MII IG PRO
2027.0.0-ballot.1 -
Germany
This page is part of the MII Implementation Guide PRO (v2027.0.0-ballot.1: 2027 Ballot 5) 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
v2026.7.0, package + GitHub release)v2026.6.0, package + GitHub release)v2026.5.2, package)v2026.5.1, GitHub release + package)v2026.5.0, GitHub release + package)v2026.4.1)v2026.4.0)v2026.3.0)v2026.2.0, Simplifier package published)This page documents the changes between versions of the MII PRO module.
Content-identical to 2027.0.0-ballot. Fixes the package manifest: the npm-style dependencies of the distributed package still declared the pre-upgrade pins (meta 2026.0.x, SDC 3.0.0, ISiK 5.1.1), so fhir install resolved outdated transitive packages. The manifest now mirrors sushi-config.yaml (meta 2027.0.0-ballot final, SDC 4.0.0, ISiK 6.0.0), the meta pin was lifted from ballot.rc3 to the ballot final, and manifest/config drift is now a hard release check. The formally published package.tgz on this site was always correct — the defect was limited to the package registry channel.
The ballot version of the 2027 line. Relative to rc5, five QA error classes were closed (294 → ~205: QuestionnaireResponse texts aligned with their questionnaire definitions, CapabilityStatement search-parameter canonicals corrected to the R4 conformance-* parameters, catalogue displays synchronised, ConceptMap linkId maps moved to logical URIs, unresolvable web references converted to display-only) and the PROMIS-29 example item order was fixed.
The remaining QA findings are documented environment and upstream classes, not defects of the module:
$lookup against tx.fhir.org, 2026-09-06).2025Jan/rendering.html); an upstream issue of the SDC package.package.tgz and the *.zip downloads resolve in the formal publication (measured HTTP 200) but not in branch previews.subscriptions-backport.r4 declares FHIR 4.0.0 and arrives transitively; not pinnable from this module.Open ballot question: a hard obligation for item.text and answer.display in QuestionnaireResponse (1..1 plus German-availability invariants) was implemented and measured, but conflicts with licence-restricted (metadata-only) instruments and paper-based capture. The profile currently ships the must-support translation pattern without the obligation — commenters are invited to weigh in.
QuestionnaireResponse: German via translation extension (2026-09-10): item.text and item.answer.valueCoding.display are now must-support with an explicit translation-extension slice, and all 20 example responses demonstrate the pattern end-to-end (350 item texts, 252 answer displays; German-primary instruments carry German directly, English-primary ones the canonical wording plus German translation extensions). The EORTC QLQ-C30 questionnaire gained the official German item wordings along the way. A hard obligation (1..1 plus German-availability invariants) was implemented and measured, but is deferred to ballot commentary: it conflicts with licence-restricted (metadata-only) instruments and paper-based capture workflows.
LOINC supplement (2026-09-08): mii-cs-pro-loinc-supplement ships the validated German answer wordings (PHQ-D, PROMIS/PHO) as designations on 24 LOINC codes — content for consumers and terminology servers; measured on both relevant publishers (2.2.11, 2.3.2), display validation does not consume local supplements yet, so the ~178 display findings remain a documented environment class.
The 2027 ballot version brings the move onto the MII KDS module template (v0.11.3) — the same toolchain as the other KDS modules. For implementers nothing changes in the FHIR artifacts: all 214 resources, their ids, canonicals and versions are unchanged (measured, 0 regressions).
What does change:
:latest, GitHub Pages deployment via Actions.urn:iso:std:iso:3166#DE (same meaning; the m49 encoding rendered "Unknown region code" in every page header).language = #de; the PROMIS-29 bundle no longer references the person module's patient profile with the PRO module version.EORTC QLQ-C30 restructured to standalone terminology (2026-09-08): the main questionnaire no longer contains its CodeSystem/ValueSets — it binds the standalone mii-vs-pro-eortc-qlq-c30-scale-4pt/-7pt, whose CodeSystem now carries the answer weights as itemWeight properties (ported 1:1 from the retired contained resources; EORTC scales are 1-based). The two modelling-experiment variants (…-variant-a, …-variant-b) are removed — they were referenced nowhere. Resolves the largest remaining QA class (82 contained-resource profile violations).
Dependency upgrade for the 2027 line (2026-09-08): SDC 3.0.0 → 4.0.0 (final), ISiK 5.1.1 → 6.0.0, kerndatensatz.meta 2026.0.0 → 2027.0.0-ballot.rc3, basisprofil 1.5.4 → 1.6.0. The SDC step is the breaking one and was migrated in full: the ordinalValue extension becomes itemWeight (395 answer options), CodeSystem weight properties become concept-properties#itemWeight, and all 90 FHIRPath scoring expressions switch from .ordinal() to .weight(). Existing QuestionnaireResponses are unaffected — weights live on the questionnaire and terminology side, not in the responses.
Details and open decisions: PR #129.
v2026.7.0, package + GitHub release)Minor release — GAD-7 as a new instrument, a shared PHQ four-point scale and a ConceptMap for item numbering. No breaking changes to existing resources.
Seven items screening for generalized anxiety disorder, sum score 0–21, severity bands 5/10/15 (Spitzer et al. 2006). English as the primary language with the validated German translation (PHQ-D; Löwe et al. 2008, n=5030). LOINC panel 69737-5, score 70274-6. Freely available, no permission required.
linkIds in the PHQ-D block namespace (phq-phq5a…phq-phq5g) rather than an instrument-specific numbering. The reason is the interlocking within the PHQ family: the first two GAD-7 items form the GAD-2, and together with two PHQ-9 items they make up the PHQ-4. The same question should carry the same linkId across instruments — otherwise a migration ConceptMap would become necessary later, as it had to be created for the PHQ-9 in 2026.5.0.
Not carried over: a PROMIS anxiety T-score conversion that existed as a FHIRPath expression in an earlier development state. Score conversions between instruments will be modelled as a CQL library.
The RuleSet Phq4PointFrequencyAnswerOptions bundles the two-week frequency scale (0–3) with the LOINC answer codes of list LL358-3 (LA6568-5…LA6571-9) and the German PHQ-D wordings. GAD-7 uses it; PHQ-9 and PHQ-4 can be switched to it.
mii-cm-pro-gad-7-linkids maps the conventional GAD-7 numbering (items 1–7, as published and common in third-party systems) onto the canonical linkIds. Explicitly not a migration of a published version — a reading aid for taking over data from third-party systems.
v2026.6.0, package + GitHub release)Minor release — six new instruments from the PCOR-MII PSS set (Persistent Somatic Syndrome), a new shared answer scale and a sharpened display-language convention. No breaking changes to existing resources.
| Instrument | Items | Answer scale | Score |
|---|---|---|---|
| SCOFF (Morgan et al. 1999) | 5 | binary (SNOMED CT) | sum 0-5 |
| WI-7 / Whiteley-7 (Fink et al. 1999) | 7 | binary (SNOMED CT) | sum 0-7 |
| PC-PTSD (Prins et al. 2003) | 4 | binary (SNOMED CT) | sum 0-4 |
| SSD-12 (Toussaint et al. 2016) | 12 | 5-point, own CodeSystem | sum 0-48 |
| ISR-Z (Tritt et al. 2008) | 3 | 5-point, own CodeSystem | mean 0-4 |
| EURONET-SOMA (Rief et al. 2017) | 2 | NRS 0-10 | no score (single items) |
All item texts come from the PCOR-MII Item Level Dictionary and were verified character-exactly against that source. All example scores are recalculated from the ordinalValue weights.
New RuleSet YesNoAnswerOptions (input/fsh/rulesets/answer-scales.fsh) for generic yes/no answers. It uses SNOMED CT 373066001 (Yes) / 373067005 (No) per the recommendation of the TC Terminologien (HL7 Germany / Interop Council) — instead of a self-defined MII CodeSystem duplicating standardised terminology.
Since no ordinalValue property can be attached to SNOMED concepts, these instruments use inline answerOption rather than answerValueSet. Answers in QuestionnaireResponses thereby carry a terminologically unambiguous coding with system and code instead of systemless integers.
The display value of an answer concept is in the language of the questionnaire; further languages are carried as designation. This is not a matter of style: in a resource with language = #de the FHIR validator expects the German display in valueCoding. With the English one there, the entire answerValueSet check fails — with the misleading follow-up message that the value is not in the options value set, suggesting a terminology problem that does not exist.
.avg() instead of .sum(), range 0-4.language follows the instrument's original language: SCOFF, WI-7 and EURONET-SOMA are EN-primary with a German translation, PC-PTSD, SSD-12 and ISR-Z DE-primary. Where no validated original could be evidenced, no translation was invented.qualifiedInterval in the ObservationDefinitions but not shipped as executable interpretation logic.v2026.5.2, package)Patch release (fix-only) — no changes to instruments, profiles or terminology. Recommended for everyone running 2026.4.0–2026.5.1.
The packages 2026.4.0–2026.5.1 could not be loaded into HAPI FHIR — the server aborted at startup:
HAPI-0838: ConceptMap[url='…/ConceptMap/mii-cm-pro-bdi-ii-to-promis-depression-observation']
contains at least one group without a value in ConceptMap.group.source
→ HAPI-1286: Error installing IG … → Application run failed → Unable to start web server
mii-cm-pro-bdi-ii-to-promis-depression-observation introduced in 2026.4.0 was an incomplete stub (only 2 of 64 PROsetta Stone anchor points, group without source/target CodeSystem). HAPI rejects ConceptMaps without group.source on package install and aborts the server start. 2026.3.0 contained no ConceptMap and therefore loaded cleanly.mii-cm-pro-phq-9-linkid-migration installs correctly (it carries sourceScope/targetScope).onLoad-ig-working.json, onLoad-ig-updated.json, onGenerate-ig-working.json — a triple copy of the ImplementationGuide with an identical canonical URL) are now filtered out in the Firely Bake build (onLoad-*/onGenerate-*/onCheck-*), as are macOS files (._*, .DS_Store) defensively. Not a HAPI startup blocker, but unclean packaging.2026.5.2. Previously shipped packages contained mixed version states (down to 2026.0.0) because fsh-generated was not regenerated on every version bump.v2026.5.1, GitHub release + package)Patch release on 2026.5.0.
BREAKING (carried over from 2026.5.0): the PHQ-9 item linkIds were switched in 2026.5.0 from the phq-phq9-q01…q10 scheme to the shared PHQ-D block namespace (phq-phq2a…i + phq-phq9-difficulty). Existing PHQ-9 QuestionnaireResponses with old linkIds no longer match the questionnaire from 2026.5.0 on.mii-cm-pro-phq-9-linkid-migration — maps the old PHQ-9 linkIds 1:1 onto the new ones (10 items: phq-phq9-q01…q09 → phq-phq2a…i, phq-phq9-q10 → phq-phq9-difficulty) for migrating existing responses. The calculated items (phq-phq9-score-total, phq-phq9-promis-tscore) were not renamed.v2026.5.0, GitHub release + package)Minor release: two new instruments (WHODAS 2.0 12-item and PHQ-15), the shared PHQ-D item bank (PHQ-9/PHQ-15), uniform MII score coding across all score ObsDefs and a CI improvement (ValueSet expansion) that permanently fixes answerValueSet answer validation.
answerValueSet (mii-vs-pro-whodas-12-answer-list) with ordinalValue weights on the CodeSystem concepts. Limitation score mii-obsdef-pro-score-whodas12-simple-sum (0–48, SNOMED 715823002, MII catalogue whodas12-simple-sum, higher = more impairment). Incl. example QuestionnaireResponse + score Observation and IG page.
copyright on Questionnaire and CodeSystem: free clinician self-use; electronic/data-capture use requires a WHO usage agreement (free for non-commercial use); translations require WHO approval; MII FHIR content CC0, WHODAS item text © WHO.answerValueSet with ordinalValue weights. Score mii-obsdef-pro-score-phq-15 (0–30, LOINC 70273-8) incl. severity categories (Kroenke et al. 2002: 0–4 / 5–9 / 10–14 / 15–30) as qualifiedInterval reference ranges. Incl. IG page. Licence: freely available (public domain), PHQ-D.phq-phq…). Items contained in both instruments (sleep phq-phq2c, fatigue phq-phq2d) share the same linkId — the basis for item-based scoring across instruments.answerValueSet + CodeSystem ordinalValue (EN-first); copyright/licence status set explicitly on PHQ resources.code.coding[mii]) added to all score ObservationDefinitions (PROMIS-29 ×8, PROMIS Cognitive Function SF4a, depression T-score, BDI-II, PHQ-9, PHQ-15) — alongside LOINC/SNOMED, uniformly queryable via the MII score catalogue (EQ-5D/EORTC/DASS-21/PRO-CTCAE already had it).expand-valuesets.js now runs after SUSHI in the IG build and writes vs.expansion from local CodeSystems. The validator can thereby resolve the MII-controlled answerValueSet answer scales; the previously reported "value not in the specified options" findings on example QuestionnaireResponses disappear (PHQ-15, WHODAS and future answerValueSet instruments).v2026.4.1)Patch release on v2026.4.0: fixes missing version metadata on the 3 EQ-5D-5L ObservationDefinitions, discovered while baking v2026.4.0.
FHIR resources:
mii-obsdef-pro-score-eq5d5l-index, …-profile, …-vas — * insert ObsDefVersion and * insert MetaProfile(...) added (previously both RuleSets were missing, so no artifact-version extension in the package and no meta.profile entry with a versioned canonical). All other ObsDefs already had both.Verification:
v2026.4.0)Two thematic additions in one release: PROMIS consolidation (PROMIS-16 PROPr, wording migration, copyright model) and symptom screening for oncological and palliative care (MIDOS2 + PRO-CTCAE oncology base screening).
PRO instruments:
Architecture:
derivedFrommidos-midos2 and proctcae-onkologisches-basisscreeningTerminology & mapping:
IG documentation & examples:
midos2.md and proms-onkologisches-basisscreening.md pages, registered under the PRO Librarydraft + experimental; MIDOS2 source verification against Stiel et al. 2010/2012 pending (bead 5jd)PRO instruments:
mii-lib-promis-16 planned)Architecture & licensing:
PROMIS_Copyright_DE with layered attribution on all PROMIS questionnaires (MII FHIR structure / PROMIS items © PHO / German translations via PCOR-MII, curated by CPCOR Charité / LOINC © Regenstrief)publisher, copyright, useContext and CPCOR contact on all PROMIS questionnaire instances; new ValueSet MII_VS_PRO_PROMIS_Intensity_Response_Scale (LOINC LL1024-0)mii-qst-pro-promis-29-de is a presentation variant only (DE-primary for renderers that ignore the translation extension); the EN-primary main version is authoritativeTooling & verification:
extract-qst-translations — extracts item texts and translation extensions from generated questionnaires and diffs them against the PCOR-MII master (MATCH/DIFF counters)v2026.3.0)PRO instruments:
FHIR resources:
mii-cm-pro-bdi-ii-to-promis-depression-observation (only 2 of 64 PROsetta Stone entries). Architectural decision: score conversions will be modelled as CQL libraries (planned for the 2027 release)mii-qst-pro-promis-cognitive-function-sf4a; added to mii-qst-pro-pro-ctcae-breast-de (displayable+collectable=true; calculatable/extractable/domainAligned=false — deliberate, pending composite-grade scoring decisions)v2026.2.0, Simplifier package published)PRO instruments:
Dependencies and tooling:
ObservationDefinition:
qualifiedInterval.context.coding to qualifiedInterval.appliesToEORTC QLQ-C30 ValueSet architecture:
Quality assurance:
{{render:infobox}} syntax replaced with Markdown blockquotes; CodeSystem/ValueSet switched to short idsNote: the DASS-21 and QA items were originally planned as a standalone v2026.1.0 release but were never published as their own package; they first shipped as part of v2026.2.0.
Bugfix release with PROMIS-29 additions and canonical URL correction.
FHIR resources:
IG documentation:
First stable release of the MII PRO module for productive use.
FHIR resources and profiles:
Version management and metadata:
{canonical}|{version}); ObsDefVersion RuleSet (R5 backport of artifact-version for R4); version RuleSets centralised in input/fsh/rulesets/version.fshDependencies and tooling:
de.medizininformatikinitiative.kerndatensatz.pros; package.bake.yaml added for the Firely Bake packaging workflowQuality assurance and developer experience:
Initial ballot version focused on SDC-based PRO capture and score calculation.
PRO instruments: PHQ-9 (raw + T-score), EQ-5D-5L (index, VAS, profile scores), PROMIS-29 Profile v2.1 (7 domains with automatic scoring), PROMIS Cognitive Function SF4a, BDI-II (reference implementation), EORTC QLQ-C30 (15 subscales).
FHIR profiles and extensions: MII_PR_PRO_Questionnaire (SDC-based, calculated expressions, conditional display), MII_PR_PRO_QuestionnaireResponse (SDC extraction), MII_PR_PRO_Score_Blueprint and MII_PR_PRO_Score_Instance, the questionnaire capabilities extension.
Terminology strategy: MII-controlled CodeSystems and ValueSets with ordinalValue extensions for reliable score calculation; German translations via translation extensions; FHIRPath .ordinal() for weight-based calculations.
Technical basis: FHIR R4 (4.0.1) with SDC 3.0.0; de.medizininformatikinitiative.kerndatensatz.meta 2026.0.0; de.gematik.isik 5.0.0.