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本文引用的文献

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Internet of things in medicine: A systematic mapping study.医学中的物联网:一项系统映射研究。
J Biomed Inform. 2020 Mar;103:103383. doi: 10.1016/j.jbi.2020.103383. Epub 2020 Feb 7.
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Wearable devices in healthcare: Privacy and information security issues.医疗保健中的可穿戴设备:隐私与信息安全问题。
Health Inf Manag. 2020 May-Sep;49(2-3):150-156. doi: 10.1177/1833358319851684. Epub 2019 May 30.
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Digital Technology and the Future of Health Systems.数字技术与未来卫生系统
Health Syst Reform. 2019;5(2):113-120. doi: 10.1080/23288604.2019.1583040. Epub 2019 Mar 25.
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Ensuring privacy and security of genomic data and functionalities.确保基因组数据和功能的隐私和安全。
Brief Bioinform. 2020 Mar 23;21(2):511-526. doi: 10.1093/bib/bbz013.
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International data-sharing norms: from the OECD to the General Data Protection Regulation (GDPR).国际数据共享规范:从经合组织到通用数据保护条例(GDPR)。
Hum Genet. 2018 Aug;137(8):575-582. doi: 10.1007/s00439-018-1919-7. Epub 2018 Aug 1.
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FDA Regulation of Mobile Medical Apps.美国食品药品监督管理局对移动医疗应用程序的监管
JAMA. 2018 Jul 24;320(4):337-338. doi: 10.1001/jama.2018.8832.
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HIPAA and Protecting Health Information in the 21st Century.《健康保险流通与责任法案》及21世纪健康信息保护
JAMA. 2018 Jul 17;320(3):231-232. doi: 10.1001/jama.2018.5630.
8
Direct-to-Consumer Genetic Testing: The Implications of the US FDA's First Marketing Authorization for BRCA Mutation Testing.直接面向消费者的基因检测:美国食品药品监督管理局首次批准BRCA突变检测上市的影响
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9
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数字时代的健康信息隐私法:HIPAA 不适用。

Health Information Privacy Laws in the Digital Age: HIPAA Doesn't Apply.

机构信息

(

出版信息

Perspect Health Inf Manag. 2020 Dec 7;18(Winter):1l. eCollection 2021 Winter.

PMID:33633522
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7883355/
Abstract

The notion of health information privacy has evolved over time as the healthcare industry has embraced technology. Where once individuals were concerned about the privacy of their conversations and financial information, the digitization of health data has created new challenges for those responsible for ensuring that patient information remains secure and private. Coupled with the lack of updated, overarching legislation, a critical gap exists between advancements in technology, consumer informatics tools and privacy regulations. Almost twenty years after the HIPAA (Health Insurance Portability and Accountability Act) compliance date, the healthcare industry continues to seek solutions to privacy challenges absent formal contemporary law. Since HIPAA, a few attempts have been made to control specific aspects of health information including genetic information and use of technology however none were visionary enough to address issues seen in today's digital data focused healthcare environment. The proliferation of digital health data, trends in data use, increased use of telehealth applications due to COVID-19 pandemic and the consumer's participatory role in healthcare all create new challenges not covered by the existing legal framework. Modern efforts to address this dilemma have emerged in state and international law though the United States healthcare industry continues to operate under a law written two decades ago. As technology continues to advance at a rapid pace along with consumers playing a greater role in the management of their healthcare through digital health the privacy guidance provided by federal law must also shift to reflect the new reality.

摘要

随着医疗保健行业拥抱技术,健康信息隐私的概念也随之发展。曾经,人们关注的是他们的谈话和财务信息的隐私,而健康数据的数字化为那些负责确保患者信息安全和隐私的人带来了新的挑战。再加上缺乏更新的、全面的立法,技术进步、消费者信息工具和隐私法规之间存在着巨大的差距。在 HIPAA(《健康保险携带和责任法案》)合规日期过去近二十年后,医疗保健行业仍在继续寻找解决隐私挑战的方法,而没有正式的现代法律。自 HIPAA 以来,已经有几次尝试控制健康信息的特定方面,包括遗传信息和技术的使用,但都没有足够的远见来解决当今数字数据为重点的医疗保健环境中出现的问题。数字医疗数据的激增、数据使用趋势的变化、由于 COVID-19 大流行而增加的远程医疗应用的使用以及消费者在医疗保健中的参与角色,都为现有法律框架未涵盖的新挑战创造了条件。尽管美国医疗保健行业仍在执行二十年前制定的法律,但现代解决这一困境的努力已经出现在州和国际法中。随着技术的快速发展,以及消费者通过数字健康在管理自己的医疗保健方面发挥更大的作用,联邦法律提供的隐私指导也必须转变,以反映新的现实。