An electronic prescription that can also be used when travelling abroad, clinical information that authorised healthcare professionals can access more easily, and data available for research under common rules: this is the direction set by the European Health Data Space (EHDS), the European Union’s new regulatory framework for digital health.
The regulation has already entered into force, but many of its provisions will apply gradually. Understanding what it entails is therefore important not only for patients and healthcare professionals, but also for hospitals, universities and companies developing healthcare software.
Let’s explore how the European Health Data Space works, the key deadlines, and why interoperability and data protection will become central to the design of e-health technologies.
Table of contents
What is the European Health Data Space (EHDS)?
The European Health Data Space (EHDS) is the European framework of rules, standards and infrastructure established by Regulation (EU) 2025/327 to facilitate access to electronic health data and their secure use.
It has two objectives: to make it easier for people to use their health information when receiving care, and to establish controlled conditions under which certain data may be used for research, innovation and public health policy. It is not a single European database into which all medical records are automatically uploaded.
How does the EHDS work? The difference between primary and secondary use
Primary use: data for patient care
Primary use means processing electronic health data to provide care to an individual. Consider an Italian citizen who needs treatment in another Member State: cross-border exchange of clinical information, in accordance with the applicable rules, can help healthcare professionals access essential information and avoid unnecessary duplication.
The European MyHealth@EU network supports this process, which will gradually be extended to further categories of documents and healthcare services.
Secondary use: data for research and innovation
Secondary use refers to the regulated reuse of health data for permitted purposes, such as scientific research, statistics, public policy evaluation and innovation. Access is neither open nor unrestricted: the regulation sets out conditions, authorisations, safeguards and restrictions to protect individuals.
HealthData@EU is the European infrastructure designed to support access to and secondary use of data by connecting the relevant bodies. The specific conditions depend on the type of data and the applicable rules.
What benefits could the European Health Data Space bring?
With reliable systems and appropriate organisational processes in place, the EHDS could help make Europe’s healthcare ecosystem more efficient. Expected benefits include:
- easier access for citizens to their own electronic health information;
- greater continuity of care when patients receive treatment in another Member State;
- standardised exchange of prescriptions and patient summaries;
- improved interoperability between electronic health record systems and other healthcare systems;
- new research opportunities through regulated data access procedures;
- the ability to develop digital solutions that can communicate with different systems and infrastructures;
- increased emphasis on security, access logging and the protection of patients' rights.
These outcomes will not happen automatically: they will require technical standards, data quality, investment and staff training.
When will the EHDS apply? Key dates to know
Regulation (EU) 2025/327 entered into force on 26 March 2025. Its general application is scheduled for 26 March 2027, with different deadlines for the main provisions.
- 26 March 202- 5 – entry into force of the regulation;
- 26 March 20- 27 – general application and the expected deadline for important implementing acts;
- 26 March - 2029 – application of key provisions concerning patient summaries and electronic prescriptions/dispensing, and the start of the main rules on secondary use;
- 26 March 2- 031 – extension to medical imaging, laboratory results and discharge reports, alongside further provisions on EHR systems and secondary use.
These dates are those indicated by the European Commission; technical specifications and obligations must be checked against the implementing acts and the circumstances of each case.
What will change for healthcare software developers?
For software companies working in e-health, the European Health Data Space reinforces the need to design solutions that exchange information using consistent formats and document the operations performed. Not every healthcare application will automatically be subject to the same obligations: the requirements depend on the product’s functions and classification.
In particular, when developing and upgrading electronic health record (EHR) systems, several aspects deserve attention from the earliest stages of a project:
- interoperability: define formats, interfaces and exchange methods that meet applicable requirements;
- security: implement access controls, data protection and measures proportionate to the risks;
- traceability: log access and operations in line with the relevant requirements;
- data quality: reduce errors, ambiguity and semantic inconsistencies;
- governance: identify responsibilities, purposes of processing and the roles of those involved;
- verification: integrate software testing, validation and monitoring throughout its lifecycle.
The EHDS Regulation complements the GDPR and other potentially relevant legislation; it does not replace them. Technical and legal-organisational considerations must therefore be assessed together.
A practical example: from digital medical records to medical research
Imagine a healthcare facility using electronic health records to document allergies, treatments and test results. In an interoperable environment, an authorised professional could access relevant information to care for a patient across borders, as European rules are gradually implemented.
In a separate scenario, a research organisation might request certain data to study epidemiological trends. In this case, access to the medical record alone would not be sufficient: the procedures and safeguards governing secondary use would be required. Understanding the distinction between these two processes is essential to understanding the EHDS.
The role of IPPOCRATE AS in digital healthcare
IPPOCRATE AS, part of JO Group, develops e-health and m-health solutions for businesses and research centres in the medical and healthcare sector. Its activities include requirements analysis, software design and development, testing and validation.
As Europe moves towards more interoperable systems, these capabilities are relevant to research and development projects in which technology must meet clinical needs, data security requirements and usability expectations. The EHDS therefore provides a strategic perspective for developing new products and partnerships; this does not mean that the company’s current software is already certified or compliant with future EHDS requirements.
Frequently asked questions about the European Health Data Space
What is the EHDS in simple terms?
It is the European framework introducing common rules and infrastructure to facilitate the secure use of electronic health data for patient care and, subject to specific conditions, for research and innovation.
Is the EHDS already operational in every Member State?
No. The regulation has been in force since 26 March 2025, but many provisions will apply gradually from 2027, with key milestones in 2029 and 2031.
Does the EHDS replace the GDPR?
No. The regulation complements the European framework for health data and establishes specific sectoral rules and safeguards without replacing the GDPR.
What is the difference between MyHealth@EU and HealthData@EU?
MyHealth@EU supports the exchange of data for healthcare delivery (primary use). HealthData@EU provides the infrastructure for regulated data reuse for research and other permitted purposes (secondary use).
Towards a more connected European healthcare system
The European Health Data Space marks an important step in the digital transformation of medicine: it puts people’s right to access and use their health information at the forefront, while enabling data to be used for public-interest purposes under specific safeguards.
For hospitals, universities and businesses in the sector, preparing means investing in interoperability, software quality and responsible design. The challenge is not solely technological: it also concerns the trust of people who entrust particularly sensitive information to digital systems.
Want to learn more about developments in e-health and medical technologies? Keep reading IPPOCRATE AS’s JOurnal.
European Commission, ‘European Health Data Space (EHDS) Regulation’.