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 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 explains every breaking change of version v2027.0.0 against v2026.0.3 — one by one, with impact and migration path. It complements the changelog, which lists all changes chronologically.
Why this page exists: the KDS calendar versioning scheme (
YYYY.n.n) carries no major signal like SemVer — the version number warns nobody. This text is the warning.
Each entry considers two perspectives separately:
From the second formal publication of this guide onwards, the IG Publisher's machine-generated version comparison will be linked here, so that explanation and technical diff sit side by side.
What changed. The prefixes y (during/after multimodal therapy), r
(recurrence) and a (autopsy) are no longer carried in the category value and
no longer represented through separate symbol observations, but as
modifierExtension directly on the respective T, N or M category:
mii-ex-onko-tnm-y-praefix,
mii-ex-onko-tnm-r-praefix,
mii-ex-onko-tnm-a-praefix.
The c/p/u prefix remains a regular extension on Observation.code — it names
the method of determination, not a divergent interpretation.
Stored data. Category instances without a prefix validate unchanged (the
modifierExtensions are 0..1). Old instances carrying the prefix through the
symbol profiles remain valid and readable — see entry 7.
Implementations. This is the actual break: ypT2 is not pT2.
Processing systems MUST know the modifierExtensions; a category must not be
interpreted without evaluating the prefix. A system ignoring the extension
reads neoadjuvantly pre-treated findings as untreated ones.
Migration. For each existing y/r/a symbol observation, set the
corresponding modifierExtension on the referenced category; the m symbol
becomes component[multipleTumoren] on the T category (component code LOINC
42030-7, value still from the UICC code system). The step is mechanical and
scriptable, since the symbol observations reference their target category
unambiguously.
What changed (GH #269). The previous LOINC answer codes in the concept
maps were systematically wrong: Karnofsky shifted by ten LA numbers, ECOG with
wrong check digits. In addition, the performance-status profiles now bind
valueCodeableConcept.coding[loinc] required to new enumerated answer
value sets (matching LL4986-7 and LL529-9 respectively, GH #236).
Stored data. Instances that adopted the old (wrong) LA codes from the concept maps become invalid — the code falls outside the required binding. Error signature: "code not in required value set" on the LOINC coding of the value.
Implementations. Systems that hard-coded the old concept map targets keep propagating wrong codes and must switch to the corrected maps.
Migration. Re-code existing values via the corrected concept maps (Karnofsky, ECOG). The mapping is 1:1 and lossless — every old code has exactly one corrected successor.
What changed. Condition.category carries a new mandatory slice
onkologie (1..1) with SNOMED CT 55342001 "Neoplastic disease" on the
primary tumour and prior tumour disease profiles. Oncological diagnoses are
thereby findable via Condition?category=http://snomed.info/sct|55342001. The
extensible core binding (problem-list-item / encounter-diagnosis) is
unaffected.
Stored data. Instances without this category become invalid. Error
signature: "slice onkologie: minimum required = 1, but only found 0" on
Condition.category.
Implementations. Search logic that identified oncological diagnoses differently (for example via ICD code ranges) can switch to the category; existing searches keep working.
Migration. Add the coding http://snomed.info/sct|55342001 to category
on every existing instance — mechanical, lossless, scriptable; existing
category entries remain in place.
What changed (GH #259). code.coding used to be unsliced; SNOMED CT is
now mandatory (1..1) with LOINC as optional secondary coding (0..1) — for
grade group, overall score and pattern. Verified LOINC codes: 94734-1 (grade
group), 35266-6 (score), 44641-9/44642-7/44643-5 (pattern).
Stored data. Instances whose code carried only LOINC (or nothing coded)
become invalid. Error signature: "slice snomed: minimum required = 1" on
Observation.code.coding.
Implementations. Reading systems that evaluated the code positionally
(coding[0]) should switch to slice- or system-based evaluation.
Migration. Add the SNOMED code belonging to the respective profile (it is stated as a pattern on the profile's artifact page); an existing LOINC code remains as secondary coding.
What changed (oBDS 15.3). The CTCAE catalogue version no longer lives in
AdverseEvent.event.coding[meddra].version but in the new extension
mii-ex-onko-nebenwirkung-ctcae-version
with a required binding to the oBDS enumeration (4, 4.03, 5.0,
Sonstige). Reason: coding.version denotes the version of the code system
the code is taken from — that is MedDRA (CTCAE v4.03 builds on MedDRA v12.0),
not CTCAE. The conflation made codes unresolvable against the value set.
Stored data. Instances carrying the CTCAE version in coding.version
remain formally valid (the extension is 0..1, coding.version is not
forbidden) — but oBDS field 15.3 is no longer read from there. The statement
itself (for example "Version 4") is correct from the cancer registry's
perspective — it names the CTCAE version — it merely sat in the wrong place:
coding.version denotes the version of the MedDRA catalogue, not of the CTCAE
catalogue.
Implementations. Systems reading or writing the CTCAE version from
coding.version must switch to the extension.
Migration. Move the value from event.coding[meddra].version into the
extension and remove coding.version. Registry-typical spellings such as
"Version 4" are mapped to the code of the oBDS XSD enumeration in the process
(here: 4, display "CTCAE Version 4") — a format alignment, not a substantive
correction.
What changed. Previously generic references are now restricted to the
professionally admissible profiles: Verlauf.hasMember (only the seven
defined members instead of any Observation),
AdverseEvent.suspectEntity.instance (radiotherapy / systemic therapy /
medication), Condition.extension:dueTo.valueReference,
Residualstatus.partOf (operation), TNM-synthetisiert.device (Device) and
Tumorkonferenz.activity[extended].reference (the three therapy
recommendation profiles).
Stored data. Instances whose reference targets do not satisfy the required profiles become invalid. Error signature: "Unable to find a profile match … among choices" or a type error on the respective reference.
Implementations. Producing systems must ensure reference targets satisfy
the target profiles — in practice usually by the target instance declaring and
fulfilling the profile in meta.profile.
Migration. Review reference targets; professionally appropriate targets
generally satisfy the profiles already, in which case the meta.profile
declaration on the target suffices. References to out-of-domain targets were
already wrong in substance — deliberately, no migration path is provided for
those.
What changed. mii-pr-onko-tnm-y-symbol, -r-symbol, -a-symbol and
-m-symbol are set to retired. Their successors are the modifierExtensions
(entry 1) and the component[multipleTumoren] on the T category.
Stored data. Remains valid and readable — the profiles continue to
exist, and hasMember on the panel still names them. retired means: no
further development, no use in new implementations.
Implementations. New implementations use the extensions or the component exclusively. Reading systems should accept both representations during a transition period.
Migration. No forced re-migration of stored data; the rewrite is mechanical (see entry 1) and recommended for data stocks under active maintenance.
What changed. Removed were the commented-out legacy radiotherapy family (profile, extension, example) and the never-activated Quantity profiles for ECOG and Karnofsky.
Stored data and implementations. No effect — these artifacts were never effective in any published version (commented out or never activated); no conforming stored data can exist. Deliberately, no migration path is provided.
What changed. 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, kerndatensatz.laborbefund 2027.0.0-ballot.rc3 (new, for
the tumour marker profile) and hl7.fhir.uv.genomics-reporting 3.0.0 (new).
Stored data. Generally no direct effect; the base modules' changelogs are authoritative — tightenings there propagate here through inheritance.
Implementations. Package resolution and validation environments must load the new dependency versions; mixed environments (oncology 2027 against 2026 base modules) are untested.
Migration. Raise dependencies together with the module; no data migration step.
What changed. Seven therapy ValueSets carried canonicals without the
onko- segment, three logical models the Simplifier-era path
…/StructureDefinition/LogicalModel/<Name>. All ten now follow the module
convention …/modul-onko/<Type>/<id>:
| old | new |
|---|---|
ValueSet/mii-vs-strahlentherapie-zielgebiet |
ValueSet/mii-vs-onko-strahlentherapie-zielgebiet |
ValueSet/mii-vs-strahlentherapie-strahlenart |
ValueSet/mii-vs-onko-strahlentherapie-strahlenart |
ValueSet/mii-vs-strahlentherapie-strahlungseinheit |
ValueSet/mii-vs-onko-strahlentherapie-strahlungseinheit |
ValueSet/mii-vs-strahlentherapie-stellungzurop |
ValueSet/mii-vs-onko-strahlentherapie-stellungzurop |
ValueSet/mii-vs-strahlentherapie-ende-grund |
ValueSet/mii-vs-onko-strahlentherapie-ende-grund |
ValueSet/mii-vs-systemische-therapie-stellungzurop |
ValueSet/mii-vs-onko-systemische-therapie-stellungzurop |
ValueSet/mii-vs-systemische-therapie-ende-grund |
ValueSet/mii-vs-onko-systemische-therapie-ende-grund |
StructureDefinition/LogicalModel/Onkologie |
StructureDefinition/mii-lm-onko |
StructureDefinition/LogicalModel/OrganspezifischeZusatzmodule |
StructureDefinition/mii-lm-onko-organspezifische-zusatzmodule |
StructureDefinition/LogicalModel/mii-lm-mvgenomseq-onkologie |
StructureDefinition/mii-lm-mvgenomseq-onkologie |
Stored data. No effect — instances never carry ValueSet or logical-model canonicals; bindings live in the profiles, which reference the new URLs.
Implementations. Only systems that address these ten canonicals directly (terminology-server requests, validation configurations, documentation links) must switch to the new URLs; everything that resolves them through the module's profiles follows automatically.
Migration. Text replacement old → new; the table above is complete.