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现行 AAMI HIT1000-1:2022
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Safety and effectiveness of health IT software and systems-Part 1: Fundamental concepts, principles, and requirements 健康IT软件和系统的安全性和有效性第1部分:基本概念、原则和要求
发布日期: 2022-03-01
AAMI HIT1000系列标准和临时标准提供了一个框架,用于管理健康IT(HIT)软件和系统的安全性和有效性,以促进更好的患者结果。AAMI HIT1000,第1部分:基本概念、原则和要求,确定了维护安全有效的健康IT软件和系统所需的核心概念和原则。它还确定了角色,并定义了管理安全性和有效性所需的职责、活动和最佳做法。本标准适用于医疗IT软件和系统的整个生命周期,适用于与该系统相关的所有规模和类型的参与者,从创建该系统的开发人员和系统集成商,到拥有、配置、实施和使用该系统的医疗保健交付组织(HDO),以及负责运行和最终退役卫生IT系统或卫生IT系统组件的人员。
The AAMI HIT1000 series of standards and provisional standards provides a framework for managing the safety and effectiveness of health IT (HIT) software and systems, for the purpose of promoting better patient outcomes.AAMI HIT1000, Part 1: Fundamental concepts, principles, and requirements, identifies the core concepts and principles needed to maintain safe and effective health IT software and systems. It also identifies roles and defines responsibilities, activities, and best practices that are necessary for managing that safety and effectiveness.This standard applies throughout the whole lifecycle of health IT software and systems and to all sizes and types of actors involved with that system-from developers and system integrators who create the systems, to healthcare delivery organizations (HDOs) who own, configure, implement, and use the systems, and to those responsible for operating and ultimately decommissioning health IT systems or health IT system components.
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