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In her State of the Union address on 16 September 2020 before the European 合法博彩网站, European Commission President Ursula von der Leyen announced a new legislative proposal to create a European health data space.

The Commission, expects the European health data space to:

• promote safe exchange of patients' data (including when they travel abroad) and citizens' control over their health data;
• support research on treatments, medicines, medical devices and outcomes;
• encourage the access to and use of health data for research, policy-making and regulation, with a trusted governance framework and upholding data-protection rules;
• support digital health services; and
• clarify the safety and liability of artificial intelligence in health.

The Commission published the proposal for a regulation on the European Health Data Space on 3 May 2022. It aims at giving control to the European citizens to their health data (primary use of health data), including regarding cross borders purposes, and at facilitating the uptake of the re use of health data (secondary use) for research, innovation and public policy purposes while ensuring compliance with the EU data protection standards.

To attain these objectives, the proposal establishes a set of rules and infrastructures to support the primary and secondary use of health data, as well as a  European governance framework.

On 14 of June 2022, the Employment, Social Policy, Health and Consumer Affairs Council  held a first discussion on the regulation. Overall, Ministers welcomed the proposal which, once adopted, will provide a stable legal framework to facilitate the exchange of health data within the Union. This is expected to improve healthcare and to spur research. The discussions also raised the need to ensure the relevant security and protection of health data. 

During is plenary session of 22 September 2022, the European economic and social committee adopted an opinion on the European health data base. Whilst supporting the proposal and its objective, the opinion insists on several framework conditions to an effective implementation of the initiative, to the benefit of healthcare of EU citizens. Trust is a key condition: it includes technical features, such as ensuring the cybersecurity of the infrastructure, but also legal features, such as a precise definition of the scope of the secondary use. Also, skills and digital literacy is to be enhanced to allow the empowerment of EU citizens, as regards the use of their own health data. Beyond the framework conditions, the opinion also includes targeted policy advice, such as the need to provide for a proper link between the European health data space and the European open science cloud, as well as the relevant life sciences infrastructures.

During its meeting of 9 December 2022, the Employment, Social Policy, Health and Consumer Affairs Council  was informed of the progress made on the file. Under the Czech Presidency, 15 technical meetings were held on the text. In particular, the discussions focused on the articulation between the proposal and the EU legal framework on the protection of personal data. On 23 May 2023, the Presidency presented the second compromise text to the working party on public health. At the Council meeting of 13 June 2023, it presented a progress report, concluding on the need for further discussions.

On 16 February 2023, the 合法博彩网站 decided to refer the proposal to ENVI and LIBE, pursuant with Rule 58 of the 合法博彩网站 Rules of Procedure. 

合法博彩网站's Committees ENVI and LIBE adopted their joint report on 28 November 2023 , with 95 votes in favour, 18 votes against and 10 abstentions. Regarding primary use, the report strengthens natural persons' right to exert access to and control of their data. In particular, they should obtain information regarding health professionals' access to their data, whilst access to EHR for primary use should be limited to health care providers. The report also creates a right to an effective remedy against binding decisions by a digital health authority. As for secondary use, the report creates an opt-out for natural persons from processing of their health data and provides for third-party certification of EHR systems. It also makes mandatory the storage of personal electronic health data  within the EU. The governance of health data is made more inclusive with the creation of an advisory forum to the EHDS board. The Plenary voted the report, and the opening of inter institutional negotiations on 13 December 2023, with 516 in favor, 95 against and 20 abstentions.

On 6 December 2023, the Council adopted its mandate for negotiations.

Four trilogue meetings were organised respectively on 13 December 2023, 30 January 2024, 20 February 2024, 7 and 15 March 2024 when a provisional political agreement was found among the co-legislators.

The agreement includes reinforced provisions to safeguard the privacy of natural persons, to ensure the trust in the solution. For instance, the right to opt-out is recognized for the primary use, by allowing patients to limit the access to their health data by healthcare professionals, with the exception of situation of vital interest. Also, the re-use of such data might also be limited by natural persons, with the exception of specific purposes such as research in the public interest.

Also, in addition to the right of options ensured to natural persons, the agreement also includes the possibility for Member States to put in place stricter access rules to specific data such as genetic data.

Member States are also authorized to establish trusted data holders in charge of processing safely the requests for access to health data.

On 9 April 2024, ENVI and LIBE endorsed the agreement with 74 votes in favour, 17 votes against, and 2 abstentions.

The Plenary voted the agreement on 24 April 2024, with 445 votes in favour, 142 against and 39 abstentions. 

On 21 January 2025, the Council adopted the Regulation. 

References:

• European 合法博彩网站, , legislative observatory, 2024
• European Commission, , 2025
• EUR-LEX, , 2025
• Council of the EU, , 2025
• Council of the EU,, 2024
• European Commission, , February 2021
• European Committee of the Regions, , CDR 5487/2020
• European Economic and Social Committee, , SOC/665-EESC-2020

Further reading:

• European 合法博彩网站, EPRS, , Briefing, June 2020
• European 合法博彩网站, EPRS, The rise of digital health technologies during the pandemic, Briefing, April 2021

Author: Clément Evroux Members' Research Service, legislative-train@europarl.europa.eu

Visit the European 合法博彩网站 homepages on EU health policy and Artificial intelligence and big data.