The European Council approved the European Health Data Space regulation after a ten-month delay, Euractiv reported.
The document will allow EU citizens to access their health data anywhere across the bloc and control how it is used. Only some data, such as diagnoses and prescriptions, will be mandatory.
However, adoption was delayed due to the heavy workload of legal linguists at the end of the previous mandate and the beginning of the current one. The regulation will now enter into force in mid-March, with implementation to be gradual.
Once the data space is adopted, EU member states will be required to ensure that electronic health records comply with the European format for the exchange of electronic health records to ensure interoperability of systems.
To improve collaboration, the EU will also engage platforms for data reuse in research, public policy and medical innovation, such as France’s Health Data Hub, Germany’s Gesundheitsdatenhub and the Dutch Health Data Coalition.
The European Health Data Space implementation conference is scheduled for 18 March by the Polish Presidency of the European Council.