On 5 March 2025, the European Health Data Space (EHDS) Regulation was officially published in the Official Journal of the European Union. The regulation enters into force on 26 March 2025, marking the start of a structured transition towards its full implementation.

Key Implementation Milestones

• March 2027 – The European Commission will adopt key implementing acts to clarify operational details.
• March 2029 – The first group of priority health data categories (Patient Summaries, ePrescriptions/eDispensations) will be exchanged across all EU Member States. Rules on secondary use will apply to most health data categories (e.g. electronic health record data – eHRD).
• March 2031 – The second group of priority health data categories (medical images, lab results, and discharge reports) will be available for exchange in all EU Member States, with expanded secondary use rules (e.g. genomic data).
• March 2034 – Third countries and international organisations can apply to join HealthData@EU for the secondary use of health data.

Built on key existing EU frameworks, including the GDPR, Data Governance Act, Data Act, and Network and Information Systems Directive, the EHDS provides a trustworthy environment for the secure access to and processing of a wide range of health data.

It is designed to benefit:

Patients

• Fast and free access to their electronic health data (EHD).
• Easy cross-border sharing with healthcare professionals.
• Greater control over their data, with options to restrict access, correct errors, track usage, and opt out of secondary data use.

Healthcare Professionals

• Faster access to patient health records across different providers and countries.
• Improved interoperability between healthcare systems, reducing administrative burden.

Researchers

• Cost-effective access to large-scale, high-quality health data for scientific studies.
• A clear and structured system for discovering datasets, their location, and their quality.

Regulators & Policymakers

• Enhanced access to electronic health records (EHRs) for public health monitoring and improved healthcare system efficiency.

Industry & Innovators

• Easier access to new markets for electronic health records (EHR) across EU Member States due to standardization.
• Greater availability of anonymised and pseudonymised health data for applied research and innovation.

By enabling secure and seamless data exchange, the main aim of the EHDS is to optimise the use of health data to:

• Improve healthcare and patient outcomes.
• Support evidence-based policymaking.
• Accelerate innovation and research.
• Foster digital advancements (promote full digitalisation of healthcare records, strengthen telemedicine and personalised treatment).

For more details, explore the freely available EU Health Policy Platform (EUHPP) webinars on the European Health Data Space:

1. Primary Use of Health Data and Electronic Health Record Systems – Watch here
2. Secondary Use of Health Data – Watch here
3. Implementation and Governance – Who Does What? – Watch here