ISO 14199:2015 保健信息学 息模型 生物医学研究集成域组（BRIDG）模型

标准编号：ISO 14199:2015

中文名称：保健信息学 息模型 生物医学研究集成域组（BRIDG）模型

英文名称：Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model

发布日期：2015-09

标准范围

This International Standard defines a set of models collectively referred to as the Biomedical ResearchIntegrated Domain Group (BRIDG) model for use in supporting development of computer software,databases, metadata repositories, and data interchange standards. It supports technology solutions thatenable semantic (meaning-based) interoperability within the biomedical/clinical research arena andbetween research and the healthcare arena. The clinical research semantics are represented as a setof visual diagrams which describe information relationships, definitions, explanations, and examplesused in protocol-driven biomedical research. These diagrams are expressed using the iconography andgrammar of the Unified Modelling Language (UML), the HL7 Reference Information Model (RIM), and aWeb Ontology Language (OWL).This International Standard establishes the links between protocol-driven research and its associatedregulatory artefacts including the data, organization, resources, rules, and processes involved in theformal assessment of the utility, impact, or other pharmacological, physiological, or psychologicaleffects of a drug, procedure, process, subject characteristic, or device on a human, animal, or othersubject or substance along with all associated regulatory artefacts required for or derived from thiseffort, including data specifically associated with post-marketing adverse event reporting.

标准预览图