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.
In health care, it is mandatory to maintain the privacy and confidentiality of medical data. To achieve this, a fine-grained access control and an access log for accessing medical images are two important aspects that need to be considered in health care systems. Fine-grained access control provides access to medical data only to authorized persons based on priority, location, and content. A log captures each attempt to access medical data. This article describes an overall middleware infrastructure required for secure access to Digital Imaging and Communication in Medicine (DICOM) images, with an emphasis on access control and log maintenance. We introduce a hybrid access control model that combines the properties of two existing models. A trust relationship between hospitals is used to make the hybrid access control model scalable across hospitals. We also discuss events that have to be logged and where the log has to be maintained. A prototype of security middleware infrastructure is implemented.