The regulation will mean changes for those who process personal data and strengthen the rights of the individual in terms of personal privacy.
In order for it to be allowed to process personal data, there must always be support in the data protection regulation, a so-called legal basis. The legal bases relating to SIR are the consent of the data subject and that it is necessary to fulfill a task of general interest, as well as for research and statistics. National and regional quality registers may process personal data as long as the individual does not oppose it (Chapter 7, Section 2 of the Patient Data Act). The Social Data Protection Study (SOU 2017: 66), has examined the patient data law and has assessed that PDL is broadly compatible with the regulation and proposed only minor adjustments to the law. The current regulation on quality registers in PDL will therefore apply after May 25.
A prerequisite for processing personal data as stated above is that the patient receives information in accordance with Chapter 8. Section 6 and Chapter 7 § 3 PDL. SIR has decided that the registration can be done if the patient receives written information. The information is usually provided in connection with the care occasion or shortly afterwards.
We have published new templates for patient information (for local ICU) on our website, which are recommended for use in all Swedish intensive care units. You can find these templates under the tab "Patient & Relatives"