The European Health Data Space, or EHDS, is the common EU framework for access, exchange, and reuse of electronic health data established by Regulation (EU) 2025/327. It connects common rules, standards, infrastructures, and governance for primary and secondary use. The regulation was published in the Official Journal on 5 March 2025, entered into force on 26 March 2025, and applies in principle from 26 March 2027.
Primary Use and Patient Rights
Primary use concerns electronic health data in the context of healthcare provision. The EHDS is intended to enable natural persons to access, control, and share their personal electronic health data across borders. The European Commission names patient summaries and electronic prescriptions in particular as categories whose cross-border availability will be progressively expanded.
In addition, the regulation creates a harmonised legal and technical framework for electronic health record systems, the EHR systems. This does not mean that every national information system is automatically interoperable. The requirements are directed towards a common European environment in which data formats, access, and the development or marketing of certain digital health solutions are to follow more uniform specifications.
For the interoperability of health data, data exchange alone is not decisive. The information must be available in the receiving country in such a way that it can be reused for care without losing its clinical context. The EHDS links this requirement to the European exchange space MyHealth@EU and to requirements for EHR systems. Which technical specifications apply in detail will be specified by the implementing acts provided for.
Secondary Use Under Regulated Conditions
Secondary use opens up the reuse of electronic health data under the conditions of the regulation for research, innovation, policy-making, regulatory activities, and other purposes in the public interest. It does not mean unrestricted access to patient records. The legal framework provides for governance structures, data access procedures, and safeguards so that the use of electronic health data is organised in a purpose-bound and trustworthy manner.
For research, it is relevant that the EHDS does not equate access to certain health data with publication. Data holders, health data access bodies, and authorised data users are assigned different roles. Implementation must also respect the rights of data subjects, including the possibility described by the Commission to object to secondary use in Member States under certain national arrangements.
The EHDS thus creates a European level for procedures without abolishing the origin and context of the data. Data from care, registries, genomics, administration, or clinical research have different conditions of origin and limitations. Approved access therefore does not yet answer whether a dataset is sufficiently complete and suitable for a specific endpoint, a target population, or a regulatory question.
Distinction from a Data Standard
The EHDS is not a data standard such as HL7 FHIR, CDISC SDTM, or a medical vocabulary. It is a data infrastructure with a binding legal framework that brings together common rules, standards, technical components, and responsibilities. Individual standards may be deployed for interoperability within the EHDS or specified in more detail by implementing acts, but they do not constitute the EHDS alone.
The General Data Protection Regulation is not replaced by the EHDS either. The EHDS Regulation creates sector-specific rules for electronic health data and its use, while the processing of personal data continues to be assessed in conjunction with general data protection law. The existing neighbouring entry data integrity addresses the accuracy and reliability of data; the EHDS, by contrast, establishes a European regulatory and access framework.
Relevance for clinical trials
For clinical trials, the EHDS may in the long term structure access to health data for feasibility analyses, research, and regulatory evaluations. However, the sponsor and study organisation must continue to distinguish precisely which data are collected directly under consent and within the study and which data are requested via an EHDS-supported secondary use pathway. An EU-wide framework does not eliminate scientific purpose limitation or the need to justify data access and data minimisation on a project-specific basis.
Full-service CROs such as Mediconomics support the classification of potential EHDS data sources into the study strategy, data protection and data access documentation, the description of data flows, and the coordination of secondary use applications with registries or data holders. For hybrid datasets, they can also specify which variables originate from the study and which were provided under EHDS conditions.
Frequently Asked Questions (FAQ)
Does the EHDS Regulation already apply in full?
The regulation entered into force in March 2025; its general application begins according to the published legal text in March 2027. Staggered dates apply to individual provisions, implementing acts, and data categories.
Does the EHDS allow researchers direct access to patient records?
No. Secondary use is regulated access to health data for specified purposes. It is subject to a governance and data access framework and is not equivalent to free retrieval of individual patient records.
Is the EHDS intended only for healthcare provision?
No. In addition to primary use in care, the regulation covers secondary use for research, innovation, policy-making, and regulatory activities, as well as an internal market dimension for EHR systems.
Regulatory References
- Regulation (EU) 2025/327 — establishes the EHDS with rules, standards, infrastructures, and governance.
- Regulation (EU) 2016/679 — provides the general data protection framework for personal data.
- European Commission, EHDS Regulation — explains primary use, secondary use, and transitional phase.