Policy Brief: will the UK participate in the European Health Data Space?

17 Jun 2025

This policy brief — published as part of the GA4GH Health Data Sharing, Privacy, and Regulatory Forum — discusses the questions that remain following publication of the text of the European Health Data Space (EHDS) Regulation, in regards to participation from outside of the European Union.

By Miranda Mourby

On 11 February 2025, the final text of Regulation 2025/327 on the European Health Data Space (EHDS) was published in the Official Journal of the European Union (EU). The “EHDS Regulation” came into force on 3 March 2025 and will apply, with some exceptions, from March 2027. 

Participation in the EHDS will still be possible for non-EU countries, such as the United Kingdom (UK). For such countries, joining the EHDS may open up access to the pseudonymised and anonymised health data of millions — even, hundreds of millions — of people. The information gathered within the EHDS’s “HealthData@EU” infrastructure for “secondary” uses — such as medical, genomic, and public health research — promises to be a formidable resource, potentially unparalleled in its geographical reach and comprehensive coverage of multiple healthcare systems. 

Will the UK Participate?

There are some early signs that the UK is interested in third-party participation in the EHDS. The National Health Service (NHS) Confederation, an entity representing national healthcare  providers, is participating in the Towards the European Health Data Space project — a joint action exploring the requirements for implementing the EHDS. This can be interpreted as a “watching brief,” or an attempt to participate in the upstream, formative discussions shaping the EHDS infrastructure. 

The UK is well positioned to participate in the EHDS. NHS England already has a secure data environment, which resembles the secure processing environments the EHDS Regulation requires (Article 73). Similar digital platforms for NHS health data access are available in Wales, Scotland, and Northern Ireland. A UK-wide national data service has also been announced. 

However, for any country considering EHDS participation, there are practical issues that will need to be addressed. These are briefly delineated below. 

Pathways to Join the EHDS

Any non-EU country wishing to join the EHDS will need to be approved by the European Commission (EC). There are two ways in which a non-EU country can participate: 

1) as an authorised participant, providing access to health data on “equivalent terms and conditions” to the rest of the HealthData@EU structure (Article 75(5));

2) by offering reciprocal access to health data on “conditions that are not more restrictive than those provided for in [the EHDS Regulation]” (Article 91). 

The “authorised participant” route is the closest a non-EU country can come to full participation in the EHDS. However, it will not be available until March 2035. 

Article 91 of the EHDS Regulation appears to offer a lower barrier to entry. The “not more restrictive” criterion may offer more flexibility around the terms on which a third country offers access to health data, which presumably do not need to be identical to the rest of the EHDS. 

Crucially, Article 91 should come into force in March 2027, at the same time as the rest of the EHDS Regulation. As such, it could prove an interim means through which non-EU researchers could apply to access data within HealthData@EU that will not take over a decade to come to fruition. 

Capacity to Join the EHDS

Participation in the EHDS will require sufficient capacity in a national platform for health data sharing. This capacity includes the hardware required for the scale of processing involved in participation in HealthData@EU. It also includes capacity in terms of human resources: sufficient numbers of staff, with sufficient time, expertise, and training to review the volume of applications that participation in HealthData@EU will involve. 

The UK’s existing digital platforms for health data should enable our systems to offer access to researchers from the EU. For example, NHS England’s Data Access Request Service already processes over 1,000 applications a year from bodies seeking to access health data for secondary purposes, and could be expanded in a reasonably straightforward and cost-effective way. But, for a country without this existing infrastructure, building the necessary capacity to participate in the EHDS would represent a significant financial investment. 

Public Support 

As well as these practical challenges, it will only be sustainable for a non-EU country to participate in the EHDS if the national patient population does not object to the sharing of their health data. For the UK, this is a non-trivial question. Even nationally, as its systems for centralising health data for research have evolved, these digital platforms have been met with a series of public backlashes to sharing patient data, particularly in England with the NHS’ 2014 care.data programme, which had to be suspended to allow for further public consultation. Backlash can come not only from patients, but also the doctors expected to share the patient data they collect in delivering care. This was also observed in a more recent initiative to centralise data from general practices in England. 

It is not frivolous to wonder how different groups within the UK public might feel about sharing their health data with the EU, particularly when it is no longer a member state. As in any country, some actors in the private sector — such as manufacturers of electronic health systems — may also be reluctant for the UK to join if it means they will need to share health data which contain trade secrets.  

Conclusion

It is by no means guaranteed that the UK will participate in the EHDS. Questions of capacity and economic cost aside, there is some political risk as to how receptive UK patients may be to having their anonymised information shared with EU researchers. The alternative, however, is that UK-based researchers will be unable to access one of the world’s largest resources of biomedical information. Therefore, despite the complexity and distant timelines ahead, non-EU countries still have significant incentives to explore participation in the EHDS. 

Further Reading

Regulation (EU) 2025/327 of The European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847: https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng. 

NHS Confederation, ‘Health Data’ (22 June 2021): https://www.nhsconfed.org/articles/health-data#:~:text=The%20NHS%20Confederation%20is%20the,of%20the%20EU%20Health%20Programmes. 

Elizabeth Redrup Hill, ‘The European Health Data Space Regulation has arrived’: https://www.phgfoundation.org/blog/the-european-health-data-space-regulation-has-arrived/. 

Kristof Van Quathem, ‘EHDS Series – 3: The European Health Data Space from the Health Data User’s Perspective’ (8 April 2024): https://www.insideprivacy.com/digital-health/ehds-series-3-the-european-health-data-space-from-the-health-data-users-perspective/.  

Rosie Richards, Maili Raven-Adams, James Maddocks, and Sarion Bowers: ‘Sharing health data – lessons for the UK from the European Health Data Space’ (2024): https://understandingpatientdata.org.uk/sites/default/files/2024-03/Lessons%20from%20EHDS%20report%20final.pdf. 

Miranda Mourby is a researcher in law at the University of Oxford.