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EDiHTA

Category: Uncategorized

  • 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.
  • 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.

  • EDiHTA Talks #2: How to make mobile health apps accessible to patients

    EDiHTA Talks #2: How to make mobile health apps accessible to patients

    EDiHTA Talks #2: How to Make Mobile Health Apps Accessible to Patients

    We are pleased to share the second episode of EDiHTA Talks, our dedicated podcast series hosted on the European Patients’ Forum (EPF) Podcast, bringing patient voices into the spotlight of Digital Health Technology Assessment (HTA).

    This new episode, “How to Make Mobile Health Apps Accessible to Patients,” with an Advocacy Specialist, Emma Andersson, explores the everyday barriers patients face when trying to use digital tools such as mobile health apps. With a focus on usability, inclusivity and real-world functionality, the discussion draws on concrete experiences to show why digital tools must be designed with patients, not just for them.

    The episode is part of Season 3 of the European Patients’ Podcast, produced by the European Patients’ Forum with support from the European Union.

    Click on the video and listen to the full interview on our YouTube channel.

    Key takeaways include:

    • The importance of co-creation in app design to reflect different patient abilities, needs and environments

    • Why accessibility goes beyond technical function—it includes language, literacy, and digital confidence

    • The role of regulators and assessors in ensuring apps meet real-world standards, not just market requirements

    • How EDiHTA is contributing to making future assessments more responsive to patient realities

    As with every episode in the EDiHTA Talks series, the goal is to explore how patients’ experiences, preferences and challenges can shape better health technology assessment—supporting innovation that works for all.

    Listen to the episode on EPF’s Spotify:
    EDiHTA Talks #2 – How to Make Mobile Health Apps Accessible to Patients

     

    Special thank you to our guest speaker Sheila Khawaja and the European Patients’ Forum team.

  • RECAP: EDiHTA joins European Commission’s HTA conference in Brussels

    RECAP: EDiHTA joins European Commission’s HTA conference in Brussels

    RECAP: EDiHTA joins European Commission’s HTA conference in Brussels

    On 2 July 2025, EDiHTA was represented at the European Commission’s flagship conference EU Health Technology Assessment: Advent of a New Era of Collaboration in Brussels. Organised by DG SANTE, the event gathered over 90 participants from across Europe, including policymakers, HTA bodies, industry leaders, researchers and patient representatives, to explore how the EU Health Technology Assessment Regulation (HTAR) can enhance collaboration, competitiveness and innovation in health systems.

    Emmanouil Tsiasiotis, EDiHTA Project Manager and Research Associate at Università Cattolica del Sacro Cuore, presented on behalf of the project during the breakout session How can we leverage HTA to boost EU competitiveness? In his intervention, he introduced EDiHTA’s co-created framework for assessing digital health technologies (DHTs), underlining the project’s alignment with HTAR principles despite DHTs currently falling outside its formal scope. He also emphasised the importance of long-term sustainability and the need to maintain stakeholder-driven processes to ensure that HTA continues to serve the evolving needs of patients, innovators, and health systems across Europe.

    This appearance follows Emmanouil ‘s participation the day before at the HTA Stakeholder Network meeting, where he represented our partnering organisation, EHMA, European Health Management Association, and contributed to reflections on the first six months of HTAR implementation, with a focus on performance monitoring and cross-sector collaboration.

    We are proud to see EDiHTA contributing to shaping the future of European HTA and supporting the vision for a more resilient, innovative and equitable health system.

    Stay tuned for more updates on EDiHTA’s activities and impact.

  • EDiHTA joins European Commission’s HTA conference “EU health technology assessment: Advent of a new era of collaboration”

    EDiHTA joins European Commission’s HTA conference “EU health technology assessment: Advent of a new era of collaboration”

    EDiHTA joins European Commission’s HTA conference “EU health technology assessment: Advent of a new era of collaboration”

    On 2 July 2025, EDiHTA will participate in the hybrid conference EU Health Technology Assessment: Advent of a New Era of Collaboration, organised by the European Commission in Brussels. The event brings together policymakers, regulators, industry, patients and experts to discuss how the new EU HTA Regulation can strengthen cross-border cooperation and support Europe’s innovation ecosystem.

    During the breakout session How can we leverage HTA to boost EU competitiveness?, Emmanouil Tsiasiotis, EDiHTA Project Manager, will present EDiHTA’s flexible, stakeholder-driven framework for assessing digital health technologies (DHTs). His talk will highlight how EDiHTA is streamlining evidence generation for innovators, accelerating safe market access for digital tools and ensuring that patient needs remain central to every assessment.

    With more than 90 participants registered, including representatives from national HTA bodies, industry, academia, patient organisations and consultancies, the session promises to spark valuable discussion on how HTA can help bring innovation to patients and boost Europe’s competitiveness in health.

  • EDiHTA researchers awarded Best Oral Presentation at HTAi 2025 Annual Meeting

    EDiHTA researchers awarded Best Oral Presentation at HTAi 2025 Annual Meeting

    EDiHTA researchers awarded Best Oral Presentation at HTAi 2025 Annual Meeting

    We are delighted to share that Dr Annapoorna Prakash from Radboud University Medical Center (RUMC) has been awarded the Best Oral Presentation prize at the HTAi 2025 Annual Meeting in Buenos Aires. Her presentation was based on collaborative work within the EDiHTA project, co-authored with her supervisor, Dr. Wija Oortwijn.

    The presentation showcased the development of a taxonomy and classification system for digital health technologies (DHTs) – a key step towards more structured, consistent and future-oriented health technology assessment across Europe. This recognition highlights the relevance and impact of EDiHTA’s research on the international stage. 

  • EDiHTA at HTAi 2025: Panel Session – Evaluating Digital Health Innovations in Hospital Settings | UCSC, HPI

    EDiHTA at HTAi 2025: Panel Session – Evaluating Digital Health Innovations in Hospital Settings | UCSC, HPI

    EDiHTA at HTAi 2025: Panel Session – Evaluating Digital Health Innovations in Hospital Settings | UCSC, HPI

    The EDiHTA project is pleased to spotlight its involvement in another insightful session at the HTAi 2025 Annual Meeting in Buenos Aires, focusing on the practicalities of evaluating digital health innovations in hospital environments.

    Panel Session: PN33 – Evaluating Digital Health Innovations in Hospital Settings
    Wednesday, 18 June | 08:30 – 09:30 AM
    Panellists: Iga Lipska (HPI), Rossella Di Bidino and Manos Tsiasiotis (UCSC)

    Hospitals play a pivotal role in adopting and assessing digital health technologies (DHTs). This session will explore how hospital-based health technology assessment (HB-HTA) frameworks are used to evaluate digital tools and services, with case studies from different healthcare systems.

    • Key discussion points will include:
      Methodologies for evaluating digital innovations in hospitals
    • Barriers and enablers to implementation in clinical practice
    • What hospitals need to support timely, informed decision-making

     

    Organised by the EDiHTA project, this session will provide attendees with practical knowledge and strategic insights for driving evidence-based digital transformation at the hospital level.

    🔗 Learn more about HTAi 2025: https://htai.org/htai2025/
    🔗 Discover EDiHTA’s mission: https://edihta.eu

  • EDiHTA at HTAi 2025: Panel Session – Novel Evidence Strategies for Assessing Digital Health Solutions: Whose Perspective is at Stake? | UCSC, AGENAS, EPF

    EDiHTA at HTAi 2025: Panel Session – Novel Evidence Strategies for Assessing Digital Health Solutions: Whose Perspective is at Stake? | UCSC, AGENAS, EPF

    EDiHTA at HTAi 2025: Panel Session – Novel Evidence Strategies for Assessing Digital Health Solutions: Whose Perspective is at Stake? | UCSC, AGENAS, EPF

    The EDiHTA project is proud to announce its contribution to one of the key discussions at the upcoming HTAi 2025 Annual Meeting in Buenos Aires. As the digital health landscape evolves, the need for inclusive, relevant and robust evidence strategies becomes ever more critical.

    Panel Session: PN17 – Novel Evidence Strategies for Assessing Digital Health Solutions: Whose Perspective is at Stake?
    Tuesday, 17 June | 11:30 AM – 12:30 PM
    Panellists: Manos Tsiasiotis (UCSC), Marco Marchetti (AGENAS), Valentina Strammiello (EPF)

    This dynamic panel will explore the diverse perspectives shaping how digital health technologies (DHTs) are evaluated. From HTA researchers and regulators to industry stakeholders and patient representatives, the session brings together voices across the spectrum to reflect on who defines the standards—and what matters most—in digital health evidence.

    Attendees will be invited to engage in open dialogue on aligning evidence generation with real-world needs, ensuring digital innovation delivers meaningful value across health systems.

    Don’t miss this timely and thought-provoking session that gets to the heart of what—and who—counts in digital health assessment.

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