European Health Data Space enters trilogue negotiations

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(18 December 2023) The European Parliament has voted in Plenary to approve its position on the European Health Data Space and enter into trilogue negotiations.

The European Parliament's position remains largely unchanged from the position approved by the Committees on Environment, Public Health and Food Safety (ENVI) and Civil Liberties, Justice and Home Affairs (LIBE) with one exception. An amendment put forward by a group of Green, S&D and Left MEPs was approved, giving countries the right to allow patients to object to the registration of their health data in an electronic health record system.

Negotiations with the Council of the European Union and the European Commission will now begin. The Council recently issued its conclusions on the EHDS, representing the positions of Europe’s Member States. The Council position – in positive steps – removes the provision on telemedicine.

However, both the Parliament and Council positions fall short in fully recognising the vital role of social partners and worker engagement. The Parliament rightly emphasises increased funding, capacity building, and training for healthcare workers, including the development of digital literacy—a key element missing in the Council position. The success of the EHDS hinges on securing strong support from the workers at the forefront of its implementation, making their engagement a critical aspect of the final text.

While both texts enhance the Commission's proposal on consent for data sharing, concerns linger. Both introduce a form of opt-out for secondary data use, with the Council's position decentralising the decision to individual countries. The Parliament, meanwhile, sees it as a built-in mechanism for all. To prioritise transparency and patient trust, we advocate for a comprehensive opt-in system for secondary data sharing. Patients deserve clear information about the use of their sensitive data, and a robust opt-in mechanism aligns with these principles. The Parliament position, including an opt-in for specific cases involving highly sensitive health data, makes progress but still requires further refinement.

The success of the EHDS requires a collaborative approach that actively engages workers, prioritises patient trust, recognises the role of social partners, and does not contribute to the further commercialisation of health and care. We encourage policymakers to consider these crucial aspects during trilogues to build a robust and effective European Health Data Space.

Read EPSU’s reaction to the European Parliament’s compromise position here