Historic milestone as EU council adopts regulation for European Health Data Space

The groundbreaking regulation marks a significant step toward empowering citizens with control over their electronic health data and fostering secure cross-border data sharing to advance healthcare across member states.

The European Health Data Space (EHDS) Regulation has been adopted by the Council of the European Union, following the European Parliament's approval in December 2024. The EHDS aims to improve cross-border access to and exchange of electronic health record (EHR) data, supporting both healthcare delivery (primary data use) and research, innovation, and policymaking (secondary data use).

Considered a ‘key pillar’ of the EU, the EHDS framework is expected to have a major impact on real-world evidence (RWE), making it easier to collect, analyze and use real-world data (RWD). In addition to enabling European citizens to access, manage and share their data, EHDS will also enable sharing of a wide range of health-related data for public interest, policy support, and scientific research.

“The digital transformation of healthcare in Europe is a key priority for Polish Presidency. The adoption of the EHDS marks a crucial step in this process, empowering EU citizens to access their health data anywhere in the EU. EHDS will enhance the quality and efficiency of medical care, while ensuring that our health system remains resilient to future challenges.” Izabela Leszczyna, Polish Minister of Health

Recognizing the fragmented health data across the EU following the COVID-19 pandemic, the EHDS was developed to create a ‘genuine single market’ for EHR systems across the EU. The EHDS is underpinned by two major components: MyHealth@EU and HealthData@EU, each serving distinct but complementary roles. MyHealth@EU will enable individuals to access and share their personal health data across borders securely. This service ensures that citizens can control their health data, such as medical records, prescriptions, and test results, regardless of their location within the EU. This seamless access promotes continuity of care for those traveling, working, or living in different member states.

HealthData@EU focuses on the secondary use of health data, enabling researchers, policymakers, and innovators to access anonymized datasets. These data are critical for advancing public health initiatives, developing new treatments, and informing evidence-based policymaking. HealthData@EU ensures that data is shared under stringent safeguards, protecting privacy while maximizing societal benefits.

In the EU’s announcement, they highlight the three main goals of the EHDS:

1. Easier access to health data for individuals

One of the EHDS’s primary goals is to empower individuals with control over their health data. Through MyHealth@EU, citizens will be able to access their EHRs in standardized formats, enabling seamless sharing of medical information. This accessibility benefits patients and reduces administrative burdens on healthcare providers, with the aim of streamlining access to complete patient histories and enhancing care delivery efficiency.

Additionally, the EHDS framework outlines the emphasizes the goal of improving digital health literacy for both individuals and health professionals.

“Improving digital health literacy is fundamental in order to empower natural persons to have true control over their health data, actively manage their health and care, and understand the implications of the management of such data for both primary use and secondary use.”

2. Greater research potential

HealthData@EU and MyHealth@EU will collectively facilitate access to high-quality, secure, anonymized datasets for research. MyHealth@EU aims to play a critical role in aggregating individual health records, which can then inform larger datasets within HealthData@EU. Researchers and policymakers will be able to work with more extensive, diverse, and interoperable data, improving the reliability and generalizability of findings.

“Electronic health data used for secondary use can bring great societal benefits. The uptake of real-world data and real-world evidence, including patient-reported outcomes, for evidence-based regulatory and policy purposes as well as for research, health technology assessment and clinical objectives should be encouraged.”

Emphasis is placed on establishing an EU dataset catalogue, a centralized framework to enhance the discoverability of datasets within the EHDS. This catalogue will assist health data holders in publishing their datasets, ensuring accurate descriptions in national catalogues. It will provide stakeholders with essential details about datasets, including quality and utility labels and information sheets, and offer health data users up-to-date insights into dataset quality and utility.

3. Ensuring interoperability

Current levels of health data digitization vary across EU Member States, complicating cross-border sharing. To address this, the new regulation requires all EHR systems to comply with EU-level specifications, ensuring RWD adheres to the FAIR principles—findable, accessible, interoperable, and reusable.

“Interoperability should be ensured between the EU dataset catalogue, the national dataset catalogues and the dataset catalogues from European research infrastructures and other relevant data sharing infrastructures.”

Recognizing the scale of the task ahead, the EHDS framework outlines a gradual approach to improving interoperability and data sharing. Initial efforts will prioritize key categories such as patient summaries, electronic prescriptions, medical imaging, laboratory test results, and discharge reports. These priority areas, critical for healthcare delivery, “form the foundation for better continuity of care and evidence generation across the EU.”

The next steps involves formal signing by the Council and Parliament, after which the regulation will enter into force 20 days following its publication in the EU's Official Journal. Once in full force, countries across Europe will need to step up their efforts to implement its requirements. The TEHDAS2 (Towards European Health Data Space) joint action plays a critical role in shaping governance frameworks and developing detailed guidelines and technical specifications for the EHDS. Complementing this, initiatives such as the HealthData@EU pilot project and Xt-EHR Joint Action focus on enabling cross-border data sharing and improving EHR interoperability whilst regionally, the VALO project aims to foster Nordic collaboration.