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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.

2. 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.

3. 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.

2. 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.

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!

We are pleased to share that the EDiHTA publication titled “Towards a harmonised Health Technology Assessment framework for Digital Health Technologies in Europe” has been selected as an Editor’s Choice paper in the April 2026 issue of Value in Health, the official journal of ISPOR. This recognition highlights the relevance and quality of the work developed within the EDiHTA project, which addresses one of the key challenges in European healthcare systems: the need for a more coordinated, transparent and adaptable approach to assessing digital health technologies (DHTs).

The EDiHTA team successfully held its webinar on 12 March 2026, presenting the EDiHTA Open Call for digital health technology developers and manufacturers. The session introduced the objectives of the Open Call and provided guidance on the application and piloting process, followed by a live Q&A with participants.

If you were unable to attend, the webinar recording and presentation slides are now available.

With the EU Health Technology Assessment Regulation (HTAR) now in its implementation phase and the European Health Data Space (EHDS) Regulation formally adopted and entering its transition phase, attention is rapidly shifting from legislative ambition to practical implementation. While the HTAR focuses on assessing at the EU level the clinical aspects of new health technologies, the EHDS aims to transform how data for those assessments will be accessed and used. Together, these initiatives signal a fundamental recalibration of how Europe evaluates, adopts and monitors health technologies. Yet their real impact will depend on how effectively Member States, regulators, industry, policymakers, patients and the other end-users translate this framework into day-to-day practice.

On 13 January, one year after the start of the implementation phase of the HTAR, the European Patients’ Forum hosted a webinar to showcase the work carried out in 2025 to ensure meaningful patient involvement from the very start of implementation. The EU-funded European Digital Health Technology Assessment (EDiHTA) project was also featured, showcasing how it actively integrates patient perspectives into its framework, with a strong emphasis on relevance, fairness, and accessibility for patients.

The webinar highlighted several key messages from speakers representing patient organisations, individual patient advocates, and the European Commission:

• Patient involvement in the HTAR process was achieved gradually, through the persistent efforts of patient organisations, which, through concrete cases and practical examples, clearly demonstrated the added value of their engagement.
• Patient involvement is essential to ensure that the HTAR meets its objectives and responds to patients’ needs, notably improving access to treatments across Europe and supporting greater harmonisation of HTA among EU Member States.
• Patients and patient organisations play a crucial role in the HTAR process, as they are best positioned to provide real-world insights into what works in practice under this new EU framework and to highlight areas where improvements can still be made.
• Further steps must be considered, including tackling language barriers, ensuring that patients and patient organisations are appropriately involved, clarifying rules on conflicts of interest, and strengthening training opportunities. These efforts are needed not only to support meaningful patient involvement, but also to ensure that HTAR and HTA are better understood by a wider range of patients and that participation does not rely on the same individuals.

Reflecting on progress over the past year, following the start of the implementation phase for the HTAR and as EHDS moves through its transitional phase, significant strides have been made, yet careful attention is needed as the EU moves from legislative groundwork to operational implementation.

Within this evolving landscape, EDiHTA sits at the intersection of the HTA Regulation and the EHDS, aiming to establish a dedicated framework for evaluating digital health technologies, one of the most complex frontiers in health technology assessment. The dynamic, iterative development of digital health technologies, their reliance on real-world performance, and their frequent updates present challenges that traditional HTA methodologies are not well equipped to address.

In response to these challenges, EDiHTA illustrates how tailored methodologies for digital health technologies can bridge this gap between rapid technological evolution and rigorous assessment standards. Success will require continuous collaboration among key stakeholders, a commitment to learning from early implementation experiences, and ensuring that digital health technologies are evaluated in ways that truly enhance patient access and outcomes across Europe.

This article was prepared by our partners from European Patients’ Forum.

Agenda (60 minutes)

5 min – Introduction to EDiHTA and the Open Call

20 min – Presentation of the Open Call: objectives, eligibility, selection process and pilot structure

35 min – Live Q&A session

Participants will have the opportunity to clarify application requirements and better understand how their DHT could be assessed within the first pan-European Digital Health Technology Assessment framework. Any remaining questions following the webinar can be addressed directly to the consortium via email info@edihta-project.eu.

Speakers

• Emmanouil Tsiasiotis, EDiHTA Project Manager (UCSC)
• Fruzsina Mezei, Health Economist & Health Policy Expert (UCSC)
• Adam Lukacs, Senior Manager New Opportunities (EIT Health)

About the Open Call

EDiHTA has launched an Open Call for DHT developers/manufacturers to validate the first pan-European Digital Health Technology Assessment framework. Two DHT use cases will be selected for a structured piloting phase to evaluate the EDiHTA toolkit in a real-world setting. Selected DHTs will be assessed by leading European HTA agencies:

• AQuAS (Spain)
• FinCCHTA (Finland)

This non-funded opportunity provides:

• Early access to the EDiHTA platform
• Specialised training
• Direct feedback on future HTA requirements
• Engagement with payers, patients and decision-makers

Application deadline: 20 March 2026, 16:00 CEST
Pilot duration: July 2026 – April 2027

Register Now

Interested DHT developers and manufacturers are encouraged to register for the webinar and submit their questions in advance. For full Open Call details and application documents, please visit the Open Call page: