Law Center and Department of Electrical and Computer Engineering, University of Houston, Houston, Texas, USA.
Department of Medicine/Medical Genetics, University of Washington, Seattle, Washington, USA.
Genet Med. 2018 Apr;20(5):531-535. doi: 10.1038/gim.2017.141. Epub 2017 Sep 14.
This article provides a brief introduction to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule's minimum necessary standard, which applies to sharing of genomic data, particularly clinical data, following 2013 Privacy Rule revisions. This research used the Thomson Reuters Westlaw database and law library resources in its legal analysis of the HIPAA privacy tiers and the impact of the minimum necessary standard on genomic data sharing. We considered relevant example cases of genomic data-sharing needs. In a climate of stepped-up HIPAA enforcement, this standard is of concern to laboratories that generate, use, and share genomic information. How data-sharing activities are characterized-whether for research, public health, or clinical interpretation and medical practice support-affects how the minimum necessary standard applies and its overall impact on data access and use. There is no clear regulatory guidance on how to apply HIPAA's minimum necessary standard when considering the sharing of information in the data-rich environment of genomic testing. Laboratories that perform genomic testing should engage with policy makers to foster sound, well-informed policies and appropriate characterization of data-sharing activities to minimize adverse impacts on day-to-day workflows.
本文简要介绍了 1996 年《健康保险便携性和责任法案》(HIPAA)隐私规则的最小必要标准,该标准适用于 2013 年隐私规则修订后基因组数据(特别是临床数据)的共享。本研究在法律分析 HIPAA 隐私层和最小必要标准对基因组数据共享的影响时,使用了汤姆森路透 Westlaw 数据库和法律图书馆资源。我们考虑了基因组数据共享需求的相关案例。在 HIPAA 执法力度不断加大的情况下,这个标准引起了生成、使用和共享基因组信息的实验室的关注。数据共享活动的特征——无论是用于研究、公共卫生还是临床解释和医疗实践支持——都会影响最小必要标准的适用及其对数据访问和使用的总体影响。在考虑基因组测试数据丰富环境中的信息共享时,对于如何应用 HIPAA 的最小必要标准,尚无明确的监管指导。进行基因组测试的实验室应与政策制定者合作,制定合理、明智的政策和适当的数据共享活动特征描述,以尽量减少对日常工作流程的不利影响。
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