Samvit Solutions Contributes to Transforming FDA's Data Exchange Standard for Product Labeling

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Samvit Solutions embarked on a transformative project with the FDA, focusing on evaluating replacing the current Structured Product Labeling (SPL) data submission standard, which is based on complex HL7 V3. The shift aims to utilize FHIR—a modern web-based standard integrating features like RESTful APIs and JSON messages—to overcome limitations. In partnership with IBM, Samvit first developed a comprehensive 'As-Is' picture of the current SPL utilization within the FDA, identifying all dependencies impacted by the V3 to FHIR transition. They subsequently crafted an innovative FHIR Implementation Guide for governing labeling data submissions. The core technical challenge addressed was architecting a solution that seamlessly replaces the SPL HL7 V3 standard with FHIR while minimizing disruption. Samvit designed a unique 'dual-submission' approach, allowing data submission in both V3 and FHIR formats. This included a critical reconciliation and synchronization component to maintain consistency for both submitters and FDA reviewers. Furthermore, they developed a robust data model and database emphasizing minimal reliance on any specific exchange standard, focusing heavily on the FDA’s business requirements. Through building a proof of concept (PoC), Samvit implemented identified SPL use cases and the dual-submission concept using FHIR and the new database. This innovative approach provides the FDA with maximum flexibility and control during the transition period, ensuring critical operations are safeguarded from disruption. The collaboration demonstrates setting the stage for a more efficient, flexible, and future-ready data exchange system.