Developing an HL7 FHIR Implementation Guide for Rare Cancers: The IDEA4RC Project Experience

Rare cancers hinder data sharing and secondary use due to low incidence, heterogeneous pathways, and fragmented sources. The IDEA4RC project addresses these issues by creating a federated ecosystem for harmonized data exchange across European Centers of Excellence. This paper presents the IDEA4RC HL7 FHIR Implementation Guide (IG), which operationalizes the IDEA4RC common data model-organizing 279 clinical variables across 19 entities-into computable specifications for semantic and computational interoperability. The IDEA4RC HL7 FHIR IG combines logical models, constrained resource profiles, terminology bindings, and grouped ConceptMaps that document traceable mappings from model entities (e.g., Cancer Episode) to FHIR profiles. Developed within a multi-stakeholder European consortium, the data model was co-designed with clinical partners and it is the topic of a specific paper; here we report its technical translation into a computable FHIR IG primarily led by technological partners; with clinicians supporting concept interpretation and early implementation feedback. Compared to existing initiatives such as mCODE, our approach strengthens longitudinal and episode-based representation needed for European research contexts. The resulting IDEA4RC HL7 FHIR IG underpins robust rare cancer data sharing and paves the way for broader harmonization across oncology standards, including future convergence with the HL7 Cancer Common Model Project.