EHDS Regulation
The EHDS Regulation is an EU regulation that improves citizens’ control over their personal health data and provides healthcare professionals with access to patient data, regardless of where patients live or receive treatment. The Regulation also facilitates the use of data for scientific research, decision-making and other secondary purposes.
The EHDS is an abbreviation for the European Health Data Space. The EHDS Regulation entered into force on 26 March 2025, and it will become generally applicable starting from 26 March 2027. The Regulation also includes several transition periods.
How will the EHDS Regulation affect private individuals and healthcare professionals?
The EHDS Regulation introduces a number of rights for private individuals at the EU level, of which Finland has already implemented the following rights:
- Private individuals in Finland can already access their personal health data in the MyKanta service and in electronic services provided by service provides.
- They can obtain information on the use or disclosure of their personal health data to another party.
- They have the right to disclose their health data or request this data to be forwarded to another service provider.
- They have the right to restrict access to their health data by means of separate prohibitions.
- They have the possibility to request that some parts of their health data be transferred to social security and insurance operators. In Finland, this means operators such as the Social Insurance Institution of Finland (Kela) and insurance companies.
New rights for private individuals to be introduced in Finland are making rectification requests through an electronic health data access service, being able to add personal health data to their electronic health records and having the right to download an electronic copy of their personal electronic health data in the European electronic health record exchange format.
Under the EHDS Regulation, healthcare professionals will have access to their patients’ personal electronic health data, regardless of the Member State in which the data was recorded.
How will the EHDS Regulation affect researchers and data controllers?
The Regulation lays down more uniform provisions on the secondary use of health data within the EU, which will make it easier to conduct cross-border research and merge datasets.
The harmonisation of rules and practices will support, among other things, international comparative research, and it may also speed up permit processes. Research data will continue to be used in secure environments, but now regulated at the EU level.
More information for researchers and data controllers is available on the website of the Health and Social Data Permit Authority, Findata:
National implementation of the EHDS Regulation
A steering group and two working groups will be set up for the national implementation of the EHDS Regulation. 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 Ministry of Social Affairs and Health is currently preparing two government proposals regarding the national implementation of the EHDS Regulation. One of them will lay down provisions supplementing the Act on the Processing of Client Data in Healthcare and Social Welfare, the Act on Electronic Prescriptions and the Act on the Market Surveillance of Certain Products. This government proposal on primary use is due to be submitted to Parliament in autumn 2025, and it is scheduled to enter into force on 1 January 2026.
The other government proposal will enact provisions supplementing the Act on the Secondary Use of Health and Social Data. This proposal is scheduled to be submitted to Parliament in autumn 2026.
Roles of different actors in implementation
Ministry of Social Affairs and Health
The Ministry of Social Affairs and Health is responsible for making the amendments required by the national implementation of the EHDS Regulation into Finnish legislation and coordinating cooperation with other digital health authorities and the Commission.
Finnish Institute for Health and Welfare, THL
The Finnish Institute for Health and Welfare, THL, is responsible for making the specifications for the data structures and creating the operating models for healthcare. It also participates in the international preparatory work on the EHDS.
- EHDS on the THL website (in Finnish)
Findata
Findata promotes the safe and efficient secondary use of health data. It grants permits for the secondary use of health and social data when data is needed from several data controllers, the private sector or from Findata’s ready-made datasets or the Kanta Services. For this reason, it will play an important role when the EHDS Regulation enters into force nationally.
Social Insurance Institution of Finland, Kela
Kela is responsible for the Kanta Services, including MyKanta, which is the most important channel for viewing personal health data. Kela is also responsible for developing the Kanta Services so that they comply with the requirements of the EHDS Regulation. It also exchanges health data with other EU countries in a secure manner. In addition, Kela supports the developers of patient data systems in testing the systems and in matters related to their specifications.
