The current mandate is nearly at an end and the institutions have already achieved several goals in strengthening the European Union’s policies on health. However, some important files are still to be finalized and some gaps highlighted by the COVID-19 pandemic still need to be bridged. Against this background, the European Health Union plan envisages the creation of the European Health Data Space (EHDS) – a health specific data ecosystem to be implemented within the scope of another 9 data spaces in as many strategic fields for the EU, and foreseen by the European data strategy (such as manufacturing, energy, agriculture and mobility).

The Commission’s proposal on the EHDS is currently still under discussion. Last week, on Tuesday 28 November, an important step forward was made with the adoption of the draft report by the parliamentary Committee on Environment, Public Health and Food Safety (ENVI) and the Civil Liberties, Justice and Home Affairs Committee (LIBE). The draft report is now expected to be voted on during the next plenary session in December.

Opportunities and controversies

Up to now, the fragmentation of standards and frameworks within and across Member States has hindered the design and deployment of new digital health services. Hence, the need to address the issue of health information system interoperability via the EHDS proposal. The proposal aims to provide new rules, common standards and practices, as well as innovative infrastructures and governance for public health data for both primary and secondary use. The former refers to the access of personal electronic health data to supply health services to individuals, while the latter involves using electronic health data for scientific research, public policy or technological development. The specific objectives of the proposal include: ensuring an equal and solid access to prescriptions, imagery and lab tests for all EU citizens across borders; establishing a genuine single market for digital health services and products; and allowing aggregated health data to be shared for research purposes, specifically concerning cancer and rare diseases. Hence, the EHDS will concretely boost patients’ control over their data, set specific rules to manage electronic health record (EHR) systems, and establish international infrastructures for both primary and secondary use to foster reliability, security and interoperability.

The legislator debate is still heated, focusing on privacy safeguards and the exchange format for the registration and exchange of Electronic Health Records in and within countries. While the EHDS is suggested to create a trustworthy and efficient data pool for innovation, policy-making and research, according to secondary use of health data, the risk is that it is not only healthcare professionals  who can take advantage of it, but also other stakeholders such as universities and industry. Thus, the crucial point is to find a balance between collecting useful data sets and protecting patients’ sensitive information. Tomislav Sokol, European Parliament Member from the EPP and Rapporteur for the dossier, declared that an agreement may be difficult to reach on the latter as the Council would opt for the format being self-assessed by manufacturers, which wouldn’t be able to place their EHR systems on the market otherwise, and the Parliament suggesting a third-party evaluation instead. On privacy concerns for primary use of data, the rapporteur has aligned with the Council suggesting the so-called “opt-out option” which would allow citizens not wishing to share their data to abstain from the system.

Next steps

As already mentioned, the file is now waiting for the Parliament to agree on its mandate. As far as the Council is concerned, the Spanish Presidency presented its third compromise text on the proposal in late October, however, an agreement has still not been reached among Member States. Once both institutions agree on their mandates they will begin inter-institutional negotiations.