The European Health Data Space (EHDS) is a landmark regulation designed to unify health data across the EU for both direct patient care and medical research. Writing in the April 2026 edition of DIA’s Global Forum magazine, Tom Brookland, Pascal Hofer, and Didier Pomeranc of Roche explain that while the EHDS offers the pharmaceutical industry powerful new datasets for innovation, it also requires companies to act as data holders by sharing their own proprietary information. Success depends on navigating complex technical requirements and legal ambiguities regarding intellectual property. To avoid a fragmented system, stakeholders must collaborate now to ensure harmonized implementation across all member states before the 2029 deadlines.
What is the European Health Data Space (EHDS) and Why Does It Matter?
The EHDS is a new piece of European law, forming part of a growing regulatory and policy ecosystem for digital and data, including artificial intelligence (AI), and was established in line with the European Commission’s 2020 Strategy for Data. The EHDS ultimately aims to establish a common framework for the use and exchange of electronic health data across the EU and aims to address specific bottlenecks currently observed with data sharing in Europe: the lack of citizen access, power, and rights over their health data; lowered quality of care in primary settings due to the insufficient capacity for sharing and portability of patient data across borders; and the fact that health data is currently trapped in silos across Europe, with various legal and technical challenges prohibiting efficient secondary use.
More specifically, the EHDS can be viewed as an “EU wide health specific ecosystem comprised of rules, common standards and practices, infrastructures and a governance framework.” This speaks to the setup of a harmonized, secure ecosystem for health data made up of both the technical specifications and the expected data governance rules for operators within the system.
The framework includes both primary and secondary uses of health data defined in the EHDS:
Primary use of health data: Processing personal electronic health data for the provision of health services and patient care. This includes the sharing of health data (such as Electronic Health Record [EHR] data, prescriptions, medical test results, etc.) across EU borders to support better individual patient care. For example, if a doctor in France accesses the records of a German patient visiting France on holiday, the doctor will be able to see the patient’s medical history and relevant health data to enable emergency or ongoing treatment and care.
Secondary use of health data: Processing electronic health data for secondary purposes such as scientific research, but which are distinct from the initial reason for collecting the data. This will include the sharing of 17 types of health data defined in the law such as registry data, EHR data, medical device data, and data from clinical trials. Each EU member state will have to designate or establish a health data access body (HDAB) which will govern access to all the health data in scope within their country. These HDABs will work closely with the data holders (the entity legally controlling the data) and together be part of the broader secondary data use node-based network. The HDABs will also be responsible for ensuring the technical setup of secure processing environments (SPE) within which data can be shared and accessed in compliance with existing EU laws concerning privacy and cybersecurity. The overarching idea is that the data is, unless necessary, not further transferred but processed within these SPEs (the concept of “Bring your questions to the data instead of moving the data”).
Each of these types of data-sharing uses will have their own technical framework and data-governance rules.
