ISO 14199:2015

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

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.

Informatique de santé — Modèle d'information — Modèle de groupe de domaine intégré de recherche biomédicale (BRIDG)

General Information

• Status: Published
• Publication Date: 16-Sep-2015
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215/WG 2 - Systems and Device Interoperability
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 03-Dec-2024
• Completion Date: 13-Dec-2025

Relations

• Revised: ISO 14199:2024 - Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model
• Effective Date: 06-Jun-2022

Overview

ISO 14199:2015 - Health informatics - BRIDG Model defines the Biomedical Research Integrated Domain Group (BRIDG) model as an implementation‑independent domain analysis model (DAM) for protocol‑driven biomedical and clinical research. The standard documents a set of harmonized information models to support development of software, databases, metadata repositories, and data interchange standards that enable semantic interoperability between research systems and healthcare. BRIDG represents clinical research semantics visually using UML, the HL7 Reference Information Model (RIM), and an OWL ontological representation.

Key topics and technical requirements

• Canonical UML representation: A comprehensive UML model plus six sub‑domain views (Common, Adverse Event, Protocol Representation, Regulatory, Statistical Analysis, Study Conduct) to describe classes, attributes, and associations for clinical research data.
• HL7 RIM mapping: RIM‑based models that express BRIDG semantics in accordance with ISO/HL7 21731 to support unambiguous data exchange with HL7‑based artifacts.
• OWL ontological representation: A Web Ontology Language (OWL/OWL‑DL) file used for semantic validation and inferencing.
• Domain analysis model characteristics: Implementation‑independent semantics, unambiguous definitions, use of domain terminology, and complex data types tailored to clinical research.
• Traceability and provenance: BRIDG elements are tagged with source project mappings (e.g., contributors such as CDISC), aiding reuse and alignment with existing standards and projects.
• Scope of regulated artifacts: Links protocol‑driven research to associated regulatory artefacts including data, organizations, resources, rules, processes, and post‑marketing adverse event reporting.

Applications and who uses it

ISO 14199:2015 (BRIDG) is used by:

• Clinical informaticians and data architects for designing interoperable data models and metadata repositories.
• Software developers and vendors building EHR integrations, clinical trial management systems (CTMS), and clinical data warehouses.
• Pharmaceutical companies, CROs, and regulatory bodies (e.g., FDA) for consistent representation of study protocols, safety reporting, and regulatory submissions.
• Standards organizations and implementers mapping clinical research standards (CDISC, HL7) and enabling semantic mediation between research and care systems. Practical uses include model‑driven software design, data interchange specification, semantic validation/inferencing, regulatory reporting workflows, and harmonization of adverse event data.

Related standards

• ISO/HL7 21731 - HL7 v3 Reference Information Model (RIM), used for BRIDG RIM mappings.
• Modeling and semantic technologies: UML, HL7 RIM, OWL / OWL‑DL.
• BRIDG content and mappings are documented and maintained with project provenance (see CDISC BRIDG resources).

Using ISO 14199:2015 helps organizations accelerate interoperable clinical research solutions, reduce semantic ambiguity, and simplify integration between research and healthcare ecosystems.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 14199
First edition
2015-09-15
Health informatics — Information
models — Biomedical Research
Integrated Domain Group (BRIDG)
Model
Informatique de santé — Modèle d’information — Modèle de groupe
de domaine intégré de recherche biomédicale (BRIDG)
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
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ii © ISO 2015 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 2
5 Overview of conceptual representations of the BRIDG model . 2
6 UML-based canonical representations . 4
6.1 General considerations . 4
6.2 Sub-domain UML views . 4
6.2.1 Common . 4
6.2.2 Adverse event . 4
6.2.3 Protocol representation . 4
6.2.4 Regulatory . 4
6.2.5 Statistical analysis . . 5
6.2.6 Study conduct . 5
6.3 UML-based models and views . 5
7 RIM-based HL7 representation . 5
7.1 General considerations . 5
7.2 RIM-based models . 6
8 Ontological OWL-based representation . 7
9 Other additional information . 7
9.1 Uses of BRIDG . 7
9.2 User’s guide for the BRIDG model . 7
9.3 Release notes . 7
9.4 BRIDG maintenance process . 7
9.5 BRIDG change list . 7
Bibliography . 8
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
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on the ISO list of patent declarations received (see www.iso.org/patents).
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For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 215, Health informatics.
iv © ISO 2015 – All rights reserved

Introduction
The Biomedical Research Integrated Domain Group (BRIDG) model was developed in response to
a growing global demand for solutions to help enhance the opportunities to more closely integrate
medical research information with healthcare, as well as integrate information within medical
research. Currently, clinical research data processes use a variety of meanings, formats, and data types
that inhibit the ability and potential to more widely share, integrate, and disseminate clinical research
data resulting in slowing, and in many cases, dead-ending, promising drug discovery and development
processes. Vast bodies of medical knowledge data either do not exist in an electronic format that is
useful for today’s dynamic decision support systems or are electronic, but are locked into discrete
proprietary systems. Once freed, information that is locked away in static documents and discrete
databases is able to flow through the processes of medical research. In an ideal world, critical data could
be read, accessed, and aggregated by any tool at any point in the process. The tools would become the
effective means of communication crossing all the existing boundaries and would enable automation
of many procedures that currently take place manually. Removing the time-consuming procedure of
translating and transcribing data contained in dissimilar and proprietary information stores would
allow scientists to focus on science and innovation.
In order for all of this to become reality, medical research data need to be machine-readable and
semantically interoperable.
The BRIDG model provides an approach to remove semantic ambiguities present in the world of medical
research. As a domain analysis model (DAM), BRIDG is intended to represent a shared view of the
semantics of the domain of protocol-driven research and its associated regulatory artefacts. The need
for this International Standard came as a result of various projects which contributed to its semantic
content. These source projects are documented in the model through the use of tags in each class and
attribute (and many an association as well). These tags indicate the source project elements from which
the concept was derived or to which the element maps.
More information about the projects contributing to the BRIDG content can be found in the BRIDG user’s
guide in the section entitled “Projects Contributing to the BRIDG Model” and in the BRIDG mapping
spreadsheet (available at: http://www.cdisc.org).
INTERNATIONAL STANDARD ISO 14199:2015(E)
Health informatics — Information models — Biomedical
Research Integrated Domain Group (BRIDG) Model
1 Scope
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,
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 International Standard 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO/HL7 21731, Health informatics — HL7 version 3 — Reference information model — Release 4
1)
BRIDG Model, UML-Based Comprehensive Model Diagram
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
adverse event
any unfavourable and unintended sign, symptom, disease, or other medical occurrence with a temporal
association with the use of a medical product, procedure, or other therapy, or in conjunction with a
research study, regardless of causal relationship
EXAMPLE Death, back pain, headache, pulmonary embolism, heart attack.
3.2
attribute
descriptive feature of a class (3.3) depicted as being contained within the class
3.3
class
concept of primary importance, i.e. the domain of interest
1) Available at http://www.cdisc.org/bridg.
3.4
domain analysis model
DAM
abstract representation of a subject area of interest that is the basis for development of lower-level
design artefacts for computer software, databases, or data exchange standards
Note 1 to entry: In this case, the subject area of interest is protocol-driven research.
3.5
unified modelling language
UML
standardized general-purpose modelling language used to specify semantic requirements for a
particular domain
3.6
web ontology language
OWL
web-based language designed for use in applicat
...