At their meeting on Friday 9 December, the EU health ministers (see other article) will hold public deliberations, including on the state of preparation of the future regulation on a European Health Data Space (EHDS).
The Czech Presidency of the EU Council will report to delegations on the progress made in the work on this file on the basis of the proposal submitted by the European Commission on 5 May (see EUROPE 12944/11).
The Presidency requested an opinion from the Legal Service on the legal basis of the text, as several states considered that the proposal could affect the organisation and delivery of health services and medical care in the states, Article 168 TFEU could be considered (Articles 16 and 114 TFEU were considered by the Commission).
In the meantime, the Presidency has proposed amendments to the original proposal, concerning Chapters II and III, in particular to better align with the General Data Protection Regulation (GDPR).
The Presidency has also proposed, but not exhaustively, the substitution of an examination procedure to an advisory procedure for implementing acts.
The Presidency proposes as well to delete the following provisions: - implementing acts determining the categories of healthcare providers recording electronic health data; - the categories of health data to be recorded; - the delegated act allowing additional tasks to be assigned to digital health authorities; - the obligation to cooperate with stakeholders.
The Presidency also proposes to remove the role of joint controllership groups in order to reduce the burden on states. It proposes as well to no longer include an obligation for states to provide digital health authorities with the necessary means.
In addition, the Presidency proposes to delete the article of the original proposal concerning the conditions for acceptance by a Member State of telemedicine services for cross-border healthcare (Article 8), which it considers not to be directly related to the establishment of the EHDS.
The EU Council Presidency states that, although work remains to be done, the text has been rather well received by delegations and particularly, for some States, as regards the alleviation of the control procedure.
Link to the Presidency note: https://aeur.eu/f/4ik (Original version in French by Émilie Vanderhulst)