The European Health Data Space (EEDS) is set to transform the way health information is accessed across the European Union. With phased implementation, the regulation will pave the way for digital medical records – including clinical summaries, diagnostic results, e-prescriptions and hospital discharge notes – to be accessible to authorised professionals right across the EU. Effective March 2029, patients' health records will be consultable between member states under a common framework, progressively expanding until full operational capability by 2035.
This legislation aims to ensure interoperability between national health systems, facilitating cross-border medical care and smoother continuity of treatment for EU citizens. While the immediate focus is hospitals and primary care centres, the regulation also allows, under strict controls, for universities, research institutions, and pharmaceutical companies to access relevant data. As outlined by the European Commission, "from March 2027, several key implementing acts setting out the detailed requirements for putting the Regulation into practice must be adopted", which will specify the technical, security and operational standards required of all national health systems.
Digital records, schedule and categories
The transition will follow a structured timeline. The first phase, from 2029, will see priority data categories—summarised clinical histories and electronic prescriptions—made available EU-wide. This will enable, for example, Spanish doctors to instantly check an allergy record for a German tourist or confirm the medication regime for a French patient needing urgent care in Portugal.
By March 2031, the next tranche of medical data becomes accessible, comprising digital imaging (X-rays, MRIs, CT scans), full laboratory results and comprehensive discharge reports, further improving treatment coordination as patients travel across Europe.
The final stage, set for March 2035, opens the system to eligible non-EU countries and international bodies such as the World Health Organization, pending stringent requirements on technical compatibility and reciprocal data access.
Consent, patient rights and privacy safeguards
Notably, the regulation does not require prior individual consent for international sharing of health records for care delivery, although each member state may offer opt-out provisions at national discretion. These rights would allow citizens to block the cross-border sharing of their data, where supported by domestic legislation. However, citizens can opt out of the digitalisation or storage of their medical information within their own country. To ensure patient privacy, rigorous protocols have been mandated: encrypted transfers, detailed access logs, and regular audits. Every data consultation will be traced, allowing individuals to check what information was accessed, by whom and for what purpose. Enforcement is aligned with existing EU General Data Protection Regulation standards, with robust sanctions for violations.
What is the European Health Data Space?
The EEDS is part of the EU's broader European Data Strategy, seeking to create a secure digital infrastructure for sharing health information across the 27 member states. It serves two main aims: improving individual care (primary use), and facilitating research, medicines regulation, and policy planning (secondary use). The legislation mandates compatible formats, real-time data transmission protocols, and common security requirements to allow seamless interpretation of health records regardless of where they originate. Governance will be overseen by national competent authorities in each country, with provisions to protect against misuse and any health or genetic-based discrimination.
Scope of medical data shared
Accessible from 2029, priority data covers clinical summaries with essential health information—such as allergies, chronic conditions, medications, and surgical history—as well as e-prescriptions, allowing medication to be dispensed across EU pharmacies. As of 2031, the second category extends to digital medical imaging, laboratory analyses (including genetic and tumour marker tests), and discharge summaries, essential for ongoing treatment and specialist referrals across borders.
Access and secondary use of health information
Access is not restricted to doctors and nurses; secondary uses, strictly governed, also become possible. Universities and research institutes can request anonymised or pseudonymised data for epidemiological studies or drug safety research. Pharmaceutical manufacturers, health authorities and regulators may use the data for monitoring treatments, assessing therapeutic value, or managing public health emergencies. Every access is logged, time-stamped and linked to a purpose, ensuring traceability and transparency.
From March 2035, non-EU countries such as the US, Canada, UK, and Japan—or international organisations such as WHO—may apply to join, provided they meet the EU's technical and legal criteria and guarantee reciprocal data access. Each external application will be individually evaluated by the European Commission, and data sharing will be subject to strict auditing, dispute mechanisms and safeguards against unauthorised use.