On March 5, the Regulation on the European Health Data Space (EHDS) has been published in the Official Journal of the EU. This pioneering initiative aims to create a secure and efficient digital health-specific data environment, benefiting all EU citizens and healthcare professionals, researchers and policymakers.
It will make it easier to exchange and access health data at EU level. It promises to improve individuals’ access to and control over their personal electronic health data, while also enabling specific data to be reused for research and innovation purposes for the benefit of European patients. By fostering a more interconnected, patient-centred, and data-driven healthcare system, the EHDS will enhance efficiency, reduce administrative burdens, and support innovation and long-term sustainability of health services.
Trust is also fundamental to the EHDS. The framework builds on existing EU regulations, including the General Data Protection Regulation (GDPR), to provide a trustworthy setting ensuring data protection.
Primary use: citizens and individuals
The EHDS places citizens at the heart of healthcare by granting them better control over their personal health data. Key benefits include:
- Fast and Free Access: Individuals will be able to swiftly access their electronic health data, facilitating seamless sharing with healthcare professionals or family members in case of need across the EU.
- Enhanced Control: Citizens will have the ability to add personal health information, restrict access to specific parts of their records or to specific persons, view who accessed their data, and request corrections if errors are found.
- Security and Privacy: The EHDS requires robust security and privacy protections by default, to align with the EU’s high data protection standards.
Learn more about the primary use of the health data in the EHDS by clicking here.
Secondary use: research and innovation
At the same time, researchers, public health authorities, and policymakers will be able to leverage health data in a secure and privacy-preserving way to accelerate the development of new treatments, improve disease prevention, and strengthen Europe’s crisis preparedness.
For research projects like HEREDITARY, the EHDS offers unprecedented opportunities:
- Access to High-Quality Data: Researchers will be able to access to large-scale health data, in anonymised or pseudonymised form, crucial for developing life-saving treatments and personalized medicines.
- Structured data discovery: A clear and structured system allows researchers to discover available data, understand its location, and assess its quality, making research more efficient and impactful.
- Ensuring interoperability of the data: The new regulation requires all electronic health record (EHR) systems to comply with the specifications of the European electronic health record exchange format, ensuring that they are interoperable at EU level, which is one of the FAIR principles that the HEREDITARY project pursues in its data management.
- Cost-Efficiency: Streamlined access to high-quality health data reduces research costs, enabling more studies and innovations within available budgets.
Learn more about the secondary use of the health data in the EHDS by clicking here.
Looking ahead
After the signing by the Council and the European Parliament and its publication in the EU’s Official Journal, the EHDS Regulation will enter into force on 26 March 2025 and will become applicable in different phases over the course of the following years, with target dates of 2029 and 2031 for full implementation.
At HEREDITARY, we are enthusiastic about the possibilities the EHDS brings. By enabling secure and seamless data exchange, the EHDS transforms healthcare for everyone: patients, professionals, researchers, public health institutions and industry alike.
Stay tuned as we continue to explore the benefits of the EHDS for our research and the broader community. Together, we are stepping into a new era of healthcare innovation and citizen empowerment.
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