MII Implementation Guide Consent
2027.0.0-ballot - Germany

MII Implementation Guide Consent - Downloaded Version 2027.0.0-ballot See the Directory of published versions

Changelog

This page includes translations from the original source language in which the guide was authored. Information on these translations and instructions on how to provide feedback on the translations can be found [here](translationinfo.html).

Change history

This page records the changes between the published versions of the Consent module, most recent version first. It follows Keep a Changelog and the KDS CalVer scheme described on the Versioning page.

Each version gets its own section with the release date and the changes grouped by category:

  • Added — new profiles, extensions, ValueSets, search parameters, pages.
  • Changed — changed constraints, bindings, notes, or documentation.
  • Deprecated — artifacts that still exist but should no longer be used.
  • Removed — withdrawn artifacts.
  • Fixed — corrections of errors.
  • Security — changes affecting security or data protection.

Categories without content are omitted. If a change goes back to an issue or a pull request, it is linked.

Breaking changes MUST be reported and explained

A version section containing a breaking change is only complete once it explicitly answers, in this changelog:

  • What exactly changed between the two versions — the artifact, the element, the old and the new constraint (not just "profile X was revised").
  • What this means for existing data: Does data that conformed to the previous version still validate against the new version? If not: which resources and elements are affected, and how does the error show up?
  • What implementers should do: the authors' recommendation for migrating existing data to the new version — transformation steps, default values, recoding guidance — or the explicit statement that no migration path is provided, and why.

What counts as a breaking change — treat a change as a breaking change if it does any of the following, even if it seems small: tightens a cardinality (0..* → 1..1), raises a binding strength (example → required), removes codes from a required ValueSet, removes or renames an element or a slice, narrows a type, adds an invariant or a must-support obligation, or changes a canonical URL. When in doubt: report it as a breaking change.

Breaking for whom: name both perspectives — stored data (instances that are 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).

The version number warns nobody. The KDS calendar versioning scheme (JJJJ.n.n) carries no major signal like SemVer — this changelog section is the only warning readers get.

Link the technical delta. From the second formal publication onward, enable the IG Publisher's version comparison (version-comparison in sushi-config.yaml — see the Versioning page for the setup and its prerequisites); it publishes a machine-generated comparison at comparison-v<Vorversion>/index.html. Link it from the version section so that the explanation and the technical diff stand side by side.

Mark such entries clearly (for example with the prefix BREAKING:) so they cannot be overlooked when skimming the section.

Version 2027.0.0-ballot

Date 14.09.2026

The module's first release from the IG Publisher toolchain. It builds on the release package 2027.0.0-ballot.rc1 and adds the QA corrections from pull requests #135 to #141 plus the parent-package bump.

  • Added — two artifacts missing from package 2027.0.0-ballot.rc1 are now shipped: the CodeSystem mii-cs-consent-version-modules (present in the repository, absent from the package) and the CapabilityStatement mii-cap-consent-server.
  • Added — four synthetic reference-target instances (two Patient, two ResearchStudy) so the examples' references resolve (#137).
  • Changed — parent package de.einwilligungsmanagement raised from 2.0.4-rc1 to the final release 2.0.4 (2026-09-09). Against the release candidate it adds two extensions (Policy, PhysicalDocumentLocation) and gives Consent.policy.uri an extensible binding to LegalBasisDataProcessing.
  • Changed — the category slices resultType and templateType get decidable pattern discriminators (#140).
  • Fixed — example policy displays aligned with the CodeSystem (#136); CodeSystem.count corrected to the actual concept count (#139); the Answer ValueSet reduced to a bare all-system include (#138); example 89f494a3 switched to the defined version-modules CodeSystem (#135).
  • BREAKING: Changed — resource ids modernised to the canonical tails (#141).
    • What exactly changed: 14 artifacts carry new id values — the three profiles (56375452-… → mii-pr-consent-documentreference, e0e166b4-… → mii-pr-consent-einwilligung, f675b1e8-… → mii-pr-consent-provenance), the three value sets (2.16.840.…11.30--20210323234509 → mii-vs-consent-answer, 2.16.840.…11.36--20230331232804 → mii-vs-consent-policy, 88464c5b-… → mii-vs-consent-signaturetypes) and the six search parameters, which carried no id at all in the previous package (now mii-sp-consent-…). The canonical URLs are unchanged; the ids now follow the MII naming convention (kebab-case of name).
    • What this means for existing data: instance data is not affected. Examples and production data reference the profiles through the canonical URL in meta.profile, and that does not change — data that validated against 2027.0.0-ballot.rc1 still validates unchanged.
    • What implementers should do: every reference that addresses an artifact by its id rather than by its canonical URL must be updated — in particular REST reads of the form [base]/StructureDefinition/e0e166b4-…, artifact ids stored in registries, and deep links into the guide's artifact pages (whose file names follow the id). No automated migration path is provided; the old → new mapping is the list above.

Fresh migration onto the official release 2027.0.0-ballot.rc1 (2026-09-04)

Date 04.09.2026

  • Changed — this branch's content basis is now the official release 2027.0.0-ballot.rc1 (tag 508a666, published 03.09.2026; the repository tree is byte-identical to the previously incorporated develop state 744f7ba — the content statements of the develop section below remain valid unchanged). Complete re-derivation of all resources from the release package (goFSH; evidence: migration-log/rederivation-diff-release-2027.txt) and delta port of the guide at version 2027.0.0-ballot.rc1 (18/18 pages; among others the restructured policy explanations on the CodeSystem page).
  • Changed — parent package pin raised to de.einwilligungsmanagement 2.0.4-rc1 (the release package's pin). The parent profile removed its own Consent.category slicing in 2.0.4; this profile now declares the four slices (consentCategory/mii/resultType/templateType) itself — validation semantics unchanged.
  • Fixed — the "differences to the base profile" tables of the Provenance and DocumentReference pages, dropped with the "Darstellung" section in the 2026 migration, have been added to the profile intro notes.
  • Deliberate, logged divergences from the shipped release package (details: migration-log/run.log, entry 5.2): harmonized artifact versions, canonical SearchParameter ids (the package ships none), publisher metadata, and the Version-Modules CodeSystem the package is missing. On operator instruction (2026-09-04) ALL content-level post-migration fixes were reverted so that QA shows the official release package's error state immediately after migration: example displays, CodeSystem counts (again 101/20), the category system of example 89f494a3 (again the undefined consent_category), the four synthetic reference-target instances, and the Answer-ValueSet compose (again a concept enumeration). All fixes remain staged and are owner decisions (with them: err = 33). Remaining technical divergences from the package: harmonized versions, canonical SearchParameter ids (the package ships id-less SPs — not expressible in FSH), publisher via sushi-config (toolchain injection), and the bundled Version-Modules CodeSystem (present in the repo tag, missing only from the package — without it the build breaks).

develop incorporation (state 744f7ba, 2026-08-21) — part of 2027.0.0-ballot.rc1

Date 01.09.2026

  • BREAKING: Changed — profile MII PR Consent Einwilligung: now derives from the HL7-D profile ConsentManagement/Consent; category slices renamed/added (loinc → consentCategory; new resultType (required binding) and templateType (extensible binding)); the category 0..* cardinality declared in the develop differential is void against the parent profile (1..) and is inherited as 1.. (upstream finding). Existing instances without a resultType category no longer validate.
  • Fixed — examples: category system switched to the defined CodeSystem mii-cs-consent-version-modules (they previously referenced the nowhere- defined mii-cs-consent-consent_category).
  • Changed — Policy CodeSystem: ~19 display corrections (ACRIBIS, PROM and SNID labels); Version-Modules CodeSystem: new concept …24.2.4055 "Version 1.7.2 Vertretende". Parent package pin raised to de.einwilligungsmanagement 2.0.3 (develop/rc line).

Version 2027.0.0-ballot.rc1

Date 31.08.2026

  • Changed — migration of the guide onto the MII KDS module template v0.13.2 (IG Publisher toolchain, DE-first language model, template page structure); content-identical to release 2026.0.0 (profiles, terminology and examples unchanged; evidence: migration-log/ on this branch). All artefact versions harmonized to the package version 2027.0.0-ballot.rc1 (previously divergent per artefact, e.g. 1.0.9/1.6.0/1.1.0).

Version 2027.0.0-ballot.rc1 (Source Release Notes)

Date 03.09.2026

  • Policies SNID corrected #121

  • Policy labels ACRIBIS corrected #129

  • MIIConsentVersionModuleCodeSystem: BC variants for representatives added #127

  • Validation and dependency problems (consent.category slices) fixed #124, #119

  • CodeSystem in examples corrected #113

  • linguistic improvement to the description of the levels #112

Full Changelog: https://github.com/medizininformatik-initiative/kerndatensatzmodul-consent/compare/2026.0.0…2027.0.0-ballot.rc1

Version 2026.0.0

Date 18.12.2025

  • ValueSet MII_VS_Consent_SignatureTypes extended by the code 1.2.840.10065.1.12.1.5 "Verification Signature"

  • CodeSystem MII Consent: Policy CodeSystem - supplemented with a period of validity per policy (property period-of-validity with an ISO 8601:2004 date string or 'einmalig') - Policy 2.16.840.1.113883.3.1937.777.24.5.3.46 "MDAT retrospektiv wissenschaftlich nutzen" is now marked as deprecated and should no longer be used - Policy 2.16.840.1.113883.3.1937.777.24.5.3.47 "MDAT retrospektiv zusammenfuehren Dritte" is now marked as deprecated and should no longer be used - Policy 2.16.840.1.113883.3.1937.777.24.5.3.16 "KKDAT 5J prospektiv speichern verarbeiten" is now marked as deprecated and should no longer be used - Policy 2.16.840.1.113883.3.1937.777.24.5.3.17 "KKDAT 5J prospektiv wissenschaftlich nutzen" is now marked as deprecated and should no longer be used - Markdown representation in table form created for displaying the CodeSystem under 'Terminologie' in the IG

  • CodeSystem mii-cs-consent-version-modules created for the BC versions and additional modules - addition of OIDs for refusals (BC v1.6d and v1.7.2)

  • Consent.provision.period.end and Consent.provision.provision.period.end are now cardinality 0..1, i.e. no longer mandatory

  • Examples revised and supplemented

  • IG: editorial revision and improved explanations - new page Empfehlungen zur praktischen Anwendung added (ResultType) - handling of withdrawals for consents of minors (period of validity or expiry of the consent) - notes on use in the Modellvorhaben Genomsequenzierung (§64e) - explanation of new search parameters added

Full Changelog: https://github.com/medizininformatik-initiative/kerndatensatzmodul-consent/compare/2025.0.3…2026.0.0

Version 2025.0.4

Date 16.06.2025

  • Terminologies: - Policy CodeSystem resource display adjusted (abbreviations -> descriptive names)

  • Bugfix: - pagelink error fixed

Version 2025.0.3

Date 12.06.2025

  • IG/Consent: - support for the additional module Fachnetzwerk Infektion - SNID (Z4) added - support for the additional module Deutsche Zentrum für Psychische Gesundheit - DZPG (Z5) added - Consent: list of the available MII Consents for use in Consent.policy.uri updated - Terminologies: Policy CodeSystem extended by SNID and DZPG policies

Full Changelog: https://github.com/medizininformatik-initiative/kerndatensatzmodul-consent/compare/2025.0.0…2025.0.3

Version 2025.0.2

Date 11.06.2025

  • IG/Consent: - support for the additional module Fachnetzwerk Infektion - SNID (Z4) added - Consent: list of the available MII Consents for use in Consent.policy.uri updated - Terminologies: Policy CodeSystem extended by SNID policies

Version 2025.0.1

Date 21.01.2025

  • IG/Consent: - list of the available MII Consents for use in Consent.policy.uri updated: - additional module ACRIBiS (Z2) - additional module Patientenbefragung (Z3)

Version 2025.0.0

Date 17.12.2024

  • Consent resource - Consent.category -> max value="*" - Consent.provision.type ->fixedCode deny removed - Consent.provision.provision.type ->fixedCode permit removed - IG/Consent adjusted accordingly

  • IG/Consent - list of the available MII Consents for use in Consent.policy.uri updated (withdrawals and minors)

  • Policy CodeSystem: acribis and PROM policies added

  • IG/Terminology: - level information corrected - formatting of the note text corrected - note 1 (FHIR+policies) corrected

Full Changelog: https://github.com/medizininformatik-initiative/kerndatensatzmodul-consent/compare/1.0.7…2025.0.0