Posted by EHDS Regulation (EU) 2025/327.
This document provides answers to frequently asked questions regarding the European Health Data
Space (EHDS) Regulation (EU) 2025/327.
The EHDS Regulation was published in the Official Journal on 5 March 2025 and entered into force 20 days later. However, it will start to apply in stages:
- Key provisions of Chapters II (on primary use) and III (on EHR systems) will apply
- four years after entry into force, i.e. from 26 March 2029, for the first group of priority categories (patient summaries, electronic prescriptions, electronic dispensations) listed under Article 14(1) of the EHDS Regulation ;
- six years, i.e. from 26 March 2031, for the remaining priority categories (medical imaging studies, medical test results, discharge reports).
- Chapter IV on secondary use will apply four years after entry into force for most of the data categories listed in Article 51, so from 26 March 2029.
- For some categories, such as genetic data, it will apply six years after entry into force, so from 26 March 2031
- Article 75(5) of the EHDS Regulation on the possibility for non-EU countries to become authorised participants in HealthData@EU will apply ten years after entry into force, i.e. from 26 March 2035.
Primary Use
The FAQ provides details on the implementation of provisions related to Primary Use for Patients, for health professionals, for Member States’authorities. Concerning the Electronic Health Record (EHR) systems and wellness apps, the document explains the specific requirements that EHR systems will have to comply with.
It gives information on the compliance to the essential requirements for the interoperability component and the logging component for EHR systems to be respected by the manufacturers of medical devices, in-vitro medical devices and/or high-risk AI systems and the Manufacturer of wellness apps claiming that these products are interoperable with EHR systems.
Secondary Use
The document lists the data categories of art 51 of the EHDS Regulation that the Health Data Holders have to make available, in providing for each data category examples of what is covered and not covered. It is mentioned what king of safeguards the EHDS Regulation includes for intellectual property and the protection of trade secrets. Others provisions are explained in details.
Governance
The EHDS Board will be the main forum for the Member States and the Commission to cooperate and exchange information. The provisions establishing the EHDS Board will apply from 26 March 2027.
Member States will designate two representatives each, covering primary and secondary use aspects. A representative of the Commission will co-chair together with a representative elected from among the Member State representatives.
In the EHDS main tasks are to assist Member States in coordinating their practices, to issue written contributions and exchange best practices on the implementation of the EHDS Regulation.
The EHDS Board can establish subgroups at working level to prepare these activities.
The EHDS Board can also cooperate with other relevant entities, such as ENISA and the EDPB. It can also invite external experts where appropriate.
The EHDS Board (and the steering groups) will gradually take over the tasks of the current eHealth Network. During a transition period until 2031, they will co-exist, with the EHDS Board taking over as more and more parts of the EHDS Regulation will become applicable.
Relationship with other EU law
The EHDS Regulation complements many of the cross-border healthcare rights provided by the EU framework for coordinating social security systems, as it facilitates the exchange of personal electronic health data that may be necessary for a natural person to receive healthcare in another Member State.
At the same time, the EHDS Regulation does not set out any rules on social security, nor does it replace the actual proof of insurance status given by the European Health Insurance Card or the Portable documents S1 or S2.
The EHDS Regulation fully respects the right of the Member States to determine social security benefits and organise their national healthcare systems. The EHDS Regulation does not interfere with existing obligations requiring national competent institutions to provide insured persons with information on their rights under the EU framework for coordinating social security systems.