Launch of the European Health Data Space (EHDS)

The European Health Data Space (EHDS) is an initiative by the European Commission aimed at transforming healthcare across Europe through digitalization and enhanced data interoperability. Introduced as a legislative proposal on May 3, 2022, EHDS seeks to create a secure environment for both primary and secondary use of electronic health data, enhancing patient access and data availability for research, policy-making, and innovation purposes (Stellmach et al., 2022; Hussein et al., 2024).

Key Objectives and Features:

1. Interoperability and Data Exchange: A pivotal aspect of EHDS is the emphasis on interoperable health data systems. The proposal includes developing a European Electronic Health Record (EHR) Exchange Format, fostering cross-border digital infrastructure, and standardizing electronic health record systems and medical devices (Stellmach, Thun, and Muzoora 2022). This approach aims to ensure that health data can be efficiently shared and utilized across European Union (EU) member states.

2. Primary and Secondary Data Use: EHDS is designed to enhance the primary use of health data for individual healthcare and secondary use for broader purposes such as research and innovation. The secondary use provisions demand mandatory data sharing by private and public entities, reviewed and permitted by new health data access bodies (Lee and Choi, 2023; Li and Quinn, 2023).

3. Citizen Empowerment and Data Control: By expanding the right to data portability, EHDS aims to give individuals greater control over their personal health data, much like the General Data Protection Regulation (GDPR) but more specifically tailored for health data. This includes allowing patients to access and control who may access their electronic health records, potentially improving continuity of care and personal health management (Li and Quinn, 2023; Hägglund et al., 2024).

4. Cybersecurity and Data Protection: The EHDS recognizes the challenges of ensuring data security in a digital healthcare environment. Essential requirements for robust cybersecurity measures are emphasized to protect sensitive health information, facilitating secure and compliant cross-border data exchange (Luidold and Jungbauer 2024).

5. Implications for Research and Real-World Data Use: The integration of real-world data (RWD) through EHDS can significantly bolster evidence-based medicine, allowing for a deeper understanding of treatment effects and patient outcomes outside controlled clinical trials. RWD from diverse sources like e-health records and registries enrich the dataset used for research and policy-making (Kympouropoulos 2023).

The EHDS presents a transformative vision for digital health in Europe, promoting data-driven healthcare advancements while addressing ethical, legal, and security concerns related to health data management and sharing.

References

Kympouropoulos, Stelios. 2023. “Real World Evidence: Methodological Issues and Opportunities from the European Health Data Space.” BMC Medical Research Methodology 23 (1). https://doi.org/10.1186/s12874-023-02014-3.

Luidold, Christian, and Christoph Jungbauer. 2024. “Cybersecurity Policy Framework Requirements for the Establishment of Highly Interoperable and Interconnected Health Data Spaces.” Frontiers in Medicine 11 (May). https://doi.org/10.3389/fmed.2024.1379852.

Stellmach, Caroline, Sylvia Thun, and Michael R Muzoora. 2022. “Digitalization of Health Data: Interoperability of the Proposed European Health Data Space.” Studies in Health Technology and Informatics 298 (August). https://doi.org/10.3233/shti220922.