About Vulcan Interoperability Bridge

The story of clinical research has always been one of astounding breakthroughs… and barriers. It’s the story of research, regulators and technologists working together, and more recently, the story of equitable access and activated patients empowered to share their experiences. Clinical research is evolving — and it’s happening through the collective efforts of a passionate, deeply engaged community.

By fostering cross-sector collaboration, Vulcan is helping clinical research organizations develop and implement interoperability standards that work in the real world, not just in theory. From aligning with regulators to engaging sites of all sizes (yes, even those without massive tech teams), Vulcan members are co-creating the infrastructure needed for research that is more efficient, inclusive, and patient-centered.

The VIB isn’t just about compliance or convenience — it’s about possibility. When HL7 FHIR is at the heart of clinical research, it opens up a new era of what that research can be.

Imagine:

• Smart product labels that do more than just list ingredients – they flag real-time updates and integrate with clinical decision tools
• Automated, accurate data exchange of lab results, vitals and adverse events between sites, sponsors and regulators — with near-zero manual errors
• Patient-reported outcomes and quality of life data that matter, seamlessly connected to the research team and integrated into the clinical record — no typing, no transcription, no lag
• Faster, more responsive studies, where insights flow effortlessly into results

These are the types of breakthroughs that are shared as the Interoperability Bridge process brings implementers together — not as hypotheticals, but as working examples already making an impact across the industry. The Vulcan Interoperability Bridge Demonstrations are not about vague future talk, but tangible results that serve as proof points for what’s possible.

How It Started

In late 2024 during an annual meeting in Washignton DC, founding members of the Vulcan HL7 FHIR Accelerator met with leadership from the Food and Drug Administration (FDA), and Office of the Assistant Secretary of Technology and Policy (ASTP formerly ONC) to share ideas on how to gain industry traction for HL7 FHIR Implementation Guides that had been in the works for several years. It became apparent that the industry needed to be supported in a pre-pilot effort to implement FHIR in technologies that are supporting clinical research.

The Vulcan Interoperability Bridge project was chartered soon after and the team set to work building out use cases that could demonstrate how Vulcan implementation guides can improve workflows around five key areas. A call for participation was put out to technology solution providers supporting clinical research facilities, pharmaceutical companies, and federal agencies by leveraging HL7 FHIR Implementation Guides to forge a path forward for clinical research data infrastructure.

The Vulcan Interoperability Bridge project team has worked with over 30 technology solutions providers, bringing them together to build and test the implementation guides in end to end workflows to demonstrate the art of what is possible. Demonstrations include the use of 4 Vulcan implementation guides and several other FHIR APIs that support clinical research infrastructure.

Cross Agency Collaboration

The HL7 Vulcan Accelerator represents a diverse, member-led community, formed in 2019, operating within HL7’s FHIR® Accelerator program and dedicated to improving data interoperability by bridging clinical care and research. Vulcan will provide the primary implementation guides and technical guidance on implementing HL7’s FHIR®.

The US Office of the Assistant Secretary of Technology Policy is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information. ASTP supports the Vulcan Interoperability Bridge Event through promotion, event management and aligning resources to strengthen the clinical trials infrastructure and optimize clinical trial data capture.

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services, protects public health by regulating human and veterinary drugs, vaccines and other biological products, medical devices, our nation’s food supply, cosmetics, dietary supplements, electronic radiation emitting products, and tobacco products. FDA will offer support to the Vulcan Interoperability Bridge by helping to establish use case requirements alongside implementers.

Shared projects across federal agencies require advancements in clinical research infrastructure. The natural progression of the HL7 FHIR standard is to build prototypes and demonstrate how it can support major projects.