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We are excited to announce EDiHTA’s participation in the upcoming THCS Shared Learning Webinar, organised by Transforming Health and Care Systems (THCS). During this webinar, we will explore the synergies and collaborative efforts between THCS and EDiHTA. With the theme “How can health technology assessment (HTA) for digital health technologies contribute to the transformation of health and social care systems?” this webinar is essential for anyone interested in the future of healthcare innovation in Europe.

Date: 26 March 2025

Time: 14:00 – 15:00 CET

EDiHTA is proud to announce its participation in the World Evidence, Pricing, and Access (EPA) Congress 2025, to be held on March 5-6 at the RAI Congress Centre in Amsterdam. Renowned as Europe’s largest gathering of market access, pricing, and evidence professionals, the World EPA Congress offers a vital platform to explore breakthroughs in health technology assessment (HTA).

During the event, EDiHTA representatives Dr. Wija Oortwijn and Emmanouil Tsiasiotis will present EDiHTA’s pioneering work to create a common EU market for digital health technologies, empowering faster integration into health systems. Accompanying them are Marco Marchetti (AGENAS), Rossella Di Bidino (UCSC), Rosa Maria-Vivanco Hidalgo (AQuAS) and Dalia Dawoud (NICE), who will also represent the EDiHTA project.

The EDiHTA partners will provide:

• Insights into the first-ever digital HTA framework, developed to assess digital health technologies.
• Discussions on how we’re integrating existing methodologies with technology-driven solutions to create a flexible, stakeholder-driven framework.
• Opportunities to connect with us to learn about the next steps in our project.

We look forward to engaging with experts, stakeholders, and industry leaders to share ideas and explore collaborations that advance healthcare systems and patient outcomes.

For those planning to attend, EDiHTA looks forward to engaging with you and delving into collaborative opportunities. Reach out to our partners!

We’re thrilled to announce that Joan Segur-Ferrer, a Health Technology Assessment Specialist at our partnering organisation, AQuAS, will be representing EDiHTA at the Mobile World Congress in Barcelona. Joan will participate in a roundtable discussion on “Digital Health Value-Based Care” on 3 March at 3 PM. This event offers a great opportunity to explore the pivotal role of digital health in advancing value-based care. We’re eagerly anticipating the insightful conversations to come!

The Mobile World Congress (MWC) is one of the world’s largest and most influential events for the mobile and connectivity industry. MWC 2025 will focus on showcasing the latest innovations and technologies in mobile communications and digital transformation. It brings together industry leaders, technology experts, and innovators from around the globe to discuss current trends, future advancements and the impact of mobile technology on various sectors. The event typically features thought-provoking keynote speeches, panel discussions, and exhibitions from prominent companies, offering insights into the future of connectivity, mobile innovations, 5G advancements, and digital health, among other topics. Follow this link to learn more about the event.

In a move highlighting the critical importance of Health Technology Assessment (HTA), the European Commission has officially launched its first request submission period for joint scientific consultations (JSCs) under the Health Technology Assessment Regulation (EU) 2021/2282. This initiative underscores the Commission’s commitment to facilitating informed development and assessment of new health technologies.

The JSCs are designed to provide a valuable platform for health technology developers (HTDs) to interact with regulatory authorities. Through these consultations, developers can share their development plans for medicinal products or medical devices and receive essential guidance on the type of information, data, analyses, and evidence required for joint clinical assessments. The consultations are managed by the JSC subgroup of the Member State Coordination Group for HTA.

Developers can submit their requests for consultations between 3 February and 3 March 2025. In their requests, HTDs can apply for the following consultation slots for medicinal products:

• Start of the procedure 2–5 June 2025 (Briefing document by 5 May 2025)
• Start of the procedure 7–10 July 2025 (Briefing document by 2 June 2025)
• Start of the procedure 1–4 September 2025 (Briefing document by 7 July 2025)

This initiative highlights the Commission’s proactive role in ensuring that developments in health technology are rigorously assessed, thereby maintaining high standards of safety and efficacy in healthcare innovations.

The EDiHTA consortium recognises the vital importance of providing the EU life science ecosystem with a new and innovative framework — one that thoroughly integrates the diverse perspectives of users in Digital Health Technologies (DHTs), including DHTs. We aim to support technology developers by accelerating the path to market access for DHTs. EDiHTA will provide relevant guidance on the requisite evidence for each DHT and TRLs  –  contributing to the goal of providing European citizens with faster access to safe and effective technologies, while also increasing trust in these innovations.

For further information and to apply, follow this link.

The EU Health Technology Assessment (HTA) Regulation, which was applied as of 12 January 2025, is set to transform the European health policy landscape. This framework is designed to streamline the clinical assessment of health technologies across the EU and help Member States make more evidence-based and timely decisions on patient access to new medicines and medical devices. At the same time, the European Health Data Space (EHDS) Regulation, which will enter into force in 2025, will revolutionise the way health data is shared and used, empowering patients to take control of their own health data while facilitating its reuse for research, innovation, policy-making, and regulatory activities.

Under the HTA Regulation, Member States will work together to produce a single report on the clinical effectiveness and safety of medicines and selected medical devices. A key feature of the HTA Regulation is its focus on patient involvement. Patients will have direct opportunities to contribute to the joint work, ensuring that their experiences and needs are reflected. The Regulation also encourages voluntary cooperation between national HTA bodies, with the possibility of extending the joint work to digital health technologies (DHTs), which are currently excluded from its scope.

The EHDS complements the HTA Regulation by improving access to high-quality, standardised health data across Member States, which is crucial for comprehensive and consistent assessments. Through the EHDS, HTA bodies will gain access to extensive datasets from electronic health records, registries, and clinical databases. The EHDS is set to play a pivotal role in generating real-world evidence and capturing patient-reported outcomes. These data streams are essential for evaluating the long-term efficacy and safety of health technologies, especially digital innovations that rely on dynamic, real-world environments to demonstrate their utility. This is particularly important for digital health technologies, such as AI algorithms, wearables and mobile health applications, where existing inconsistencies in interoperability and evaluation methodologies make it difficult to assess their added value. By facilitating access to anonymised and pseudonymised health data, the EHDS will enable HTA bodies to monitor the added value of DHTs, ensuring that they deliver tangible benefits to patients.

At the intersection of the HTA Regulation and the EHDS is the EU-funded European Digital Health Technology Assessment (EDiHTA) project. EDiHTA builds on the context of the HTA Regulation to develop a specific framework for the assessment of digital health technologies, ensuring the involvement of all stakeholders, including patients. While the EHDS provides the data infrastructure, EDiHTA will establish specific criteria and methodologies for the assessment of digital health technologies, drawing on the real-world data and patient-reported outcomes. 

In short, the HTA Regulation sets the stage, the EHDS provides the data, and the EDiHTA project can ensure that digital health technologies are assessed in a way that improves patient access and outcomes across Europe.

On November 4, 2024, EDiHTA was invited to join a Sustainability Roundtable hosted by the ASSESS DHT project. The event successfully convened over 30 experts from HTA bodies in 13 countries, along with representatives from 3 supra-national organisations. This pivotal event centred on fostering dialogue about sustaining the innovative approaches and tools being developed within the projects for the future of health technology assessment (HTA) for digital health technologies (DHT). During the roundtable, both projects shared insights into their current progress and laid out their plans for achieving greater harmonisation of HTA for DHT across Europe.

The event opened with insightful remarks from Claudia Wild (Austrian Institute for Health Technology Assessment GmbH (AIHTA), Juan Carlos Rejon-Parrilla (Andalusian HTA Unit (AETSA) within the Fundación Progreso y Salud) and the EDiHTA Project Manager, Emmanouil Tsiasiotis (Università Cattolica del Sacro Cuore). Their insights helped set the tone for the engaging discussions that followed.

Attendees participated in three dynamic pitch sessions that focused on key topics:

• Taxonomy (ASSESS DHT & EDiHTA): Led by our partner, Wija Oortwijn (Radboud University Medical Center), in collaboration with ASSESS DHT representatives, this session explored progress towards creating a standardised classification for digital health technologies.
• Lifecycle Approach (ASSESS DHT): Addressing evidence generation and evaluation across the technology lifecycle.
• Framework and Toolkit (EDiHTA): Our partner and work package leader, Rosa Maria-Vivanco Hidalgo (Agency for Health Quality and Assessment of Catalonia) discussed the development of practical tools for streamlined assessment processes.

These sessions led to an interactive discussion segment and a Q&A session. This collaborative setting allowed participants to exchange perspectives and engage with critical questions. The success of the roundtable was driven by the active participation of all attendees and the invaluable collaboration between the EDiHTA and ASSESS DHT projects.

Thank you to all attendees, speakers and organisers for making this event a success. Stay tuned for more updates on our ongoing collaboration with the ASSESS DHT project!

Last week, the EDiHTA consortium came together online for the second General Assembly meeting. The two-day meeting, held on December 3rd and 5th, 2024, provided an excellent opportunity for the consortium to review the significant progress made in the first year of the EDiHTA project and prepare for the upcoming steps towards the design and development of the EDiHTA framework in 2025.

More than 50 participants from all 16 EDiHTA partners participated in the meeting, allowing for fruitful scientific discussions and updates across all work packages. The work package leaders presented their progress, challenges, and next steps, as well as their interactions with other work packages.

The first day of the meeting focused on updates from work packages 2, 3, and 4.

• WP2: Data security and privacy policy requirements for EDiHTA.
• WP3: EDiHTA framework design.
• WP4: EDiHTA Framework Development.

Interactive activities during the meeting allowed partners to collaborate and address the most challenging points, while also gathering valuable feedback from the rest of the consortium to further use in their work.

The second day began with updates from the remaining work packages 1, 5, 6, 7, and 8.

• WP1: Project coordination and innovation management.
• WP5: EDiHTA Framework Digitalisation.
• WP6: EDiHTA Framework piloting, evaluation and finalisation.
• WP7: EDiHTA Outreach.
• WP8 Education and Exploitation.

A special session dedicated to scientific dissemination, led by project coordinator Americo Cicchetti, allowed partners to explore potential strategies for sharing the project’s results next year. The meetings were expertly moderated by the EDiHTA Project Manager Emmanouil Tsasiotis.