Vulcan Making Progress on FHIR Adoption in Clinical Research

Hosted by HL7’s Vulcan FHIR Accelerator, the Vulcan Interoperability Bridge (VIB) brings together clinical research stakeholders using the FHIR standard to enable faster and more connected clinical research. Program manager Sandy Vance recently spoke with Healthcare Innovation about the VIB’s plans to launch a second cohort while eyeing the creation of VIB programs in Europe and Japan.

Vulcan is one of eight FHIR Accelerators created to speed up FHIR adoption for specific healthcare needs. The other seven include Argonaut (early data exchange), CodeX (oncology/genomics), Da Vinci (payer/provider), FAST (infrastructure), Gravity Project (social care), CARIN Alliance (consumer access), and Helios (public health). A ninth accelerator focused on medical device interoperability is planned for 2026.

Vulcan was established to help speed up things such as clinical trial feasibility assessments and subject searches, monitoring protocol execution, pre-populating case report forms and collection of patient-reported outcomes.

The VIB implementation guides focus on operational efficiencies at research sites and accessing quality real-world data for study cohorts or safety reporting. 

Launched in late 2024, the VIB is hosted in collaboration with the Food & Drug Administration (FDA) and the Assistant Secretary of Technology and Policy (ASTP). It involves 34 companies, including clinical trial sponsors, EHR vendors such as Epic, life science leaders, technology innovators, and academic medical centers, including the Medical University of South Carolina, Memorial Sloan Kettering Cancer Center, UCSF, the University of Washington, and Vanderbilt University. 

Vance explained that with the interoperability bridge, they are bringing together organizations that have joined Vulcan to test with each other and send information back and forth. “For instance, we were able to engage the FDA to send adverse event reporting. This is something that has been done for a long time with Excel spreadsheets and e-mail,” she explained. “We were able to use the FHIR standard to demonstrate how that information can be pushed through an API directly to the FDA using what they call a MedWatch form, which is the form that they use to monitor adverse events.”

By making that connection electronic, that data goes automatically to the FDA, but it also means that it doesn't have to be reported separately by a bunch of different organizations, she added, so everybody has the same information at the same time, “which is a really big deal when you're talking about things that impact how drugs are used.”

Another aspect of that work is that the product labels — the little paper that goes in with the drug — get updated, and they need to be updated based on the information learned from the adverse events reporting. “We're facilitating that happening at a much faster, more efficient pace,” she said. 

In the HL7 process, an implementation guide has to go through three connect-a-thons, and it takes about a year to get through that process, which includes some vetting and balloting, where the community weighs in. “But once they're through that process, that's when we can engage them with the interoperability bridge,” Vance added.

With the second cohort getting ready to enter the VIB, Vance said they anticipate added FHIR-to-OMOP, a project that provides a standardized approach to transform data from FHIR into the OMOP common data model. They could also add Vulcan Interoperability Guides from other projects as they mature. 

“We want to continue to expand the use of these standards,” Vance said. “The idea is not to build standards just for the sake of having the standards, but to have standards that are in action, that are being implemented by these organizations, and show how much better things can be by using these standards, so that we can get widespread adoption.”

In its first cohort, the Vulcan Interoperability Bridge has five main focus areas: 

• Internal Sponsor Systems: This workflow outlines how clinical research sponsors leverage internal systems, structured authoring tools, and technology providers to streamline protocol development, data collection, and reporting using FHIR standards. “Instead of using spreadsheets, e-mail communication, and shared documents, we were able to take a lot of those transactions that happen and show how an API can streamline the process,” Vance explained. “Most of these life sciences companies are global, so they are solving a problem in the United States, and they're also working in Japan, but there they are using a completely different process. What this does is standardize that process of digitizing their clinical protocols across the board, and they're able to use that same process globally.”

• Research Site to Sponsor: Leveraging clinical trial protocols to guide structured data collection. According to VIB, this approach enhances data accessibility, streamlines processes, and accelerates research timelines. “This is another use case where in the clinical research community uses these electronic data capture (EDC) systems to pull all of that information together,” Vance said, “and we need them to be using a standard so that the data can easily move from EHR to EDC.” The execution of clinical trials is addressed through a couple of implementation guides, and one is around the schedule of activities — all of that population selection for who's going to be in a clinical trial and all of the activities that happen from the time that the the trial is set up through engaging patients to reporting the information, Vance explained. Some of the standards that the Vulcan Accelerator has developed are now being used for those processes.

• Regulatory Focus Area: Support rapid investigation of new or increased adverse events related to medical products. As Vance explained earlier, this provides the ability to support rapid investigation of new or increased adverse events related to medical products, and structured drug labeling information.

• Patient Focus Area: This effort explores ways to engage patients to allow them to directly share their real-world data such as patient-reported outcomes with clinical researchers.

• Health Information Exchange: Enabling secondary use of data. Executives from InterSystems and Manifest MedEx are among those working on ways to allow federated compilation of data into a single set that can be used for real world research questions that are approved by an honest broker. 

“The Vulcan Interoperability Bridge is a really important step," Vance said. “This is where the rubber meets the road. This is where we're getting these implementation guides actually built into systems. We're getting these technology solutions providers to work with the clinical community, to work with the life sciences community, and to work with governments across the globe to make sure that they know what's possible. Being able to see that we've implemented these things and how they can facilitate these other projects really helps gain support and traction.”

Vance also mentioned the goal of expanding overseas. “In Europe, there are a number of national projects where the government is trying to figure out how to push interoperability forward to improve healthcare,” she said. “We were able to engage recently with the European Health Data Space and talk about using the FHIR standard. Vulcan partnered with that organization to put on an event that brought those people together, and it really engaged a lot of great projects. We are working actively to recruit some organizations that are working in the European space to be a part of this next cohort.”

She said it is important for FHIR accelerators to provide visibility, so that organizations can see who's actually doing this work, and for regulatory bodies and others that are spearheading major global projects to see that this is the best way to do it.