Samvit Solutions Involvement in Transforming FDA’s Data Exchange Standard for Product Labeling

Samvit Solutions embarked on a transformative project with the FDA, focusing on evaluating the possibility of replacing the existing Structured Product Labeling (SPL) data submission standard. The current standard, based on the complex and challenging HL7 V3, has been undergoing a revolutionary shift towards HL7’s Fast Healthcare Interoperability Resources (FHIR). This modern web-based standard is set to overcome the limitations of its predecessor by integrating advanced features like RESTful APIs and JSON-based messages. The objective of this project is to evaluate how using FHIR would streamline and future-proof the process of submitting labeling data to the FDA.

In this ambitious undertaking, and in partnership with IBM, Samvit’s team is playing a pivotal role. Our initial task involved developing a comprehensive As-Is picture of the current SPL standard’s utilization within the FDA, identifying all dependencies potentially impacted by the transition from HL7 V3 to FHIR. Samvit’s consultants then crafted an innovative FHIR Implementation Guide, laying the groundwork for the new standard governing labeling data submissions to the FDA.

Samvit Solutions was presented with the challenge of architecting a solution that seamlessly replaced the SPL HL7 V3 standard with HL7 FHIR, ensuring minimal disruption to the FDA’s current processes. We designed a unique dual-submission approach allowing data submission in both SPL V3 and HL7 FHIR formats. This strategy included a critical reconciliation and synchronization component, maintaining transparency and consistency across submissions for both submitters and FDA reviewers.

Our proposed implementation strategy involved more than just the dual-submission approach. We developed a robust data model and database for SPL submissions, emphasizing minimal reliance on any specific data exchange standard and focusing heavily on the FDA’s business requirements. Our analysts worked closely with the implementation team to build a proof of concept, implementing identified SPL use cases and the dual-submission concept while leveraging the FHIR standard and the new database.

Throughout this project, the Samvit team collaborated extensively with subject matter experts across various FDA centers. This collaboration was crucial in gathering comprehensive insights on the current utilization of the SPL HL7 V3 standard and understanding the potential impacts of transitioning to the HL7 FHIR standard. Our team’s expertise and collaborative efforts have been instrumental in navigating this complex landscape and setting the stage for a more efficient, flexible, and future-ready data exchange system.

This innovative approach offers the FDA numerous benefits. It ensures a seamless implementation of the new standard, safeguarding FDA’s critical operations from disruption. Additionally, it grants the FDA maximum flexibility and control over the transition period for adopting the new FHIR standard and phasing out the HL7 V3 standard. As the FDA continues to develop and test the proof of concept in collaboration with subject matter experts and future submitters, we stand at the brink of a new era in healthcare data exchange, demonstrating Samvit’s commitment to innovation and excellence in healthcare IT solutions.

Note: The FDA has not yet announced formal plans to replace its current process of receiving labeling data (SPL) in HL7 V3 format with HL7 FHIR format.