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欧盟关于基因组数据库和生物样本库隐私的法律。

EU Laws on Privacy in Genomic Databases and Biobanking.

作者信息

Townend David

机构信息

David Townend, LL.B., M.Phil, Ph.D., is the Professor of Law and Legal Philosophy in Health, Medicine and Life Sciences, CAPHRI (School for Public Health and Primary Care), Maastricht University, NL and Visiting Professor of Health Law, University of Lincoln, UK.

出版信息

J Law Med Ethics. 2016 Mar;44(1):128-42. doi: 10.1177/1073110516644204.

DOI:10.1177/1073110516644204
PMID:27256129
Abstract

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be "fair and lawful" and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data.

摘要

欧盟和欧洲委员会都与基因组数据库和生物样本库中的隐私问题相关。在立法方面,目前欧洲主要通过95/46/EC号指令对与隐私权相关的个人数据处理进行规范,该指令要求处理必须“公平合法”并遵循一系列原则,这意味着数据仅用于规定目的,处理目的要充分,仅在实现这些目的所需的时间内保留,并且要安全保存,仅在处理所需的必要时间内以可识别状态保存。欧洲隐私制度并不要求对基因组数据库或生物样本库中使用的个人数据进行去识别(匿名化)处理,并且除了这种做法外,知情同意以及治理和监督机制也为基因组数据提供了保护。

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Resusc Plus. 2023 Jun 16;15:100414. doi: 10.1016/j.resplu.2023.100414. eCollection 2023 Sep.
2
Use and Understanding of Anonymization and De-Identification in the Biomedical Literature: Scoping Review.生物医学文献中匿名化和去识别化的使用与理解:范围综述
J Med Internet Res. 2019 May 31;21(5):e13484. doi: 10.2196/13484.
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Conclusion: harmonisation in genomic and health data sharing for research: an impossible dream?
结论:基因组和健康数据在研究中的共享协调:一个不可能的梦想?
Hum Genet. 2018 Aug;137(8):657-664. doi: 10.1007/s00439-018-1924-x. Epub 2018 Aug 17.