HL7 Europe is proud to have contributed to a landmark event, co-organized by TEHDAS2 and HL7 Vulcan, that took place on October 9 in Copenhagen, Denmark. Leaders from the government, healthcare, research community/industry, and patient organizations participated in this event. The forum centred on turning the EHDS regulation into practice, with a focus on secondary use of health data. Strategic cases, such as Gravitate-Health and xShare, which aim to support HL7 standards, were presented as models of how interoperable frameworks can empower citizens and secure standards-based health data exchange throughout Europe. These efforts illustrate how the principles of EHDS are already being implemented: opening access to, using, and focusing on individual-centered health data.
Themes and Insights
- From Policy to Implementation: A conversation about progressing beyond regulation toward real-world, interoperable and ethical reuse of health data across borders
- Standards and Technical Guidelines: TEHDAS2 delivered a set of draft standards and technical specifications, covering metadata catalogues; access frameworks; license arrangements, etc., to support member states in developing connected trusted infrastructures. A consultation on TEDHAS2 guidelines opened to receive responses by November 30, 2025 (https://tehdas.eu/public-consultations/
- Global Interoperability & Collaboration: Participants discussed how efforts in Europe can be optimized and aligned with global standards (e.g., HL7 FHIR®) to advance data interoperability and the delivery of innovative solutions worldwide
- Trust and Transparency: The conversation also highlighted the role of trust when using health data, engaging citizens, maintaining ethical governance, and transparency in data reuse.
HL7 Vulcan Stakeholder Forum Roundtable
Sharing successful experiences from the Vulcan electronic Product Information (ePI) project supported by the European Union (EU) Gravitate-Health projects, the panelists looked forward to the new health data category, patient summary for research (IPS+), proposed by the EU xShare project, and its links to the digital protocol for clinical trials supported by the EU READI project. The panelists explored ways to improve and optimize clinical trials throughout their lifecycle, using HL7 FHIR in coordination with other standards such as CDISC and SNOMED. Connections to current and future Vulcan projects and HL7 FHIR implementation guides, including protocol specification, feasibility testing, eligibility criteria, and recruitment, were explored. The roundtable brought together Catherine Chronaki, HL7 Europe; Nersey Ratan, CTO Synergist; Yoanni Matsakis, Vice President EUCRF; Jannik Wheler, Researcher at Department of Clinical Epidemiology Aarhus University, Denmark; and Peter Casteleyn, eSource TF, I~HD the European Institute for Innovation Through Health Data. Short comments by Rebecca Baker (CDISC), Hugh Glover (Vulcan), Luc Nicolas (EHTEL), and Panagiotis Telonis (EMA) were all entertained.
Outcomes
The TEHDAS2 deliverables (guidelines and technical specifications) are under consultation by EHDS stakeholders.
- Member states and organizations were invited to start preparing the sociotechnical and legal organizational infrastructure environment for the implementation of EHDS
- EHDS Forum reiterated that the success of EHDS will require a ‘cross-sector’ standards-based approach – including regulators and researchers, industry, clinicians, and citizens and that is where HL7 FHIR has a vital role to play
Why It Matters
Vision is turning into reality in Europe.
Researchers and others who hold data are gaining greater clarity on access to and re-use of health-related data across borders. For citizens and patients, this work means greater transparency, stronger protection, and more tangible health benefits.
HL7 European remains dedicated to embracing this transformation, fostering interoperability standards and joint projects like Gravitate-Health and xShare, while standing for secure, ethical, and efficient health data exchange across Europe.
