The Standard

Join the Vulcan FHIR® Accelerator on March 26 as we kick off a monthly forum inviting open dialogue on the development of a HL7 Fast Healthcare Interoperability Resources (FHIR®) implementation guide (IG) for the exchange of a digital clinical trial protocol. Input across the broader HL7 community will help ensure a more robust and widely applicable IG.

About

The Utilizing the Digital Protocol (UDP) project focuses on developing a FHIR IG for exchange of protocols aligned to ICH M11 (Clinical electronic Structured Harmonized Protocols). UDP is an umbrella project to accelerate exchange of ICH M11 compliant protocols through collaboration and integration of work products across Vulcan, CDISC and TransCelerate.     

Vulcan’s UDP team will:

• Provide regular project updates, offering a touchpoint for stakeholders who want to stay informed.
• Create a platform for discussion, allowing community members to raise questions, share insights, and engage more directly.

The Vulcan FHIR® Accelerator, in coordination with the US Assistant Secretary for Technology Policy/ Office of the National Coordinator (ASTP/ONC) and the Food and Drug Administration (FDA), invites you to an informational webinar for the Vulcan Interoperability Bridge (VIB) event.

The VIB event aims to accelerate the adoption of healthcare data standards for research – underscoring the value of using HL7 Fast Healthcare Interoperability Resources (FHIR®) to solve existing challenges and explore novel opportunities in research data interoperability.

The August 21 webinar is designed to share information on how we will convene clinical research sponsors, including pharmaceutical companies and academic medical centers, EHR providers, clinical research sites, and technology solutions providers to work together to demonstrate how clinical care and research interoperability is achievable utilizing existing HL7 FHIR® standards and implementation guides.

On behalf of the HL7 US Realm Steering Committee (USRSC), we are pleased to share an update on last year's priorities and highlight our focus for 2022.

2021 Highlights

Visibility was a key theme of our work in 2021 and included supporting pilot work on a standards dashboard, tracking accelerator activity and promoting key ballots.

Before we dive into 2022, we want to highlight a few key points for all US Realm (USR) members.

• SMART v2: published new guidance on granular controls
• Bulk Data v2: published with numerous new features 
• Errata release of Consolidated CDA (C-CDA): companion guide to support January 2022 ballot  
• C-CDA Companion Guide: January 2022 ballot to add USCDI v2 guidance
• US FHIR Core - January 2022 ballot: to add USCDI v2 guidance
• Hosted reviews on HL7 Standards Dashboard Prototype
• C-CDA Web Publishing Trial Draft using FHIR Structure Definition
• Facilitated US@ project with ONC team

Clinical care data is a foundation for research. It is used to understand patient populations and as the core for clinical data capture. The introduction of HL7 Fast Healthcare Interoperability Resources (FHIR®) and its adoption rate creates a new opportunity to exchange data for clinical and translational research. Building off the work already accomplished to create interoperability standards for the exchange of healthcare data bridges clinical research into the greater healthcare ecosystem.

HL7 FHIR® accelerators have been a successful catalyst for standards development and adoption. Following the path of other accelerators, the research community collaborated to create Vulcan. In August 2020, Vulcan was launched by convening the following member organizations: TransCelerate Biopharma, Duke University, Johns Hopkins, Oregon Health and Sciences University, UT Health San Antonio, Society for Clinical Data Management, U.S. National Library of Medicine, National Center for Advancing Translational Sciences (NCATS), Danish Medicines Agency and U.S. Food and Drug Administration. Membership is rapidly growing with new organizations being onboarded each month.

Vulcan Use Cases

After consultation with the Steering and Operations Committee of Vulcan, project teams have been formed to move forward three use cases. These were selected from a larger effort to collect as many as eighteen uses cases which were prioritized based on impact and the ability to deliver to the community. The initial selected use cases include:

• Real world data (including secondary use of electronic health record data)
• Phenopackets
• Schedule of activities