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现行 ISO 14199:2015
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Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model 健康信息学 - 信息模型 - 生物医学研究综合领域组(Bridg)模型
发布日期: 2015-09-17
ISO 14199:2015定义了一组模型,统称为生物医学研究综合领域组(BRIDG)模型,用于支持计算机软件、数据库、元数据存储库和数据交换标准的开发。它支持在生物医学/临床研究领域以及研究与医疗领域之间实现语义(基于意义)互操作性的技术解决方案。临床研究语义表示为一组视觉图表,描述协议中使用的信息关系、定义、解释和示例- 推动生物医学研究。这些图是使用统一建模语言(UML)、HL7参考信息模型(RIM)和Web本体语言(OWL)的图像和语法表示的。 ISO 14199:2015建立了协议驱动研究及其相关监管人工制品之间的联系,包括正式评估药物、程序、过程、受试者特征或装置对人类、动物的效用、影响或其他药理、生理或心理影响所涉及的数据、组织、资源、规则和过程,或其他主体或物质,以及该工作所需或衍生的所有相关监管人工制品,包括专门与post相关的数据- 营销不良事件报告。
ISO 14199:2015 defines a set of models collectively referred to as the Biomedical Research Integrated Domain Group (BRIDG) model for use in supporting development of computer software, databases, metadata repositories, and data interchange standards. It supports technology solutions that enable semantic (meaning-based) interoperability within the biomedical/clinical research arena and between research and the healthcare arena. The clinical research semantics are represented as a set of visual diagrams which describe information relationships, definitions, explanations, and examples used in protocol-driven biomedical research. These diagrams are expressed using the iconography and grammar of the Unified Modelling Language (UML), the HL7 Reference Information Model (RIM), and a Web Ontology Language (OWL). ISO 14199:2015 establishes the links between protocol-driven research and its associated regulatory artefacts including the data, organization, resources, rules, and processes involved in the formal assessment of the utility, impact, or other pharmacological, physiological, or psychological effects of a drug, procedure, process, subject characteristic, or device on a human, animal, or other subject or substance along with all associated regulatory artefacts required for or derived from this effort, including data specifically associated with post-marketing adverse event reporting.
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归口单位: ISO/TC 215
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