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.
About nine in 10 Canadians support legislation that would protect patient confidentiality. However, the Canadian public is not consistent in its views regarding privacy. Data suggest that the public's attitudes to privacy, and particularly access to medical records, are heavily influenced by the context in which the situation is presented and potential benefits to the individual or to the public.
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.
Use of shared electronic health records opens a whole range of new possibilities for flexible and fruitful cooperation among health personnel in different health institutions, to the benefit of the patients. There are, however, unsolved legal and security challenges. The overall aim of this article is to highlight legal and security challenges that should be considered before using shared electronic cooperation platforms and health record systems to avoid legal and security "surprises" subsequent to the implementation. Practical lessons learned from the use of a web-based ulcer record system involving patients, community nurses, GPs, and hospital nurses and doctors in specialist health care are used to illustrate challenges we faced. Discussion of possible legal and security challenges is critical for successful implementation of shared electronic collaboration systems. Key challenges include (1) allocation of responsibility, (2) documentation routines, (3) and integrated or federated access control. We discuss and suggest how challenges of legal and security aspects can be handled. This discussion may be useful for both current and future users, as well as policy makers.
Cites: J Diabetes Sci Technol. 2011 May 01;5(3):768-77 PMID 21722592
Cites: Stud Health Technol Inform. 2011;169:417-21 PMID 21893784
Cites: JMIR Res Protoc. 2016 Jul 18;5(3):e148 PMID 27430301