European Parliament and Council support creation of a European health data space: Another step towards cross-border healthcare
On 6 December and 13 December respectively, the Council and the European Parliament announced their support for the creation of a European Health Data Space (EHDS). According to the Council press release, the EDHS will make it possible for “a Spanish tourist to pick up a prescription in a German pharmacy, or for doctors to access the health information of a Belgian patient undergoing treatment in Italy.” But the proposed regulation (3 May 2022) also highlighted the importance of well-functioning health data exchange in border and cross-border regions. There can be little doubt that the proposed regulation is key to enabling and promoting cooperation and mobility in cross-border healthcare. Crises, such as the Covid-19 pandemic, have undoubtedly highlighted the paramount importance of such cooperation and mobility. For example, imagine a person from Liège working in Maastricht. In a critical emergency scenario, the doctor would have immediate access to his health information without having to make lengthy phone calls or handle physical documents.
Nevertheless, the proposal has raised public concerns about patients’ rights to the privacy of their personal medical data and sparked debates about whether the EU has the competence to adopt such far-reaching healthcare regulations. Both the Council and the EP raised these privacy concerns in their recently adopted positions to begin their inter-institutional (trilogue) negotiations.
To strike a balance between safeguarding privacy and facilitating access to data in the public interest, the EP and Council propose to: (1) strengthen individuals’ rights to access and control their own data, (2) give Member States the discretion to introduce an opt-out system for health data used for research or policy-making, (3) inform data subjects when and which healthcare providers have accessed their data, and (4) require explicit consent for the exchange of sensitive data, such as genetic data. It also calls for individual national and cross-border profiles to be included in the European Electronic Health Record (EHR) format, and furthermore proposes changes to the governance mechanisms, expanding the role of member states on the EHDS board and steering committees.
All in all, the EDHS has great potential for supporting healthcare in (cross-border) regions, but there is still a long way to go before the European Health Data Space is a reality. The growing focus on innovation and the use of data and artificial intelligence in healthcare also highlights the challenges that remain in cross-border data sharing. 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 overdue. The regulation also provides for a future infrastructure for the exchange of health data for secondary purposes, such as scientific research or policy-making.
The future will show whether the Commission has been too ambitious in expecting the EHDS to be (partially) operational by 2025. Finding a consensus on the timeline for implementing the regulation could be a stumbling block in the upcoming negotiations, as co-rapporteur Tomislav Sokol pointed out. While the EP seeks a more realistic timeline compared to that proposed by the Commission, the Council proposes a two-year delay in implementation, along with an additional five to seven years for recording certain data in electronic health records.