Last year in 2022, the HL7 Germany working group “Consent Management” reported on the concepts and background of the HL7 Germany FHIR standard for consent management and presented initial results.

This FHIR standard of the HL7-D “Consent Management” working group is the starting point for the work of the Consent Implementation Taskforce in the Medical Informatics Initiative (MII). The task force has developed the core data set module “Consent” based on this preliminary work. This specification concretizes the generic approaches of the HL7-D working group “Consent Management” in order to achieve the most standardized and uniform procedure possible with regard to the structured documentation, retrieval and enforcement of consents within the MII.

The resulting basic module “Consent” of the MII core data set is a central solution element for the uniform consideration of patient consent in medical research. Standardized search parameters are defined as an “interface” to the MII’s Research Data Portal Health (FDPG) to enable researchers to carry out feasibility queries and thus determine the availability of data and biosamples at the MII sites.

Dr. Martin Bialke and Lars Geidel from the Trusted Third Party of the University Medicine Greifswald are part of the HL7 Germany working group “Consent Management” and the MII’s Consent Implementation Taskforce. They have accompanied the work of the taskforce from the very beginning with regard to the established concepts of consent management gICS.  gICS has supported this FHIR-based technical standard since version 2.13.4 and has also offered compatibility with the MII core data set Consent (v1.0.3) since May 2023. This enables the search for FHIR Consent resources according to the specifications of the Consent Implementation Taskforce and conveniently supports a connection to the FDPG.

The print version of the article was published in September 2023 and is now also available online. The article can be cited as follows: Stäubert S*, Bialke M, Geidel L, Merzweiler A, Jörg R, Buckow K, Lang S. Standards-Serie #17 – HL7-FHIR-STANDARD FÜR EINWILLIGUNGSMANAGEMENT AUF DEM WEG IN DIE PRAXIS. E-HEALTH-COM. 9/2023; 5:44-47.

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