Gunn Patrick P, Fremont Allen M, Bottrell Melissa, Shugarman Lisa R, Galegher Jolene, Bikson Tora
Cooley Godward LLP, San Francisco, California, USA.
Med Care. 2004 Apr;42(4):321-7. doi: 10.1097/01.mlr.0000119578.94846.f2.
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule, intended to address potential threats to patient privacy posed by the computerization and standardization of medical records, provides a new floor level of federal protection for health information in all 50 states. In most cases, compliance with the Privacy Rule was required as of April 2003. Yet considerable confusion and concern remain about the Privacy Rule and the specific changes it requires in the way healthcare providers, health plans, and others use, maintain, and disclose health information. Researchers worry that the Privacy Rule could hinder their access to health information needed to conduct their research.
In this article, we explain how the final version of the Privacy Rule governs disclosure of health information, assess implications of the Privacy Rule for research, and offer practical suggestions for researchers who require access to health information.
The Privacy Rule is fundamentally changing the way that healthcare providers, health plans, and others use, maintain, and disclose health information and the steps that researchers must take to obtain health data. The Privacy Rule requires researchers who seek access to identifiable health information to obtain written authorization from subjects, or, alternatively, to demonstrate that their research protocols meet certain Privacy Rule requirements that permit access without written authorization. To ensure continued access to data, researchers will need to work more closely than before with healthcare providers, health plans, and other institutions that generate and maintain health information.
《健康保险流通与责任法案》（HIPAA）隐私规则旨在应对医疗记录计算机化和标准化对患者隐私构成的潜在威胁，为美国所有50个州的健康信息提供了新的联邦保护底线。在大多数情况下，自2003年4月起就要求遵守隐私规则。然而，对于隐私规则及其要求医疗服务提供者、健康计划机构和其他机构在使用、维护和披露健康信息方式上的具体变化，仍然存在相当多的困惑和担忧。研究人员担心隐私规则可能会阻碍他们获取开展研究所需的健康信息。
在本文中，我们解释隐私规则的最终版本如何管理健康信息的披露，评估隐私规则对研究的影响，并为需要获取健康信息的研究人员提供实用建议。
隐私规则正在从根本上改变医疗服务提供者、健康计划机构和其他机构使用、维护和披露健康信息的方式，以及研究人员获取健康数据必须采取的步骤。隐私规则要求寻求获取可识别健康信息的研究人员从受试者那里获得书面授权，或者， alternatively，证明他们的研究方案符合隐私规则的某些要求，这些要求允许在无需书面授权的情况下获取信息。为确保继续获取数据，研究人员将需要比以往更紧密地与医疗服务提供者、健康计划机构以及其他生成和维护健康信息的机构合作。
