There can be little doubt that the proposed regulation is of great importance for enabling and fostering cooperation and mobility in cross-border healthcare. Crises, like the Covid-19 pandemic, have made clear beyond a doubt that such cooperation and mobility is of the greatest importance. Envision, for instance, an individual from Liège working in Maastricht. In a critical emergency scenario, the doctor could immediately access his health information without the necessity of making lengthy phone calls or handling physical documents.

Nevertheless, the proposal has raised concerns in the public regarding patients’ rights to the privacy of their private medical information and has sparked discussions on whether the EU has the competence to adopt such a far-reaching regulation in the field of healthcare. Both the Council and the EP addressed these privacy concerns in their recently adopted positions to commence their interinstitutional (trilogue) negotiations.

In order to strike a balance between safeguarding privacy and facilitating access to data for the greater public good, the EP and Council are proposing to: (1) enhance individuals’ rights to access and control their own data, (2) provide Member States with discretion to introduce an opt-out system for health data used for research or policymaking, (3) inform data subjects about when and which healthcare providers have accessed their data, and (4) mandate that the exchange of sensitive data, such as genetic data, be subject to explicit consent. Also, the Council calls for incorporating separate national and cross-border profiles within the European Electronic Health Record (EHR) format, and, additionally, proposes changes to the governance mechanisms, expanding the role of Member States in the governing board of the EHDS and the steering groups.

All in all, the EDHS has a lot of potential in supporting healthcare in (cross)border regions, but there is a long journey ahead before the European Health Data Space materializes. The growing focus on innovation and the use of data and artificial intelligence in healthcare also highlight the challenges that persist in cross-border data exchange. These challenges were examined in the 2022 ITEM Cross-border Impact Assessment. The European Health Data Space is a key pillar in building the European Health Union. A common legal framework, common standards and a cross-border infrastructure for electronic health data are long due. The Regulation also establishes a future infrastructure for exchanging health data for secondary purposes, such as scientific research or policymaking.

The future will tell whether the Commission has been too ambitious to expect the EHDS to be (partly) operational by 2025. Finding a consensus for the timeline for implementing the regulation may be a stumbling block in the upcoming negotiations, as the co-rapporteur Tomislav Sokol pointed out. While the EP is striving for a more realistic timeline compared to the one suggested by the Commission, the Council is proposing a two-year delay in implementation, along with an additional five to seven years for the registration of certain data in electronic health records.

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