The Swedish Presidency of the Council of the European Union sent clarifications to the Member States, on 15 March, which were obtained by EUROPE, on some of the amendments included in its first compromise proposal on the European Commission’s proposal for a Regulation for a European Health Data Space (EHDS).
The amendments concern Articles 66 and 66A of the proposal, relating to the two groups of joint responsibility for processing, linked to the two European cross-border infrastructures provided for in Articles 12 and 52: the central platform MyHealth@EU allowing the primary use of health data and the central platform HealthData@EU allowing the secondary use of data.
According to the Commission’s proposal, these steering groups will be established by the Commission and should include representatives of the National Contact Points and other authorised participants. These groups are expected to make operational decisions about infrastructure and decisions about accepting authorised participants and disconnecting them from infrastructure.
On the one hand, the Presidency warns of potential conflicts of interest, if groups were to make decisions about their own participation in the infrastructure.
On the other hand, the Presidency considers it difficult to identify which authorised participants should be addressed for legal action. These decisions have legal effect, the Presidency stresses. However, these groups do not appear to be legal entities.
The Presidency wants to see clarification in Article 52(14) of the compliance checks that the Commission will be responsible for carrying out before decisions are taken to join or disconnect approved infrastructure participants, and of the criteria for the HealthData@EU infrastructure, which the Commission will define through implementing acts.
The Presidency also proposes that decisions on the acceptance and disconnection of authorised participants should be taken by the Commission.
Finally, the Presidency proposes in Article 66A to create two fora which would, in its view, allow the inclusion of other authorised participants in cross-border infrastructures.
Link to the document: https://aeur.eu/f/611 (Original version in French by Émilie Vanderhulst)