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
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.
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