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Genomic Databases and Biobanks in Denmark.

https://arctichealth.org/en/permalink/ahliterature280292
Source
J Law Med Ethics. 2015;43(4):743-53
Publication Type
Article
Date
2015
Author
Mette Hartlev
Source
J Law Med Ethics. 2015;43(4):743-53
Date
2015
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Biological Specimen Banks - legislation & jurisprudence
Confidentiality - legislation & jurisprudence
Databases, Genetic - legislation & jurisprudence
Denmark
Genetic Research - legislation & jurisprudence
Humans
Abstract
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.
PubMed ID
26711414 View in PubMed
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The confidentiality of patient and physician information in pharmacy prescription records.

https://arctichealth.org/en/permalink/ahliterature181323
Source
CMAJ. 2004 Mar 2;170(5):815-6
Publication Type
Article
Date
Mar-2-2004
Author
Dick E Zoutman
B Douglas Ford
Assil R Bassili
Author Affiliation
Department of Pathology and Molecular Medicine, Queen's University, 76 Stuart Street, Kingston, Ontario K7L 2V7, Canada. zoutman@cliff.path.queensu.ca
Source
CMAJ. 2004 Mar 2;170(5):815-6
Date
Mar-2-2004
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Canada
Confidentiality - legislation & jurisprudence
Disclosure - legislation & jurisprudence
Drug Prescriptions
Humans
Informed Consent - legislation & jurisprudence
Medical Records Systems, Computerized - legislation & jurisprudence
Pharmacy
Physician-Patient Relations
Notes
Cites: JAMA. 2000 Jan 19;283(3):373-8010647801
Cites: J Law Med Ethics. 1997 Summer-Fall;25(2-3):98-110, 8211066504
Cites: CMAJ. 2000 Oct 31;163(9):1146-811079059
Cites: CMAJ. 2002 Aug 20;167(4):393-612197705
Cites: BMJ. 2003 Feb 15;326(7385):37312586673
Cites: CMAJ. 2003 Jul 8;169(1):5, 712847016
Cites: CMAJ. 1998 Oct 20;159(8):997-10169834730
Comment In: CMAJ. 2004 Sep 28;171(7):711-2; author reply 71215451823
PubMed ID
14993178 View in PubMed
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A framework for an institutional high level security policy for the processing of medical data and their transmission through the Internet.

https://arctichealth.org/en/permalink/ahliterature192425
Source
J Med Internet Res. 2001 Apr-Jun;3(2):E14
Publication Type
Article
Author
C. Ilioudis
G. Pangalos
Author Affiliation
Informatics Laboratory, Faculty of Technology, Aristotle University of Thessaloniki, Thessaloniki, 54006, Greece; iliou@eng.auth.gr
Source
J Med Internet Res. 2001 Apr-Jun;3(2):E14
Language
English
Publication Type
Article
Keywords
Access to Information - legislation & jurisprudence
Canada
Computer Security - legislation & jurisprudence - standards
Confidentiality - standards
Databases as Topic - classification - legislation & jurisprudence
Education, Professional - legislation & jurisprudence
Europe
Guidelines as Topic
Humans
Informed Consent - legislation & jurisprudence
Internet - standards
Medical Informatics Computing - legislation & jurisprudence - standards
Medical Records Systems, Computerized - standards
Organizational Policy
Patient Rights - legislation & jurisprudence
Quality of Health Care - legislation & jurisprudence
United States
Abstract
The Internet provides many advantages when used for interaction and data sharing among health care providers, patients, and researchers. However, the advantages provided by the Internet come with a significantly greater element of risk to the confidentiality, integrity, and availability of information. It is therefore essential that Health Care Establishments processing and exchanging medical data use an appropriate security policy.
To develop a High Level Security Policy for the processing of medical data and their transmission through the Internet, which is a set of high-level statements intended to guide Health Care Establishment personnel who process and manage sensitive health care information.
We developed the policy based on a detailed study of the existing framework in the EU countries, USA, and Canada, and on consultations with users in the context of the Intranet Health Clinic project. More specifically, this paper has taken into account the major directives, technical reports, law, and recommendations that are related to the protection of individuals with regard to the processing of personal data, and the protection of privacy and medical data on the Internet.
We present a High Level Security Policy for Health Care Establishments, which includes a set of 7 principles and 45 guidelines detailed in this paper. The proposed principles and guidelines have been made as generic and open to specific implementations as possible, to provide for maximum flexibility and adaptability to local environments. The High Level Security Policy establishes the basic security requirements that must be addressed to use the Internet to safely transmit patient and other sensitive health care information.
The High Level Security Policy is primarily intended for large Health Care Establishments in Europe, USA, and Canada. It is clear however that the general framework presented here can only serve as reference material for developing an appropriate High Level Security Policy in a specific implementation environment. When implemented in specific environments, these principles and guidelines must also be complemented by measures, which are more specific. Even when a High Level Security Policy already exists in an institution, it is advisable that the management of the Health Care Establishment periodically revisits it to see whether it should be modified or augmented.
Notes
Cites: Med Inform Internet Med. 2000 Oct-Dec;25(4):265-7311198188
PubMed ID
11720956 View in PubMed
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