THE REQUIREMENTS OF THE RESEARCH. The government wants it to be easier and more predictable to plan and carry out clinical research. In a legislative council referral, amendments are therefore proposed to the Patient Data Act which make it clear that the processing of personal data when calculating numbers for clinical research is permitted.
“The fact that clinical studies are located in Sweden strengthens Sweden as a life science nation and provides better conditions for conducting clinical studies and publicly funded clinical research. It also enables Swedish healthcare to receive early information about planned research and the opportunity to participate in studies that provide new knowledge in the development of modern care. This is beneficial for patients, care providers and society at large”, says Education Minister Anna Ekström.
In order to be able to plan clinical research, the researchers need to know how many potential people could be included in the study, based on the criteria the researchers set. This is called number calculation and involves the processing of personal data in medical record systems and quality registers within healthcare.
Clear legal support
The legal support for processing personal data in connection with number calculations has been unclear and has led to a varying practice within different regions of Sweden. In a legislative council referral, the government therefore proposes changes to the Patient Data Act (2008:355) which means that a clear legal support is introduced for the processing of personal data that is necessary when calculating numbers for clinical research.
The regulation will apply to all care providers’ processing of personal data in health care and in national and regional quality registers. In order to preserve personal integrity and patient safety, it is proposed that the result of number calculation for clinical research should be disclosed to the person who made the request only in the form of information about the number of people or the range of people who meet the criteria set in advance.
The changes are proposed to enter into force on March 1st, 2023.
BY: PRESS RELEASE FROM THE MINISTRY OF EDUCATION
