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Official URL: http://onconova.github.io/fhir/ImplementationGuide/onconova.fhir				Version: 0.2.0
Active as of 2026-03-18				Computable Name: Onconova

Introduction

Onconova is an open-source precision oncology platform focused on enabling advanced cancer research. The FHIR interface exposes key resources, profiles, and value sets to facilitate standardized data exchange and integration with EHRs, registries, and analytics platforms.

This implementation guide provides a comprehensive overview of the FHIR-based server interface to Onconova, supporting interoperability, data exchange, and integration with clinical and research systems. It complements the OpenAPI specification and is designed for healthcare organizations, developers, and integrators seeking to leverage Onconova's oncology data.

Relation to mCODE

This FHIR interface is designed to align with the minimal Common Oncology Data Elements (mCODE) STU4 Implementation Guide, leveraging established, community-driven standards for oncology data. The Onconova IG refines and constrains mCODE resources to ensure consistent data elements and terminology bindings. Additionally, it defines new profiles to address oncology use cases not yet covered by the mCODE IG.

Understanding this Guide

The Onconova Implementation Guide (IG) serves as a “Software” IG that explains how to work with Onconova’s FHIR interface and outlines the additional constraints Onconova places on top of the mCODE standard.

The page layouts and symbols are explained in the FHIR documentation. In viewing a profile page, note that there are multiple views. The "Differential Table" view represents the difference between the current profile and its base resource or profile. When interpreting this view, bear in mind that the immediate parent may not be a base FHIR resource, but could be a US Core profile or another profile in this guide. The "Snapshot Table" represents the entire profile, with all elements.

Page layouts and symbols follow the conventions described in the official FHIR documentation. When you open a profile page, you’ll notice several different views:

• Differential Table: This view highlights the differences between the current profile and its immediate parent (which might be a base FHIR resource, a US Core profile, or another profile defined within this guide).

• Snapshot Table: This view shows the complete profile, listing every element in its fully expanded form.

If you encounter any inconsistencies between the rendering of pages in this IG and the corresponding FHIR artifacts, treat the FHIR artifacts as the authoritative source.

Safety Considerations

This Implementation Guide specifies the data elements, resources, formats, and exchange methods used to share research healthcare information. Because clinical safety is paramount, additional safety guidance for the many possible implementations can be found at the HL7 FHIR safety page: https://www.hl7.org/FHIR/safety.html.

While the guide includes provisions that support adherence to data‑protection and security regulations, merely using the specification does not ensure compliance. Compliance must be achieved through appropriate safeguards applied during implementation projects and in routine operations.

Governance

The Onconova FHIR IG is managed by the Onconova development group.

Credits

The authors thank the mCODE Working Group for their diligent effort and solid contributions, which have been essential to the project's progress.

IP Statements

This document is licensed under Creative Commons "No Rights Reserved" (CC0).

HL7®, HEALTH LEVEL SEVEN®, FHIR® and the FHIR ® are trademarks owned by Health Level Seven International, registered with the United States Patent and Trademark Office.

This implementation guide contains and references intellectual property owned by third parties ("Third Party IP"). Acceptance of these License Terms does not grant any rights with respect to Third Party IP. The licensee alone is responsible for identifying and obtaining any necessary licenses or authorizations to utilize Third Party IP in connection with the specification or otherwise.

This publication includes IP covered under the following statements.

• The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
  Show Usage
  • Unified Code for Units of Measure (UCUM): OnconovaLifestyle and OnconovaTumorMutationalBurden
• This material contains content from LOINC. LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
  Show Usage
  • LOINC: AminoAcidChangeTypes, OnconovaCancerStage... Show 14 more, OnconovaECOGPerformanceStatus, OnconovaGenomicVariant, OnconovaImagingDiseaseStatus, OnconovaKarnofskyPerformanceStatus, OnconovaLifestyle, OnconovaMicrosatelliteInstability, OnconovaTumorBoardRecommendations, OnconovaTumorBoardReview, OnconovaTumorMarker, OnconovaTumorMutationalBurden, OnconovaVitalSignsPanel, TumorMarkerAnalyte, TumorMarkerAnalytes and TumorMarkerTests
• This material contains content that is copyright of SNOMED International. Implementers of these specifications must have the appropriate SNOMED CT Affiliate license - for more information contact https://www.snomed.org/get-snomed or info@snomed.org.
  Show Usage
  • SNOMED Clinical Terms® (SNOMED CT®): AdverseEventMitigation, AdverseEventMitigationDrugs... Show 52 more, AdverseEventMitigationManagements, AdverseEventMitigationProcedures, AdverseEventMitigationTreatmentAdjustments, CancerImagingMethods, CancerPatientCauseOfDeath, CancerPatientVitalStatus, CausesOfDeath, ExpectedDrugEffects, HomologousRecombinationDeficiencyInterpretation, HomologousRecombinationDeficiencyInterpretations, MolecularTumorBoardTherapeuticRecommendation, ObservationBodySites, OnconovaCancerFamilyMemberHistory, OnconovaComorbidities, OnconovaImagingDiseaseStatus, OnconovaLifestyle, OnconovaLymphomaStage, OnconovaMedicationAdministration, OnconovaMolecularTumorBoardReview, OnconovaPrimaryCancerCondition, OnconovaRadiotherapyCourseSummary, OnconovaSecondaryCancerCondition, OnconovaSurgicalProcedure, OnconovaTNMDistantMetastasesCategory, OnconovaTNMGradeCategory, OnconovaTNMLymphaticInvasionCategory, OnconovaTNMPerineuralInvasionCategory, OnconovaTNMPrimaryTumorCategory, OnconovaTNMRegionalNodesCategory, OnconovaTNMResidualTumorCategory, OnconovaTNMSerumTumorMarkerLevelCategory, OnconovaTNMVenousInvasionCategory, OnconovaTumorBoardRecommendations, OnconovaTumorBoardReview, PrimaryCancerRecurrenceType, RecreationalDrugs, RecurrenceTypes, SmokingStatus, TNMDistantMetastasisCategories, TNMGradeCategories, TNMGradeCategoryMethods, TNMLymphaticInvasionCategories, TNMPerineuralInvasionCategories, TNMPrimaryTumorCategories, TNMRegionalNodesCategories, TNMResidualTumorCategories, TNMSerumTumorMarkerLevelCategories, TNMVenousInvasionCategories, TherapyLineIntent, TreatmentIntents, TreatmentTerminationReasons and VitalStatus
• This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
  Show Usage
  • Observation Category Codes: OnconovaAneuploidScore, OnconovaCancerRiskAssessment... Show 8 more, OnconovaGenomicVariant, OnconovaHomologousRecombinationDeficiency, OnconovaImagingDiseaseStatus, OnconovaLossOfHeterozygosity, OnconovaMicrosatelliteInstability, OnconovaTumorMarker, OnconovaTumorMutationalBurden and OnconovaTumorNeoantigenBurden
  • identifierType: OnconovaCancerPatient
  • ObservationInterpretation: TumorMutationalBurdenStatus and TumorMutationalBurdenStatusInterpretations

Dependency Table

Package hl7.fhir.uv.extensions.r4#5.2.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.genomics-reporting#2.0.0 Guidelines for reporting of clinical genomics results using HL7 FHIR. (built Mon, May 9, 2022 16:52+0000+00:00)

Package hl7.fhir.uv.extensions.r4#1.0.0 This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Sun, Mar 26, 2023 08:46+1100+11:00)

Package hl7.fhir.uv.bulkdata#2.0.0 FHIR based approach for exporting large data sets from a FHIR server to a client application (built Fri, Nov 26, 2021 05:56+1100+11:00)

Package hl7.fhir.uv.sdc#3.0.0 The SDC specification provides an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR. This includes two components: * Support more sophisticated questionnaire/form use-cases such as those needed for research, oncology, pathology and other clinical domains. *Support pre-population and auto-population of EHR data into forms/questionnaires for uses outside direct clinical care (patient safety, adverse event reporting, public health reporting, etc.). (built Tue, Mar 8, 2022 18:32+0000+00:00)

Package ihe.formatcode.fhir#1.1.0 Implementation Guide for IHE defined FormatCode vocabulary. (built Thu, Feb 24, 2022 16:55-0600-06:00)

Package hl7.fhir.us.core#6.1.0 The US Core Implementation Guide is based on FHIR Version R4 and defines the minimum conformance requirements for accessing patient data. The Argonaut pilot implementations, ONC 2015 Edition Common Clinical Data Set (CCDS), and ONC U.S. Core Data for Interoperability (USCDI) v1 provided the requirements for this guide. The prior Argonaut search and vocabulary requirements, based on FHIR DSTU2, are updated in this guide to support FHIR Version R4. This guide was used as the basis for further testing and guidance by the Argonaut Project Team to provide additional content and guidance specific to Data Query Access for purpose of ONC Certification testing. These profiles are the foundation for future US Realm FHIR implementation guides. In addition to Argonaut, they are used by DAF-Research, QI-Core, and CIMI. Under the guidance of HL7 and the HL7 US Realm Steering Committee, the content will expand in future versions to meet the needs specific to the US Realm. These requirements were originally developed, balloted, and published in FHIR DSTU2 as part of the Office of the National Coordinator for Health Information Technology (ONC) sponsored Data Access Framework (DAF) project. For more information on how DAF became US Core see the US Core change notes. (built Fri, Jun 30, 2023 14:02+0000+00:00)

Package hl7.fhir.us.mcode#4.0.0 mCODE™ (short for Minimal Common Oncology Data Elements) is an initiative intended to assemble a core set of structured data elements for oncology electronic health records. (built Sun, Feb 16, 2025 19:03+0000+00:00)

Package hl7.fhir.uv.tools.r4#1.1.0 This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Mar 3, 2026 22:50+1100+11:00)

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Onconova is an open source project and welcomes all contributors. The source code for this IG is maintained in the Onconova Github. All of the profiling work is done using FHIR Shorthand and SUSHI. All content is subject to change.