健康软件.第2部分:健康和健康应用程序.质量和可靠性

[中文适用范围]： 本文件规定了健康应用的质量要求，并定义了一个健康应用程序质量标签，以可视化地传达健康应用的质量和可靠性。 本文件适用于作为健康软件的一种特殊形式的健康应用。它涵盖了健康应用的整个生命周期。 本文件旨在供应用程序制造商以及应用程序评估组织使用，以沟通健康应用的质量和可靠性。 消费者、患者、护理人员、医护人员及其组织、卫生当局、医疗保险商及更广泛公众可以使用健康应用质量标签报告，在推荐或选择健康应用供使用，或在护理指南、护理路径和护理合同中采用时进行参考。 [外文原描述]： This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps. This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts. NOTE 1 Health apps can be subject to national legislation, such as for medical devices. NOTE 2 See Annex C for additional details on the scope. Outside the scope of this document are guidelines to comply to the medical device regulation.