On Wednesday 6 December, the Committee of Permanent Representatives of the Member States to the EU (Coreper) approved the EU Council’s negotiating mandate for the proposed regulation on a European Health Data Space (EHDS).
The Spanish Presidency of the EU Council now has a mandate to begin negotiations with the European Parliament as soon as possible, with a view to reaching a provisional agreement on the proposed regulation. The Parliament is expected to adopt its position on 13 December (see EUROPE 13302/16).
The new rules are designed to give people faster and easier access to electronic health data, whether they are in their country of origin or in another Member State. The infrastructure already in place to facilitate the cross-border exchange of electronic health data, MyHealth@EU, will be extended. EU countries will also be required to set up a digital health authority responsible for implementing the new provisions.
A new platform, HealthData@EU, will be set up to facilitate cross-border access to health data. At national level, bodies responsible for access to health data will examine requests for access to data and issue authorisations for data processing.
The Council’s mandate clarifies issues such as the scope of the regulation, consistency with the General Data Protection Regulation (GDPR) and the criteria for access to electronic health data.
The Council proposes the creation of two steering groups composed of representatives of the Member States and responsible for managing MyHealth@EU and HealthData@EU; other stakeholders may be invited as observers to discuss relevant issues.
The mandate expands the role of EU Member States in the proposed EHDS governing board and requires national digital health authorities to publish a progress report every two years. It also provides that the European format for exchanging electronic medical records may include separate national and cross-border profiles, and Member States will have a margin of discretion to allow patients to opt out of the new data-sharing system. Finally, the mandate postpones the application of the regulation until two years after its entry into force. (Original version in French by Lionel Changeur)