Short Description

This track will test the conversion of Structured Product Label (SPL) documents to FHIR Bundles using the FHIR SPL to FHIR Implementation Guide profiles and mappings.

Long Description

The FHIR SPL to FHIR IG provides a set of profiles on the Medicinal Product Definition resources along with a set of mappings from the HL7 V3 SPL specification to the FHIR profiles.  The track intends to test the mappings as well as the profiles.  It will focus on the conversion of SPL documents to FHIR as well as FHIR Bundles to SPL documents.

Type

Test an Implementation Guide

Track Lead(s)

Jean Duteau ; Scott Gordon

Track Lead Email(s)

jean@duteaudesign.com ; gideon.gordon@fda.hhs.gov

Specification Information

http://build.fhir.org/ig/HL7/fhir-spl/branches/main/index.html

Call for participants

Organizations and vendors that support creation of existing SPL documents

Track Prerequisites

  1. Have read the SPL FHIR IG: http://build.fhir.org/ig/HL7/fhir-spl/branches/main/index.html
  2. Have software that can either generate V3 SPL documents or FHIR SPL documents

Zulip stream

https://chat.fhir.org/#narrow/stream/179308-BRR---Pharmacy-model/topic/FHIR.20SPL.20IG.20Connectation.20Track

Track Kick off Call

September 12, 2022 - 1pm Eastern - https://us02web.zoom.us/j/87364633133?pwd=N0w2V0RCREp6M20xNGhHSzVHRFI3QT09

Recording:  https://us02web.zoom.us/rec/share/cdjryEVtmF2wrabmFp4zjg3Xsrhz5H2A3j1SLav7cwYFERF35UU8o6Jl9Vionvp2.JfhN91FVeQtbnoTU

Clinical Input Required?No
Related Tracks?2022 - 09 Vulcan/Gravitate Health - ePI/IPS (Phase 4)

Testing Scenario:

System roles

Generator of SPL Drug Product Label documents

Able to generate SPL Drug Product Label documents and submit them to a system that converts to FHIR Bundles

Generator of FHIR Drug Product Document Bundles

Able to generate FHIR Document Bundles that are conformant to the IG profiles and submit them to a system that converts to SPL documents

Receiver of FHIR Drug Product Document Bundles

Able to receive FHIR Document Bundles and either display them or convert them to SPL documents and display them

Receiver of SPL Drug Product Label documents

Able to receive SPL documents and display them

SPL / FHIR Converter

System that can convert SPL documents to FHIR Bundles and vice versa


For SPL generation/receiving, no advance preparation is required as the mappings provided are intended to create/take FHIR Documents and convert to proper SPL.

Scenarios

SPL to FHIR Submission

Action:

  • Create an SPL Drug Product Label document and submit to a SPL/FHIR Converter system
  • Retrieve the resultant converted FHIR Bundle
  • Display the FHIR Bundle as a Drug Product Label

Success Criteria:  

  • SPL document is converted correctly
  • Converted FHIR Bundle validates and displays properly
  • All SPL information is found in the FHIR Bundle

FHIR to SPL Submission

Action:

  • Create a FHIR Drug Product Label Document Bundle and submit to a SPL/FHIR Converter system
  • Retrieve the resultant converted SPL Drug Product Label
  • Display the SPL Drug Product Label

Success Criteria:  

  • FHIR document is converted correctly
  • Converted SPL Drug Product Label validates and displays properly
  • All SPL information is found in the FHIR Bundle
Available Tools and Servers

SPL Generation Tools

https://validator.pragmaticdata.com/validator-lite/validator/spl-form/

Source of existing SPLs

https://dailymed.nlm.nih.gov/dailymed/

https://labels.fda.gov

SPL to/from FHIR Conversion Tools

http://splfhir-demo.com.s3-website.us-east-2.amazonaws.com