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European Health Data Space – what changes await us?
On 26 March 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council on the European Health Data Space (EHDS) entered into force. This marked the beginning of a transition period, which primarily involves preparing the technical infrastructure and establishing the relevant bodies.
The main objectives of the EHRD are:
▪️to enable cross-border data exchange for the provision of healthcare services within the EU, while ensuring that patients have full control over their medical information;
▪️to harmonise electronic health record systems.
In practice, this means that patients will have fast and secure access to their medical records in any EU Member State. At the same time, they will be able to easily decide who will have access to their records and to what extent.
In addition, the EPDZ will ensure a consistent and effective system for the use of health data, including in scientific research, innovation, policy-making and regulatory activities, by providing access to anonymised or pseudonymised medical information. This solution is intended to support increased competitiveness by creating innovative products (such as medicinal products or health applications) that respond to the real needs of society, identified on the basis of health data.
The EPDZ is expected to be fully operational in 2031, while according to the Ministry of Health, the first categories of data will be exchanged within the system as early as 2029. Currently, in preparation for the implementation of the system, work is underway on amending the regulation on the types, scope and templates of medical documentation and the manner of its processing, as well as on amending the regulation on the types of electronic medical documentation.