Biobanking in Denmark is regulated via patients' rights laws, data protection laws, and research ethics reviews. Danish law recognizes tissue samples as personal data for purposes of the data protection laws, meaning research with tissue samples may be subject to research ethics review, data protection laws, and patients' rights requirements depending on the circumstances of collection. However, research on information gained through whole genome sequencing is subject only to data protection laws, despite the similarity in the nature of the information. The regulatory framework treats biobank samples collected from patients differently than samples collected from research participants, particularly with respect to autonomy. Importantly, biobanks established for future unspecified research are not subject to research ethics review. Biobank-based research has gained more prominence on the national level recently, and the potential for a less fragmented and more consistent regulatory approach may emerge from this attention.
This article looks at the development in the increasing use of medical records in the Danish Courts as well as outside the courts in cases of personal injury. The Danish Supreme Court puts the presence of all material above the protection of the confidential relationship between doctor and patient. It is not yet clear to what extent the use of medical records will be accepted. This development raises questions regarding legal security for patients and sets higher requirements for medical and legal personnel. Medical records give important testimony in cases regarding personal injury. It is therefore important for medical personnel to be aware of the content of the medical record, as it might be used and interpreted in the courtroom in a different manner than intended.