In a document sent on 28 February to the delegations of the Member States by the Swedish Presidency of the Council of the European Union and obtained by EUROPE, the Swedish Presidency clarifies some of the changes it is putting forward in its first compromise proposal on Chapters V (Additional actions), VI (European governance and coordination), VII (Delegation and Committee) and VIII (Miscellaneous) of the European Commission’s proposal for a Regulation on a European Health Data Space (or EHDS) (see EUROPE 12944/11).
In Chapter V, the Presidency underlines that Articles 61 and 62 complement the rules on transfer to a third country or to an international organisation. It specifies that its proposed amendments to Articles 61 and 62 aim to clarify the link with the rules of the General Data Protection Regulation or GDPR (Regulation (EU) 2016/679). The Presidency points out that in Articles 61 and 62 the term ‘anonymous data’ is used instead of ‘non-personal data’. For the Presidency, in the majority of cases, the electronic health data implemented in the EHDS “will originate from and relate to natural persons, either as anonymous data or as personal data”.
In Chapter VI, the Presidency underlines that Article 66, which deals with the urgency procedure, is excluded from the compromise proposal for the time being, as the Presidency wishes to continue the discussions and work on the mapping of data flow and responsibilities and roles in the cross-border infrastructure, referred to in Articles 12 and 52.
In Chapter VIII, the Presidency underlines that discussions are, at this stage, suspended with regard to Article 70, which concerns the evaluation of the future regulation. The Presidency justifies this current restriction of the scope of its compromise proposal because of the strong link between Article 70 and Article 72, which is contained in Chapter IX and deals with the deferred application of the Regulation and its final provisions.
Work is also progressing in the European Parliament, in the Committee on the Environment, Public Health and Food Safety (ENVI) and the Committee on Civil Liberties, Justice and Home Affairs (LIBE) (see EUROPE 13132/14).
The discussions of the Members of the European Parliament concern the modalities of consent of patients to the secondary use of their data (by express consent or by a partial or total right of opposition), the involvement or not of industry representatives in the governance of the EHDS, the budget allocated to the centralised level of the EHDS and the conditionality of access to it.
Some MEPs hope to finalise the legislative work for a European Health Data Space before the end of this ninth European Parliament term in 2024.
Link to the Presidency document: https://aeur.eu/f/5nd (Original version in French by Émilie Vanderhulst)