Overview
ISO 8472-1:2024 - Biotechnology - Data interoperability for stem cell data - Part 1: Framework defines a practical framework for making human stem cell data interoperable across systems such as databases, data management systems, web interfaces and APIs. It is applicable to all human stem cell types (including hESC, iPSC and tissue stem cells) and explicitly excludes animal and plant stem cells. The standard is intended for data generators, IT implementors, data providers and data consumers and can be applied to existing architectures and systems.
Key topics and technical requirements
- Data interoperability scope: Guidance on creating, exchanging and consuming stem cell data with clear expectations of content, context and meaning.
- Core data elements: Considerations for cell characteristics, donor and ethical provenance, technologies used to generate and analyse data, and metadata requirements (including data provenance and raw data handling).
- System interfaces: Recommendations for interoperability across APIs, web interfaces, database schemas and application layers to support data sharing and exchange.
- Data discoverability and usability: Requirements for data searchability, accessibility and usability to enable findability and reuse by researchers, clinicians and industry.
- Ethics, security and regulation: Obligations to document and address local, national and international ethical, privacy and regulatory requirements affecting stem cell data.
- Risk and quality: Considerations for data quality, security, risk management and provenance tracking to support trustworthy data exchange.
- Flexibility and compatibility: The framework supports implementation within existing systems and calls for compatibility with existing ISO biotechnology and IT standards.
- Informative annexes: Annex A provides examples of data sharing/exchange schemes; Annex B lists example databases to guide implementation.
Applications and who should use it
- Research institutions and biobanks: Standardizes data from stem cell repositories and biobanks to enable cross‑site collaboration and meta‑analysis.
- Clinical researchers and trial sponsors: Improves interoperability for clinical-grade stem cell data used in trials and translational research.
- IT architects and implementors: Guides design of data management systems, APIs, database schemas and web portals to meet interoperability requirements.
- Industry and regulatory bodies: Supports harmonized data exchange across pharma, biotech and regulatory stakeholders for safety, traceability and compliance.
- Data consumers and integrators: Facilitates discovery, access and reuse of stem cell datasets for secondary analyses, modelling and drug screening.
Related standards
- Prepared by ISO/TC 276 (Biotechnology) and intended to be compatible with existing ISO biotechnology and information‑technology standards. See the ISO catalogue for related parts in the ISO 8472 series and linked ISO/IEC documents referenced in the framework.
Keywords: ISO 8472-1:2024, stem cell data, data interoperability, biotechnology, APIs, data sharing, metadata, data provenance, data accessibility.