健康信息学. 远程医疗服务. 质量计划指南

[中文适用范围]： 本文件提供了当远程医疗服务用于支持医疗保健活动时可用于分析医疗保健质量和安全以及护理连续性风险的流程。 使用风险管理流程，得出质量目标和程序，为远程医疗服务的运营提供指南。 这些包括但不限于以下领域： ——医疗保健组织对远程医疗质量流程的管理； ——与法规、知识管理（最佳实践）和指南相关的战略和运营流程管理； ——与人相关的医疗保健流程，例如医疗保健活动、规划和责任； ——管理财务资源以支持远程医疗服务； ——远程医疗服务中使用的信息管理和安全管理； ——与规划和提供供远程医疗服务使用的人力资源、基础设施、设施和技术资源有关的流程。 本文档提供了一组示例指南，其中包含每个领域的质量目标和程序。 组织可以应用第 5 条和第 6 条中描述的质量和风险管理流程来制定适合其提供的远程医疗服务的质量目标和程序。 本文件不为设备、产品或技术系统的制造、组装、配置、互操作性或管理提供指导。 附件 A 提供了大型组织实施远程医疗服务的程序。 附件 B 提供了在不同类型的现实世界远程医疗服务中应用质量规划指南的用例。 [外文原描述]： This document provides processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. Using risk management processes, quality objectives and procedures are derived which provide guidelines for the operations of telehealth services. These include but are not limited to the following domains: — management of telehealth quality processes by the healthcare organization; — strategic and operational process management relating to regulations, knowledge management (best practice) and guidelines; — healthcare processes relating to people such as healthcare activities, planning, and responsibilities; — management of financial resources to support telehealth services; — management of information management and security used in telehealth services; — processes related to the planning and provision of human resources, infrastructure, facilities and technology resources for use by telehealth services. This document provides a set of example guidelines containing quality objectives and procedures for each domain. Organizations can apply the quality and risk management processes described in Clauses 5 and 6 to develop quality objectives and procedures appropriate to the telehealth services they provide. This document does not provide guidance for the manufacture, assembly, configuration, interoperability or management of devices, products or technical systems. Annex A provides procedures for the implementation of telehealth services by a large organization. Annex B provides use cases for the application of quality planning guidelines in different types of real-world telehealth services.