European Health Data Space: European Council and European Parliament Strike A Deal

The European Council and European Parliament have reached a provisional agreement on the European Health Data Space (“EHDS”). See our recent article on the draft text – Shaping the Future: the European Health Data Space.

The main objectives of the EHDS is to improve individual access and control over patient health data in the EU and to facilitate cross-border research and innovation in health.

Changes to the latest EHDS draft

The key changes to the latest draft of EHDS, agreed by the European Parliament and the European Council, relate to patients’ ability to opt-out of the EHDS and the ability of EU Member States to put in place stricter measures governing access to certain kinds of sensitive data.

Health data for primary use allows EU citizens to access and share their health data to ensure they can continue to receive healthcare when they move within the EU. As specified in the latest EHDS draft, patients will be able to opt-out from healthcare professionals accessing their data for primary uses; except in circumstances where processing their data is necessary to protect the vital interests of the patient or another person.

The EHDS will also allow access to a minimal set of health data for secondary uses. This is to allow researchers, innovators and policymakers to access patient health data in a uniform manner across the EU, within a secure framework which is compliant with EU legislation. The key change in the latest draft of the EHDS is to allow patients to opt-out from their data used for secondary uses, with certain exceptions (such as for public interest, policy-making or statistical analysis).

EHDS Challenges

At the very least, this EHDS will provide a safer – and more compliant – framework for sharing health data across the EU. However, every development is faced with challenges.

One of the key debates surrounded the ability of patients to opt-out of their data being used for secondary uses. A balance has to be struck between balancing patients’ right to privacy and the need for advancement in scientific research which heavily relies on patient data. Clearly, an individual’s right to privacy and ability to retain control over how their data is used in this space was considered as important as the need for scientific research developments. However, pharmaceutical companies in particular are concerned that the quality of data for research purposes could be undermined as a result of mass patient opt-outs.

Next Steps

The provisional agreement will now have to be endorsed by the European Council and European Parliament. It will then be formally adopted by both institutions after legal-linguistic revision. The regulation will enter into force 20 days after publication in the EU’s Official Journal.