New EU regulation to improve citizens’ control over their personal health data

The Council of the EU adopted a regulation on 21 January 2025 that will facilitate the exchange of health data within the EU. The regulation will improve citizens’ control over their personal health data and provide healthcare professionals with access to patient data, regardless of where patients live or receive treatment.

The new regulation, known as the European Health Data Space (EHDS) regulation, aims to promote the availability of electronic health data and harmonise the processing of such data. The regulation will also streamline the use of health data for scientific research, decision-making and other secondary purposes.  

“The aim is to make the EU a common Health Data Space. Until now, the provisions on the exchange and secondary use of health data have varied from one Member State to another. But now we will have a uniform way of operating,” says Senior Ministerial Adviser Joni Komulainen from the Ministry of Social Affairs and Health. 

National implementation has already begun

Finland has already begun the national implementation of the EHDS regulation, and a steering group and two working groups have been set up for this purpose. The Government Programme states that Finland will actively participate in the work carried out within the framework of the EHDS regulation, remove obstacles to research and harmonise research legislation.

The national implementation of the EHDS regulation requires amendments to legislation. The Ministry of Social Affairs and Health is currently preparing two government proposals related to the regulation. One of these proposals would lay down provisions that supplement the Act on the Processing of Client Data in Healthcare and Social Welfare and the related acts, and it is scheduled to be submitted to Parliament within the timetable set for the finance and expenditure acts in 2025.

The other proposal would enact provisions supplementing the Act on the Secondary Use of Health and Social Data, and this is scheduled to be submitted to Parliament within the timetable set for the finance and expenditure acts in 2026.

In addition to the implementation of the EHDS regulation, the Ministry of Social Affairs and Health is working on a legislative project to amend the Act on the Secondary Use of Health and Social Data. The government proposal for amending the Act is due to be submitted to Parliament within the timetable set for the finance and expenditure acts in 2025.

Inquiries:

Joni Komulainen, Senior Ministerial Adviser, tel. +358 295 163 453

Tuula Helander, Director of Biotechnology and Medicines Unit, tel. +358 295 163 480

firstname.lastname(at)gov.fi