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

Area of Science:

• Medical Informatics
• Health Data Standards
• Clinical Document Management

Background:

• Clinical documents contain valuable unstructured data crucial for research.
• Existing data models lack standardization, hindering interoperability and scientific access.
• The German Medical Informatics Initiative (MII) aims to improve data utilization in healthcare.

Purpose of the Study:

• To develop a standardized and harmonized information model for clinical documents.
• To leverage the HL7 FHIR specification for creating an interoperable data model.
• To facilitate internal organization and external scientific access to clinical document data.

Main Methods:

• Developed an HL7 FHIR profile based on the DocumentReference resource.
• Utilized existing profiles from clinical routine and the MII Core Data Set.
• Created a new extension for representing document processing status using natural language processing.

Main Results:

• An HL7 FHIR profile for clinical documents was successfully created.
• The profile integrates with existing MII Core Data Set modules.
• A novel natural language processing extension was introduced for document status.

Conclusions:

• The developed MII CDS module provides a foundation for research involving clinical documents.
• This standardized model simplifies coordination and enhances the use of unstructured data.
• Interoperable standards are essential for advancing research with clinical documents.