EHDS has been approved by the Council.

The legislative process for establishing a new regulation in the EU takes an average of one and a half to three years. The EHDS (European Health Data Space) is therefore at the upper end of this time frame. The Economic and Financial Affairs Council adopted the regulation on 21 January after two years and eight months.

Following its adoption by the European Parliament in December last year, this represents the - almost - final step on the long road to this legislative act, which was presented by the European Commission on 3 May 2022. The ordinance will now be formally signed by the Council and the European Parliament. Following its publication in the EU's Official Journal, the EHDS will come into force 20 days later, thereby initiating the transitional periods for full implementation.

The beginning

In its 2020 data strategy, the European Commission planned to create ten common data spaces, including agriculture, energy and - as a first step - health.

On 3 May 2022, the European Commission presented its proposal for a regulation about the EHDS. It intended to make electronic treatment data and prescriptions available to insured people through their electronic patient files that would be accessible across borders (primary use). The EHDS is intended to help improve cross-border healthcare and make things significantly easier for mobile insured people within the EU. It also creates the basis for making the health data available in the member states usable for research, further developing care and optimising the healthcare systems (secondary use).

The development

One central question arose after the regulation’s text was presented: that of responsibilities. The European Parliament had to clarify which committee was responsible for what. It was agreed that responsibility would be shared between the Committee for Civil Liberties, Justice and Home Affairs (LIBE) and the Committee for the Environment, Public Health and Food Safety (ENVI).

It was clear to the Council that the Health Council (EPSCO) was responsible. However, there were concerns as to whether the Commission should intervene so deeply in the competences and healthcare systems of the member states. The ordinance is based on Article 114 Treaty on the Functioning of the European Union (TFEU), which regulates the internal market whilst maintaining a high level of health protection. The competence to organise their healthcare systems remains with the member states under Article 168 TFEU.

The member states were initially able to define their position in the Council and they advocated strengthening their co-determination rights, particularly with regard to governance and defining the technical specifications. Patients’ rights to co-determination have also been clarified when compared to the European Commission’ proposal. It should be left up to the member states to define the opt-out regulations, i.e. the right to object to the use and sharing of health data. Another change concerned the exchange format to be used for the electronic health record (EHR), in which the Council wishes to distinguish between a national and a cross-border profile.

The European Parliament adopted its position in plenary a week later. The MEPs focussed on cross-border data exchanging from the outset. The focus was on patients' co-determination rights as well as data protection and data security. The question of which health data may be recorded, used and shared was treated with particular sensitivity. An amendment adopted at short notice during the plenary session led to discussions: It clarified that member states may grant natural persons a comprehensive right to object ("opt-out") not only to the use but also to the recording of their personal data in an EHR.

No time was to be lost at the end of the mandate in order to be able to adopt the dossier on time. After three months and 27 technical meetings, an agreement was reached between the Council and Parliament in the trialogue held back in March 2024. The opt-out regulations, EHR systems and implementing the deadlines were particularly controversial discussion issues.

Although the European Parliament and the Committee of Permanent Representatives (Coreper) approved the political agreement in April 2024, the legal and linguistic verification could not be finalised before the European elections in May 2024. This delayed the legislative process. However, things moved quickly once the review had been completed: Parliament adopted the regulation on 17 December 2024 and the Council approved it one month later, on 21 January 2025. EHDS is coming.

The perspective

The regulation will be implemented in stages: Depending on the regulation’s subject matter, it will come into effect after two to six years. The first data exchanges are scheduled to occur either at the end of 2028 or the beginning of 2029. In the meantime, numerous details will be regulated in implementing acts. Most of these are likely to have been adopted by the end of 2026 or early 2027.

Here in Germany nothing has been put to bed with the adoption of the ordinance text - things are really getting going now. It is necessary to examine which additions need to be made to the Digital Act or the Health Data Utilisation Act to ensure that the EHDS can be implemented smoothly at national level. It will also be necessary to clarify which adjustments need to be made to the German Social Code and if any structures need to be established.

DSV has repeatedly emphasised in statements just how important it is to strengthen the co-determination rights of the member states. Health data should be used to serve the common good and primarily benefit patients as well as the social and healthcare systems. Projects that demonstrably create added value for them should therefore be eligible for use. DSV will closely follow the EHDS implementation with this in mind.