The European Health Data Space (EHDS) is the largest health data initiative underway in Europe. It seeks to:

  • make it easier for people to use, access and control their health data across EU borders for improved continuity of care and healthcare delivery
  • create clearer, more consistent routes for secure and privacy-preserving use of health data for research and policy making.

The UK won’t be part of EHDS as it is not an EU Member State. But the reality is that EHDS will shape how cross-border health data research works, and it will influence the standards and frameworks that partners across Europe build around.

That’s why HDR UK and other UK organisations have engaged with the public consultations on the draft EHDS implementation guidelines, including the second consultation that closed on 30 November.

So, what are the key points for the UK health data research community?

Why UK Alignment matters (now and later)

Although the UK won’t be part of the EHDS, strong alignment with EHDS standards and practices will be important. In the near term, it helps facilitate continued research collaborations with the EU.

In the longer term, it would put the UK in a strong position to pursue formal routes to participation in the EHDS that are available to third countries. These include a reciprocal access pathway (Article 91) and authorised participant status (Article 75(5)) under the EHDS Regulation. The authorised participant route is the closest a non-EU country can come to full participation, but European Commission guidance suggests it won’t be available until March 2035.

Where we are already moving in the same direction

Data infrastructure

EHDS emphasises the importance of access to sensitive data being through secure processing environments. This aligns closely with the UK’s aim of building a federated network of trusted research environments through the DARE UK programme, and UK involvement in the EOSC-ENTRUST, a European initiative that seeks to build a similar network across the EU, alongside common approaches being taken on data quality and standards.

Data governance

EHDS proposals set out a single point of control on a national level, the Health Data Access Body (HDAB), which will provide a unified response at a country level to health data access requests. The UK’s Health Data Research Service, announced in April 2025, shares this principle of streamlined access through a single gateway, though with a narrower focus on research access to NHS data rather than the broader remit of HDABs, which extends to regulatory purposes and patient safety

Cross-border collaboration

EHDS seeks to provide a common framework for use and exchange of electronic health data across EU country borders. As each UK nation has separate regulatory frameworks for health data use, there are relevant learnings from UK experience that may inform EHDS approaches to third country participation. For example, the first UK-wide population health research study, COALESCE, demonstrated methods for harmonising data and coordinating governance across jurisdictions with different regulatory frameworks – challenges analogous to those EHDS will face in enabling third country participation.

Trust and transparency

Building trust through public and patient involvement and engagement is an essential foundation for impactful health data research, with EU and UK initiatives, such as the European Patients Forum and PEDRI (the Public Engagement in Data Research Initiative) already playing a key role. EHDS guidelines in this area will the focus of the third public consultation in May 2026.

Looking ahead

The overall picture is encouraging with key areas of alignment already demonstrating the strong compatibility between EU and UK approaches to enabling trustworthy use of health data for research.

The opportunity now is to build on this progress with practical steps. Shared standards, interoperable approaches and governance will be key to enabling research collaboration and shared learnings beyond borders, to improve health outcomes for all.