Since last October’s Cancer Data Summit, we’ve made substantial progress in our goal to enable interoperability across cancer patient data and systems. Using mCODE™ to collect, share, and extract data from EHRs means that every interaction between a clinician and cancer patient provides data that could be used to improve care for all future patients.
More and more people are learning how mCODE could help their organizations meet the needs of cancer patients. Stakeholders—including patients, vendors, providers, payers, research organizations, and government agencies—are starting to work together within the new CodeX™ HL7 FHIR Accelerator and elsewhere.
New CodeX Members and Use Cases
One way to bring oncology stakeholders together is through CodeX (Common Oncology Data Elements eXtensions), the new HL7 FHIR Accelerator focused on implementing and testing solutions.
CodeX is building a community to accelerate interoperable data modeling and application development, leveraging mCODE. By convening project work groups, CodeX is developing and testing solutions around new use cases, including radiology, clinical pathways, registry reporting, and patient - clinical trial matching.
CodeX members get the benefits of HL7’s Accelerator Program, pioneered through efforts such as the Argonaut and Da Vinci projects. CodeX members can work and learn together, and leverage advanced tooling and processes that speed implementation, adoption and, ultimately, value to cancer patients and all stakeholders.
Founding CodeX Members (so far) include: The Alliance for Clinical trials in Oncology Foundation, EMD Digital, HL7, MITRE, and Pfizer. Many other organizations are in the process of joining.
Please visit here for more information on membership and use cases.
New CodeX / mCODE Community of Practice
We created the CodeX / mCODE Community of Practice to expand the network of health systems, which have been and will be at the forefront of piloting mCODE in real-world settings. This group of cancer centers meets online monthly to share experiences and develop best practices for implementing mCODE into production EHRs and other systems.
Joining the Community of Practice is free and open to all interested parties. Participants in the first meeting in January included: Brigham and Women’s Hospital, Dana Farber Cancer Institute, Duke University Health System, Intermountain Medical Center, Kaiser Permanente, Memorial Sloan Kettering Cancer Center, MITRE, Partners HealthCare, Trinity Health/Saint Joseph Health System, University of California San Francisco Medical Center, and the University of Texas Southwestern Medical Center.
If you're interested in joining the Community of Practice, please contact Blake Bergstrom, firstname.lastname@example.org.
New ICAREdata Study Pilots
The ICAREdata Study is piloting the application of mCODE to support the prospective collection of high-quality real-world data to enable clinical oncology research. The ICAREdata Study collaborates with clinical trials to collect key outcome data not yet well represented in EHRs and partners with clinical sites to share this critical outcome data, as well as the rest of mCODE. ICAREdata’s hypothesis is that dramatic improvements in clinical trial operational efficiency and reductions in clinical trial cost will be achieved by using the patient’s EHR as the source of study data.
In Phase 2 of our ICAREdata work, MITRE and the Alliance for Clinical Trials in Oncology are partnering with clinical trials to demonstrate the real-world data from the EHR based on mCODE can support equivalent clinical trial endpoints. The first trials include:
- A071701 – Genomically Guided Treatment Trial in Brain Metastases
- A021703 – SOLARIS: Randomized Double-blind Phase III Trial of Vitamin D Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer
We are looking for other partners/clinical trials. Those that have already begun planning for the implementation of prioritized mCODE data elements within their EHRs to support the ICAREdata Study include:
- Massachusetts General Hospital
- Brigham and Women’s Hospital
- Dana Farber Cancer Institute
- The Mayo Clinic
- The University of Pennsylvania Health System
mCODE Version 1.0 Approved
The mCODE underwent an HL7 ballot as a trial standard in September 2019. The ballot process involves collecting comments from the broad HL7 voter community and formally resolving each comment. All comments have now been addressed, and the mCODE team expects HL7 to officially publish mCODE Standard for Trial Use version 1.0 in March 2020.
mCODE 1.0 contains 90 data elements across six domains: patient, disease, labs/vitals, treatment, genomics, and outcomes. The 1.0 version—stable for adoption and approved for trial use—will be available in March from here and on GitHub for developers to test.
On behalf of the mCODE / CodeX Team ... Very best regards,
Steven R. Bratt, Ph.D.
Leader, CodeX HL7 FHIR Accelerator
Leader, MITRE Health Standards and Interoperability Group