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
The focus of this Technical Report is clinical databases or other computational services, hereafter referred toas a clinical data warehouse (CDW), which maintain or access clinical data for secondary use purposes. Thegoal is to define principles and practices in the creation, use, maintenance and protection of a CDW, includingmeeting ethical and data protection requirements and recommendations for policies for informationgovernance and security. A distinction is made between a CDW and an operational data repository part of ahealth information system: the latter may have some functionalities for secondary use of data, includingfurnishing statistics for regular reporting, but without the overall analytical capacity of a CDW.This Technical Report complements and references standards for electronic health records (EHR), such asISO/TS 18308, and contemporary security standards in development. This Technical Report addresses thesecondary use of EHR and other health-related and organizational data from analytical and populationperspectives, including quality assurance, epidemiology and data mining. Such data, in physical or logicalformat, have increasing use for health services, public health and technology evaluation, knowledge discoveryand education.This Technical Report 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 ofa clinical data warehouse. Security issues are extended with respect to the EHR in a population-basedapplication, affecting the care recipient, the caregiver, the responsible organizations and third parties whohave defined access. This Technical Report is not intended to be prescriptive either from a methodological ora technological perspective, but rather to provide a coherent, inclusive description of principles and practicesthat could facilitate the formulation of CDW policies and governance practices locally or nationally.
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