本文件: -？将临床信息模型（CIMs）指定为医疗保健概念，可用于定义和构建医疗保健中各种用途的信息，并实现信息重用； -？描述CIMs内容、结构和上下文的要求，以及其数据元素、数据元素关系、元数据和版本控制的规范，并提供指导和示例； -？指定用于用例概念和逻辑分析的CIMs的关键特征，例如（参考）体系结构、信息层、EHR和PHR系统、互操作性、卫生领域的系统集成，以及数据的二次使用，包括公共卫生报告； -？定义质量管理体系（QMS），以便在CIMs的开发、测试、分发、应用和维护的整个生命周期内，对其进行系统有效的治理、质量管理和测量； -？通过卫生信息技术的广泛变化，为临床信息模型的转换和应用提供原则。 本文件不包括: -？任何特定临床信息模型或临床信息建模方法的内容或应用要求； -？临床信息模型的具体应用，如工作流的动态建模； -？对许多CIMs的整个领域或集合进行建模的规范，如完整的评估文件或出院总结。它没有规定CIMs的组成； -？说明如何让特定临床医生参与，如何实施治理，包括信息治理，或如何确保患者安全。

This document: —？Specifies clinical information models (CIMs) as health and care concepts that can be used to define and to structure information for various purposes in health care, also enabling information reuse; —？Describes requirements for CIMs content, structure and context and specification of their data elements, data element relationships, meta-data and versioning, and provides guidance and examples; —？Specifies key characteristics of CIMs used in conceptual and logical analysis for use cases such as (reference) architectures, information layers, EHR and PHR systems, interoperability, systems integration in the health domain, and secondary use of data including for public health reporting; —？Defines a Quality Management System (QMS) for a systematic and effective governance, quality management, and measurement of CIMs through their lifecycle of development, testing, distribution, application and maintenance; —？Provides principles for the transformation and application of clinical information models through the wide variation of health information technology. This document excludes: —？Requirements on the content or application of any particular clinical information model or clinical information modelling methodology; —？Specific applications of clinical information models such as for dynamic modelling of workflow; —？Specifications for modelling entire domains or aggregates of many CIMs such as complete assessment documents or discharge summaries. It does not specify CIMs compositions; —？Specification of how to involve specific clinicians, how to carry out governance including information governance, or how to ensure patient safety.