Overview
ISO/TS 8376:2023 - Genomics informatics - Requirements for interoperable systems for genomic surveillance - defines design principles and service/standards requirements to enable interoperable, federated genomic surveillance systems. The Technical Specification targets digital systems, platforms and networks that support genomic surveillance across local, regional and international settings. It focuses on technical, structural and syntactic interoperability (with recognition of semantic needs) and covers data representation, discovery, access, analysis and linkage for pathogen genomics and contextual data.
Key Topics and Technical Requirements
- Design principles: explicitness, scalability, transparency, extensibility, and trust/cooperation to support federated architectures.
- Data representation:
- Unique data identifiers for genomes and contextual records.
- Platform/vendor‑agnostic data access and retrieval.
- Recommendation to adopt standard data models and formats for genomic and metadata exchange.
- Data discovery:
- Web interfaces and APIs for search and discovery.
- Web service patterns to enhance discoverability and inter‑network networking.
- Data access:
- Mechanisms for researcher authorization.
- Clear criteria and processes for data access decision making, balancing openness and governance.
- Data analysis:
- Web interfaces for workflow execution and monitoring.
- Registration and sharing of computational tools and services.
- Support for reproducible workflow languages to ensure repeatable analyses.
- Data linkage:
- Guidance on linking genomic and other ‘omics, epidemiological data and medical records while preserving context and governance.
- Scope and limitations: the document does not prescribe a single data model or a full domain ontology, nor does it address organizational/business interoperability beyond technical/structural/syntactic requirements.
Applications and Who Uses It
ISO/TS 8376:2023 is practical for organizations building or operating interoperable genomic surveillance solutions:
- Public health agencies designing national/regional surveillance networks.
- Clinical and diagnostic laboratories implementing pathogen sequencing pipelines.
- Bioinformatics platform vendors and system architects seeking interoperability best practices.
- Research consortia, universities and NGOs sharing genomic and contextual data across jurisdictions.
- Policy makers and standards teams assessing technical requirements for federated data sharing.
Adopting these requirements improves real‑time pathogen tracking, outbreak response, monitoring of variants and antimicrobial resistance, and cross‑border collaboration.
Related Standards
- Prepared by ISO/TC 215 (Health informatics).
- References interoperability modelling work such as ISO 23903 (architecture and modelling) while focusing on practical service and syntactic requirements.
Keywords: ISO/TS 8376:2023, genomics informatics, genomic surveillance, interoperable systems, federated surveillance system, data representation, data discovery, data linkage, public health interoperability.
