MCODE FHIR IG Proposal

HL7 FHIR Implementation Guide: minimal Common Oncology Data Elements (mCODE)

Owning work group name

Clinical Interoperability Council

Committee Approval Date:

May 23 2019

Publishing Lead

Publishing Facilitator (per PSS): Laura Heerman Langford (Laura dot Heermann at imail dot org)

Technical IG Publisher Lead: Chris Moesel (cmoesel at mitre dot org)

Contributing or Reviewing Work Groups

• Clinical Information Modeling Initiative WG
• Clinical Genomics WG
• Public Health WG

FHIR Development Project Insight ID

1509 [1]

Scope of coverage

This IG covers elements that are key for cancer management and care according to US clinical practice, including patient demographics, details about the disease and treatment, as well as outcomes. It is intended to provide a standard for data gathered from clinician-patient interactions that take place during routine healthcare delivery, and leveraging this "real world data" for other applications, such as quality measurement, comparative effectiveness research, and shared decision making. The IG aligns with other relevant US-realm FHIR IGs, such as the Argonaut Data Query IG.

Content location

https://github.com/HL7/fhir-mCODE-ig

Proposed IG realm and code

us/mcode

Maintenance Plan

mCODE is a large, highly visible initiative sponsored by the American Society of Clinical Oncology (ASCO) and developed in partership with the MITRE Corporation, in consultation with the Biden Cancer Initiative and the National Cancer Institute (NCI). ASCO has has established a governance body for mCODE through its Executive Committee, and there is commitment from the CIC WG to maintain the IG. Specifically, the MITRE Corporation is committed to maintaining the mCODE IG.

Short Description

This IG specifies a core set of common data elements for cancer that is clinically applicable in every electronic patient record with a cancer diagnosis. It is intended to enable standardized information exchange among EHRs/oncology information systems and reuse of data by other stakeholders (e.g. quality measurement, research).

Long Description

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 (EHRs). The goal is to facilitate cancer data interoperability and improve overall cancer data quality for patient care and research by establishing a set of elements that would form the basic data that would populate all EHRs for patients with cancer. mCODE™ has been created and is being supported by the American Society of Clinical Oncology (ASCO®) in collaboration with the MITRE Corporation. mCODE™ consists of a core set of structured data elements necessary to support clinical care and oncology research across all cancers.

Involved parties

This guide was authored by the MITRE Corporation with extensive content expertise provided by the American Society for Clinical Oncology (ASCO), CancerLinQ, and with input and contributions from the HL7 community, including the Clinical Interoperability Council WG (sponsor), the Cancer Interoperability Project Group, Clinical Information Modeling Initiative WG (co-sponsor), the Clinical Genomics WG, and the Public Health WG.

Expected implementations

This IG is already being used for a couple of applications:

• Creating a “patients like this” comparative effectiveness tool, designed to be used by clinicians and patients to improve shared decision-making when it comes to cancer treatment options. The tool extracts mCODE data and deliver reports to providers and patients—empowering shared decision making (currently under implementation with Intermountain Health Care)
• Using mCODE to support data collection for clinical trials with the goal to validate the clinical endpoint data collected via the EHR, by showing that it matches the results obtained using standard study-specific electronic case report forms (currently being implemented in iCAREData project, in partnership with the Alliance for Clinical Trials in Oncology, Brigham and Women's Hospital and the Dana-Farber Cancer Institute).

Content sources

• North American Association of Central Cancer Registries (NAACCR) version 18
• American Joint Committee on Cancer (AJCC) Staging Manual (8th Edition)
• HL7 FHIR Implementation Guide: Genetic Reporting STU 1
• HL7 Domain Analysis Model: Clinical Genomics Release 1
• HL7 CDA® Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1 – US Realm
• HL7 FHIR Implementation Guide: Breast Cancer Data, Release 1 - US Realm

Example Scenarios

• Use in comparative effectiveness and shared-decision making tools
• Data collection for clinical trials

IG Relationships

This IG depends on Argonaut Data Query IG/US Core. There are also some inter-dependencies with the Genomics Reporting FHIR IG.

Timelines

Currently targeting the September 2019 ballot, so IG would be ready by early August.

When IG Proposal Is Complete

When you have completed your proposal, please send an email to FMGcontact@HL7.org