San Francisco State University, Health Equity Institute, San Francisco, California, USA Betty Irene Moore School of Nursing, University of California Davis, San Francisco, California, USA.
San Francisco State University, Health Equity Institute, San Francisco, California, USA.
J Am Med Inform Assoc. 2014 Jul-Aug;21(4):714-9. doi: 10.1136/amiajnl-2013-002308. Epub 2013 Dec 3.
There is currently limited information on best practices for the development of governance requirements for distributed research networks (DRNs), an emerging model that promotes clinical data reuse and improves timeliness of comparative effectiveness research. Much of the existing information is based on a single type of stakeholder such as researchers or administrators. This paper reports on a triangulated approach to developing DRN data governance requirements based on a combination of policy analysis with experts, interviews with institutional leaders, and patient focus groups. This approach is illustrated with an example from the Scalable National Network for Effectiveness Research, which resulted in 91 requirements. These requirements were analyzed against the Fair Information Practice Principles (FIPPs) and Health Insurance Portability and Accountability Act (HIPAA) protected versus non-protected health information. The requirements addressed all FIPPs, showing how a DRN's technical infrastructure is able to fulfill HIPAA regulations, protect privacy, and provide a trustworthy platform for research.
目前关于分布式研究网络（DRN）治理要求制定的最佳实践信息有限，DRN 是一种新兴模式，可促进临床数据再利用并提高比较效果研究的及时性。现有的大部分信息都是基于单一类型的利益相关者，例如研究人员或管理员。本文报告了一种基于政策分析与专家、机构领导访谈以及患者焦点小组相结合的方法，用于制定 DRN 数据治理要求。该方法以可扩展的国家效果研究网络为例进行了说明，该网络产生了 91 项要求。这些要求根据公平信息实践原则（FIPPs）和《健康保险携带和责任法案》（HIPAA）进行了分析，分为受保护和不受保护的健康信息。这些要求涵盖了所有 FIPPs，展示了 DRN 的技术基础设施如何能够满足 HIPAA 法规，保护隐私并为研究提供值得信赖的平台。
