assembly in Barcelona

    The EDiHTA consortium gathered last week in the heart of Catalonia for its 4th General Assembly, hosted by our partners from Agency for Health Quality and Assessment of Catalonia (AQuAS). Over two days, partners met to discuss progress, share insights and shape the next steps in developing Europe’s first flexible framework for digital health technology assessment.

     

    From design to implementation

    Set in the modernist surroundings of AQuAS headquarters, the meeting opened with a warm welcome from the host team and remarks from the coordination partners at Università Cattolica del Sacro Cuore (UCSC). The first sessions dived into the evolving structure of the EDiHTA framework — with presentations from AQuAS, Hospital Clínic de Barcelona (HCB/FCRB), and DNV outlining advances in evidence requirements, platform architecture and digitalisation.

    Day one also featured updates on the first pilot phase from UCSC and a deep-dive into Task 4.3 on methodology validation and stakeholder mapping led by Odense University Hospital (OUH). As the day came to a close, discussions continued over dinner, where participants reflected on how EDiHTA is transitioning from design to real-world testing.

     

    Strategic alignment and stakeholder inclusion

    The second day focused on preparing for the project’s next milestones. UCSC and EITH shared plans for the second pilot phase, while AGENAS guided a lively discussion on exploitation strategy and sustainability. The session by EHMA explored synergies with related European projects, and EPF led an engaging conversation on patient involvement — a crucial element in ensuring that EDiHTA remains patient-centred and inclusive.

    The assembly concluded with a forward-looking planning session for 2026, setting the stage for upcoming pilot activities and the long-term vision for framework uptake and policy integration.

     

    A collective effort towards impact

    The Barcelona General Assembly meeting captured the collaborative spirit of EDiHTA: 17 partners from across Europe working together to advance the assessment of digital health technologies. The two days were marked by open discussion, strategic alignment and shared commitment to the project’s mission, supporting Europe’s transition towards evidence-based, harmonised digital health evaluation.

     

    A sincere thank you to our hosts at AQuAS for their hospitality and excellent organisation, and to all partners for their continued engagement and contributions.

  • 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.
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