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HIPAA 对基因组数据的个人访问权:协调安全和公民权利。

HIPAA's Individual Right of Access to Genomic Data: Reconciling Safety and Civil Rights.

机构信息

Law Center and Department of Electrical and Computer Engineering, University of Houston, Houston, TX 77204, USA.

出版信息

Am J Hum Genet. 2018 Jan 4;102(1):5-10. doi: 10.1016/j.ajhg.2017.12.004.

Abstract

In 2014, the United States granted individuals a right of access to their own laboratory test results, including genomic data. Many observers feel that this right is in tension with regulatory and bioethical standards designed to protect the safety of people who undergo genomic testing. This commentary attributes this tension to growing pains within an expanding federal regulatory program for genetic and genomic testing. The Genetic Information Nondiscrimination Act of 2008 expanded the regulatory agenda to encompass civil rights and consumer safety. The individual access right, as it applies to genomic data, is best understood as a civil-rights regulation. Competing regulatory objectives-safety and civil rights-were not successfully integrated during the initial rollout of genomic civil-rights regulations after 2008. Federal law clarifies how to prioritize safety and civil rights when the two come into conflict, although with careful policy design, the two need not collide. This commentary opens a dialog about possible solutions to advance safety and civil rights together.

摘要

2014 年,美国赋予个人获取自身实验室检测结果(包括基因组数据)的权利。许多观察人士认为,这项权利与旨在保护接受基因组检测人群安全的监管和生物伦理标准相冲突。本评论将这种紧张关系归因于不断扩大的联邦遗传和基因组检测监管计划中出现的成长之痛。2008 年的《遗传信息非歧视法案》扩大了监管议程,将民权和消费者安全纳入其中。就适用于基因组数据的个体访问权而言,它最好被理解为一项民权法规。在 2008 年后最初推出基因组民权法规时,安全和民权这两个相互竞争的监管目标并未成功整合。尽管需要精心的政策设计,但联邦法律明确了当两者发生冲突时如何优先考虑安全和民权。本评论开启了一个关于如何共同推进安全和民权的对话。

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