Free FHIR Genomics Conformance Validator Released for QA and CI Pipelines

Details

The FHIR Genomics Conformance Validator provided by UNMIRI primarily checks compliance with the R4 IG. Key validation points include the Bundle envelope, required fields on DiagnosticReport and Observation resources, and expected LOINC codes for variant observations and biomarkers (TMB, MSI, PD-L1). Optional features include mCODE compatibility checking—useful for cancer registry pipelines—and UNMIRI's open-schema conventions, which validate AMP/ASCO/CAP tier values and the shape of evidence.externalLevels extension. Crucially, the validator only accepts synthetic bundles and cannot process real patient data (PHI), as it is not a HIPAA-covered surface. For PHI validation in a compliant workflow, an enterprise feature must be used. Technically, it is designed for CI use, accepting POST requests to an API endpoint. This method offers a fast, pragmatic check that avoids the overhead of full StructureDefinition resolution required by official HL7 validators, making it ideal for rapid development cycle testing and vendor onboarding.