MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 -
Germany
MII IG Kerndatensatz-Modul Onkologie
2027.0.0-ballot.1 -
Germany
This page is part of the MII IG Kerndatensatz-Modul Onkologie (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
All changes to this module are listed here. The complete, detailed release history is maintained in the German edition of this page; the current release cycle is translated in full below.
kerndatensatz.molgen raised to 2027.0.0-ballot.1: molgen's own dependency-hygiene patch (its ballot still pulled meta rc3 / base rc1 / biobank rc2 transitively; no structural changes — all StructureDefinitions verified identical). The dependency tree of this module is now uniformly on the plain ballot line. No content changes in this module.kerndatensatz.studie removed as a hard dependency: no artefact of this module references a studie canonical — the study-participation profile binds focus[studie] to plain Reference(ResearchStudy), with the SHOULD-recommendation to MII_PR_Studie_Studie documented in the element definition. studie is the last module still on an rc; without the pin it no longer gates this ballot line.BREAKING Canonical URLs aligned with the naming convention (10 artefacts): seven therapy ValueSets gained the missing onko- segment, three logical models lost the Simplifier-era …/LogicalModel/<Name> path — complete old→new table and migration guidance in Migration from v2026, entry 10. Instances are unaffected (they never carry these canonicals); profile bindings follow automatically.kerndatensatz.meta, .base, .biobank, .medikation and .molgen now at plain 2027.0.0-ballot; kerndatensatz.laborbefund also at plain 2027.0.0-ballot. Pre-checked for snapshot/slicing compatibility.$sct alias, CalVer table): all 166 pin-relevant codes verified active, 19 filter roots expand loss-free, versioned $lookup/$expand confirmed on the MII terminology server. ConceptMap targetVersion deliberately keeps its curation provenance.approvalDate 2026-09-15 and effectivePeriod 2027 across all ~330 artifacts (rulesets, Library, IG resource); the genetic-variant profile now carries both topics (Neoplasm C3262 + Genetics C17457); the URL-keyed profile variant completed (license/package-source, versionAlgorithm, effectivePeriod, experimental).fix QA slicing groups resolved: Gleason score/grade-group discriminators (explicit .system values), study-participation focus[studie] reduced to one resolve() target type, mandatory slices completed in the FOLFOX and tumour-marker examples (12+3+5 QA errors).fix Known issue documented: the SU terminology server does not host the historical ATC year editions 2018–2026, so the yearly substance ValueSets currently produce non-actionable QA errors (bfarm/atc version YYYY).chore IG resource id renamed mii-ig-onko-de-v2026 → mii-ig-onko-de (version lives in the version field); package id and module canonical unchanged.These changes may require adjustments in existing implementations. Each entry is explained individually on the Migration from v2026 page — with its effect on stored data, its effect on implementations, and a concrete migration path:
BREAKING UICC prefixes y, r and a as modifierExtension at category level: The prefixes are no longer carried inside the category value but are represented on the respective T, N or M observation via the new extensions mii-ex-onko-tnm-y-praefix, mii-ex-onko-tnm-r-praefix and mii-ex-onko-tnm-a-praefix.
ypT2 (assessment during or after initial multimodal therapy) is not the same as pT2. Processing systems MUST know these extensions and must not interpret a category without evaluating the prefix.mii-ex-onko-tnm-cp-praefix on Observation.code (it names the method of assessment, not a different interpretation).BREAKING Karnofsky/ECOG LOINC ConceptMaps corrected (GH #269): The previous target codes were systematically wrong (Karnofsky shifted by ten LA numbers, ECOG with wrong check digits). Systems that adopted the old LA codes from the ConceptMaps must correct their data. In addition, the performance-status profiles now bind valueCodeableConcept.coding[loinc] required to new enumerated answer value sets (≙ LL4986-7 and LL529-9, GH #236).BREAKING Oncology flag on the diagnosis is now mandatory: Condition.category carries a new required slice onkologie (1..1) with SNOMED CT 55342001 "Neoplastic disease" on the primary-tumour and prior-tumour profiles, making oncological diagnoses discoverable via Condition?category=…|55342001. Existing instances without this category become invalid; the extensible core binding (problem-list-item / encounter-diagnosis) is unaffected.BREAKING Gleason profiles: code.coding is sliced (GH #259): SNOMED CT is mandatory (1..1), LOINC optional as a secondary coding (0..1) — for grade group, total score and pattern. Verified LOINC codes: 94734-1, 35266-6, 44641-9/44642-7/44643-5.BREAKING CTCAE catalogue version moved out of the MedDRA coding (oBDS 15.3): the version is no longer written to AdverseEvent.event.coding[meddra].version but to the new extension mii-ex-onko-nebenwirkung-ctcae-version, bound required to the oBDS enumeration (4, 4.03, 5.0, Sonstige, new code system mii-cs-onko-nebenwirkung-ctcae-version). Reason: coding.version denotes the version of the code system the code was drawn from — that is MedDRA (CTCAE v4.03 is built on MedDRA v12.0), not CTCAE. The conflation made codes unresolvable against the value set. Systems that read the CTCAE version from coding.version must be adjusted.BREAKING Reference types hardened: previously generic references are now restricted to the clinically valid profiles — Verlauf.hasMember, AdverseEvent.suspectEntity.instance, Condition.extension:dueTo.valueReference, Residualstatus.partOf, TNM-synthesised.device and Tumorkonferenz.activity[extended].reference. Instances with other target types become invalid.BREAKING TNM symbol profiles deprecated: mii-pr-onko-tnm-y-symbol, -r-symbol, -a-symbol and -m-symbol are retired. The y/r/a prefixes are carried as modifierExtension on the category profiles, the m suffix as the new component[multipleTumoren] on the T category (component code LOINC 42030-7, value still from the UICC code system). Legacy data remains readable; new implementations should use the extensions and the component.BREAKING Legacy artefacts removed: the commented-out radiotherapy "alt" family and the never-activated ECOG/Karnofsky quantity profiles.BREAKING Dependencies moved to the 2027 ballot line: kerndatensatz.meta 2027.0.0-ballot.rc3, kerndatensatz.base 2027.0.0-ballot.rc1, de.basisprofil.r4 1.6.0, kerndatensatz.biobank and kerndatensatz.molgen 2027.0.0-ballot.rc2 each, kerndatensatz.studie 2027.0.0-ballot.rc1, kerndatensatz.medikation 2027.0.0-ballot.rc5. Newly added: kerndatensatz.laborbefund 2027.0.0-ballot.rc3 (for the tumour marker profile) and hl7.fhir.uv.genomics-reporting 3.0.0.feat Synthesized TNM classification finalized (mii-pr-onko-tnm-klassifikation-synthetisiert): merges several report-related TNM classifications into one coherent state at the time of decision (e.g. tumor board).
399703000 "Integrated TNM category"; the type value set mii-vs-onko-tnm-klassifikation-typ was extended accordingly (clinical / pathologic / integrated)value (UICC stage) now 1..1: the stage is the purpose of the synthesis; on the report panel value remains 0..1component[tnmFormel] (CodeSystem mii-cs-onko-tnm-formel) for the generated TNM formula (e.g. "ypT0 ypN0 cM0"); it MUST match the hasMember observations including prefixes and SHOULD be generated, not maintained manuallyderivedFrom to the source classifications is REQUIRED (1..*), device is MS — for automated derivation the generating system including its version SHOULD be documented; an additional Provenance resource MAY be added for audit requirementsfeat New SearchParameters tnm-y-praefix and tnm-r-praefix for searching over the new prefix modifierExtensions.feat Relationship axes of the diagnosis completed: In addition to occurredFollowing (temporal sequence, oBDS 5.9 — target now also includes previous tumor disease), there is the new extension mii-ex-onko-transformation-von (lineage continuity, e.g. MDS → AML, meningioma /0 → /3) and a slice on the HL7 standard extension condition-dueTo (causation, e.g. t-AML after chemotherapy, radiogenic angiosarcoma). Three-axes guidance with CUP distinction on the diagnosis page; six new example instances including a CUP example bundle with best-of resolution.feat ICD-O revision artifacts (resolves, among others, the Heidelberg finding on 2014 codes): version-pinned year value sets for topography and morphology (first revision 2014 / second revision 2019), main value set as the union of both states, transition ConceptMap mii-cm-onko-icdo3-transitions-2019 with the changed morphology codes (56 after the BfArM reconciliation, see below).feat ATC year value sets 2018–2026 version-pinned (3,422 entries) plus transition ConceptMap 2022 (monoclonal antibodies move L01XC → L01F); fixes the version ambiguity of the terminology server for year-versioned code systems.feat Reportable-tumor value set + warning invariant for the ICD-10 coding of the oncological diagnosis (mii-vs-onko-icd10-meldepflichtige-tumoren, block codes C00–C97, D00–D09, D32/D33, D35.2–.4, D37–D48): reports non-reportable codes as a warning without forbidding them.feat MedicationStatement systemic therapy: medicationReference is now allowed as an alternative to medicationCodeableConcept (both 0..1 with medication[x] 1..1, GH #288) — eases reuse of existing KDS medication resources.feat Curated KDL value set mii-vs-onko-kdl-dokumentklassen (45 document classes along the oncological treatment path) as a non-binding companion artifact for the document level.feat AdverseEvent: event.coding extended by a SNOMED CT slice (MedDRA binding unchanged on the MedDRA slice).feat Approved community changes: morphology extension morphology-behavior-icdo3 now 0..* (GH #298), FIGO stages codeable (GH #297), Gleason scores < 6 allowed and pattern titles corrected (GH #260/#261).feat ConceptMap MedDRA → SNOMED CT for the CTCAE adverse events (mii-cm-onko-nebenwirkung-meddra-sct): all 790 CTCAE v4.03 terms, 708 mapped (638 equivalent, 28 narrower, 42 wider), 82 deliberately unmapped. Target codes verified against the curation version SNOMED International 20260501.feat Tumour-marker profile mii-pr-onko-tumormarker: derived from MII_PR_Labor_Laboruntersuchung (CDS module Laboratory Report), binding Observation.code extensibly to the new union list mii-vs-onko-tumormarker-loinc (48 curated LOINC codes), with focus on the diagnosis.feat Cancer-predisposition value sets from the §65c list: mii-vs-onko-praedispositionssyndrome-orpha (55 Orphanet codes) and mii-vs-onko-praedispositionsgene-hgnc (109 HGNC genes).feat Structured gene identity: Observation.component:gene-studied is bound extensibly to mii-vs-onko-marker-gene-hgnc (40 HGNC genes). For the IGHV special case mii-vs-onko-ighv-gensegmente-hgnc lists all 167 segments; mutated/unmutated remains represented via the oBDS qualifier (M/W).feat TNM 9th edition: codes T1b3 (cervix) as well as M1c1 and M1c2 (lung) added to the UICC code system and the value sets.feat CRMI metadata on all conformance resources (324 of 325), following the pattern of the base module.feat ECOG and Karnofsky profiles with focus on the primary-tumour diagnosis.feat OPS laterality on the surgery profile exposed as must-support (the oBDS carries no separate laterality field for surgery).feat Link to the CDS module Medical Research Project (GH #232): Studienteilnahme.focus[studie] points to MII_PR_Studie_Studie.feat oBDS mapping on the logical model: all 16 areas and 85 sub-elements mapped to their oBDS field numbers.refactor SearchParameter for the c/p/u prefix consolidated: The three defective SearchParameters tnm-t-cppraefix, tnm-n-cppraefix and tnm-m-cppraefix were replaced by the shared SearchParameter mii-sp-onko-observation-tnm-cp-praefix (code tnm-cp-praefix). The extension exists exactly once on Observation.code; the distinction between T, N and M category is made via the observation's category code (combination with the code SearchParameter).note Known issue — ~4,100 ATC QA messages are a Publisher bug, not invalid codes: the IG Publisher validates enumerated value-set codes via a $batch-validate-code dialect that omits the url parameter per validation; the MII terminology server correctly rejects each request ("must specify either valueSet or url"), which the Publisher then reports as "code not valid in the value set 'null'". The codes are server-verified as valid (e.g. L01XE01@2020 → Imatinib). Affects the annual substance value sets and ATC transition maps; reproduced unchanged with Publisher 2.3.2 and 2.3.4, upstream issue pending.fix CapabilityStatement canonical moved into the module's namespace: the URL was …/fhir/modul-onko/CapabilityStatement/metadata — missing the ext/ segment, which made it the only resource of this module outside its own canonical base, and ending in metadata rather than its id. It is now …/fhir/ext/modul-onko/CapabilityStatement/mii-cps-onko-capabilitystatement. Formally a canonical change; in practice no profile or instance references a CapabilityStatement canonical, and the old URL pointed nowhere, since nothing is published under /fhir/modul-onko/.fix SNOMED CT code for pure immunotherapy corrected (GH #267): in mii-cm-onko-therapie-typ-sct, oBDS therapy type IM (Immun-/Antikörpertherapie) mapped to 897713009 "Antineoplastic chemoimmunotherapy" — asserting a chemotherapy that does not take place in pure immunotherapy. The target is now 76334006 "Immunotherapy (procedure)". 897713009 remains correct for the combinations CI and CIZ. The ConceptMap is experimental, dates from 2024 and is not referenced by any profile, so no migration is required.documentation LOINC-SNOMED anchors for the tumour markers: verified for 23 of 28 markers (seven newly determined). For gastrin, calcitonin, M-protein, IgA and IgM no "Measurement of …" grouper exists in the ontology.documentation UICC code system: cross-edition union documented as a deliberate decision — the edition in use is carried as a separate data element (TNM version, oBDS 8.2); edition-specific validation is planned as a later stage.fix Organ modules aligned with the official oBDS numbering (basisdatensatz.de and oBDS XSD v3.0.5): the numbers are flat (M1–M8, KR1–KR10, P1–P9, MM1–MM4); the earlier hierarchical entries do not exist officially. Misassignments corrected (PSA was P1, officially P7; Clavien-Dindo P5, officially P9) and missing fields added.fix ICD-O transitions ConceptMap reconciled with the official BfArM update list (2021-01-29): 56 instead of 55 transitions; 8153/1 added.fix MVGenomSeq ConceptMap corrected against the actual data set: 13 of 15 target fields did not exist in OncologyCase.json.fix Example instances: unresolvable references cleaned up.fix experimental = false on 37 module terminologies.fix Curation status of the first-generation oBDS-SNOMED ConceptMaps disclosed: the 28 maps from 2024 are marked experimental = true and are neither officially endorsed nor finally quality-assured.fix UICC copyright on the TNM code system replaces the previous CC-BY-4.0 licence statement.documentation Implementation Guide moved to the HL7 IG Publisher (away from Simplifier, onto the MII CDS module template), built bilingually from the repository.documentation New overview page "Concept Mappings": all 1,459 mappings in five SQL-generated tables, produced at build time from the package database.documentation ENCR Table 4 on the tumour-marker page, plus the specimen-matrix question for serotonin/5-HIAA, HVA/VMA, catecholamines and the newly added metanephrines.documentation KDL document classes with mapping table (IHE XDS official via the DVMD ConceptMap, SNOMED CT and LOINC curated).documentation oBDS diagnostic certainty 16.4 and morphology cardinalities: the leading system for the therapy protocol is documented (Procedure.usedCode is authoritative, MedicationStatement.note.text only for schema assignment), as is the deliberate asymmetry of the morphology statements (diagnosis 0..*, histology observation exactly one per finding).documentation Toronto classification: §65c transmission rules added.documentation Genetics: transmission notation of the §65c marker list (two-position model, HGVSp/HGVSc, fusion notation).documentation TNM: the three coding mechanisms explained.documentation New guidance section "Manifestations of the TNM classification" on the TNM classification page: describes clinical staging, pathological staging, follow-up and the synthesized classification and how they are distinguished via the code axis and prefix modifiers.Technical maintenance release: packaging fix on macOS (AppleDouble contamination), dependency updates (biobank 2026.0.1, medikation 2026.0.1, studie 2026.0.2), Firely Terminal 3.5.0. Details in the German edition.
Terminology release: ATC-DE 2026 value set update (23 new codes, L01EP), 27 ATC display names corrected, ATC transition ConceptMap 2026. Details in the German edition.
First 2026 releases including a breaking canonical-URL typo fix for the radiotherapy application-type value set (HDB-708, GH #219). Full details in the German edition.
The release history before v2026 is documented in the German edition of this page.