Common Data Model Harmonization (CDMH) II
This project allows short-term data harmonization efforts to continue to focus on curation and publication of mappings between FHIR and common data models with the cooperation of the National Cancer Institute's (NCI) Cancer Data Standards Registry and Repository (caDSR). CD2H continues to engage with the CDC, FDA, CCDH, NCATS, and others in the curation and harmonization of these models. Collaboration with ACT leadership to define a practical ontology is also underway. ACT provides a practical, less abstract model for investigators and researchers that distills the raw structures of EHRs and FHIR interfaces into a more friendly and approachable syntax. The Next Generation Core's immediate efforts focus on how FHIR APIs can be used by CTSA hubs to create ACT repositories to simplify the effort and process. Because extensions and practical elements needed by the translational researchers continue to arise, work is being conducted with big-Pharma and HL7 through the Vulcan FHIR Accelerator (see below) as a mechanism to create consensus FHIR extension relevant to translational research.
 Healthcare Open Terminology (HOT) Ecosystem
Requirements, Use Case, and Methods Development:
Building on progress developed in Phase II, the Next Generation Core will develop two user stories and associated functional requirements based on Cancer Data Commons scenarios of data curation/uploading and a data commons end-user. In future cycles, this core will continue to develop user stories to accompany EMR with public health and surveillance reporting being developed in the CDC MedMorph project. Continuing the development approach where we adopt established tooling and develop novel technology where gaps are identified, we will complete a detailed inventory of established terminology tools and services to prioritize next cycle technology development. In support of this approach, we will capture and disseminate the repeatable process method developed at UNC to expose content and functional gaps in terminology ecosystem architecture. A review of key semantic resources required for translational research as identified by the CCDH project will be completed and will include the US Core and OBO foundry terminologies. This master list will be used to develop and disseminate a prioritization approach to inform the next development cycle, and an inventory of published and planned FHIR resources and IGs and associated terminologies will be created to additionally inform HOT content and server development.
Terminology Server Infrastructure (Back-end) Deployment:
Based on Phase II's evaluation of FHIR terminology servers, tools, and components, the Next Generation Core is incrementally enhancing the currently implemented prototype terminology server incorporating design features found in both the HL7 FHIR and CTS2 terminology services specifications. The terminology server deployment in Phase III will serve up codes, code lists, maps, and value sets from a common core model and include ingestion or “load” functionality to OWL, allowing terminologies, models and other content to be “map-able.” When complete, the NCATS ACTS ‘ontology cell’ content, LOINC, and components of SNOMED CT (reference sets, subsets and code lists such as the DICOM and veterinary sets) will be loaded. At this stage, the server could additionally support subsequent loading of any the 171 OBO Foundry ontologies. Related to and a component of this implementation will include development and deployment of a new, prototype uniform terminology common core model for codes, code lists, maps, value sets, and their associated metadata. Derived from multiple sources evaluated in Phase II, the content model includes attributes of the caDSR and code set recommendations from the CDMH project. The model will support metadata traceability and complex mapping such as those supporting FHIR into datasets based on the CAMP-FHIR demonstration project.
 HL7 Vulcan Accelerator
In 2019, the National Center for Data to Health (CD2H) and NCATS, in partnership with major pharmaceutical companies and academic medical centers, catalyzed the formation of an HL7 FHIR Accelerator group for clinical and translational research. The new Accelerator is called Vulcan (think of the ancient god and a forge) and is being generously administered by the TransCelerate Consortium. The Vulcan Data Accelerator project will define or enhance existing FHIR resources that connect real world data (RWD) with clinical trials and regulated submissions.
The goals of the Vulcan Accelerator project are to:
- Bridge existing disparities by closing gaps between clinical care and clinical research to improve patient lives, decrease costs, and improve efficiency.
- Strategically connect industry collaborators by coordinating strategies among stakeholders and leverage existing work within HL7 and other groups, including TransCelerate BioPharma Inc., the Society for Clinical Data Management (SCDM), Clinical Data Interchange Standards Consortium (CDISC), FDA, NCATS, and others.
- Maximize collective resources by leveraging communication from the shared community for the return-on-investment and return-on-value that a unified network offers to various parties, and to provide comprehensive recommendations to global regulators.
Deliver integrated tools and solutions by advancing FHIR Research Resources to their maturity. The Accelerator Program will manage prioritized use cases for secondary use of EHR data that meet interested parties’ needs and goals.
The Vulcan Project specifically develops preliminary use cases, such as creating a FHIR profile for a research subject from patient resources, and further using those resources to connect adverse events to the profile. The Accelerator Program welcomes input from all impacted communities, particularly the CTSA whose model is to fund development of FHIR resources and profiles after consensus determination about use case priorities. The Vulcan Project works side-by-side with the HL7 Biomedical Research and Regulation (BR&R) working group. CTSA participants interested in advancing the use of EHR data for clinical research are welcome to contact CD2H or join the HL7 BR&R working group.