Category: Uncategorized

  • 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.

  • EDiHTA at HTAi 2026: partners to present research on digital health technology assessment in Istanbul

    EDiHTA at HTAi 2026: partners to present research on digital health technology assessment in Istanbul

    EDiHTA at HTAi 2026: partners to present research on digital health technology assessment in Istanbul

    The EDiHTA project will be strongly represented at the Health Technology Assessment international (HTAi) 2026 Annual Meeting, taking place in Istanbul from 6 to 10 June 2026.

    Across several oral and poster presentations, EDiHTA partners will share emerging research on how digital health technologies can be assessed in a more systematic, transparent and context-sensitive way. The contributions reflect the breadth of the EDiHTA framework, covering legal and regulatory requirements, safety, patient-related evidence, sociocultural and ethical dimensions, policy alignment and the development of a shared European approach to digital health technology assessment.

     

    Strengthening legal and regulatory assessment of digital health technologies

    On Monday, 8 June, from 11:45 to 12:45, Per Atle Bakkevoll from the Norwegian Centre for E-health Research will present EDiHTA research on the legal and regulatory dimensions of digital health technology assessment frameworks.

    The study is based on a scoping review and stakeholder survey examining how legal and regulatory aspects are addressed in the assessment of digital health technologies. The findings highlight four key domains: data protection, transparency, accountability and regulatory compliance. Their importance increases with higher technology maturity and more advanced artificial intelligence capabilities. This work contributes to EDiHTA’s efforts to support more robust, transparent and trusted decision-making for digital health technologies across Europe.

    Authors and contributors: Per Atle Bakkevoll, Elisa Salvi, Line Silsand, Kassaye Yitbarek Yigzaw, Line Helen Linstad.

     
    Assessing patient-related evidence in digital HTA

    On Tuesday, 9 June, from 11:00 to 11:30, Annapoorna Prakash from Radboudumc will present the poster “Patient-Related Evidence For Health Technology Assessment Of Digital Health Technologies: A Literature Review And Stakeholder Survey” in Rumeli Hall, Lütfi Kırdar Congress and Exhibition Center (ICEC).

    The research explores how patient-related evidence can be more systematically integrated into the assessment of digital health technologies. Based on a scoping review, the study examines which patient-related aspects are currently measured and how they are assessed. It proposes a streamlined framework of key topics and outcome measures to support more systematic, transparent and patient-centred evaluation.

    Authors and contributors: Annapoorna Prakash, Marcia Tummers, Bianca Pop, Wija Oortwijn.

     
    Aligning digital HTA with European policy priorities

    Also on Tuesday, 9 June, from 11:00 to 11:30, Line Linstad from the Norwegian Centre for E-health Research will present EDiHTA research on how HTA can evolve into a system-shaping tool for digital health technologies.

    The poster examines how European policy priorities, including the European Health Data Space, are shaping the development of a harmonised HTA framework for digital health. Through policy analysis and stakeholder engagement across multiple Member States, the study identifies key themes related to individual rights, technological requirements and human-technology interaction. These insights point to the need for a flexible and standardised approach that can support decision-making at different levels of the health system.

    Authors and contributors: Elisa Salvi, Line Silsand, Karianne Lind, Kassaye Yitbarek Yigzaw, Alexandra Makhlysheva, Rouven Besters, Per Atle Bakkevoll, Kari Dyb, Line Linstad.

     

    Building a multi-domain European framework for digital HTA

    On Wednesday, 10 June, from 09:00 to 09:45, Joan Segur-Ferrer from the Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQuAS) will present EDiHTA research on the development of a multi-domain framework for assessing digital health technologies.

    The presentation, part of the track “Breakthrough and New Approaches in HTA”, will take place in Rumeli Hall, Lütfi Kırdar Congress and Exhibition Center (ICEC).

    The work outlines a collaborative effort involving multiple European institutions to define the structure and content of the EDiHTA framework. It brings together evidence from extensive literature reviews and stakeholder engagement to establish 13 assessment domains, covering topics, outcomes, methods and evidence requirements. These domains are designed to adapt to different technology characteristics, including maturity level and artificial intelligence capabilities, and to support decision-making across health system levels.

    Authors and contributors: Joan Segur-Ferrer, Enric Rubiella Navarro, Mireia Moreno Lorente, Roland Pastells Peiró, Sandra Ankomako Ankomako, Iga Lipska, Wija Oortwijn, Manos Tsiasiotis, Rosa Maria Vivanco Hidalgo.

     
    Integrating ethical and sociocultural dimensions into HTA

    On Monday, 10 June, from 11:45 to 12:45, Livio Battaglia will present EDiHTA research on how sociocultural and ethical dimensions can be systematically integrated into the assessment of digital health technologies.

    The study is based on a scoping review and an experts’ focus group examining how these dimensions are currently addressed and how they can be structured within an HTA framework. The findings highlight the need to integrate sociocultural and ethical considerations as transversal elements across all stages of assessment, strengthening their systematic inclusion within HTA practices. The abstract has been shortlisted in the category Oral Presentations – Student.

    Authors and contributors: Livio Battaglia, Simona Paone, Marco Marchetti, Costanza Raimondi, Pietro Refolo, Dario Sacchini, Manos Tsiasiotis, Americo Cicchetti.

     
    Advancing safety requirements for digital health technology assessment

    EDiHTA partners will also present the poster “Safety Requirements for a European Digital Health Technology Assessment Framework (EDiHTA): A Scoping Review and Stakeholder Survey”. The poster will be presented by Joan Fibla Reixachs and Sonia Muñoz-López from FCRB-Hospital Clínic de Barcelona / Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS).

    The work reflects a collaborative effort across EDiHTA partners, including FCRB-HCB, AQuAS, Uniklinik Frankfurt and the Norwegian Centre for E-health Research. It contributes to ongoing discussions on how to strengthen approaches to evaluating digital health solutions, with a focus on safety and evidence-informed decision-making.

    Authors and contributors: Joan Fibla Reixachs, Sonia Muñoz-López, Joan Segur-Ferrer, Enric Rubiella Navarro, Roland Pastells Peiró, Elina Nürenberg-Goloub, Per Atle Bakkevoll, Adrián Valledor Sánchez, Paula Closa Granados, Marcelo Soto Alarcón, Sandra Ankomako Ankomako, Catalina Jaramillo, Benjamin Friedrichson and Laura Sampietro-Colom.

     
    Contributing to international dialogue on digital HTA

    Together, these contributions show how EDiHTA is advancing a comprehensive framework for digital health technology assessment that reflects the complexity of digital transformation in healthcare. By addressing legal, regulatory, safety, patient-related, ethical, sociocultural and policy dimensions, the project supports more coherent and evidence-informed approaches to digital HTA in Europe and beyond.

    Participation in HTAi 2026 offers an important opportunity for EDiHTA partners to exchange with the international HTA community, share research findings and contribute to discussions on how assessment frameworks can better respond to digital health innovation.

    If you are attending HTAi 2026 in Istanbul, we invite you to connect with EDiHTA partners and learn more about the project’s contributions to the meeting.

     

  • EDiHTA referenced in Dagens Medisin opinion article on digital health governance and HTA

    EDiHTA referenced in Dagens Medisin opinion article on digital health governance and HTA

    EDiHTA referenced in Dagens Medisin opinion article on digital health governance and HTA

    Photo credit: Jarl-Stian Olsen, Norwegian Centre for E-health Research, Dep. Of Communication and Public Relations

    An opinion article published in Dagens Medisin, Norway’s leading independent professional and news outlet for the health and care sector, highlights the need for stronger governance of digital health in Europe and points to Health Technology Assessment (HTA) as a key tool for informed decision-making.

    The article, authored by Line Linstad and Line Silsand, our partners from the Norwegian Centre for E-health Research, references the EDiHTA project in the context of developing approaches that can better support the evaluation of digital health technologies. It argues that while traditional HTA has been developed mainly for medicines and medical devices, digital health solutions, including apps and AI tools, require more adaptive and lifecycle-based assessment methods.

    The article underlines the relevance of EDiHTA’s work towards a digital health technology assessment framework that can support evidence-based, sustainable and patient-centred digital transformation in healthcare. EDiHTA aims to develop and validate a comprehensive framework for evaluating digital health technologies in real healthcare environments.

    Follow this link to read the article in Dagens Medisin.

    The English translation of the article is available below.

    Europe lacks governance of digital health — HTA could be the key

    Europe stands at a crossroads in the digitalisation of healthcare. The experience of the digital COVID certificate demonstrated that secure, cross-border use of health data is both possible and politically feasible when urgency demands it. This gave momentum to the development of the European Health Data Space (EHDS).

    EHDS provides data, but not governance

    The ambition is considerable: to establish a shared European infrastructure for health data that supports treatment, research, and innovation. EHDS is more than a data-sharing project — it is an entirely new knowledge infrastructure for health decisions, regulation, and innovation.

    However, EHDS does not in itself resolve what is perhaps the greatest governance challenge: how should authorities actually prioritise between an ever-growing number of digital solutions, with varying levels of documented effectiveness, rapid development cycles, and significant resource demands?

    HTA as a tool for responsible decision-making

    To realise the full benefits of EHDS, we need tools that can translate data into a sound basis for decisions. This is where Health Technology Assessment (HTA) becomes critical. HTA is a governance tool that gathers and evaluates research-based knowledge as the foundation for strategic and policy decisions. HTA provides systematic assessment of benefit, risk, and value, and can build confidence in which digital health services actually work.

    This evidence base is essential for authorities to determine which technologies should be adopted and which should be phased out of healthcare.

    Technology evolves faster than assessments

    Current HTA frameworks were developed for pharmaceuticals and medical devices — not for digital health services that are data-driven, adaptive, and continuously evolving. How does one assess an app or an AI tool that is updated frequently?

    We need lifecycle-based and adaptive HTA that keeps pace with technological development and the use of real-world data. This is precisely where EHDS could become the enabler of digital health service evaluation, both in Norway and across EU member states.

    New knowledge through the EDiHTA project

    The EU project EDiHTA (European Digital Health Technology Assessment) addresses this challenge directly. The project develops shared European frameworks for how digital health technologies can be assessed throughout their entire lifecycle.

    The Norwegian Centre for E-health Research is an active contributor, with the aim of linking data infrastructure and decision-making processes in a way that genuinely strengthens the scope for political action.

    From knowledge to decision-making power

    This points to a central gap in knowledge: we still know too little about how HTA and data infrastructure can be incorporated into an operational governance tool for authorities. Without such a link, EHDS risks becoming a data platform without clear political direction, and digitalisation a series of isolated initiatives without coherent prioritisation.

    For European decision-makers, this is therefore not simply a matter of technology — it is a matter of governance. Who decides which solutions are to be adopted? On what basis? And how do we ensure that investments in digital health actually deliver better services, more equitable access, and sustainable health systems?

    If Europe is to succeed in the digital transformation of healthcare, HTA must be elevated from a technical instrument to an integral part of political and strategic governance. EHDS provides the data foundation. A modernised, digitally adapted HTA framework provides the decision-making power.

    The link between the two may prove decisive in determining whether Europe takes a leading role in developing a responsible, evidence-based, and sustainable digital health service — or is left with fragmented solutions and weakened governance.

    Fact box:

    EHDS (European Health Data Space) is described by the European Commission as a shared framework for the use and sharing of health data, supporting research, innovation, and policy. HTA is a tool for assessing the medical, economic, social, and ethical dimensions of health technology. The EU’s HTA framework also facilitates joint clinical assessments and more coordinated European collaboration, making the combination of EHDS and HTA particularly relevant in a governance context.

     

  • EDiHTA workshop at HTAi 2026: closing the gaps in evaluating AI-enabled Digital Health Technologies

    EDiHTA workshop at HTAi 2026: closing the gaps in evaluating AI-enabled Digital Health Technologies

    EDiHTA workshop at HTAi 2026: closing the gaps in evaluating AI-enabled Digital Health Technologies

    How should AI-enabled Digital Health Technologies be evaluated across different health systems, care contexts and countries?

    EDiHTA will contribute to this important discussion at the Health Technology Assessment international (HTAi) 2026 Annual Meeting, taking place from 6 to 10 June 2026 in Istanbul, Türkiye. The HTAi Annual Meeting is a leading international forum for the global Health Technology Assessment community and, in 2026, will focus on the theme “HTA As A System Shaper”, exploring how HTA can support resilient, equitable and sustainable health systems.

    As part of the pre-conference programme, EDiHTA will host an interactive workshop on Saturday, 6 June 2026, bringing together international experts and stakeholders to discuss how AI-enabled Digital Health Technologies intended to diagnose, treat and monitor diseases can be evaluated across different countries and healthcare systems.

    WS07: Closing the gaps in evaluating Digital Health Technologies

    The workshop, titled “Closing the Gaps in Evaluating Digital Health Technologies: Findings from the EDiHTA Project and Global Perspectives”, will build on findings from the EDiHTA project, which is developing a flexible, inclusive and validated European Health Technology Assessment framework for Digital Health Technologies, including telemedicine, mobile health applications and AI-enabled solutions.

    Workshop details

    Date: Saturday, 6 June 2026
    Time: 13:30-17:00, Istanbul local time
    Location: Bahcesehir University, Besiktas South Campus, Ciragan Caddesi Osmanpasa, Mektebi Sokak No: 4-6, 34353 Besiktas, Istanbul
    Session: WS07
    Registration: Participation requires registration via the HTAi 2026 Annual Meeting platform:

    Register here

    A multi-stakeholder discussion on AI-enabled digital health assessment

    AI-enabled Digital Health Technologies are increasingly used to support diagnosis, treatment and disease monitoring. However, their evaluation raises important methodological and implementation questions, particularly when technologies are used across different health systems, regulatory environments, clinical pathways and patient populations.

    The workshop will bring together HTA bodies, hospital-based HTA units, policymakers, clinicians, AI experts, patients, industry representatives and international researchers to examine how evidence requirements, assessment criteria and contextual factors can be addressed in a more consistent and actionable way.

    The first part of the workshop will provide strategic and methodological perspectives from international experts. The second part will actively involve participants in a structured co-creation and consensus-building exercise. Participants will contribute to discussions aimed at:

    • validating the EDiHTA framework;
    • identifying which elements of Digital Health Technology assessment are globally transferable and which are context-specific;
    • discussing evidence requirements for AI-enabled Digital Health Technologies;
    • supporting more consistent, inclusive and practically applicable approaches to digital health assessment.
    Chairs and presenters

    The workshop will feature contributions from:

    • Emmanoil Tsiasiotis
    • Americo Cicchetti
    • Rossella Di Bidino
    • Marco Marchetti
    • Annapoorna Prakash
    • Teresa Barcina Lacosta
    • Valentina Strammiello
    • Iben Fasterholdt
    • Gurmit Sandhu

    Together, they will guide discussions on how HTA methods can better respond to the complexity of AI-enabled Digital Health Technologies and support evidence-based decision-making in healthcare innovation.

    Contributing to future approaches for Digital Health Technology assessment

    Through this workshop, EDiHTA aims to support international dialogue on how Digital Health Technologies can be evaluated in ways that are scientifically robust, patient-centred and adaptable to different healthcare settings. This aligns with the project’s broader goal of developing common methods for assessing Digital Health Technologies and supporting value-based decision-making across Europe.

    Stakeholders interested in Health Technology Assessment, AI, digital health, evidence generation and healthcare innovation are warmly invited to join the workshop and contribute to shaping future approaches for the evaluation of AI-enabled Digital Health Technologies worldwide.

    Learn more about the HTAi 2026 Annual Meeting: HTAi 2026 Annual Meeting
    Learn more about Register for the workshop: Registration link

  • EDiHTA at HTAi 2026: Contributing to Advancing Digital Health Assessment in Europe

    EDiHTA at HTAi 2026: Contributing to Advancing Digital Health Assessment in Europe

    EDiHTA at HTAi 2026: Contributing to Advancing Digital Health Assessment in Europe

    EDiHTA will contribute to the HTAi 2026 Annual Meeting, taking place from 6 to 10 June 2026 in Istanbul! EDiHTA is also supporting the event as a Diamond Sponsor.

    The HTAi Annual Meeting is a leading international forum bringing together the global Health Technology Assessment community. The 2026 edition, held under the theme ‘HTA As A System Shaper’, focuses on the evolving role of HTA in supporting resilient, equitable, and sustainable health systems.

    In this context, EDiHTA partners will present a range of research outputs addressing the assessment of digital health technologies and contributing to ongoing discussions on methodological development, policy alignment, and system transformation.

    OVERVIEW OF EDiHTA SESSIONS

    EDiHTA will be represented through a series of contributions across the conference, reflecting the project’s collaborative work on advancing digital health technology assessment in Europe.

    Pre-conference workshop

    • WS07 – Closing The Gaps In Evaluating Digital Health Technologies: Findings From The EDiHTA Project And Global Perspectives
    • Facilitators: Emmanouil Tsiasiotis, Teresa Barcina Lacosta, Valentina Stramiello
    • This workshop will examine how gaps in evaluating digital health technologies can be addressed through more harmonised approaches. It will engage participants in identifying practical tools and strategies to support lifecycle-based assessment and strengthen stakeholder collaboration.

    Panel session

    • PN16 – The Role Of HTA In Driving The Digital Health Transition In Europe. The Case Of The EDiHTA Project
    • Contributors: D. Sacchini, M. Marchetti, J. Segur-Ferrer, T. Barcina-Lacosta
    • This panel will explore how HTA can support the integration of digital health technologies into healthcare systems, with a focus on its role in informing policy and guiding decision making.

    Oral presentations

    1. Legal And Regulatory Domain In The European Digital Health Technology Assessment Framework (EDiHTA): Scoping Review And Online Survey 
      Monday, 8 June 2026, 11:45–12:45
    • Presenter: Per Atle Bakkevoll
    • This presentation explores how legal and regulatory considerations can be systematically integrated into the assessment of digital health technologies, with a focus on key domains such as data protection, transparency, accountability, and compliance.
    1. Developing A European Digital Health Technology Assessment (EDiHTA) Framework: Defining Domains Through a Multi-Institutional Collaborative Effort
      Wednesday, 10 June 2026, 09:00–09:45
    • Presenter: Joan Segur-Ferrer
    • This research presents the development of a multi-domain framework for digital health technology assessment, outlining the definition of 13 domains to support structured and context-sensitive evaluation.
    1. Sociocultural And Ethical Domains For A European DHT Assessment Framework (EDiHTA): A Scoping Review And Experts’ Focus Group
      Monday, 10 June 2026, 11:45–12:45
    • Presenter: Livio Battaglia
    • This presentation focuses on integrating sociocultural and ethical dimensions into HTA, highlighting key themes such as equity, accessibility, transparency, and user autonomy.

    Poster presentations

    1. HTA As A System Shaper: Building A Harmonized Framework For European Digital Health Technologies Assessment (EDiHTA)
      Tuesday, 9 June 2026, 11:00–11:30
    • Presenter: Line Linstad
    • This poster explores how HTA can support system-level decision making in digital health, highlighting the role of policy alignment and stakeholder engagement in shaping a harmonised framework.
    1. Patient-Related Evidence For Health Technology Assessment Of Digital Health Technologies: A Literature Review And Stakeholder Survey
      Tuesday, 9 June 2026, 11:00–11:30
    • Presenter: Annapoorna Prakash
    • This poster examines how patient-related aspects are currently assessed in digital health technologies and proposes a streamlined framework to support more systematic and patient-centred evaluation.
    1. Evidence requirements on safety aspects for a European Digital ​Health Technology Assessment Framework (EDiHTA): A Scoping Review and Stakeholder Survey​
      Wednesday, June 10, 2026, 11:15 – 11:35
    • Presenter: Joan Fibla
    • This poster examines digital health technologies’ safety assessment criteria and proposes a structured set of topics and subtopics for its appropriate and comprehensive assessment

    Through its participation at HTAi 2026, EDiHTA contributes to advancing the assessment of digital health technologies by promoting methodological development, stakeholder engagement, and alignment with evolving European policy frameworks, supporting more consistent, transparent, and evidence-based approaches to HTA and enabling health systems to respond effectively to the opportunities and challenges of digital transformation. Follow EDiHTA channels for updates and insights from the conference.

    Stay tuned for dedicated posts highlighting each session and speaker in more detail!

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