Category: Uncategorized

  • New Plain Language Summary Highlights EDiHTA Research on Harmonised Digital Health Technology Assessment

    New Plain Language Summary Highlights EDiHTA Research on Harmonised Digital Health Technology Assessment

    New Plain Language Summary Highlights EDiHTA Research on Harmonised Digital Health Technology Assessment

    A new plain language summary of the EDiHTA study Toward a Harmonized Health Technology Assessment Framework for Digital Health Technologies in Europe is now available from ISPOR, The Professional Society for Health Economics and Outcomes Research.

    We would like to thank ISPOR for preparing and publishing this plain language summary, which helps make the study findings more accessible to a wider audience.

    The study, authored by Manos Tsiasiotis, Fruzsina Mezei, Rossella Di Bidino, Michele Basile, Livio Battaglia, Valentina Strammiello, Kristian Kidholm, Wija Oortwijn, Americo Cicchetti and Dario Sacchini, brought together the perspectives of 97 stakeholders from across Europe. Participants included decision-makers, HTA agencies, technology developers, healthcare providers and patients.

    The findings showed broad agreement on the need for greater harmonisation of health technology assessment methods for digital health technologies, while retaining sufficient flexibility to reflect different national contexts.

    The study also highlighted the importance of collaboration between stakeholder groups and the need for assessment approaches that can evolve alongside rapidly changing digital technologies and emerging evidence.

    By bringing together perspectives from across the European health technology assessment ecosystem, the research contributes to EDiHTA’s wider work to support the development of a more consistent and fit-for-purpose framework for assessing digital health technologies in Europe.

    The new plain language summary makes the study’s main findings more accessible to a wider audience and provides an overview of the key considerations for future digital health technology assessment.

    Click here to read the plain language summary.

  • EDiHTA at the IX ISPOR Colombia Congress

    EDiHTA at the IX ISPOR Colombia Congress

    EDiHTA at the IX ISPOR Colombia Congress

    On 21 August 2026, Joan Segur-Ferrer, HTA Methodologist at the Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS), will represent EDiHTA at the IX ISPOR Colombia Congress.

    During his presentation, Joan will explore the assessment of digital health technologies, highlighting both the opportunities these technologies can offer health systems and the need for assessment approaches that take account of their specific characteristics.

    He will also introduce EDiHTA and its work to develop a common European framework for the assessment of digital health technologies. The framework aims to support more consistent, evidence-based and informed decision-making across Europe.

    The presentation will be followed by a roundtable discussion bringing together decision-makers, health technology assessment professionals and developers from the Colombian healthcare system. The session will provide an opportunity to exchange perspectives on current challenges and approaches in digital health technology assessment across different healthcare settings.

    EDiHTA looks forward to contributing to this international discussion and sharing its work with the wider HTA and digital health community.

    Event details

    • Date: 21 August 2026
    • Event: IX ISPOR Colombia Congress
    • More information: isporcolombia.org
  • New EDiHTA publication maps assessment domains for digital health technologies

    New EDiHTA publication maps assessment domains for digital health technologies

    EDiHTA publishes its third scientific paper on the development of a European framework for Digital HTA

    We are pleased to share our new peer-reviewed paper, published in Value in Health: “Domains in Health Technology Assessment of Digital Health Technologies: A Mapping Review.”

    Authored by Jeremy Dietz, Zoe Garrett, Lynda Ayiku, Livio Battaglia, Iga Lipska, Wija Oortwijn, Dario Sacchini, Joan Segur Ferrer, Emmanouil Tsiasiotis and Dalia Dawoud, the paper maps the health technology assessment domains used in assessing digital health technologies. In doing so, it lays the evidence base for determining which domains should be considered in the EDiHTA framework.

    Across 44 documents, including published studies, HTA agency methods guidance and a sample of European digital health technology HTA reports, the review identifies 13 assessment domains. While areas such as clinical effectiveness, safety and economic aspects appear consistently, environmental, technical, legal, regulatory, and some ethical and human aspects remain inconsistently included.

    The findings highlight where alignment already exists across digital health technology HTA and where further work is needed to reduce divergence in evidence expectations.

    Read the paper: Value in Health | DOI: https://doi.org/10.1016/j.jval.2026.06.017

    Abstract

    Background

    Health Technology Assessment (HTA) plays an important role in evaluating digital health technologies (DHTs) to inform decision-making. Commonly used HTA frameworks have been criticised as inadequate for assessing DHTs leading to the development of many DHT-specific HTA frameworks. The proliferation of frameworks creates a lack of clarity around evidence expectations for DHT HTA and perceptions of divergence in approach to HTA.

    Objectives

    The study, which was completed for the European Digital Health Technology Assessment (EDiHTA) project, reviews the domains used for DHT HTA.
     
    Methods
    The study had 3 parts: (1) scoping review (2) targeted search of HTA agency websites and hospitals for DHT methods documents (3) review of European DHT HTA reports. Data were extracted into a common template and analysed descriptively to identify the domains and topics included in the documents.
     
    Results
    A total of 44 documents were included: 1) 11 published studies 2) 13 HTA agencies’ methods documents 3) a sample of 20 DHT HTA reports. From these documents, 13 domains were identified. Topics relating to HTA domains health condition, technology use, clinical safety, clinical effectiveness, economic aspects, organisational aspects appeared consistently in retrieved documents. Topics relating to environmental, technical, legal and regulatory, and some ethical and human aspects were not consistently included or reported in the documents.
     
    Conclusion
    This study identifies commonalities in DHT HTA across established areas of HTA and areas of DHT HTA where there remains inconsistency in reporting of information and where efforts towards further alignment and refinement are still needed.
  • EDiHTA gathers patient perspectives at PEOF 2026 to shape the future of digital health assessment

    EDiHTA gathers patient perspectives at PEOF 2026 to shape the future of digital health assessment

    EDiHTA gathers patient perspectives at PEOF 2026 to shape the future of digital health assessment

    On 4 June 2026, the EDiHTA project organised an interactive session at the Patient Engagement Open Forum (PEOF) 2026 in Seville, bringing together 22 participants from patient organisations, research, clinical practice, industry, health technology assessment (HTA) and regulatory bodies to explore how patients can play a meaningful role in the assessment of digital health technologies (DHTs).

    The session, “Mapping the HTA journey for Digital Health Technologies: Co-creating patient involvement within the EDiHTA project”, combined expert presentations with a hands-on co-creation workshop. Organised by partners from the European Patients’ Forum (EPF) together with colleagues from Radboud University Medical Center, Hospital Clínic Barcelona / FRCB-IDIBAPS and Università Cattolica del Sacro Cuore, the session focused on ensuring that patient perspectives are embedded throughout the HTA process rather than being limited to individual consultation activities.

    Participants discussed how the EDiHTA framework can better reflect the needs and experiences of patients by strengthening the use of patient-generated evidence, improving accessibility and usability, and supporting meaningful patient involvement throughout the assessment journey.

    Want to learn more? Read the full session summary and explore the key recommendations from the co-creation workshop on the Patient Engagement Synapse platform (click the button below):

    EDiHTA sincerely thanks all speakers, facilitators and participants for their active engagement and valuable contributions to the discussion. Special thanks go to Valentina Strammiello and Bianca Pop (European Patients’ Forum), Annapoorna Prakash (Radboud University Medical Center), Sonia Muñoz López (Hospital Clínic Barcelona / FRCB-IDIBAPS) and Emmanouil Tsiasiotis (Università Cattolica del Sacro Cuore) for leading the session and helping shape this important dialogue on patient-centred digital health assessment.

  • EDiHTA publishes its third scientific paper on the development of a European framework for Digital HTA

    EDiHTA publishes its third scientific paper on the development of a European framework for Digital HTA

    EDiHTA publishes its third scientific paper on the development of a European framework for Digital HTA

    EDiHTA partners have published a new peer-reviewed scientific article presenting the conceptual design of the project’s European framework for the assessment of digital health technologies (DHTs).

    The article, titled “A European Framework for the Assessment of Digital Health Technologies: Conceptual Advances, Challenges, and Future Directions” is authored by Chiara de Waure, Ilaria Valentini, Nicolò Scarsi, Wija Oortwijn, Zoe Garrett, Iga Lipska, Rossella Di Bidino, Emmanouil Tsiasiotis, Americo Cicchetti and Dario Sacchini. The publication describes the conceptual foundations of the EDiHTA framework and outlines how it has been developed through a co-creation process involving policymakers, HTA agencies, clinicians, patients, technology developers, researchers, and healthcare providers across Europe.

    Read the paper: Frontiers in Digital Health (2026) | DOI: 10.3389/fdgth.2026.1809237

    Abstract

    Digital health technologies (DHTs) are transforming healthcare by enabling for example new care models, improving patient access and engagement, and streamlining healthcare workflows. They have the potential to increase efficiency, reduce administrative burdens, and enhance the overall quality of care. However, across Europe, DHTs evaluation frameworks remain fragmented, and while new approaches continue to emerge, they often focus on specific types of DHTs or particular stages of the product lifecycle. Moreover, traditional Health Technology Assessment (HTA) frameworks have been developed mostly to evaluate medicinal products, which may limit their applicability to DHTs, ultimately constraining health systems’ ability to capture DHTs’ added value. The European Digital Health Technology Assessment (EDiHTA) is a EU-funded project, which started in January 2024 to co-create an HTA framework for DHTs in order to face these challenges. It is aimed at co-developing together with different key stakeholders a comprehensive and flexible assessment framework tailored to different DHTs, applicable across DHTs lifecycle and across EU member states. In this perspective article, we present our concept design that is being used as foundation of the development of the EDiHTA framework, and we address current challenges in the assessment of DHTs, and the opportunities that lie ahead.
  • EDiHTA highlights from HTAi 2026: Collaboration, innovation and global dialogue

    EDiHTA highlights from HTAi 2026: Collaboration, innovation and global dialogue

    EDiHTA highlights from HTAi 2026: Collaboration, innovation and global dialogue

    As the Health Technology Assessment International Annual Meeting in Istanbul comes to a close, EDiHTA would like to thank everyone who contributed to making the event a valuable and memorable milestone for the project.

    Over the course of the conference, EDiHTA was proud to contribute to the scientific programme through:

    • A dedicated panel session exploring the future implementation and sustainability of the EDiHTA framework;
    • An interactive workshop bringing together the international HTA community to discuss how AI-enabled Digital Health Technologies intended to diagnose, treat and monitor diseases should be evaluated across different health systems;
    • Seven scientific posters showcasing the project’s methodological developments and research findings.

     

    These contributions reflect the collaborative efforts of our consortium and our shared ambition to advance rigorous, transparent and lifecycle-based Health Technology Assessment for Digital Health Technologies. One of the highlights of this year’s meeting was the opportunity to engage with experts from across the world in shaping the future evaluation of AI-enabled Digital Health Technologies. The enthusiasm, constructive discussions and willingness to collaborate confirmed that there is a growing international momentum towards developing more harmonised and globally relevant methodological approaches.

    For EDiHTA, Istanbul marks not the end of the journey, but the beginning of a new phase. As the project moves towards its final year, our focus is increasingly on sustainability, international collaboration and ensuring that the framework continues to evolve beyond the lifetime of the project.

    We now look ahead to HTAI 2027 in Brussels, where we hope to celebrate a major milestone for EDiHTA by presenting the project’s final outcomes, sharing the progress made towards a globally applicable framework for Digital Health Technologies, and continuing the dialogue with the international HTA community. A sincere thank you to all consortium partners, collaborators, presenters, participants and everyone who stopped by our sessions to exchange ideas and challenge our thinking.

    The future of Digital Health Technology Assessment will be built together. See you in Brussels!

  • EDiHTA and ASSESS-DHT meet in London to advance collaboration on digital health technology assessment

    EDiHTA and ASSESS-DHT meet in London to advance collaboration on digital health technology assessment

    EDiHTA and ASSESS-DHT meet in London to advance collaboration on digital health technology assessment

    Representatives from the EDiHTA and ASSESS-DHT projects recently came together in London for a two-day in-person workshop, kindly hosted by NICE, to discuss the scientific work developed across both projects, their respective end products, and their shared ambition to strengthen the European digital health ecosystem.

    The discussions focused on how the two initiatives can contribute to a common vision for the future of digital health in Europe, while clearly articulating and communicating the unique value each project brings.

    A key outcome of the meeting was the recognition of the strong complementarity between the expected results of ASSESS-DHT and EDiHTA.

    ASSESS-DHT is contributing to this vision by developing approaches and tools that enable faster, safer and more appropriate evaluation of clinical digital health technologies (DHTs) by embedding all aspects of oversight within a seamless system spanning the entire device lifecycle. The project also supports stakeholders in generating the evidence needed for effective evaluation of DHTs throughout their lifecycle.

    EDiHTA, in turn, is focused on accelerating equitable patient access to valuable digital health technologies within European health systems by developing the first harmonised European HTA framework for DHTs, helping to ensure that these technologies are sustainable, accessible and affordable.

    The London workshop marked an important step in aligning perspectives, clarifying complementarities and strengthening the collective contribution of both projects towards more effective evaluation and timely adoption of digital health technologies across Europe.

  • EDiHTA gathers patient and stakeholder input at the Patient Engagement Open Forum 2026

    EDiHTA gathers patient and stakeholder input at the Patient Engagement Open Forum 2026

    EDiHTA gathers patient and stakeholder input at the Patient Engagement Open Forum 2026

    On 4 June 2026, EDiHTA held a dedicated co-creation session at the Patient Engagement Open Forum 2026 in Seville, Spain. The session brought together 22 external participants, including patients and patient organisations, HTA professionals, industry representatives and healthcare professionals.

    The workshop focused on how the EDiHTA framework and platform can remain relevant, useful and sustainable for patients and patient organisations. Participants shared valuable perspectives on patient involvement, patient-generated evidence, educational resources and the long-term uptake of digital health technology assessment.

    Discussions highlighted the importance of continuous patient involvement, practical use cases, accessible training materials and clear pathways for patient organisations to contribute to digital health technology assessment. Participants also emphasised the need for plain-language and multilingual educational resources, including videos, webinars, FAQs, infographics and practical guidance on how patients can engage with HTA processes.

    A key message from the session was that patient perspectives should remain central to the future development and sustainability of the EDiHTA framework. Participants encouraged stronger visibility of patient experience data, ongoing feedback mechanisms and collaboration with patient advocacy networks to support uptake at national and European levels.

    The input collected during the workshop will directly inform EDiHTA’s ongoing work, particularly the development of educational resources and future sustainability planning.

    We warmly thank all participants for their active engagement and valuable contributions. Special thanks also go to Bianca Pop and Valentina Strammiello (European Patients’ Forum), Prakash, Annapoorna (RUMC), Sonia Muñoz (IDIBAPS/HCB) and Emmanouil Tsiasiotis (UCSC). We also thank our project partner, the European Patients’ Forum (EPF), for organising the Patient Engagement Open Forum and creating this valuable opportunity for dialogue and co-creation with patients and other stakeholders.

  • EDiHTA to Host Panel Session at HTAi 2026 Annual Conference

    EDiHTA to Host Panel Session at HTAi 2026 Annual Conference

    EDiHTA to contribute to PEOF 2026 Global Gathering with interactive session on patient involvement in digital HTA

    The EDiHTA project will be featured at the HTAi 2026 Annual Conference in Istanbul through a dedicated panel session exploring the role of Health Technology Assessment (HTA) in supporting Europe’s digital health transition.

    Taking place on Monday, 8 June, from 16:45 to 17:45, the session, titled “The Role of HTA in Driving the Digital Health Transition in Europe: The Case of the EDiHTA Project,” will bring together leading experts from the fields of health technology assessment, digital health, policy, and regulation.

    The discussion will focus on how lifecycle assessment approaches for Digital Health Technologies (DHTs) can strengthen the contribution of HTA to evidence-based decision-making and support the transformation of healthcare systems across Europe. Participants will explore the role of HTA throughout the development, implementation, and evaluation of digital health solutions, highlighting both research and regulatory perspectives.

    The panel will feature:

    • The session will be chaired by Dario Sacchini (Università Cattolica del Sacro Cuore)
    • Teresa Barcina (MedTech Europe)
    • Joan Segur Ferrer (Agència de Qualitat i Avaluació Sanitàries de Catalunya – AQuAS)
    • Marco Marchetti (Agenzia Nazionale per i Servizi Sanitari Regionali – AGENAS)

    By bringing together representatives from key stakeholder groups, the session will provide valuable insights into the opportunities and challenges associated with assessing digital health technologies and their impact on healthcare systems in Europe.

    We look forward to welcoming conference participants to this engaging discussion and sharing the latest developments from the EDiHTA project.

  • EDiHTA to contribute to PEOF 2026 Global Gathering with interactive session on patient involvement in digital HTA

    EDiHTA to contribute to PEOF 2026 Global Gathering with interactive session on patient involvement in digital HTA

    EDiHTA to contribute to PEOF 2026 Global Gathering with interactive session on patient involvement in digital HTA

    On 4 June 2026, the EDiHTA project will contribute to the PEOF 2026 Global Gathering in Seville, Spain, with the interactive session “Mapping the HTA Journey for Digital Health Technologies: Co-creating Patient Involvement within the EDiHTA Project”. The session will explore how patients can meaningfully contribute to Health Technology Assessment (HTA) processes for digital health technologies, and how more patient-centred approaches can support safer, more effective and more responsive digital innovation in healthcare.

    Co-creating patient involvement in digital health technology assessment

    Digital health technologies are increasingly shaping healthcare delivery, decision-making and patient experience. To ensure these technologies respond to real needs and can be implemented responsibly, patient perspectives must be integrated into assessment processes from an early stage. The EDiHTA session will invite participants to reflect on how patients can contribute across the HTA journey, from identifying relevant outcomes and usability considerations to discussing implementation barriers, evidence needs and the broader value of digital health solutions. Through interactive discussions and co-creation activities, participants will work together to strengthen patient involvement mechanisms, improve tools and resources, and identify capacity-building needs for the uptake of digital HTA practices across Europe.

    Session details

    Session title: Mapping the HTA Journey for Digital Health Technologies: Co-creating Patient Involvement within the EDiHTA Project
    Event: PEOF 2026 Global Gathering
    Date: 4 June 2026
    Time: 09:30-11:15 CEST
    Location: Seville, Spain

    Speakers and moderator

    The session will feature contributions from:

    • Emmanoil Tsiasiotis, Università Cattolica del Sacro Cuore
    • Annapoorna Prakash, Radboud University Medical Centre Nijmegen, the Netherlands / Radboud University
    • Sonia Muñoz-López, FCRB-Hospital Clínic de Barcelona / Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)

    The session will be moderated by Valentina Strammiello from the European Patients’ Forum.

    Supporting more patient-centred digital HTA

    By bringing together patient representatives, researchers and HTA experts, the session will contribute to EDiHTA’s wider work on developing a European framework for digital health technology assessment. The discussion will help identify how patient involvement can be made more systematic, practical and impactful in the evaluation of digital health technologies.

    This contribution reflects EDiHTA’s commitment to supporting assessment approaches that are not only methodologically robust, but also responsive to patient needs, healthcare realities and the evolving digital health landscape.

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