How to access clinical data
Human data for research can be accessed from several sources such as: medical records, quality registries, research databases, etc. If sensitive personal data (definition) will be used, the research project must be approved by the Swedish Ethical Review Authority. This applies even if all the sensitive personal data being processed is pseudonymised. Moreover, necessary legal measures must be in place before the data can be transferred from the agency or organisation that provides the source data. Exactly how the procedures for requesting data for research and how the data is disclosed differ between various authorities or organisations.
Patient records and medical records
Healthcare staff document patient interactions, and after a confidentiality assessment, this information can be requested for medical research. In Sweden, the 21 regions are responsible for most healthcare services, while municipalities handle services like home care, and private practitioners manage their own records. Consequently, to conduct research using patient records from across the country, it may be necessary to request data from multiple sources.
The Swedish quality registries aim to improve the health care system by collecting individualised health data about, for example, certain diagnoses or problems (further information in Swedish). Data from a certain registry can be requested by researchers after approval by a steering group consisting of health care professionals and patient representatives.
Healthcare providers must inform patients before their medical information is collected in a quality register. This procedure differs from the inclusion of a research subject in a study, where written consent is required. However, personal data cannot be processed in a quality register or research study if the individual objects. If a person opposes the processing of their personal data after it has begun, the information should be erased from the register as soon as possible (further information in Swedish).
Every quality registry in Sweden is connected to one of six centres that provide support: