EU Council agrees position on health digitalisation

11 months ago 36

EU lawmakers are a step closer to starting interinstitutional negotiations on the European Health Data Space (EHDS) regulation, with the Council agreeing on their position on Wednesday (6 December) and the Parliament due to vote on theirs next week.

The EHDS, proposed by the European Commission in May 2022, aims to tap into the full potential of health data within and across the EU member states to support healthcare delivery – ‘primary use of data’ – and inform health research and policy-making – ‘secondary use of data’.

The proposal is the first of nine European sector- and domain-specific data spaces set out by the Commission in its 2020 communication, ‘A European strategy for data’.

The Council proposed the creation of two steering groups, made up of member-state representatives, to manage MyHealth@EU and HealthData@EU. Other stakeholders may be invited as observers to discuss relevant issues.

The mandate also expands the role of EU member states in the proposed EHDS governing board and requires national digital health authorities to publish an activity report every two years.

As for the European electronic health record, the exchange format may have separate national and cross-border profiles. Additionally, member states will have the discretion to allow patients to opt out of the new data-sharing system.

“The mandate agreed on today provides for an EU-wide data space that will enable us to share and access health data safely and efficiently,” said Mónica García, Spanish Minister for Health, in the press release.

The Council’s mandate for a new law stipulates that the regulation will apply two years following its entry into force.

All eyes on the Parliament

As the Council has formed its mandate, now it is on the Parliament to finalise theirs before inter-institutional negotiations, so-called trilogues, begin. The Parliament is expected to finalise its position on 13 December 2023, with the vote in the plenary session.

Last week, on 28 November, Parliament’s committees responsible for the file – Health Committee (ENVI) and Civil Liberties, Justice and Home Affairs (LIBE) – voted on the draft joint report on the file.

In the draft report, the co-rapporteurs stressed the importance of guaranteeing data protection by ensuring compliance with the EU GDPR and providing for penalties in case of misuse of personal health data. The report also includes the obligation to store health data in the EU.

As it comes to the provision concerning data shared from clinical trials, only electronic health data from clinical trials, subject to the transparency provisions outlined in current Union law, should be accessible.

“This rectification was essential as the Commission’s initial text lacked clarity on this matter,” Tomislav Sokol, Croatian Christian democrat and co-rapporteur of the file told Euractiv after the committee’s vote.

Purposes for which the exchange of data can be possible in secondary use were narrowed.

Sokol after the vote in the committees told Euractiv that he finds the final report “quite balanced”.

“I also believe that main groups of stakeholders – patients’ organisations, healthcare professionals and industry can be satisfied,” he said.

However, Sokol’s proposals for stronger engagement of stakeholders in the governance of EHDS bodies – digital health authorities, health data access bodies and the EHDS board did not find support.

“As a compromise, political groups agreed to compose so so-called Advisory forum, which will consist of different stakeholders and will make recommendations to the EHDS board,” he said.

For Sokol, keeping the opt-out option in the secondary use is the most important aspect to keep within the regulation.

“Moreover, the timeline of the EHDS is also a key for us, because we do not want to postpone implementation of the Regulation for too long. We will see what will be the position of member states during the trilogues in regards to that,” Sokol said.

[Edited by Nathalie Weatherald]