ISO 14199:2015 PDF

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.