European Parliament and Council adopt their positions.

The creation of a European Health Data Space (EHDS) is clearing two important hurdles. In December, the European Parliament and the Council adopted their respective positions on the Proposal for a Regulation presented by the European Commission a year and a half ago. This clears the way for the inter-institutional negotiations - the trialogue. An initial meeting was held in December.

European Parliament

The report presented by rapporteurs Tomislav Sokol (EPP, HR) and Annalisa Tardino (ID, IT) was adopted by a large majority of 516 votes in favour, 95 against and 20 abstentions. From the outset, MEPs have focussed on cross-border data exchange in their discussions on the EHDS. In addition to protection of privacy and data security, the focus was also on the co-determination rights of patients. The question of which health data should be recorded, used and passed on is very sensitive and has been discussed for a long time. An amendment adopted in plenary is now intended to make it clearer that Member States can grant natural persons a right to object ("opt-out") to the recording of personal data, and not just to the use thereof in an electronic health record (EHR). The regulations on the opt-out procedure for the EHR planned in Germany with the Digital Act (DigiG) therefore do not contradict the parliamentary position. With regard to the further use of health data, the so-called secondary data use, the European Parliament calls for an opt-out in principle, except for particularly sensitive data categories, such as genomic and genetic data.

Council

After three Council presidencies and many rounds of negotiations with compromise proposals, the Council adopted its general approach in November. The Member States advocated strengthening their co-determination rights, particularly with regard to governance and the definition of technical specifications. The Council also clarified the co-determination rights of patients compared to the European Commission's proposal. It should be left to the discretion of the Member States to define opt-out regulations. Another specific change relates to the exchange format of the EHR. The Council would like to distinguish between two profiles – a national and a cross-border profile.

Finding a compromise

Even though time has elapsed since the draft regulation was presented, the fact that the Council and the European Parliament were able to agree on their respective positions is already a success. Rapporteur Tomislav Sokol seemed confident that the European Council and Parliament would be able to find a compromise. There is agreement that the European Commission must provide significantly more funding for the EHDS. According to Sokol, there will be agreement on the timing of the realisation and entry into force of the EHDS. However, it is still to be discussed on how the opt-out regulations for patients should be organised in specific terms.

It remains to be seen how realistic it is that both institutions will be able to reach an agreement on such a technically complex and sensitive dossier during the current legislative term of the European Parliament. A possible trialogue result would have to be confirmed by the European Parliament in April.

Background

In May 2022, the European Commission presented a proposal for a regulation to create a European Health Data Space (EHDS). Being the central digitisation project in the healthcare sector, it is an ambitious, large-scale one. The aim of the proposed regulation is to make electronic patient records available across borders for healthcare provision in the EU (primary data utilisation). In addition, health data for research, innovation and policy-making are to be brought together and made usable across borders (secondary data utilisation). The German Social Insurance (DSV) had taken a position on the project in a detailed opinion.