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 in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
This page records the changes between the released versions of the Molecular Tumor Board module, newest version first. It follows Keep a Changelog and the KDS calendar versioning scheme described on the Versioning page.
Each version gets its own section with the release date and the changes grouped by category:
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of the following, even when it looks small: tightens a cardinality
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obligation, or changes a canonical URL. When in doubt, report it as
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Breaking for whom: state both perspectives — stored data (instances valid against the old version) and implementations (clients and servers built against it; a removed search parameter breaks implementations while every stored instance stays valid).
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Link the technical delta. From the second formal publication on,
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Added
DeviceDefinition templates for NGS panel products, a panel-capability CodeSystem/ValueSet pair, a gene-list extension and nine HGNC-ID-coded gene-list ValueSets, plus the Panel-Katalog page with a community feedback call.mii-vs-mtb-interpretation-high-low (replacement for the ValueSet removed from Genomics Reporting STU3); NCIt topic Tumor Board Review (C93304) on the ImplementationGuide.Changed
.1 fixes); de.basisprofil.r4 1.6.0; Genomics Reporting 3.0.0.Procedure.basedOn of both systemic-therapy profiles now constrains the oncology parent's inherited tumorkonferenz slice to MII_PR_MTB_Therapieplan (onkologie 2027 breaking change).mii-ig-mtb (template pattern; packageId and canonical unchanged); three artifact ids aligned to their canonical tails; the logical model's canonical dropped the non-standard /LogicalModel/ path segment.Removed
de.medizininformatikinitiative.kerndatensatz.consent dependency (no artifact consumes it — the module's consent profile derives from plain Observation).Dependency updates and documentation improvements.
fix Oncology: update from 2026.0.1 to 2026.0.3 (AppleDouble cleanup, snapshot corrections, extension-version fix)fix Consent: update from 2025.0.4 to 2026.0.0 (2026 release)feat QA validation: page completely reworked — all advisor.json filters documented, LOINC LIST-filter errors described, external dependencies updated (see QA and Validation)fix package.bake.yaml: adjustment for local builds with --input fsh-generated/resources and sushi --snapshotFirst stable version of the MII CDS module Molecular Tumor Board after the successful ballot phase.
The module comprises profiles for the structured capture of:
feat NGSBericht: structured capture of next-generation-sequencing reports with GenomicStudy-based analysesfeat GenomicStudy: integration with HL7 Genomics Reporting STU3 for genomic studies and analysesfeat Genomic Study Device: structured capture of sequencing devices (sequencer, library preparation kit, sequencing kit) in NGS workflowsfeat Genomic variants: profiles for SNVs (EinfacheVariante), CNVs (CopyNumberVariant), DNA fusions (DNAFusion), RNA fusions (RNAFusion)feat Biomarkers: tumor mutational burden (Mutationslast), microsatellite instability (Mikrosatelliteninstabilitaet, MSI), HRD score (HRDScore), BRCAness (BRCAness), ploidy (Ploidie)feat Molecular biomarkers: structured capture with a value set for HGNC gene symbols and pharmacogenetic markersfeat Immunohistochemistry: profiles for IHC stains (Immunohistochemistry), specialized profiles for HER2 (IHC_HER2), MMR (IHC_MMR), PD-L1 (IHC_PDL1), phosphorylation (IHC_Phosphorylation)feat In-situ hybridization: profiles for ISH examinations (InSituHybridization) with a specialized HER2 ISH profile (ISH_HER2)feat HER2 status: combined biomarker profile (BiomarkerHER2Status) for diagnostic and therapeutic implicationsfeat MolecularPathologyReport: DiagnosticReport for molecular-pathology findings integrating IHC/ISH resultsfeat Behandlungsepisode: ClinicalImpression-based capture of MTB recommendations and therapy decisionsfeat Therapy recommendations: profiles for single therapies (TherapieempfehlungMedikation) and combination therapies (TherapieempfehlungKombination)feat Evidence grading: extension for documenting the level of evidence per NCT criteria with addendum referencesfeat Therapieplan: CarePlan for structured therapy planningfeat SystemischeTherapie: MedicationStatement for administered systemic therapies with a dose-density extensionfeat ResponseBefund: Observation for therapy response with RECIST/iRECIST assessmentfeat FollowUpClinicalImpression: ClinicalImpression for follow-up documentation with implementation statusfeat AntragKostenuebernahme: Claim for cost-coverage applications for off-label/compassionate use with an application-stage extensionfeat AntwortKostenuebernahme: ClaimResponse for health-insurance decisions with a rejection-reason extensionfeat StudieneinschlussAnfrage: ServiceRequest for study-enrolment requestsfeat Studie: ResearchStudy profile for clinical studiesfeat BiopsieAuftrag: ServiceRequest for re-biopsy/new biopsy with a justification extensionfeat HistologieEvaluationAuftrag: ServiceRequest for histological re-evaluationsfeat HumangenetischeBeratungAuftrag: ServiceRequest for human-genetic counsellingfeat DiagnosePrimaertumor: Condition profile with OncoTree coding and tumor spreadfeat Tumorzellgehalt: Observation for tumor-cell content with determination methodfeat DiagnostischeImplikation: diagnostic significance of genomic findingsfeat TherapeutischeImplikation: therapeutic significance of genomic findings with an approval-status extensionfeat MTB-specific CodeSystems: 18 CodeSystems for MTB-specific concepts (evidence levels, therapy-status reason, recommendation status, follow-up status, genomic-analysis method types, etc.)feat ValueSets: 29 ValueSets for structured coding incl. OncoTree, WHO grade CNS, molecular biomarkers, MSI, MMR expressionfeat ConceptMaps: mappings of therapy-status reason to SNOMED CT and oBDSfeat Multilingualism (i18n): complete translations (de-DE, en) for all 52 profiles, 18 CodeSystems and 29 ValueSetsfeat QA validation: documentation of known validation limitations (see QA and Validation)feat Example data: 120+ example instances demonstrate typical MTB scenariosfeat CapabilityStatement: complete server-capability documentationInitial ballot version for the MII commenting phase.