Standardized Information Model for Clinical Texts: The MII Core Data Set Module Document.

The objective is to create a standardized, harmonized information model for clinical documents based on the HL7 FHIR specification. The connection between unstructured data and its metadata facilitates internal organization and external access for scientific use. A profile was developed by an interdisciplinary group of experts participating in the German Medical Informatics Initiative (MII) based on the HL7 FHIR R4 DocumentReference and existing profiles from the clinical routine. The result is an HL7 FHIR profile consisting of an HL7 FHIR DocumentReference with a new extension and relations to existing modules of the MII Core Data Set. We introduce a specific natural language processing extension for the representation of the respecitve document processing status. In conclusion, the developed MII CDS module serves as a foundation for any research involving clinical documents containing unstructured data, simplifying coordination through the use of interoperable standards.