Designing and Implementing a Hospital Quality Assurance Program
Designing and Implementing a Hospital Quality Assurance Program
复制标题
设计和实施医院质量保证计划
作者：
L. Reid;M. Lotter;J. Burton;Ita Richardson
医院质量保证计划 (H-QAP) 通过患者和软件系统管理方面基于证据的最佳实践，确保现实临床环境中的合规性。嵌入硬件设备中的软件系统在医疗保健环境中越来越普遍。它们通常集成来自收集、存储、操作和报告临床数据的设备和应用程序的信息。美国食品和药物管理局 (FDA) 等机构负责监管硬件设备中的软件，欧盟最近也将独立软件视为医疗设备。
A hospital quality assurance program (H-QAP) assures compliance in the real-world clinical environment via evidence-based best practices in patient and software systems management. Software Systems Embedded within hardware devices are increasingly prevalent in healthcare settings. They typically integrate information from devices and applications that collect, store, manipulate, and report clinical data. Authorities such as the US Food and Drug Administration (FDA) regulate software within hardware devices and the EU has recently deemed stand alone software to be medical device.