ISO/TR 22221:2006 健康信息学 临床数据库用优等原则及规程

标准编号：ISO/TR 22221:2006

中文名称：健康信息学 临床数据库用优等原则及规程

英文名称：Health informatics - Good principles and practices for a clinical data warehouse

发布日期：2006-11

标准范围

ISO/TR 22221:2006的重点是临床数据库或其他计算服务，以下称为临床数据仓库（CDW），用于维护或访问临床数据以供二次使用。目标是定义创建、使用、维护和保护CDW的原则和实践，包括满足道德和数据保护要求，以及信息治理和安全政策的建议。CDW和卫生信息系统的运行数据存储库部分之间存在区别:后者可能具有一些数据二次使用的功能，包括为定期报告提供统计数据，但不具备CDW的总体分析能力。ISO/TR 22221:2006补充和参考了电子健康记录（EHR）标准，如ISO/TS 18308，以及正在开发的当代安全标准。ISO/TR 22221:2006从分析和人口角度阐述了EHR和其他健康相关和组织数据的二次使用，包括质量保证、流行病学和数据挖掘。这些物理或逻辑格式的数据越来越多地用于卫生服务、公共卫生和技术评估、知识发现和教育。ISO/TR 22221:2006描述了CDW的原则和实践，尤其是其创建和使用、安全考虑以及与临床数据仓库的有效性相关的方法和技术方面。在基于人群的应用程序中，安全问题会扩展到EHR，影响到护理接受者、护理者、责任组织和定义了访问权限的第三方。ISO/TR 22221:2006的目的不是从方法论或技术角度进行规定，而是对可能有助于在当地或全国范围内制定CDW政策和治理实践的原则和实践进行连贯、全面的描述。

The focus of ISO/TR 22221:2006 is clinical databases or other computational services, hereafter referred to as a clinical data warehouse (CDW), which maintain or access clinical data for secondary use purposes. The goal is to define principles and practices in the creation, use, maintenance and protection of a CDW, including meeting ethical and data protection requirements and recommendations for policies for information governance and security. A distinction is made between a CDW and an operational data repository part of a health information system: the latter may have some functionalities for secondary use of data, including furnishing statistics for regular reporting, but without the overall analytical capacity of a CDW.ISO/TR 22221:2006 complements and references standards for electronic health records (EHR), such as ISO/TS 18308, and contemporary security standards in development. ISO/TR 22221:2006 addresses the secondary use of EHR and other health-related and organizational data from analytical and population perspectives, including quality assurance, epidemiology and data mining. Such data, in physical or logical format, have increasing use for health services, public health and technology evaluation, knowledge discovery and education.ISO/TR 22221:2006 describes the principles and practices for a CDW, in particular its creation and use, security considerations, and methodological and technological aspects that are relevant to the effectiveness of a clinical data warehouse. Security issues are extended with respect to the EHR in a population-based application, affecting the care recipient, the caregiver, the responsible organizations and third parties who have defined access. ISO/TR 22221:2006 is not intended to be prescriptive either from a methodological or a technological perspective, but rather to provide a coherent, inclusive description of principles and practices that could facilitate the formulation of CDW policies and governance practices locally or nationally.

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