MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 -
Germany
MII IG Kerndatensatz-Modul Molekulares Tumorboard
2027.0.0-ballot.1 -
Germany
This page is part of the MII Implementation Guide Molecular Tumor Board (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version. For a full list of available versions, see the Directory of published versions
Technical guidance for DIC implementers on implementing the profiles of the Molecular Tumor Board module (ETL from primary systems, FHIR API, validation).
The following overview shows the module's profiles, their content and their inheritance relations. The image can be viewed and downloaded individually (provided as .svg).
The following overview shows the references between the resources. The image file can be viewed and downloaded individually (provided as .svg).
This section documents the FHIR validation status of the MII module Molecular Tumor Board (MTB).
The module is continuously validated against the FHIR R4 standard and the defined profiles. The validation status is documented here transparently.
Which numbers come from which terminology server matters here. The CI build validates against the MII terminology server (SU-TermServ) through the organization's client certificate (the template's proxy mechanism) and currently reports 55 errors (all dependencies on their final 2027.0.0-ballot versions). A build without that certificate — e.g. a local build — falls back to the public HL7 server (tx.fhir.org) and reports around 107 errors: the difference is one family — tx.fhir.org does not host the German terminology content this module validates against. The table below describes that public-tx-only family; none of it appears on SU-TermServ.
| Class | ~Count | Root cause |
|---|---|---|
ATC codes (L01XA02 carboplatin, L01DB01 doxorubicin) "not in ValueSet mii-vs-medikation-atc" |
24 | the Medikation module's ValueSet includes BfArM ATC per yearly version (2020–2026); tx.fhir.org hosts no BfArM ATC at all ("Invalid criteria version"), so the expansion fails and every membership check errors |
Condition/PatientKimMusterperson-PrimaryDiagnosis-2: "no matching profile" + reasonReference:Primaertumor "matching slice not found" + C56.9 not in the ICD-O-3 topography ValueSet |
30 (4+10+16) | one cascade: tx.fhir.org cannot expand ICD-O-3, so the diagnosis's bodySite (C56.9) cannot be validated → the instance fails its profile check → the therapy recommendations' resolve()-based Primaertumor slice discriminator cannot match. The instance and the slices are correctly authored |
SNOMED CT edition …/900000000000207008/version/20250701 "definition not found" |
12 | the expansion manifest (input/resources/Parameters-expansion-manifest.json) pins the international edition 2025-07-01, which tx.fhir.org does not serve |
| LOINC display-name deviations, single Genomics-Reporting ValueSet misses | <10 | display/version drift between the pinned packages and the tx server |
the nine panel gene-list ValueSets: per-concept $validate-code rejected ("must specify either valueSet or url parameter") |
up to ~2,486 | SU-TermServ (Ontoserver) rejects the IG Publisher's batch validation of enumerated ValueSet.compose concepts from the second concept on — for symbol and HGNC-ID coding alike, while the module's own HGNC instance codings validate fine. Validation for exactly these nine resources is skipped via the IG no-validate parameter until the server issue is fixed (reported upstream); the codes themselves are verified HGNC IDs from hgnc_complete_set |
None of these is a defect in the module's profiles or examples; they are terminology-server capability gaps and are tracked here deliberately instead of being suppressed.
MII Terminology Server: https://termserv.mii.medizininformatik-initiative.de/fhir
Validation configuration: advisor.json
These messages are suppressed via advisor.json:
| Error code | Context | Rationale |
|---|---|---|
Terminology_TX_NoValid_16 |
ImplementationGuide, StructureDefinition, ValueSet, CodeSystem | External terminology-server limitation: the TX server cannot validate certain codes |
UNABLE_TO_INFER_CODESYSTEM |
ImplementationGuide, StructureDefinition, ValueSet, CodeSystem | The validator cannot automatically infer the code system |
Structural_VAL_Array_Empty |
ImplementationGuide.definition.page | Empty array in the IG page definition (Simplifier artifact) |
MSG_DRAFT |
global | Expected warning for resources in draft status during the development phase |
dom-6 |
DomainResource | FHIR base invariant, known validator artifact |
eld-20 |
ElementDefinition | ElementDefinition invariant, known validator artifact |
LOINC LIST filter |
Observations, Procedures | There is no declared filter called LIST on code system http://loinc.org — the CI TX server does not support the LOINC LIST filter (see below) |
SNOMED code 1381317004 not known to the TX server |
SNOMED CT | New SNOMED CT code not yet available in the TX-server version |
Reference_REF_CantMatchChoice |
global | The validator cannot resolve choice-type references (known limitation) |
Validation_VAL_Profile_NoSnapshot |
global | Referenced profile without snapshot (e.g. from dependency packages without snapshots) |
| Profile | Category | Description | Status |
|---|---|---|---|
| Genomics Reporting | Extension | HL7 Genomics Reporting extensions have known validation warnings | 🔵 EXTERNAL |
| GenomicStudyAnalysis | Profile mismatch | Bundle validation cannot resolve the profile chain (see below) | 🔵 EXTERNAL |
| Immunohistochemistry | Slicing | code.coding slicing with pattern discriminator and value set (see below) | 🔵 EXTERNAL |
When validating bundles with nested profile references, the FHIR validator may report PROFILE_MISMATCH errors although the resources are correctly profiled. This occurs in particular for the GenomicStudyAnalysis resource, which is referenced through a profile chain:
Profile chain:
MII_PR_MTB_NGS_Bericht → references MII_PR_MTB_Genomic_StudyMII_PR_MTB_Genomic_Study → references MII_PR_MTB_Genomic_Study_AnalysisMII_PR_MTB_Genomic_Study_Analysis → based on MII_PR_MolGen_GenomicStudyAnalysisError message:
PROFILE_MISMATCH: Unable to find a profile match for Procedure/mii-exa-mtb-...-genomic-study-analysis-1
Cause: The FHIR validator cannot fully resolve this multi-level profile chain in bundle contexts, because the profile references are distributed across several IG packages (MTB → MolGen → HL7 Genomics Reporting).
Status: These are validator artifacts, not actual conformance problems. The profiles are correctly defined and the example resources conform.
The MII_PR_MTB_Immunohistochemistry profile uses a slicing on code.coding with two slices:
1234806008 (fixed)Error message:
Slicing cannot be evaluated: Could not match discriminator ($this) for slice spezifisch
Cause: The FHIR validator has difficulty evaluating #pattern discriminators on $this with value-set-bound slices, because the pattern cannot be derived unambiguously from the value set.
Status: The profile semantics are correct. The validator cannot fully evaluate the slicing, but the instances conform.
| Terminology | Description | Status |
|---|---|---|
| HGNC | Gene symbols not available on all TX servers | 🔵 EXTERNAL |
| Oncotree | Tumor classification is external, not validatable via FHIR TX | 🔵 EXTERNAL |
| LOINC | Panel codes for genomics partly not validatable; LIST filter not supported (see below) |
🔵 EXTERNAL |
| SNOMED CT | Newer codes (July 2025+) not available on MII TX servers | 🔵 EXTERNAL |
The CI validation reports 14 errors of the form:
Error from http://127.0.0.1:8090/fhir: Error: There is no declared filter called LIST on code system http://loinc.org
Cause: The hl7.fhir.uv.genomics-reporting IG (v3.0.0) uses value sets with LOINC LIST filter expressions. The terminology server used in CI does not support this filter. This affects all resources using LOINC codes from Genomics Reporting value sets.
Affected resources (14):
| Resource | Element |
|---|---|
| Bundle (Kim Musterperson) | GenomicStudyAnalysis, EinfacheVariante (TP53, PIK3R1), CNVariante (CCNE1) |
| Observation (Einfache Variante) | value, method, component[0].value |
| Observation (Copy Number Variant) | component[0].value |
| Observation (RNA Fusion) | value |
| Procedure (GenomicStudyAnalysis) | extension.value |
Status: 🔵 EXTERNAL — the error lies in the CI TX server, not in the profiles or examples. The message is filtered via advisor.json.
The following SNOMED CT codes are correct, but newer than the version available on the terminology server. They therefore cannot be validated automatically.
| Code | Display | Use |
|---|---|---|
1363313004 |
In situ hybridization technique (qualifier value) | ISH method (generic) |
1303773004 |
Fluorescence in situ hybridization technique (qualifier value) | FISH method |
787997001 |
Chromogenic in situ hybridization (qualifier value) | CISH method |
787998006 |
Silver in situ hybridization (qualifier value) | SISH method |
| Code | Display | Use |
|---|---|---|
1365744007 |
Ratio of erb-b2 receptor tyrosine kinase 2 to chromosome 17 centromere signals per cell in malignant neoplasm of breast in excised tissue specimen by in situ hybridization technique (observable entity) | HER2/CEP17 ratio ISH |
1365743001 |
Human epidermal growth factor receptor 2 gene copy number in malignant neoplasm of breast in excised tissue specimen by in situ hybridization technique (observable entity) | HER2 copy number ISH |
1365742006 |
Human epidermal growth factor receptor 2/centromeric probe 17 ratio in malignant neoplasm of breast in excised tissue specimen by in situ hybridization technique (observable entity) | HER2/CEP17 ratio (alternative) |
| Code | Display | Use |
|---|---|---|
1234806008 |
Observation using immunohistochemistry (observable entity) | IHC observation (generic) |
12645001 |
Gene amplification (finding) | ISH interpretation |
| Package | Version | Description |
|---|---|---|
de.medizininformatikinitiative.kerndatensatz.meta |
2027.0.0-ballot | MII Core Dataset Meta |
de.medizininformatikinitiative.kerndatensatz.base |
2027.0.0-ballot | MII Core Dataset Base |
de.medizininformatikinitiative.kerndatensatz.onkologie |
2027.0.0-ballot.1 | MII Oncology module |
de.medizininformatikinitiative.kerndatensatz.molgen |
2027.0.0-ballot.1 | MII Molecular Genetics module |
de.medizininformatikinitiative.kerndatensatz.patho |
2027.0.0-ballot | MII Pathology module |
de.medizininformatikinitiative.kerndatensatz.medikation |
2027.0.0-ballot | MII Medication module |
de.medizininformatikinitiative.kerndatensatz.biobank |
2027.0.0-ballot | MII Biobank module |
de.medizininformatikinitiative.kerndatensatz.studie |
2027.0.0-ballot | MII Study module |
hl7.fhir.uv.genomics-reporting |
3.0.0 | HL7 Genomics Reporting IG |
The former dependency on de.medizininformatikinitiative.kerndatensatz.consent
was removed: no artifact of this module consumes the Consent package — the
module's informed-consent profile (mii-pr-mtb-consent-given) derives from
plain Observation.
| Symbol | Status | Meaning |
|---|---|---|
| 🔴 | TODO | Errors to be actively fixed |
| 🟡 | MONITOR | Watch, action may be required |
| 🔵 | EXTERNAL | External problem, outside our control |
| ⚪ | FILTERED | Filtered via advisor.json |
The FHIR validation runs automatically on every push via GitHub Actions:
The validation results, including detailed output, are available as artifacts in the workflow runs.
If you would like to contribute to improving validation:
TODO-marked error that interests youNote: this section is maintained manually. For the most current technical state see the CI runs in the repository.