The European Health Data Space (EHDS) is reshaping how health data can be securely accessed, shared and used for research, innovation and public health across Europe. For VAC4EU, these developments are directly relevant: our network depends on timely, trustworthy and operationally feasible access to real-world health data to generate evidence on vaccine safety and effectiveness. Our primary engagement with EHDS is through participation in public consultations through TEHDAS2, and our involvement in the new IHI-funded project FORTIFY.
5 documents finalised from TEHDAS2 with feedback from VAC4EU members incorporated
TEHDAS2, the second Joint Action Towards the European Health Data Space, develops practical guidelines and technical specifications to ensure full efficiency for future EHDS operations. Throughout 2025 and 2026, TEHDAS2 have released several drafts for public consultation, covering key topics such as data access, data minimisation, secure processing environments and the technical infrastructure needed for EHDS.
VAC4EU has dedicated significant effort in coordinating input from members of our network with relevant expertise across three waves of review, ensuring that the practical perspective of a distributed vaccine monitoring network was reflected in the consultation process. We are pleased to announce that TEHDAS has now published final versions of some of these documents, with feedback from VAC4EU members well-represented.
Draft technical specification for health data access bodies on the implementation of secure processing environments
Reviewed by Debabrata Roy (DSRU), this response called for clearer legal and practical framing, stronger role definitions, and more detail on secure processing environment collaboration, interoperability, export checks and disclosure control. The final specification reflects much of this feedback through clearer requirement categories, expanded stakeholder roles, and stronger sections on federation, secure transfer, proportionality, logging and export control, although detailed implementation requires further work.
Draft guideline for health data access bodies on data minimisation, pseudonymisation, anonymisation and synthetic data
Reviewed by Giampiero Mazzaglia (UNIMIB), Estel Plana and Andrea Margulis (RTI-HS), this response asked for clearer responsibilities, more practical guidance on data minimisation trade-offs, cross-holder pseudonymisation, anonymisation, synthetic data, risk assessment and tooling. The final guidelines incorporated many points through role-based tables, expanded examples, stronger pseudonymisation and relative anonymity sections, and more detailed guidance on privacy risk assessment, documentation and tools.
Draft guideline for health data holders on their duties regarding data description
Reviewed by Rosa Gini (ARS) on behalf of RWE4Europe, this response asked for stronger alignment with MINERVA, DIVERSE and existing metadata catalogues. It made clear that, from the perspective of investigators reusing real-world data sources, it should be more clearly indicated that some “datasets” compose the same data source because they have the same underlying populations. There was an invitation to include persistent identifiers. The final guideline reflects this through expanded HealthDCAT-AP guidance, stronger coverage of population, provenance, identifiers, data dictionaries, controlled vocabularies and implementation support.
Draft technical specification on the national metadata catalogue
Also reviewed by Rosa Gini (ARS), this response highlighted the burden of maintaining high-quality metadata, the need for clear responsibility, interoperability with existing catalogues, persistent identifiers and recognition of real-world data sources. The final specification adds clearer metadata flows, expanded roles, user stories on metadata reuse, requirements for versioning, identifiers, validation, search and EU synchronisation, plus non-functional requirements and support needs.
Draft guideline for data users on good application and access practice
Reviewed by Rosa Gini (ARS), this response asked for clearer definitions of anonymised and pseudonymised data, better examples of individual versus aggregate level data needs, inclusion of benefit-risk and safety monitoring purposes, clearer protocol and ethics expectations, and a more user-friendly structure. The final guideline adds clearer definitions, decision guidance, examples, document checklists, application guidance, and stronger sections on data minimisation, secure processing environments, ethics, data quality and applicant obligations.
VAC4EU contributes to IHI FORTIFY
VAC4EU is also contributing to FORTIFY, a project funded by the Innovative Health Initiative (IHI). This multi-stakeholder, co-creational public private partnership will support implementation of EHDS. VAC4EU, as a research network specialising in the secondary use of health data for research purposes, is one of the use cases FORTIFY will test to validate its framework. Through this role, VAC4EU is helping ensure that the emerging EHDS framework is tested against the practical needs of distributed real-world evidence generation and vaccine monitoring.
This is a concrete example of VAC4EU’s impact beyond individual studies: by contributing practical expertise from across our member network, VAC4EU is helping shape the policy and technical landscape that will determine how health data research is conducted in Europe in the years ahead. Watch this space as more final documents are published, and as work in the FORTIFY project progresses!