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