Laws and Regulations

Laws and regulations directly governing biobank operations:

Biobank Act (2023:38) Swedish Code of Statutes 2023:2023:38
Act (2002:297) on Biobanks in Health and Medical Care, also known as the Biobank Act

Biobank Regulation (2023:43) Swedish Code of Statutes 2023:2023:43
Regulation on Biobanks in Health and Medical Care (2002:746)
Public Access to Information and Secrecy Act (SFS 2009:400)
Public Access to Information and Secrecy Ordinance (2009:641)
Act on Ethical Review of Research Involving Humans (2003:460), also known as the Ethical Review Act Regulation on Ethical
Review of Research Involving Humans (2003:615)
Patient Act (2014:821) Patient Safety Act (2010:659)
Patient Safety Ordinance (2010:1369)
Patient Data Act (2008:355)
General Data Protection Regulation (GDPR), replacing the Personal Data Act (PuL) in May 2018
Transplantation Act (1995:831)
National Board of Health and Welfare's Regulations on Donation and Preservation of Organs, Tissues, and Cells (SOSFS 2009:30)
Act on Autopsy, also known as the Autopsy Act (1995:832)
National Board of Health and Welfare's Regulations and General Advice on Clinical Autopsies (SOSFS 1996:28)
National Board of Health and Welfare's Regulations on Information Management and Record-keeping in Health and Medical Care (SOSFS 2008:14)