This page is part of the MII IG Kerndatensatz-Modul Onkologie (v2027.0.0-ballot.1: Release) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

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Official URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-onko/ImplementationGuide/mii-ig-onko-de				Version: 2027.0.0-ballot.1
Active as of 2026-09-15				Computable Name: MII_IG_Onko_DE

Introduction

This specification describes the FHIR representation of the Core Dataset (CDS) module Oncology of the Medical Informatics Initiative (MII). It covers the module's use cases and the associated FHIR profiles, extensions and terminology resources in their normative form. The MII Core Dataset enables the standardized secondary use of routine clinical data for medical research.

The Oncology module is based on the German oncology base dataset (oBDS), which forms the foundation of national cancer registration. It covers diagnostic and histological parameters as well as information on treatment, tumor staging at baseline and during follow-up, the recording of adverse events and the detection of metastases.

Publication
Version	2027.0.0-ballot.1 (CalVer YYYY.n.n)
Status	active
Realm	DE

Content and purpose of the modeling

The CDS module Oncology aims to correctly represent the oncological data that arises in primary care and in cancer registry reporting, and to relate it to other data sources.

The focus of the first implementation version is the transfer of the registry data collected under the oBDS for secondary use with the German Portal for Medical Research Data (FDPG) and other projects within PM4Onko. This version therefore only contains data points of clinical-diagnostic or therapeutic character. Administrative (e.g. report, reporter) or person-identifying (person, tumor assignment) data points are out of scope.

In addition to the base dataset, the oBDS provides for organ-specific data fields. Organ-specific modules (including breast, prostate, colorectal) are being added incrementally.

Mapping to open data standards

The oBDS contains value lists primarily defined by ADT/GEKID without a direct relationship to open terminologies such as SNOMED CT or LOINC. The coding of the answer options was adopted as it exists in the primary systems. At the same time, this implementation guide provides a preliminary mapping of the fields and answer options to SNOMED CT (and other terminologies where applicable) as FHIR ConceptMaps. The federal state cancer registries and BfArM are working towards an official national mapping of oBDS cancer registry data to SNOMED CT; once published, the mapping contained here will be updated accordingly.

Target audience

Contents

• Guidance — getting started and domain notes.
• Conformance — the KDS-wide conformance rules (requirements language, Must Support, handling missing data) are maintained centrally by the Meta module; the module-specific Security and Privacy considerations are part of this guide.
• Profiles and the further artifact pages — the technical artifacts.
• Examples — example instances.
• Dependencies — the ImplementationGuide resource with the dependency table and copyright statements.

Related guides

This module is part of the MII Core Dataset. It builds on the German base profiles (de.basisprofil.r4) and the CDS modules Meta and Base, and references the modules Biobank, Medication, Molecular Genetics Report (MolGen) and Study/Research Project; the other CDS modules are described at medizininformatik-initiative.de.

More FHIR implementation guides can be found in the official FHIR IG Registry.

Imprint

This guide was created within the Medical Informatics Initiative and is subject, by its governance process, to the coordination procedure of the Interoperability Forum and the technical committees of HL7 Germany.

Contact

• Thomas Debertshäuser, Berlin Institute of Health (Charité)
• Martin Boeker (DIFUTURE)
• Sylvia Thun, Berlin Institute of Health (Charité)
• Karoline Buckow, TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.
• Franziska Klepka, TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.

Questions about this publication can be asked on the HL7 FHIR Zulip chat.fhir.org in the german/mi-initiative stream, or on the MII Zulip mii.zulipchat.com in the MII-Kerndatensatz stream. Comments and issues are welcome as Issues on GitHub.

Authors (in alphabetical order)

• Christian Gulden (BZKF / Erlangen)
• Jori Kern (DKFZ Heidelberg)
• Julian Saß, Berlin Institute of Health (Charité)
• Margaux Gatrio, Berlin Institute of Health (Charité)
• Lotte Schwiening, Berlin Institute of Health (Charité)
• Paul Müller, Berlin Institute of Health (Charité)
• Nina Haffer, Berlin Institute of Health (Charité)
• Sophie Klopfenstein, Berlin Institute of Health (Charité)
• Thomas Debertshäuser, Berlin Institute of Health (Charité)
• Yuan Peng, Institut für Medizinische Informatik und Biometrie (TU Dresden)

Copyright and License

© 2019+ TMF e. V., Charlottenstraße 42, 10117 Berlin

The content of this specification is public and is released under CC0-1.0 (Public Domain Dedication); reuse and republication are not restricted.

For the usage rights of the underlying FHIR technology, see the FHIR base specification. Some of the code systems used are published and maintained by other organizations; the copyright of the respective publishers applies.

Disclaimer

The content of this document is public. Please note that parts of this document are based on FHIR version R4, which is copyrighted by HL7 International.

Although this publication was prepared with the greatest care, the authors cannot accept any liability for direct or indirect damage that may arise from the content of this specification.