Amendments to the Act on the Secondary Use of Health and Social Data concerning clinical trials and investigations to enter into force on 1 January 2026

As of 1 January 2026, the Act on the Secondary Use of Health and Social Data will no longer apply to obtaining register data for clinical trials, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. 

The decision on the necessity of register data in clinical trials is made as part of the evaluation carried out by Tukija and Fimea in assessing research plans. For medical device investigations and in-vitro performance studies, the assessment is carried out by a regional ethics committee. A permit may be granted if accessing and processing data is necessary. The register and procedure must be stated in the research plan and in the study information sheet. In other words, the use of register data requires the research participant’s consent. 

More information: 

Use of register data in research