European Health Data Space
Contents
What is it?
The European Health Data Space (EHDS) is a key initiative by the European Union aimed at transforming the way health data is accessed, shared, and used across Europe. Its purpose is to empower citizens to control their own health data and facilitate access for healthcare professionals, researchers, policymakers, and innovators to high-quality data, in a secure manner while respecting privacy.
This digital infrastructure will allow both primary use of data —such as diagnosing and treating patients— and secondary use, intended for research, innovation, policy formulation, and improving healthcare. The EHDS is built on solid ethical and legal principles, aiming to establish a common, interoperable, and secure framework that promotes healthcare cohesion among Member States.
Main objectives:
- People: Ensure individuals’ access to and control over their health data, and enable professionals to use it.
- Data: Establish a common framework for the safe primary and secondary use of health data.
Primary use of data
The primary use of data within the European Health Data Space (EHDS) refers to the direct access and use of health information by patients and healthcare professionals to provide safe, effective, and personalized care. This use is aimed at diagnosis, treatment, monitoring, and disease prevention, as well as improving coordination across different levels of healthcare.
Thanks to the EHDS, EU citizens will be able to access their electronic health records, prescriptions, test results, and other clinical data from any Member State in a secure and controlled manner. This is particularly relevant in mobility contexts, such as when a person receives medical care during travel or temporarily resides in another Member State.
Healthcare professionals, in turn, will be able to consult relevant clinical information in an agile and accurate manner, helping to improve decision-making, avoid duplicate tests, reduce medical errors, and optimize treatments. All this will take place within an interoperable environment that ensures privacy protection and compliance with the General Data Protection Regulation (GDPR).
Primary use of health data places the patient at the center of the European healthcare system, enhancing the efficiency and quality of care through secure, cross-border access to medical information.
Secondary use of data
The secondary use of data within the European Health Data Space (EHDS) refers to the reuse of health information for purposes other than direct patient care. This includes key areas such as biomedical research, technological innovation, public health policy formulation, healthcare statistics, and overall system improvement.
This approach allows clinical data, duly anonymized or pseudonymized, to become a strategic resource for generating knowledge, developing new treatments, evaluating the effectiveness of medicines and medical devices, and anticipating epidemiological trends or health crises. The EHDS provides a regulated and harmonized framework for researchers, public institutions, developers, and health authorities to access this data ethically, securely, and in compliance with GDPR and other specific regulations.
One of the pillars of secondary use is transparency and trust: citizens will be aware of how their data is used, who requests it, and for what purpose. Furthermore, each data access request will be evaluated by responsible bodies ensuring that strict public interest criteria and respect for fundamental rights are met.
The secondary use of data in the EHDS opens new possibilities for more predictive, preventive, and personalized medicine, while driving innovation and the sustainability of European healthcare systems.
Benefits of EHDS
The European Health Data Space (EHDS) represents a major advancement in the digital transformation of the European healthcare system, with multiple benefits for citizens, healthcare professionals, researchers, and policymakers.
For patients, one of the main benefits is the full control and access to their health data from any EU country. This promotes more agile, continuous, and personalized care, particularly in cross-border mobility contexts. Additionally, the EHDS promotes greater transparency and patient empowerment in making health decisions.
Healthcare professionals will benefit from more efficient and secure access to relevant medical information, reducing errors, duplicate tests, and improving the quality of diagnoses and treatments. All this will occur within an interoperable environment that meets high cybersecurity standards.
In the realm of research and innovation, the EHDS will facilitate ethical and regulated access to large volumes of data, boosting the development of new treatments, healthcare technologies, and evidence-based policies. This will enable the advancement of predictive and personalized medicine.
Moreover, public authorities will have more powerful tools to monitor population health, manage health crises, and design effective and sustainable policies.
In conclusion, the EHDS strengthens European healthcare cohesion, fosters innovation, and places Europe at the forefront of digital health.
Challenges and Risks
While the European Health Data Space (EHDS) offers a transformative opportunity for the healthcare sector, its implementation involves a series of challenges and risks that need to be addressed with rigor and responsibility.
One of the main challenges is ensuring the privacy and security of personal health data, which is particularly sensitive. Despite advances in cybersecurity and regulation, there is a risk of unauthorized access, breaches, or misuse. To mitigate this, the EHDS must rely on robust encryption technologies, traceability, access control systems, and clear and auditable governance mechanisms.
Another key challenge is the technical and semantic interoperability between healthcare information systems across Member States. Differences in digital infrastructures, clinical languages, and levels of digitalization can hinder effective data integration at a European scale.
Additionally, there is a need to ensure equitable access and use of data, avoiding a concentration of benefits in countries or actors with greater technological capabilities, leaving behind less developed systems.
From an ethical standpoint, the secondary use of data requires transparent management, with informed consent from citizens or solid alternative frameworks that ensure respect for fundamental rights.
The success of the EHDS will depend on how these challenges are addressed, balancing innovation, rights protection, and cohesion among European healthcare systems.
Applicable Legislation
Regulation 2025/327 of the European Health Data Space
When does it come into effect?
Regulation (EU) 2025/327 on the European Health Data Space (EHDS) entered into force on March 26, 2025. However, its application will be gradual:
• General provisions will apply starting March 26, 2027.
• Some specific obligations, such as those related to secondary data use, will apply from March 2029.
• Other provisions, such as those concerning the exchange of certain data types (e.g., medical images and test results), will become mandatory from March 2031.
This phased approach aims to allow Member States and stakeholders to prepare adequately to comply with the EHDS requirements.
