ISO 14199:2024

Overview

ISO 14199:2024 - Health informatics - Information models - Biomedical Research Integrated Domain Group (BRIDG) Model - is a high‑level, complementary International Standard that describes the BRIDG conceptual model, with a focus on BRIDG v5.3.1. The document provides an overview of the BRIDG Domain Analysis Model (DAM), its canonical UML representation, subdomain views, and links to downloadable artefacts (release packages, user’s guide, mapping spreadsheet and a change list detailing differences between BRIDG v3.2 and BRIDG v5.3.1). It is not the full UML model itself but points implementers to the official BRIDG release resources.

Key topics and technical requirements

• Canonical UML representation: BRIDG uses UML as its primary, implementation‑independent representation. The standard emphasizes class and instance diagrams to express static data semantics.
• Subdomain views: BRIDG provides a large comprehensive model plus ten subdomain UML views (for example: Adverse Event, Biospecimen, Experiment, Imaging, Protocol Representation, Statistical Analysis, Study Conduct). These views improve understandability and targeted reuse.
• Domain Analysis Model (DAM): BRIDG is an implementation‑independent DAM focused on protocol‑driven clinical research, enforcing unambiguous definitions and domain terminology to support semantic interoperability.
• Traceability and harmonization: Classes and attributes are tagged to show source project mappings (CDISC, HL7, NCI, FDA and others), enabling traceability and harmonization across contributing standards/projects.
• Artefacts and change management: ISO 14199:2024 documents where to obtain BRIDG v5.3.1 artefacts (Enterprise Architect model, XMI export, User’s Guide, mapping spreadsheet) and provides a change list from v3.2 to v5.3.1.
• Representations in earlier versions: BRIDG v3.2 included HL7 RIM‑based and OWL ontological representations; later versions (including v5.3.1) emphasize UML as canonical and do not include RIM/OWL artefacts.

Applications and who uses it

• Clinical research informaticians and data modelers use BRIDG to design interoperable data models and database schemas for protocol‑driven studies.
• Regulatory agencies, sponsors, CROs and pharmaceutical organizations employ BRIDG semantics to harmonize submission datasets and regulatory artefacts.
• Standards bodies and implementers (CDISC, HL7, NCI, FDA collaborators) use BRIDG for cross‑standard mappings and semantic coordination.
• EHR and clinical trial system vendors leverage BRIDG to enable machine‑readable clinical research data and improve automation of data exchange.

Related standards and resources

• ISO 14199:2015 (first edition) - superseded by this second edition.
• BRIDG release download page, BRIDG User’s Guide, mapping spreadsheet and the v3.2 → v5.3.1 change list (links referenced in ISO 14199:2024).

Keywords: ISO 14199:2024, BRIDG model, BRIDG v5.3.1, health informatics, UML, domain analysis model, semantic interoperability, clinical research, CDISC, HL7.