MII Implementation Guide Medizinisches Forschungsvorhaben
2027.0.0-ballot - Germany

This page is part of the MII Implementation Guide Medizinisches Forschungsvorhaben (v2027.0.0-ballot: 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

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  • Removed — artifacts that were withdrawn.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