The HL7 CodeX FHIRĀ® Accelerator enters the fall with use cases moving from planning into practice. Synthetic pilots for electronic REMS exchange are getting underway at major health systems. Oncology prior authorization requirements are flowing into the Da Vinci implementation guides. Two use cases have advanced to their next phase, one in radiation therapy and one in cardiovascular health. Together, these milestones show how CodeX turns real-world interoperability problems into tested, adoptable FHIR solutions.
PVRM Pilots Move from Design to Proof
The CodeX Pharmacovigilance and Risk Management (PVRM) use case, led by Kelee Petzelt, is moving from planning and technical preparation into execution. It focuses on the FDAās Risk Evaluation and Mitigation Strategies (REMS) program, which today relies heavily on manual, disconnected processes.
Two pilot tracks are running in parallel. An FDA synthetic pilot will validate the PVRM Implementation Guideās technical functionality. A separate business pilot will apply the use case in a real-world context. The synthetic pilot was slated to begin in September at participating health systems including Henry Ford Health, Cedars-Sinai, UCSF and Northwestern, following their internal reviews.
The pilots test how standards-based exchange can support REMS requirements, dispense authorization and compliance activities among prescribers, pharmacies and REMS administrators. The technical approach combines HL7 FHIR, SMART on FHIR, CDS Hooks and NCPDP SCRIPT. Participants span the FDA, health systems, manufacturers, pharmacies, REMS administrators, EHR vendors, intermediaries, MITRE and the CodeX community.
The goal is not to change REMS program requirements. Instead, the work aims to reduce administrative burden, improve patient access to therapy, and build a scalable foundation for broader interoperability. Beyond technical validation, the pilots are also meant to show real industry demand for interoperable REMS solutions.
Bringing Oncology into the Da Vinci Prior Authorization Guides
The CodeX Prior Authorization use case team, led by Amy Krane, is working with the HL7 Da Vinci Project to add oncology-specific requirements to future versions of the Da Vinci burden reduction implementation guides. These are Coverage Requirements Discovery (CRD), Documentation Templates and Rules (DTR), and Prior Authorization Support (PAS). Together, they support standards-based workflows for discovering coverage requirements, collecting documentation and submitting prior authorization requests.
A central goal is letting an entire oncology treatment regimen move through prior authorization as a single entity. Today, individual components of a treatment plan are often handled separately. Treating the regimen as a whole better reflects how cancer care is planned and delivered, and it could simplify workflows and reduce burden for both providers and payers.
By contributing these requirements directly to the Da Vinci standards, CodeX is helping ensure that future editions of the burden reduction guides can support prior authorization for cancer treatment.
Two Use Cases Advance to Their Next Phase
The CodeX Steering Committee recently approved two use cases to move forward in the CodeX methodology.
Detailed Radition Therapy Data (RTTD)
Detailed Radiation Therapy Treatment Data has advanced from Ideation to Discovery. Led by Charles Mayo, Mary Feng, and Abigail Stockham, MD, DipOL, it builds on the foundation set by the existing Radiation Therapy Treatment Data (RTTD) use case. RTTD established standardized exchange of radiation therapy information for care coordination and data reuse. The new work will explore how to represent and exchange more detailed treatment data using HL7 FHIR, supporting research, quality improvement and real-world data needs. In Discovery, the team will refine scope, engage stakeholders, identify priority data and workflow requirements, and assess how existing standards can help. CodeX is seeking input from providers, professional societies, technology vendors, and researchers in the radiation therapy community.
Hypertension Management
Hypertension Management has advanced from Execution to Adoption. Led by Melissa Christian and Dr. James Tcheng, it aims to enable blood pressure data to flow between home devices, patient data management solutions and health systems. That gives care teams standardized information to support ongoing hypertension management in both home and clinical settings. With the foundational standards and implementation work in place, the team is now moving into real-world pilots in actual care delivery environments.
From Idea to Use Case
Every CodeX use case begins as an idea: a real-world health data interoperability challenge where collaboration and standards could make a difference. Ideas move through the CodeX lifecycle of Ideation, Discovery, Planning, Execution, and Adoption. Each phase builds the community, clarifies the problem, defines requirements, and charts a path to real-world implementation. The Detailed Radiation Therapy Treatment Data use case is a current example of that journey.
Much of CodeXās most impactful work starts with challenges raised by community members. A fully developed proposal isnāt required. The Ideation process explores promising ideas, identifies interested stakeholders, and decides whether there is an opportunity to advance the work. Anyone with an idea for a new use case can contact pmo@hl7codex.org.
Leadership and Team Updates
Andy Iverson has joined the CodeX Steering Committee as Co-Chair. He is a Senior Principal Software Engineer in Cardiac Rhythm Management at Medtronic, with a career spanning data science, clinical outcomes, and interoperability engineering. A longtime HL7 contributor, he has served on the CodeX Operating Committee since 2022 and previously co-chaired the HL7 Biomedical Research and Regulation Work Group. Within CodeX, he participates in the CardX domain, advancing FHIR-based standards in cardiovascular health.
The CodeX Program Management Office also has a new Membership Engagement Manager. Brian vanOosten is moving on after two years in the role, during which he helped onboard more than 25 new members, launched the Academic membership category, ran the first member engagement survey, and helped the Radiation Therapy Advisory Council launch its first use case. Dr. Emily Bordeleau succeeds him. She previously served as Use Case Coordinator for the GenomeX Pathogen Genomics use case, and holds a PhD in Biochemistry from McMaster University, with postdoctoral research at the University of British Columbia and Simon Fraser University. Her expertise spans antimicrobial resistance and pathogen genomics. She can be reached at Emily@HL7CodeX.org.
Get Involved
To follow CodeX progress, visit the CodeX public Confluence site, the CodeX Use Case Dashboard and the CodeX Events Calendar. Organizations interested in the radiation therapy work or in proposing a new use case can contact pmo@hl7codex.org.
