Federal Institute for Drugs and Medical Devices presents updates on the development of the Iris system in relation to the implementation of ICD-11 (International Classification of Diseases, 11th Revision).
Strategy Plan for Iris with ICD-11
To support the development and maintenance of Iris in preparation for ICD-11 implementation, the Iris Core Group established a strategy plan covering short-, medium-, and long-term objectives.
This strategy aligns with the original priorities of Iris development while also addressing current and future requirements in health information management and the expanded use of mortality health data.
The document is continuously evolving and subject to periodic updates.
Impact of COVID-19 on Mortality Data
The COVID-19 pandemic introduced additional demands on mortality statistics.
Accurate and timely recording of mortality data is essential for:
- real-time analysis during public health events
- future planning to strengthen health systems
Reflections on these challenges have been documented to support improved data handling.
Transition from ICD-10 to ICD-11
Following the strategy and evaluation activities, a Transition Project has been initiated to develop a new version of Iris capable of coding using ICD-11.
The Iris system has been used for more than 20 years for mortality coding under ICD-10.
Since November 2025, Iris is also available for ICD-11 mortality coding and is intended for routine statistical use.
Project Support
The Transition Project is funded by:
- the Office for National Statistics (ONS)
- the CDC Foundation
Support includes project management from the ONS Data Science Campus and dedicated software development resources.
Additional IT support is provided by the CDC Foundation.
Evaluation Project on Iris and ICD-11
Following the release of ICD-11 by World Health Organization in June 2018, an Evaluation Project was initiated to assess the requirements for transitioning to ICD-11.
Key Considerations
- Mortality coding is performed using automated systems such as Iris
- Transition requires adapting decision tables that contain ICD codes and rules
- Decision tables must be fully aligned with ICD-11 structure and coding rules
Coding Structure and Changes
- ICD-11 coding rules for mortality are expected to remain largely similar to ICD-10
- Existing programming and structures may be reused
- ICD-11 introduces structural changes, including the use of multiple codes to describe a single condition
Objectives of the Evaluation Project
The Evaluation Project aims to:
- assess how Iris can be adapted for ICD-11
- estimate resources required for full implementation
- explore potential enhancements based on ICD-11 IT infrastructure
Country-specific implementation aspects are not included within the scope of this project.
Project Contributors
The Evaluation Project was financed by:
- Australian Bureau of Statistics (ABS)
It was conducted by:
- University of Udine (UNIUD)
- Italian National Institute of Statistics (Istat)
Additional Resources
The Iris Institute provides access to various supporting documents, including:
- Report Evaluation Project
- Interim Report
- Technical Annex
Further information on ICD-11 is available through WHO resources.
Access and Contact
The Iris software can be accessed through the downloads section.
For further information, contact the Iris Institute via email: [email protected]
Supporting Regulatory Processes
Adapting systems such as Iris to evolving standards like ICD-11 requires coordinated planning, technical alignment, and structured implementation across multiple stages.
Regulatory and data frameworks continue to evolve to support more consistent and scalable health information systems. Know more how Baupharma can support: https://www.baupharma.com/services-categories/regulatory-affairs/#Regulatory-affairs-services
For more information: Iris and ICD-11
