European Commission's proposal on the regulation is still awaited.

If things had gone according to plan, heads in Brussels – and not only there – would have been bent over a mountain of paper from 5 April. On that day, the European Commission planned to make its proposal for a regulation establishing a European Health Data Space (EHDS) public. This did not take place. A version leaked in March continues to be discussed. And that is not necessarily helpful.

Major changes are expected

Unmistakable advice comes from political observers and insiders not to pay too much attention to the leaked version in circulation. This is not the only indication that the plans being pursued in the European Commission are in need of significant discussion. The postponement of the publication also suggests that the working levels in the European Commission still have to undertake major reorganisation measures in terms of content.

EHDS is mammoth task

The EHDS is intended to improve the pooling and cross-border use of health data. Insured persons should have digital access to their own treatment data and be able to decide on its use, including cross-border use (primary use). Health data should also be made more useful for research and the development of innovations (secondary use). In addition to the creation of infrastructure, interfaces and common standards, the responsibilities of the Member States and the European Commission as well as questions regarding the use, processing and utilisation of data must be regulated.

Respecting subsidiarity

The organisation of healthcare and medical care, thus also the topic of eHealth is the responsibility of the Member States under Article 168 paragraph 7 Treaty on the Functioning of the European Union (TFEU). With the EHDS there will be the important question how much practical influence the European Commission can have. The very fact that the EHDS is to be imposed as a directly applicable regulation is being contended.

In addition, the fact that the hitherto voluntary digital eHealth service infrastructure MyHealth@EU will become mandatory and, according to the draft version circulating, will replace communication between the Member States and the Commission in the eHealth network, raises questions. This does not only concern the political role that Member States would have in the future network. It also relates to whether this is in line with the General Data Protection Regulation and to who is ultimately responsible for compliance with data protection requirements and for controlling the cross-border electronic infrastructure and its processes.

Supplement expected in May

Regardless of the open questions, the goals of the European Health Data Space are to be supported (cf. Statement of the DSV (German Social Insurance) of 27 January 2021). A common data space holds great opportunities both for cross-border medical care and for the use of health data for scientific research.  

The example of the orphan disease makes this particularly clear. This is because the scientific development of high medical expertise goes hand in hand with corresponding treatment options for those affected – health data are indispensable for this. It is in the interest of all stakeholders that the European Commission comes up with a workable and politically acceptable proposal for an EHDS. A supplement is now expected early May.