What is ISO 25720?

ISO 25720 is officially titled:

"Health informatics โ€” Genomic sequence variation โ€” Data exchange format"

The standard provides a uniform framework for:

  1. ๐Ÿ”ฌ Unique identification of biological and medical samples
  2. ๐Ÿ“ฆ Labeling, coding, and data exchange formats
  3. ๐Ÿงฌ Genomic and biospecimen traceability
  4. ๐Ÿ”— Interoperability across laboratories, research institutions, and healthcare providers

The key objective of ISO 25720 is to ensure that each sample can be reliably identified and traced throughout its lifecycle, even as it moves across systems or jurisdictions. It plays a critical role in areas such as:

  1. Clinical trials
  2. Personalized medicine
  3. Pathology labs
  4. Biorepositories
  5. Public health surveillance


Why is ISO 25720 important?

Without standardized identification, biological samples are at risk of:

  1. โŒ Mislabeling or loss during transfer or storage
  2. โš ๏ธ Data errors and patient safety issues
  3. ๐Ÿ” Difficulty in tracking samples across systems
  4. ๐Ÿ’ธ Regulatory non-compliance or project delays

ISO 25720 helps prevent these risks by establishing a globally accepted identification and data format system, supporting both physical and electronic sample tracking.

What are the benefits of ISO 25720?

Adopting ISO 25720 ensures consistent and reliable sample identification with wide-ranging benefits:

  1. ๐Ÿงฌ Standardized Sample Identification

Enables unambiguous labeling and tracking of DNA, tissue, blood, and other specimens.

  1. ๐Ÿ”— Cross-System Interoperability

Ensures sample data is usable and consistent across LIMS, EHRs, and databases.

  1. ๐Ÿงพ Improved Data Accuracy and Integrity

Reduces transcription and labeling errors that can lead to diagnostic mistakes.

  1. ๐Ÿ”’ Enhanced Patient Safety

Ensures test results and research findings are linked to the correct individual.

  1. ๐Ÿ“Š Supports Data Sharing and Research

Enables secure and consistent exchange of bio sample data in research and clinical trials.


What kind of businesses can benefit from ISO 25720?

With GMCโ€™s ISO 25720 consulting services, your organization can unlock the following operational and strategic advantages:

  1. โœ… Strengthen Compliance and Accreditation

Meet requirements from WHO, FDA, EMA, and ISO 20387 (biobanking) frameworks.

  1. โœ… Streamline Sample Handling Processes

Minimize manual errors in labeling, documentation, and logistics.

  1. โœ… Enhance Research Reproducibility

Ensure traceability of biospecimens used in genomic and clinical studies.

  1. โœ… Increase Patient and Stakeholder Trust

Promote safe, secure, and accountable bio sample management.

  1. โœ… Enable International Collaboration

Standardized formats make it easier to participate in global health and research networks.

  1. โœ… Support Integration with Other Health Informatics Standards

Aligns well with HL7, ISO/TS 20428, ISO 15189, and ISO 20387.


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