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IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.
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IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR-based submission architecture. The Implementation Guide will provide profiles on FHIR resources as well as a mapping to and from the existing SPL V3 specification. Additionally, it will document an initial FHIR-based architecture for handling existing FDA SPL use cases in parallel with the current SPL-based architecture.