MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

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

Changelog

This page records the changes between the released versions of the Medizinisches Forschungsvorhaben 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:

  • Added — new profiles, extensions, value sets, search parameters, pages.
  • Changed — modified constraints, bindings, guidance or documentation.
  • Deprecated — artifacts that still exist but should no longer be used.
  • Removed — artifacts that were withdrawn.

Changes Ballot version v2027.0.0-ballot (as of 31.08.2026)

New Profiles and Functionality

  • ResearchSubject added to the Logical Model: New BackboneElement "ResearchSubject" (person participating in a study) added

  • Translations added for profiles:

    • ResearchSubject profile: German and English translations added for title, description, and elements (identifier, status, period, study, individual, consent)
    • Study Inclusion Request profile: German and English translations added for elements (status, intent, category, code, reasonReference, supportingInfo)
    • English version of the Implementation Guide
Bug Fixes
  • Extension context restricted: Context of the ResearchStudy extensions (study registry, eligibility, acronym, recruitment, funding, ethics approval, backport AssociatedParty/Label) explicitly restricted to ResearchStudy
  • Logical Model corrected: "id" element of the BusinessID renamed to "identifier", since the Logical Model namespace already assigns its own id to every element
  • Validator errors resolved:
    • No-longer-needed dependency (hl7.fhir.uv.xver-r5.r4) removed from the ImplementationGuide
    • Home page added to the table of contents
    • pagecontent folder moved to the correct path
  • Spelling errors fixed: Typo in the title of the German Implementation Guide corrected, "DE" label added to the title
  • Broken link fixed: Reference to the IPS rules on must-support elements updated, warning icon added to the associated table
Harmonization and Technical Improvements
  • Aliases harmonized: Terminology aliases unified and standardized (including $SCT, $LNC, $UCUM), usage in examples and profiles adjusted accordingly
  • Rulesets standardized:
    • New "MetaProfile" RuleSet introduced for versioning of meta.profile entries
    • Translation RuleSet revised with clearer parameter names
    • Placeholder file for license terms (license-terms.fsh) added
  • Language setting added: Language tag "de-DE" added to sushi-config.yaml

Changes final version v2026.0.1 (published 09.01.2026)

New Profiles and Functionality

  • ResearchSubject Profile: Adoption of the profile for capturing study participants (subjects) from the Person module
    • Integration: In Implementation Guide with Capability Statements
    • Subject Snapshot: Added to the IG
    • Examples: Added for ResearchSubject
    • Reference Resources: Added for examples
  • Study Inclusion Recommendation Profile: New profile for study inclusion recommendations
    • Examples: Added for study inclusion requests
    • Integration: In Implementation Guide
  • UML Diagrams: Comprehensive UML diagram for the MII study model adjusted
    • Visual Documentation: Of the module architecture improved

Implementation Guide Improvements

  • Documentation updated:
    • CapabilityStatement documentation corrected (typos fixed)
    • Referenzen.md updated with current information
    • Context documentation (KontextimGesamtprojektBezgezuanderenModulen.md) updated
    • References to outdated ART-DECOR removed
    • Simplifier issue references replaced with GitHub
    • References to base and extension modules removed where no longer applicable

Example Data Extensions

  • Test bundle and examples added:
    • Comprehensive example bundle added for testing
    • ResearchStudy examples extended with extension elements
    • EvidenceVariable examples extended with additional elements
    • Patient and Consent examples updated
    • Subject (participant) identifier structure modified
    • Example URLs updated for consistency
    • Current example structure reorganized
    • ValueSets added for examples

Validation and Quality Improvements

  • HDB issues resolved:
    • HDB-722: FHIR profiles moved to FHIR-Profile subfolder
    • HDB-723: Broken image references in documentation corrected
    • HDB-725: meta.profile for inclusion and exclusion criteria corrected
    • HDB-726: meta.profile for registry, PractitionerRole, ResearchStudy, ResearchSubject corrected
    • HDB-727: ResearchStudy example not included - fixed
  • Search Parameters and Logical Model:
    • Numbering in search parameters corrected
    • MS flag removed from reasonReference where not applicable

Technical Improvements

  • Dependencies and Package Management:
    • package.json dependencies updated
    • Meta dependency updated to the latest version
    • Specific meta dependency version set
    • Version information updated throughout the module

Conformance and Standards

  • KDS Release Guideline 2025.0.0 Conformance:
    • Conformance with KDS Release Guideline 2025.0.0 ensured
    • Data and metadata corrected
    • Checklist for Implementation Guide publication for the comment version completed

Translations

  • Translations pull request merged
  • Multilingual support improved