SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
Official URL: http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl | Version: 0.2.0 | |||
IG Standards status: Trial-use | Maturity Level: 1 | Computable Name: FHIR_SPL |
This FHIR Implementation Guide is focused on supporting the FDA implementation of the HL7 Structured Product Labeling (SPL) standard using FHIR. Currently, vendors submit their drug labels using the HL7 V3 SPL standard. This Implementation guide provides details on how future submissions can be made using the FHIR specification. It provides a set of FHIR profiles that outline the required data elements and any needed extensions to the core FHIR resources. It also provides a set of XSL transforms that allow for the conversion of SPL submissions to FHIR Bundles as well as from FHIR Bundles to SPL submissions.
The first phase of the project focuses on SPL-to-FHIR and FHIR-to-SPL data element mapping and processing related to Medicinal Products and Establishment/Facility Registration. The scope includes the four use cases listed below along with their corresponding SPL document types:
At the end of this phase, this guide will have captured the following:
NOTE: The following product elements are out-of-scope for this phase: Products intended for Animals, Dietary Supplements, Medical Food Products, Device Products, and Cosmetic Products.