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ISO - DIS 14199

Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model

pending
Organization: ISO
Publication Date: 22 May 2023
Status: pending
Page Count: 15
ICS Code (IT applications in health care technology): 35.240.80
scope:

This document 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).

This document 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.

This document updates the BRIDG model to version 5.3.1.

Document History

DIS 14199
May 22, 2023
Health informatics — Information models — Biomedical Research Integrated Domain Group (BRIDG) Model
This document 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,...
September 15, 2015
Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model
This International Standard 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,...

References

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