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Comment: updated CardX use case; moving from discovery to planning and updating tasks, accomplishments

The purpose of this CodeX Use Case Project Dashboard is to provide status updates for the most significant, overarching tasks associated with each Use Case. This dashboard will act to facilitate discussions regarding Use Case progress and performance for key tasks. CodeX Use Cases projects are in one of 3 stages:

  • CodeX Use Cases projects are in one of 3 stages, transitioned according to the Use Case Development Guidelines:

    • Use Cases are in the Discovery are ideas in the Backlog that have been proposed for future consideration, with a small group discussing, and aligning on a concept.
    • Use Cases in Active Community Planning are, as the name implies, being planned with Members - Identifying necessary stakeholders, objectives, deliverables, measures of success and schedules for fast-moving phases.
    • Use Case Projects in Active Community Execution are projects where models, mCODE-based FHIR IGs, implementations and pilots are currently under development, led by CodeX members.

Contact CodeX Program Management to learn more about any of the Use Cases below. Pre-Discovery and Archived Use Case Concepts can be found here. All are welcome to join the CodeX/mCODE Community of Practice to hear presentations on implementation work inside and outside of CodeX.


Early member group defining problem, goals, value and scope

Engaging interested community members and preparing for public CodeX meetings to discuss the first CardX use case, develop a proposed solution/workflow, and identify end goal

Use Cases and Objectives

Key Work Underway

Key Accomplishments

Active Community Execution



Cancer Registry Reporting

Enable reporting of mCODE-based cancer data from health center EHRs to a state and a private registry that are aggregating data for different reasons, substantially reducing duplication and burden while increasing reporting speed and accuracy.

Status
colourGreen
titleCOMPLETE
 Phase 0 - Collect requirements and build technical architecture needed for pilot activity - conveying essential patient data to registries in a timely/low burden way

Status
colourGreen
titleCOMPLETE
Phase 0 - Health system(s) commitment for implementation, pilot activity completed

Status
colourYellow
titleOn Track
Begin phase 1 activities as outlined in the Cancer Registry Reporting section.

Status
colourGreen
titleCOMPLETE
 Phase 0 - Determine patient data to use

Status
colourGreen
titleCOMPLETE
 Phase 0 - Determine state registry endpoint for pilot

Status
colourGreen
titleCOMPLETE
Phase 0 - Determine private registry endpoint for pilot

Status
colourGreen
titleCOMPLETE
Phase 0 - Implement MedMorph reference architecture at a Health system and create plan definitions for a state and a private registry.

Status
colourGreen
titleCOMPLETE
Phase 0 - Complete the data exchange between the health system and the state registry and the private registry, proving the underlying architecture. 

Status
titleCANCELED
 Drafting PSS in FHIR IG Publishing Process - decided to publish under MedMorph as Content IG, separate PSS as needed

EHR Endpoints for Cancer Clinical Trials (ICAREdata)

Collect research-quality mCODE-based data in and share from EHRs to increase the value of real-world data for clinical trials, and reduce and potentially eliminate manual and/or duplicate data entry into case report forms. 

Status
colourYellow
titleOn Track
ICAREdata Phase 2 - 11 clinical trials participating in ICAREdata (5 activated embedded trials and 6 under the companion protocol). 10 health systems with contracts. 2 health systems currently sharing data to the ICAREdata infrastructure.

Status
colourRed
titleDELAYED
 ICAREdata Adverse Event Reporting - Drafted initial AE model in draft CTCAE IG and documented AE clinical workflow. Developed IT implementation tracker. Pursuing a no cost extension into 2023. Project will engage sites that have already completed or close to completion of The ICAREdata project to participate in the AE project. 

Status
colourGreen
titleCOMPLETE
 Draft FHIR IG 

Status
colourGreen
titleCOMPLETE
 Phase 1 – Demonstrated successful collection of Cancer Disease Status as a structured phrase in patient clinical note

Status
colourGreen
titleCOMPLETE
Phase 2– An operational infrastructure with mCODE data flowing from health systems to the ICAREdata infrastructure


Integrated Trial Matching for Cancer Patients and Providers 

Leverage mCODE-based data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching services to improve the ability for patients to find clinical trials for which they may be eligible. 

Status
titleDEFERRED
Phase 2A – integration with PDMs and production clinical trial matching services, working with patient advocacy organizations to recruit patients to join application and test capability, expand to multiple cancer types and evaluate clinical trial matching service coverage

Status
colourYellow
titleOn Track
Phase 2B – expand data analysis to include additional patients and cancer types, integrate clinical trial matching at the point of care for prospective pilot 

Status
colourGreen
titleCOMPLETE
 Draft FHIR IG  

Status
colourGreen
titleCOMPLETE
 Phase 0 Pilot using synthetic data to find trials via one matching services (Report)

Status
colourGreen
titleCOMPLETE
 Trial Matching PSS approved by HL7 BR&R Workgroup and TSC

Status
colourGreen
titleCOMPLETE
 Phase 1A – integration with Cancer Insights, recruiting patients to join application and test capability, evaluating the optimized patient data elements

Status
colourGreen
titleCOMPLETE
 Phase 1B – use of retrospective patient data from UTSW and Massive Bio, evaluating the optimized patient data elements 

mCODE++ Extraction

Software to enable existing EHRs and other systems to share cancer patient data conformant to the mCODE FHIR IG, to support a variety of use cases.

Status
colourYellow
titleOn Track
 Implementing Extraction framework to support the ICAREdata project within the EHR Endpoints for Cancer Clinical Trials use case. 

Status
colourGreen
titleCOMPLETE
 Extraction Framework published 

Radiation Therapy Treatment Data for Cancer

Leverage mCODE and extensions to enable sharing of critical radiation therapy treatment data for care coordination or data reuse (research, quality measurement, payer-required reporting).

Status
colourYellow
titleOn Track
Phase 3 – finalizing Prescription and Plan profiles and implement in XRTS technical spec and CodeX RT IG

Status
colourYellow
titleOn Track
Phase 4 – modeling RTTD team's defined list of Phase 4 data elements

Status
colourYellow
titleOn Track
Phase 3 – gathering all Sept. 2022 HL7 ballot comments, resolve negative comments, and update CodeX RT IG to reflect decisions

Status
colourYellow
titleOn Track
Phase 3 – Varian & RaySearch begin designing initial pilot with interested health site(s) – Michigan, VA, MD Anderson, UCSF, Penn

Status
colourYellow
titleOn Track
Phase 3 – Preparing for upcoming December 2022 IHE-RO Exchange of Radiotherapy Summaries (XRTS) Workshop


Status
colourGreen
titleCOMPLETE
Phase 2 complete - Epic, Varian, and RaySearch implemented the radiotherapy profiles in the XRTS framework at the May 2022 XRTS Workshop

  • RTTD held a Public Call on July 19th, 2022 to provide project updates and upcoming plans

Status
colourGreen
titleCOMPLETE
RayCare 6A supports the mCODE Radiotherapy Course Summary and Radiotherapy Volume

Status
colourGreen
titleCOMPLETE
CodeX RT IG officially submitted to September 2022 Ballot Cycle

Prior Authorization in Oncology

Facilitate sharing of mCODE-based clinical data between providers and payers to reduce burden and speed authorization or requests for more information.

Status
colourYellow
titleOn TRACK
Phase 1 - Use case is in the Execution Phase 

Members (eviCore/Evernorth, Varian, Mettle Solutions, ASTRO, MCG, ONS, Telligen, McKesson/Ontada) have confirmed prostate radiation oncology pilot. 

McKesson has identified clinical level practice management/workflow SMEs to engage in workflow evaluation, technical requirements and data.  They are focusing on synthetic data and test system for with a prime focus on prostate at this time

Bi-weekly technical team are progressing.  Workflow has been completed.  Identification of Data elements (demo graphics and clinical) has been completed (see below). 

Status
colourGreen
titleCOMPLETE
Phase 1 - Test site system preparation by EHR/Varian and McKesson pilot sites

Status
colourGreen
titleCOMPLETE
FHIR server set up by Varian and CRD, DTR programming by eviCore

Status
colourYellow
titleIN PROGRESS
Phase 1 -  PAS process

Status
colourYellow
titleIN PROGRESS
Phase 1 - Drafting of implementation documentation is progressing.   

Status
colourGreen
titleCOMPLETE
Phase 1 - Identification and documentation creation Scenarios to be tested


Documentation found here - PA in Oncology - Documents

Status
colourGreen
titleCOMPLETE
Develop an end-to-end proof of concept with full prior authorization in conformance with Da Vinci standards

Status
colourGreen
titleCOMPLETE
  The proof of concept features the Da Vinci prior authorization information exchange with two synthetic cancer patients who have mCODE elements.  The exchange shows extraction of mCODE from the EHR via a SMART-on-FHIR application.  This data pre-populate the FHIR questionnaires used in interaction between provider and payer.

Status
colourGreen
titleCOMPLETE
  Breast and Prostate use cases and champions identified.  Request to move to planning phase completed.  Phases of Planning and key efforts to accomplish have been identified and vetted with members and the public.  

Status
colourGreen
titleCOMPLETE
Identification of test site piloter

Status
colourGreen
titleCOMPLETE
New demonstration from implementer/developer, MCG, was completed 5.11.22.  See PA in Oncology - Documents for demo video

Status
colourGreen
titleCOMPLETE
 Evaluation of patient demographic and clinical data elements to be used in use case and gap analysis to mCode.  Initial evaluation has been done but with a deeper dive into the workflow to identify the need for PA, the data needed at each step, may alter the data elements needed or not needed.

Status
colourGreen
titleCOMPLETE
Phase 0 Pilot metrics identified by members




Active Community Planning



Risk Evaluation and Mitigation Strategies

Create integrated, automated, efficient, and effective REMS programs by leveraging open data standards and creating the data infrastructure to enable REMS integration into the current workflow and data sharing across REMS stakeholders reducing undue burden 

Status
colourYellow
titleIN PROGRESS

Leadership meets weekly. Forming membership for the technical subgroup that will plan and execute on the pilot.  

Public meetings are scheduled for January, February, March and April 2023. Registration details follow: 

The REMS use case team are presenting an update on their work at the February CodeX Community of Practice on 2/24/23 at 12:00 PM ET. Register here



Discovery

CardX - Hypertension Management

Status
colourYellow
titleIN PROGRESS

Awaiting approval of HL7 Project Scope Statement. HL7 Project Proposal submitted and approved by Clinical Interoperability Council (CIC) with agreement to act as sponsoring work group, and co-sponsorship from the  Mobile Health Work Group.

Engaging interested community stakeholders, growing the member community, and identifying roles for members (i.e. potential pilot site, personal health intermediary, etc.)

Solidifying phased plan for testing, validation, and proof of concept

Status
colourGreen
titleCOMPLETE
Use case identified by community Leadership and scope defined

Status
colourGreen
titleCOMPLETE
Champions identified and Leadership team established meeting regularly






Discovery



GenomeX - FHIR Genomics Data Exchange

Status
colourYellow
titleIN PROGRESS

Phase 0 MVP Pilot implementation that will enable Vanderbilt University Medical Center to request a FHIR based genomics report from Tempus using a restful FHIR API, receive and verify FHIR transmission and import it into the Epic Genomics Module.

Establishing sub-work groups, Payload to determine data elements for transmission and Transport to determine data transmission mechanism for the next phases of work.

Status
colourYellow
titleOn TRACK

Transition to Planning end of January and Execution Q1 2023

Status
colourGreen
titleCOMPLETE

Use case goals, value and scope defined; Champions identified and Leadership team established meeting regularly

Planning for Phase 0 Pilot and Identification of focus areas for future Phases

Genomics Operations: Enabling Access to Complex Genomic Information through FHIR Genomics Operations

Status
colourYellow
titleIN PROGRESS

Engaging interested community members and preparing for an initial pilot phase focused on the Genomic Reporting IG operations in support of molecular tumor review boards


Status
colourYellow
titleOn TRACK

Transition from Discovery to Planning stage by the end of February 2023

Status
colourGreen
titleCOMPLETE

Use case goals, value and scope defined; Champions identified and meeting regularly

Quality Measures for Cancer

Create a solution that demonstrates the ability to author and evaluate digital quality measures using the FHIR data model and mCODE, where applicable, for value-based programs and clinical quality improvement in the oncology domain


Status
colourYellow
titleOn Track
Preparing project materials to support transition from Pre-Discovery to Discovery. Focusing efforts on:

  1. New member orientation
  2. Discussing what moving to the Discovery Stage entails
  3. Reviewing the Use Case Development Guidelines page for next steps

Status
colourGreen
titleCOMPLETE
CodeX Quality Measures Proposal approved by CodeX Steering Committee and use case officially moved to the Discovery Stage


On Hold

Oncology Clinical Pathways 

Enable clinicians to use an oncology clinical pathway applications that accurately navigates to recommended treatments using mCODE-based data from the EHR.