On 13 December 2023 during the Strasbourg plenary session, Members of the European Parliament (MEPs) overwhelmingly voted in favor of the proposal for the European Health Data Space (EHDS).
The EHDS is an initiative aimed at simplifying access to health data across the EU, benefitting both patients and healthcare workers by facilitating cross-border care. Furthermore, it seeks to harness the wealth of health datasets within the bloc for research and innovation purposes. The proposal garnered extensive support at the Parliament level, with an impressive 516 MEPs voting in favor, while 95 voted against, and 20 abstained.
As we look ahead, trilogue negotiations are expected to conclude before the European Elections in June. However, potential delays may arise due to disparities between the Council and Parliament positions, particularly concerning the mandatory sharing of specific data types (Article 33) and data localization requirements.
Negotiations between the Council, the Commission, and the Parliament are scheduled to commence on 14 December 2023. The ENVI and LIBE Committees advocated for enhanced patient control over their health data, proposing an opt-out mechanism for sharing health data for secondary use. MEPs voted in favor of an opt-in approach for sharing sensitive data types, such as genetic data, for secondary use purposes. During the vote, an approved amendment, proposed by 70 MEPs, grants countries the authority to allow patients to object to the inclusion of their health data in an electronic health record system. This significant step marks a positive stride toward a more connected and accessible European health data landscape.
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