UK's route into the European Health Data Space remains unresolved

The PHG Foundation at the University of Cambridge has published an analysis of the European Health Data Space (EHDS) — the EU's framework for enabling the secondary use of health data across member states for research, policy, and innovation — and assessed what it means for the United Kingdom as a non-member third country.

The EHDS regulation entered force in 2024 and is now moving into its operational phase, with member states establishing national Health Data Access Bodies and data holders preparing to comply with new obligations around data quality, interoperability, and access. The framework distinguishes between primary use (clinical care) and secondary use (research, statistics, training of algorithms) of health data, and is expected to significantly expand the volume and variety of genomic and health data available for cross-border research projects.

For the UK, however, no formal third-country access mechanism has yet been agreed. The PHG Foundation notes that the UK's post-Brexit adequacy decisions under UK GDPR and EU GDPR cover personal data transfers but do not automatically extend to the EHDS's specific access architecture. Researchers and institutions on both sides face uncertainty about whether UK-based studies will be able to query EHDS-held datasets, participate in federated analyses, or contribute data reciprocally.

The analysis identifies several possible models — including bilateral negotiation, observer status, or alignment with the EHDS's third-country provisions — and calls for early policy engagement to prevent the UK from being structurally excluded from what may become the world's largest linked health-data research infrastructure. The post-Brexit landscape for UK genomics research policy is described as one where the consequences of inaction are accumulating quietly.