European Heath Data Space
On 3 May 2022, the European Commission published its proposal for the European Health Data Space (EHDS) Regulation, marking a significant step towards enabling EU countries to make better use of health data to improve healthcare outcomes, support research and innovation, and address health inequalities.
The EHDS is a sector-specific framework designed to strengthen patients’ rights to access and control their health data, while facilitating the secure access to and exchange of health data across Europe, including through the MyHealth@EU network. The framework also establishes rules for the secondary use of health data for research, innovation and evidence-based policy-making.
The Regulation was officially published in the Official Journal of the European Union on 5 March 2025 and entered into force on 26 March 2025. Its key obligations for Member States will apply progressively:
- From March 2029, for the first priority data categories (patient summaries and ePrescriptions) and most secondary-use provisions;
- From March 2031, for the second priority category, including medical imaging, as well as clinical trial and genetic data;
- By 2035, for the remaining transitional provisions.
The initiative supports both primary uses of health data, such as healthcare delivery, and secondary uses, such as research, innovation, and public health planning. It also seeks to establish a single market for electronic health record (EHR) systems. Achieving these objectives requires a robust governance framework, with dedicated structures being established at national and EU level to oversee system certification, provide guidance, and coordinate access to health data. These include (i) national Health Data Access Bodies, (ii) Digital Health Authorities, and (iii) an EU-level European Digital Health Authority.
Within this framework, medical imaging has been designated as a second priority data category, with mandatory cross-border exchange of imaging studies required across all Member States from March 2031, alongside lab results and hospital discharge reports.
The secondary use provisions of the EHDS establish a harmonised legal and technical framework, enabling radiological data to be accessed by researchers, innovators, and public authorities for purposes such as scientific research, public health, and regulatory decision-making. By codifying interoperability standards, data quality requirements, and safeguards for pseudonymisation and data security, the EHDS aims to reduce fragmentation across Member States, thereby fostering a more competitive and innovation-conducive environment for evidence-based radiological research.
This framework is already being supported by several large EU-funded initiatives, which are developing the technical infrastructure needed to enable such secondary use in practice. Projects such as EUCAIM, IDERHA, and BigPicture are building federated infrastructures to pool cancer imaging and pathology data for AI model training and validation, while keeping raw patient data within controlled environments.
As an active member of the BioMed Alliance and the European Cancer Organisation, and a dedicated participant in the EU Commission eHealth Stakeholder Group, the ESR acknowledges the transformative potential of the EHDS in advancing modern European medical technology. The ESR is firmly committed to ensuring that healthcare professionals and researchers have equitable and secure access to health data, recognising its positive impact on patients’ health outcomes, fostering innovation and driving progress in healthcare and medical science.
In this regard, the ESR has been actively engaged in the Second Joint Action Towards the European Health Data Space (TEHDAS2), contributing to stakeholder surveys on key aspects of the technical implementation of the EHDS, including data protection, data access and secure IT systems. TEHDAS2 is an EU Joint Action supporting the implementation of the EHDS by developing technical specifications and guidelines for the secure cross-border access and secondary use of health data.
The ESR remains dedicated to working closely with both EU and national policymakers throughout the EHDS implementation process, ensuring the framework is practical, workable, and truly fit for purpose for radiologists and the wider medical imaging community.
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