Amendment to implement Article 27(2) of Act No. 44/2014, on Scientific Research in the Health Sector
18th January 2024
Amendment to implement Article 27(2) of Act No. 44/2014, on Scientific Research in the Health Sector
In Article 27(1) of Act No. 44/2014, it is stated that a scientific ethics committee authorizes access to health data for scientific research that has been authorized by the committee. In paragraph 2, it is stated that access is subject to the consent of the data controller. The scientific ethics committee has thus not issued a permit until the approval of the so-called registry holder or data controller is available. In the opinion of the committee, and in consultation with the Data Protection Authority, it is appropriate to change that practice. Afterwards, the committee will not wait specifically for the approval of the registry holder before the committee’s permit is issued. It is noted that access to health data is obviously still subject to the consent of the data controller, but the committee will not specifically request such consent from the data controllers of scientific research.