FDA’s Commitment to HL7 Standards
Health Level Seven (HL7) is a standards developing organization aimed at providing a comprehensive framework and related standards for the exchange, integration, sharing, and retrieval of electronic health information that supports clinical practice and the management, delivery, and evaluation of health services. HL7® is supported by more than 1,600 members from over 50 countries. FDA utilizes several HL7 standards and has been an active member of HL7 since the year 2000.
HL7 has a suite of standards, and one is Fast Healthcare Interoperability Resources (FHIR). “FHIR® leverages the latest web technologies and applying a critical focus on implementation”. The organization has convened several accelerator programs to assist communities and implementers with an interest in using FHIR to address common use cases. The HL7 Accelerator program will help such communities initiate and efficiently navigate through the standards development process by providing guidance on how to navigate and work with HL7 work groups, product families and project teams.
FDA’s Role in the HL7 Vulcan Accelerator
FDA is one of the founding members of one of the HL7 Accelerators’ program called Vulcan. Vulcan is dedicated to connecting clinical research and healthcare, resulting in making clinical trials faster, more inclusive, simple, and efficient. It was formed in September 2019 by a group of invested representatives from government agencies, academia, technology companies, standards developing organizations, patients, and industry consortiums. The Center for Drug Evaluation and Research’s (CDER) Office of Translational Sciences (OTS), Office of Strategic Partnership (OSP), and Office of Surveillance and Epidemiology (OSE) representatives are active members of the HL7 Vulcan Accelerator, serving on the steering and operations committees, the Real-World Data (RWD) and the Adverse Events Clinical Research workgroups.
Adverse Events and Real-World Data
The FHIR Adverse Events Clinical Research implementation guide was published recently in May 2024. The OSE representative served as the co-chair of this workgroup.
The Vulcan Real-World Data (RWD) group is co-led by CDER OSP. The first iteration Implementation Guide “Retrieval of Real World Data for Clinical Research”, aims to help define a minimal set of clinical research FHIR resources and elements in an electronic health record (EHR) system, that can be utilized in an interoperable and consistent manner for clinical research objectives (e.g., academic, regulatory, etc.) to facilitate downstream use (directly or after transformation) for submissions to pharmaceutical regulatory agencies. Since publication, the group has been working with the Vulcan Program Management Office to identify potential partners to collaborate in robust “real world” testing.
The source data capture from EHRs and other sources of real-world data (RWD), such as digital health technologies have the potential to improve the reliability, quality, traceability, provenance and integrity of data from electronic source to regulatory submission.
