FHIR Osiris Implementation Guide
1.1.0 - trial-implementation

Publication Build: This will be filled in by the publication tooling

## Home

Official URL: https://ig-osiris.cancer.fr/ig/osiris/ImplementationGuide/inca.fhir.uv.osiris | Version: 1.1.0
Draft as of 2025-04-03 | Computable Name: OsirisImplementationGuide

### Background

The OSIRIS (Interoperability and data sharing of clinical and biological data in Oncology) is a national initiative launched in 2015 to address data heterogeneity and how to accelerate cancer research in France by making better use of the molecular-based clinical trials data. Through a national and bottom-up approach, we have defined a minimum set of clinical and genomic data relevant to the field of precision medicine in oncology, a Common Data Model (CDM) and a technical framework for sharing and enhancing data retrieval in compliance with national and European regulatory procedures.

The osiris model is divided on multiple parts:

- The patient general information
- The tumor pathology event data
- The treatments
- The sequencing analysis, containing omics data
- The radiomics / radiotherapy module

### Patient general information

These resources are directly bound to patient and contain general information about the patient and the cancer clinical history (ex: family cancer history, clinical trials participation, vital status, etc).

### Cancer History Modelization

The Tumoral Pathology Event (TPE) is a central resource in the FHIR-OSIRIS model, it will describe a tumoral event (primary or metastasis). All analysis, treatments and omics data will be linked to a TPE.

Other profiles like weight and height are also used by the osiris model. These profiles are not added to the osiris-core ig because they are already defined by the FHIR documentation.

### Treatments

Treatment plan, drug administrations, surgical procedures, as well as adverse events that could occur.

### Sequencing

This category contains the results of sequencing analysis.

The sequencing analysis is modelised by the Analysis profile.

Genetic Variants are modelised by SNP , CopyNumber , Expression or Fusion profiles. Additional information as the comparison to the reference sequence, is / can be(?) added with the Annotation profile.

### Radiomics and Radiotherapy

This category contains the description of imaging studies, radiotherapy tratments and the summary of radiomics criteria, measurements and filterings used for the analysis of the images.

### About

The FHIR osiris implementation guide has been generated using FSH and the FHIR publisher. Source files including FSH files are available open source on github . You can also download the FHIR NPM Package .

### Contributors

The OSIRIS project is mainly financed by the INCA (Institut National du Cancer, The French National Cancer Institute). The core contributors to the original data model are Institut Curie, Institut Bergonié, the oncology center Léon Bérard, with the contribution of a dozen oncology centre and French hospitals. The current FHIR version of the data model was realized by the same stakeholders in partnership with the start-up Arkhn .