Publication
Michel Silvestri, Daniela Trocilo, Cecilia Vanhainen, Mari Mäkinen, Minna Liikala, Jenina Soimala, Rebekka Björg Guðmundsdóttir
Published
16.12.2025
The VALO project, funded by the Nordic Council of Ministers, aims to strengthen Nordic cooperation in the secondary use of health data and support the implementation of the European Health Data Space (EHDS). Active participants in VALO were Finland, Iceland and Sweden, as well as Denmark and Norway. For the second half, the Baltic countries Estonia and Lithuania joined as observers.
Work Stream 2 (WS2) focused on establishing the Nordic EHDS2 Competence Forum, coordinating national progress reporting, and fostering collaboration on metadata, legal frameworks, and technical infrastructure. From September 2024 to September 2025, four Competence Forums were held across Nordic countries, with a fifth planned for October 2025. These forums brought together representatives from ministries and authorities across the Nordic and Baltic regions to share experiences, identify challenges, and explore harmonisation opportunities in implementation of EHDS2, i.e. the dimension of EHDS specifically concerning secondary use of health data.
Key outcomes include:
• National Progress Reports: A harmonised survey template enabled tracking of EHDS2 readiness across countries. Reports revealed varying levels of legal, organisational, and technical preparedness, with common challenges around Health Data Access Body (HDAB) appointment, metadata catalogues, and Secure Processing Environment (SPE) interoperability.
• Breakout Sessions: Themed discussions on HDAB/SPE, metadata, and legal aspects highlighted fragmentation in national approaches and the need for Nordic alignment. Topics such as fee structures, ethical review, opt-out models, and metadata standards were explored in depth.
• Legal Harmonisation: Countries are adapting national laws to EHDS, but timelines and interpretations vary. Joint Nordic efforts are recommended to align on permitted purposes, fee principles, opt-out mechanisms, and Intellectual Property (IP) rights handling.
• Recommendations for VALO2: The approved extension of the project into 2026 will in WS2 focus on identifying and mitigating bottlenecks in health data access. Continued Competence Forums, expanded breakout sessions, and deeper integration of metadata and legal workstreams are planned.
Overall, VALO and WS2 have laid a strong foundation for Nordic-Baltic collaboration in EHDS2 implementation. The project demonstrates the value of structured dialogue, shared tools, and coordinated strategies in navigating complex regulatory and technical landscapes.
VALO2 will build on these achievements to further enhance regional leadership in the secondary use of health data.
Nordic EHDS2 Competence Forum – final report
Sitra
Helsinki
2025
33
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