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
This section bundles the domain guidance on implementing and using the Consent module.
For the KDS-wide conformance requirements, see the conformance rules of the Meta module; for the technical artifacts, see Profiles.
The Consent extension module provides the electronic representation of the MII Consent and, beyond that, can also enable the representation of further consents. This is a prerequisite for taking the patient's will into account when the patient's medical data collected in the course of care is used for research purposes. Consent is required above all when the purpose of use goes beyond the research clauses of the respective applicable laws.
An important measure for medical research is, among other things, how many patients meet certain criteria (case count) and whether these patients have consented to the use of their data for research purposes. Such queries can only be processed and answered efficiently by electronic means if the consent status can be checked electronically. Case-count queries of this kind that take the consent status into account are essential for use cases such as 'case-count estimation', 'feasibility queries', and 'data sharing', for the MII cross-consortium use cases CORD and POLAR, as well as for the use cases of the MII consortia.
The standardized representation of the consent information in the Core Data Set is required so that it can be included as a search criterion, in particular for cross-site queries.
The representation of the consent questionnaires (Questionnaire-based content) is described on the subpage Questionnaires.