European Parliament Approves Establishment of European Health Data Area
On 24 April, the European Parliament definitively approved the agreement for the establishment of the European Health Data Area, with 445 votes in favor, 142 against, and 39 abstentions. This new initiative aims to allow individuals to access their health data in electronic format, even from a European Member State different from their own, and enable healthcare professionals to consult patient files with their consent from other EU countries.
The electronic health records will include patient reports, electronic prescriptions, medical images, and laboratory results. This data can be securely transferred to healthcare providers in other European countries through the MyHealth@EU platform, particularly beneficial for citizens who move to another country.
Furthermore, this regulation will allow anonymized health data to be shared for research purposes, such as on rare diseases. Strict privacy protections will be in place to regulate how sensitive data is shared, ensuring that data is used only for public interest purposes, including research, statistics, and policy development.
Patients will have the right to refuse access to their health data by professionals and for research purposes, except for specific public interest, political, or statistical research purposes. They will also be informed every time their data is accessed and will have the right to request corrections to any incorrect data.
Tomislav Sokol, co-rapporteur of the Committee on the Environment, stated that the European Health Data Area will enable safe and secure utilization of data for vital research into new treatments, while also ensuring that healthcare professionals can access patients’ records across borders. Annalisa Tardino, co-rapporteur of the Committee on Civil Liberties, emphasized that this initiative will improve access to healthcare for everyone and allow for better care and resource utilization.
However, the formal approval of the European Council is still pending. Once published in the Official Journal of the EU, the regulation will come into force twenty days later, with full implementation expected in two years. Some exceptions, including the primary and secondary use of data categories, will have varying implementation timelines ranging from 4 to 6 years.
This development marks a significant step forward for digital healthcare in the EU, providing increased access to healthcare data and facilitating cross-border healthcare cooperation.