MII Implementation Guide Consent
2027.0.0-ballot -
Germany
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
The work on the core data set specifications is based, wherever possible, on international standards and terminologies — in particular on the preparatory profiling work of the AG Einwilligungsmanagement on FHIR Consent.
All elements of the core data set, adapted to the details and requirements of the use cases of the Medical Informatics Initiative, are described below in the form of FHIR StructureDefinitions. The need for adapting the FHIR profiles is explained in textual form beneath the respective profiles.
For mandatory elements or elements marked as must-support, please refer to the corresponding rules of the IPS, which also apply to this ImplementationGuide.
The profiles of this module:
In addition to Consent, Provenance, and DocumentReference, further profiles are relevant for handling consents and consent templates; they are adopted unchanged from the Einwilligungsmanagement implementation guide.
Support for the following profiles is mandatory when using this guide:
| FHIR profile | For the representation of / used for |
|---|---|
| Organization | Responsible organization |
| ResearchStudy | Research project |
| Patient | Affected person (pseudonymized) |
If the Broad Consent is represented or captured by means of FHIR Questionnaires, the following profiles should additionally be used:
| FHIR profile | For the representation of / used for |
|---|---|
| QuestionnaireResponse | Completed consent |
| QuestionnaireComposed | Consent template (renderable) |
| TemplateFrame | Consent template (structure definition) |
| TemplateModule | Consent module |