Faculty of Medicine and Health, University of Leeds, Leeds, UK
School of Health and Related Research, The University of Sheffield Faculty of Medicine Dentistry and Health, Sheffield, UK.
BMJ Open. 2023 Oct 4;13(10):e069925. doi: 10.1136/bmjopen-2022-069925.
Real-world data encompass data primarily captured for the provision or operation of services, for example, electronic health records for direct care purposes, but which may have secondary uses for informing research or commissioning. Public benefit is potentially forfeited by the underutilisation of real-world data for secondary uses, in part due to risk aversion when faced with the prospect of navigating necessary and important data governance processes. Such processes can be perceived as complex, daunting, time-consuming and exposing organisations to risk. By providing an overview description and discussion around the role of six key legal and information governance frameworks and their role regarding responsible data access, linkage and sharing, our intention is to make data governance a less daunting prospect and reduce the perception that it is a barrier to secondary uses, thus enabling public benefit.
真实世界数据包括主要为提供或运营服务而采集的数据，例如直接护理目的的电子健康记录，但这些数据也可能具有用于为研究或委托提供信息的次要用途。如果未能充分利用真实世界数据的次要用途，则可能会丧失公共利益，部分原因是在面临导航必要和重要的数据治理流程的前景时存在风险规避。这些流程可能被视为复杂、令人生畏、耗时且使组织面临风险。通过提供有关六个关键法律和信息治理框架的角色的概述描述和讨论，以及它们在负责任的数据访问、链接和共享方面的作用，我们的目的是使数据治理不再令人生畏，并减少将其视为次要用途障碍的看法，从而实现公共利益。
