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Sweden: Riksdag approves amendments to Patient Data Act

The Swedish Parliament ('Riksdag') announced, on 23 March 2023, that it approved the Government's proposal for amendments to the Patient Data Act (2008:355), based on the Social Committee's Report 2022/23:SoU2020 titled 'Proposition 2022/23:31 Processing of personal data when calculating numbers for clinical research'. More specifically, the report outlines that the amendments mean that personal data may be processed for number calculation prior to clinical research, which includes calculating how many people meet certain pre-set criteria and who may therefore be included in the research.

Further, the report provides that the amendments will apply to all healthcare providers processing personal data when calculating numbers within the healthcare system and in national and regional registers.

Notably, the report details that the amendments to the Patient Data Act will enter into effect on 1 May 2023.

You can read the announcement here and the report here, both only available in Swedish.