FHIR Server (HL7)

This Request for Quote (RFQ-2026-75F40126Q00368) is issued by the Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) to acquire an enterprise-grade Fast Healthcare Interoperability Resources (FHIR) Server. Conducted via the NASA SEWP V IDIQ as a Total Small Business set-aside (NAICS 541519), this is a firm-fixed-price solicitation on a brand name (InterSystems IRIS for Health) or equal basis. The selected server will serve as the backbone for CBER's Sentinel Biologic Effectiveness and Safety Innovative Methods (BEST IM) platform, recently migrated to CBER's High-performance Integrated Virtual Environment (HIVE). The required solution must be operation-ready and fully managed by the contractor, including security, backups, and maintenance. Key system requirements include supporting the latest HL7/FHIR and USCDI standards, open API-based definitions, multi-method authentication (OAuth 2.0, Cognito, OKTA, Azure AD), and integration with open-source clinical research tools like the OMOP common data model. The contract has a 12-month period of performance. It features two primary Line Items: CLIN 001 for the FHIR Server and optional CLIN 002 for remote technical support and software maintenance. Additionally, the quote includes optional hardware items (NVIDIA DGX H100 servers and rack-mounted PDUs). All support personnel must sign HIPAA-compliant Business Associate Agreements (BAAs) prior to accessing healthcare data. Performance security risk is designated as Tier 1 (Low Risk), and invoicing will be managed electronically through the U.S. Department of Treasury’s Invoice Processing Platform (IPP).