European Health Data Space: UK alignment as a strategic priority to enable improved outcomes for all

The European Health Data Space (EHDS) is major health data initiative being rolled out across the European Union (EU). It aims to give individuals easier access to and control over their health data across EU borders, while enabling trustworthy use of health data for research and innovation across the 27 member states and 450 million people.

The scope and scale of the EHDS means it is already having a major influence on health data infrastructure, standards and approaches, and the decisions being taken now will shape the future of international health data research for years to come.

Why this matters for the UK

The UK is home to world-leading health data assets and a globally recognised life sciences sector, with clear ambitions to lead in data-driven research and innovation. Although the UK is not part of the EHDS, alignment with it matters enormously.  Under the current EHDS Regulation the UK can seek to collaborate with the EHDS though a reciprocal access pathway and authorised participant status. This should be prioritised.

Whether developing treatments for rare diseases or evaluating the impact of new interventions, researchers increasingly need access to health data from larger and more diverse populations than any single country can provide. For UK researchers and life sciences organisations, alignment with EHDS data infrastructure and approaches could help reduce barriers around data access, interoperability and governance, making it easier to participate in international research collaborations and make discoveries that benefit patients everywhere.

The alternative is not exclusion but added friction and complexity. As common EHDS infrastructure and approaches become embedded, countries that are aligned will find it easier to participate in large-scale collaborative research programmes than those operating through entirely separate frameworks.

What the latest consultation tells us

To lay the foundations for the EHDS, specialists have been setting out guidelines and technical specifications for the health data infrastructure and governance approaches to be used by each EU country. Many of these have been prepared for Health Data Access Bodies (HDABs), national bodies that will be responsible for managing and facilitating access to electronic health data for research purposes.

Health Data Research UK responded to all seven draft guidelines shared in the third and final public consultation. Four themes stood out, each with clear read-across to the UK’s own health data research ecosystem:

1. Aligned approaches for data discovery and use

Three guidelines set out approaches for enabling trustworthy data discovery and use that are well-aligned with UK practice. These include a user guide for researchers navigating the EU’s central health metadata catalogue, comparable to the UK’s Health Data Research Gateway. This is alongside guidance on data linkage and enrichment through secure processing environments, similar to the UK’s network of secure data environments, and on the common data standards needed for interoperability and large-scale, cross-population studies.s, and on the common data standards needed for interoperability and large-scale, cross-population studies.

2. Trust and transparency

New guidance sets out how HDABs should inform the public about the use of their health data for research — the first EHDS document on this topic. HDR UK involved its Public Advisory Board in shaping its response, which stressed the importance of engaging patients and the public from the outset to build trust. Similarly, how research outputs such as findings, code, and other digital assets should be shared echoes principles already embedded in the UK’s Five Safes framework.

3. Legal and governance frameworks

Further guidance addresses how HDABs should work together and build on existing EU research infrastructures in health. It highlights the difficulty of enabling legally compliant, secure cross-border data access in a timely way when legal and ethical requirements differ between countries. Similar challenges have been identified by the UK’s own Pan-UK Data Governance Steering Group , with some common solutions emerging to streamline and simplify data access, ethics and governance to bring public benefit.

 4. International cooperation and collaboration

The final guideline sets out how HDABs will assess data access applications from researchers outside the EU, including the UK — with direct implications for wider international collaboration. A recent workshop run by Understanding Patient Data, bringing together representatives from a range of non-EU countries, underlined the importance of alignment, interoperability, effective governance, and public involvement for this to work in practice.

A strategic priority

The UK has a strong foundation. World-leading datasets, trusted research infrastructures and a mature approach to responsible data use. But global research requires partnership, collaboration and connectivity, as well as capability.

Securing a reciprocal access pathway and authorised participant status under the EHDS Regulation should therefore remain a strategic priority. Done well, alignment with EHDS would help UK researchers collaborate internationally, support innovation, and ultimately enable discoveries that improve health outcomes for people in the UK and beyond.