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

Questionnaires

The AG Einwilligungsmanagement has dealt comprehensively with the modeling of consents and consent templates.

This Implementation Guide builds substantially on that preliminary work.

The profiles Questionnaire Composed, Template Frame and Template Module are based on the FHIR resource Questionnaire and serve to represent the consent form (here: MII Broad Consent).

The Template Module constitutes a reusable basic building block that is used or embedded in one or more form sections (TemplateFrames). One or more TemplateFrames can be composed into a complete, renderable form (QuestionnaireComposed).

The profile QuestionnaireResponse electronically represents the questionnaire completed by the patient. Here the patient's answers to the referenced questionnaire (QuestionnaireComposed) of the MII Broad Consent are documented.

To represent the answers, the value set "MII Consent: Answer ValueSet" should be used:

Checkbox Code designator Code (OID)
'Yes' checked gültig 2.16.840.1.113883.3.1937.777.24.5.2.1
'No' checked nicht gültig 2.16.840.1.113883.3.1937.777.24.5.2.2
not checked unbekannt 2.16.840.1.113883.3.1937.777.24.5.2.3

Answers (checkbox), code designators and OIDs

The data elements of the MII Broad Consent form in versions 1.6d and 1.6f are modeled as a dataset in ART-DECOR; see the section Datasets incl. descriptions.

Use of uniform policies

The required value sets are likewise modeled in ART-DECOR) and associated with the corresponding data elements. Compatibility with IHE BPPC (Integrating the Healthcare Enterprise, "Basic Patient Privacy Consent" profile) is addressed via policies.

The operationalization and enforcement of the consent information is supported by a uniform policy value set. This can be used interoperably in IHE BPPC.