HL7 Vulcan

HL7 FHIR® is the communication standard for exchanging healthcare data being adopted worldwide. Past announcements from the FDA and current developments by the European Union (European Health Data Space, European Medicines Agency: IDMP, Unicom, Gravitate Health ) all prioritize FHIR as the underlying data transmission standard. Vulcan uses a non-competitive development environment to help boost the adoption of FHIR for clinical research. In the 2 years since launch, Vulcan has established 6 active projects, produced 3 implementation guides and now has a membership of over 40 organizations with global presence. Current Vulcan Projects: Vulcan projects are establishing standards across a broad spectrum of clinical research use cases. The first three projects are currently being balloted by HL7 International. 1. ePI: Electronic Product Information In collaboration with Gravitate Health), making Medicinal Product Information machine processable. 2. RWD: Real World Data Setting minimum standards for adoption of the International Patient Summary (IPS) to allow EHR data to be used for Clinical Research 3. SoA: Schedule of Activities Representing the schedule of activities in machine readable format. The basis for full protocol representation. 4. AE: Adverse Events The FHIR AdverseEvent resource has been updated for research; an Implementation Guide is being written for balloting in 2023 5. Phenotypic Data Representation of genomic data in the EHR using HL7 FHIR 6. FHIR to OMOP Establishing a gold standard mapping from the many that exist 7. UDP: Utilizing the Digital Protocol Bringing together multiple initiatives developing a digital representation of a Study Protocol