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重新构建《健康保险携带和责任法案》对研究的影响。

Reframing the influence of the Health Insurance Portability and Accountability Act on research.

机构信息

Graduate School of Nursing, University of Massachusetts Medical School, Worcester, MA.

Center for Health Care Financing, University of Massachusetts Medical School, Worcester, MA.

出版信息

Chest. 2012 Mar;141(3):782-786. doi: 10.1378/chest.11-2182.

DOI:10.1378/chest.11-2182
PMID:22396563
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3662190/
Abstract

The purpose of this article is to review the Health Insurance Portability and Accountability Act (HIPAA), the Privacy Rule, the Security Rule, and common issues encountered by researchers related to these federal privacy and security requirements. This article discusses the misconceptions that researchers may hold about HIPAA, including the process for reviewing protected health information when preparing to conduct a study, potential constraint on participant recruitment, and application of HIPAA to a researcher's clinical population. We also present ways to reframe the negative connotations associated with this regulation and provide tips for researchers about how to work with HIPAA when planning and conducting a study and reporting on study findings. Finally, we suggest that the principles of HIPAA be considered when conducting studies in international settings.

摘要

本文旨在回顾《健康保险流通与责任法案》(HIPAA)、隐私规则、安全规则,以及研究人员在遵守这些联邦隐私和安全要求时遇到的常见问题。本文讨论了研究人员可能对 HIPAA 的误解,包括在准备进行研究时审查受保护健康信息的过程、对参与者招募的潜在限制,以及 HIPAA 对研究人员临床人群的应用。我们还提出了一些方法来重新定义与该法规相关的负面含义,并为研究人员提供了一些关于如何在研究计划和进行以及报告研究结果时使用 HIPAA 的提示。最后,我们建议在进行国际研究时考虑 HIPAA 的原则。

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本文引用的文献

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Privacy versus public health: the impact of current confidentiality rules.隐私与公共卫生:现行保密规则的影响。
Am J Public Health. 2010 Mar;100(3):407-12. doi: 10.2105/AJPH.2009.166249. Epub 2010 Jan 14.
2
Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.逐渐停滞:监管负担加重对研究及质量改进工作的影响。
Clin Infect Dis. 2009 Aug 1;49(3):328-35. doi: 10.1086/605454.
3
Influence of the HIPAA Privacy Rule on health research.《健康保险流通与责任法案》隐私规则对健康研究的影响。
JAMA. 2007 Nov 14;298(18):2164-70. doi: 10.1001/jama.298.18.2164.
4
The HIPAA authorization form and effects on survey response rates, nonresponse bias, and data quality: a randomized community study.《健康保险流通与责任法案》授权书及其对调查回复率、无应答偏差和数据质量的影响:一项随机社区研究。
Med Care. 2007 Oct;45(10):959-65. doi: 10.1097/MLR.0b013e31805468b0.