On January 21, 2025, the Council of the EU adopted the European Health Data Space Regulation (EHDS), marking a significant milestone in the EU's efforts to enhance the management and accessibility of health data across member states. The EHDS Regulation is poised to reshape how health data is managed and processed across Europe. By enhancing patients' control over their data concerning health while facilitating its use in clinical research, the EHDS aims to foster innovation in the healthcare sector and improve patient outcomes. As EU member states prepare for embodying the EU rules into local legislation, Healthcare organizations and professionals, pharmaceutical companies and medical devices manufacturers must adapt to these new regulations to harness the benefits of this comprehensive framework effectively.
Why does the EHDS represent a disrupting step for clinical research in Europe?
- Enhanced Data Availability: EHDS Regulation clearly improves access to a vast pool of health data, which can enhance the quality, pertinence and safety of clinical research projects.
- Regulatory Compliance: Stakeholders must prepare to comply with new obligations regarding to their data management and sharing processes.
- Opportunities for Innovation: The regulation opens avenues for developing new medical products and services by leveraging health data for training algorithms and conducting extensive research.
All electronic health record (EHR) systems shall be based on the specifications of the European electronic health record exchange format to be interoperable at EU level. Although digitalisation of health data varies from one member state to another, the EU looks well-placed to benefit from this initiative with a clear understanding among European governments' commitment towards modernising digital health practices and assisting the secondary use of data for research purposes.
The regulation will now be formally signed by the Council and the EU Parliament and comes into force 20 days after its publication in the EU’s official journal. Then, the requirements underlying the regulation will be phased in, with full compliance anticipated by 2029 for most secondary use rules. Certain requirements pertaining to clinical trial data and human genetic information will apply by 2031.