On December 6, 2023, the Council of the European Union (the Council) announced that it had agreed on a mandate for the proposed regulation for a European Health Data Space (EHDS).

What are the amendments put forward by the Council?

The Council explained that the agreed mandate further develops the proposed EHDS in several key areas, such as:

• providing clarity on issues such as the scope of the regulation, alignment with the General Data Protection Regulation (GDPR), and the criteria for providing access to electronic health data;
• proposing the creation of two steering groups, made up of Member State representatives, to manage MyHealth@EU and HealthData@EU;
• expanding the role of Member States in the proposed EHDS governing board and requiring national digital health authorities to publish an activity report every two years;
• clarifying that the European electronic health record exchange format may have separate national and cross-border profiles; and
• clarifying that Member States will have the discretion to allow patients to opt out of the new data-sharing system.

Importantly, the mandate delays the application of the regulation to two years following its entry into force.

What are the next steps?

The Council will now begin negotiations with the European Parliament to reach a provisional agreement on the proposed regulation. The Parliament is expected to finalize its position on December 13, 2023.

You can read the Council's press release here.