Pace Wilson D, Staton Elizabeth W, Holcomb Sherry
Department of Family Medicine, University of Colorado Health Sciences Center, Denver, Colorado, USA.
Ann Fam Med. 2005 May-Jun;3 Suppl 1(Suppl 1):S38-45. doi: 10.1370/afm.301.
We wanted to explore potential effects of the Health Insurance Portability and Accountability Act (HIPAA) on research activities of practice-based research networks (PBRNs).
To understand the approaches PBRNs are using to advance their research while adhering to HIPAA standards, we combined a literature review, our experiences, and discussions with local HIPAA officers, PBRN researchers in the United States, and individuals involved in drafting HIPAA.
HIPAA requires researchers to pay special attention to how they handle patients' protected health information (PHI). For researchers working within PBRNs, which collect information from patients and health care professionals in multiple institutions, the HIPAA Privacy Rule presents additional challenges. PBRN researchers can obtain patient authorization to use PHI, but this process is difficult and may taint the findings of some research studies. Some institutions may allow patients to provide a blanket authorization for study recruitment. PBRNs additionally can collect only "de-identified" data (data with identifying information removed) or, with a data use agreement, can work with a limited data set. PBRNs that blend quality improvement and research can work with PHI, but the researcher and practices must enter into a business agreement. PBRN researchers may need to play active, educational roles in institutional privacy boards to facilitate their research.
There are a number of ways for PBRN researchers to comply with HIPAA short of obtaining patient consent and authorization for every study. Careful planning and consideration of HIPAA issues during study design can go a long way toward reducing frustration later.
我们希望探讨《健康保险流通与责任法案》（HIPAA）对基于实践的研究网络（PBRN）研究活动的潜在影响。
为了解PBRN在遵守HIPAA标准的同时推进其研究的方法，我们结合了文献综述、自身经验，并与当地HIPAA官员、美国的PBRN研究人员以及参与起草HIPAA的人员进行了讨论。
HIPAA要求研究人员特别注意他们处理患者受保护健康信息（PHI）的方式。对于在PBRN内工作的研究人员而言，PBRN从多个机构的患者和医疗保健专业人员那里收集信息，HIPAA隐私规则带来了额外的挑战。PBRN研究人员可以获得患者使用PHI的授权，但这个过程很困难，而且可能会影响一些研究的结果。一些机构可能允许患者为研究招募提供全面授权。PBRN还可以只收集“去识别化”数据（去除识别信息的数据），或者通过数据使用协议，使用有限数据集。将质量改进与研究相结合的PBRN可以使用PHI，但研究人员和医疗机构必须签订商业协议。PBRN研究人员可能需要在机构隐私委员会中发挥积极的教育作用，以促进他们的研究。
PBRN研究人员有多种方法可以在不获得每项研究的患者同意和授权的情况下遵守HIPAA。在研究设计过程中仔细规划和考虑HIPAA问题，对于减少后期的挫折感大有帮助。
