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HL7 ICSR DSTU UPDATE

HL7 ICSR DSTU UPDATE. Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting. HL7 ICSR DSTU Update. Progress to Date: Identification of testing stakeholders FDA Harmonization Vocabulary Domains Schema Generation Tool: XFORM PSSIG Harmonization Efforts

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HL7 ICSR DSTU UPDATE

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  1. HL7 ICSR DSTU UPDATE Patient Safety SIG RCRIM Joint Meeting HL7 January Working Group Meeting

  2. HL7 ICSR DSTU Update • Progress to Date: • Identification of testing stakeholders • FDA Harmonization • Vocabulary Domains • Schema Generation Tool: XFORM • PSSIG Harmonization Efforts • ISO/CEN/HL7/JIC ICSR • GHTF • VICH • Next Steps

  3. HL7 DSTU ICSR Update • Identification of Stakeholders • US Govt: VA & NIH • Regulators: • Australian Competent Authority • VICH GL 42 • Japan • Healthcare Providers: • Mirixa Corp. (Pharmacy services provider) • ASTER Project: Pfizer & Brigham and Women’s Hospital • Vendors • Quantros • GlobalSubmit

  4. HL7 ICSR DSTU Update • Developed high-level templates to collect information about what will be tested: • Interactions and storyboards • End user tooling • Vocabulary requirements • Held teleconferences in Oct and Nov

  5. HL7 ICSR DSTU Update • FDA Harmonization: • MedWatchPlus, FAERS, Pre-market AEs • Mapping across all data collection forms • Mapping to existing e-submission formats Which resulted in: • Identification of Vocabulary Domains

  6. HL7 ICSR DSTU Update • Vocabulary Domains: • Performed a high-level review of what is currently available as FDA or outside reference sources: HL7, NCI, UMLS, others • Streamlined the work to a even higher-level to help prioritize the work with NCI

  7. HL7 ICSR DSTU Update • Schema Generation Tool: • FDA XFORM • New HL7 Schema Generation tool now available • Developed and hosted by GlobalSubmit: • Current prototype: 3500 and 3500A • “crude” 1st step for schema generation and validation to help implementers • Generates HL7 XML and transforms to E2B(M) • Next generation will cover coding and other product areas (animal reporting, eMDR)

  8. HL7 ICSR DSTU Update • PSSIG Outreach and Harmonization Efforts: • ISO/CEN/HL7: Pharmacovigilence (ICSR) • VICH GL 42 • GHTF N87 • BRIDG AE Harmonization

  9. HL7 ICSR DSTU Update • ISO/CEN/HL7 JIC ICSR • Completed initial mapping, identified gaps and the need to clarify how ICH content is represented in “hidden” attributes • EX: Use of code/value pairs for investigative subjects, concurrent observations, reporting criteria • VICH GL42 • VICH parties signed agreement to test HL7 ICSR, most likely Release 3 • Provided DSTU instance examples for Release 2, FDA harmonization of vet terms

  10. HL7 ICSR DSTU Update • GHTF N87 • Presented HL7 ICSR to GHTF Oct ’07 • Mapped N87 to HL7 ICSR • Discussing “extensions” used in other countries: UK & Germany • Meeting planned with UK Q1-Q2 ’08

  11. HL7 ICSR DSTU Update • BRIDG AE Harmonization • Active participation by identified stakeholders since June ’07 through weekly telecons! • Programs/projects mapped • ICSR • FAET • caAERS • SDTM

  12. HL7 ICSR DSTU Update • Finalize agreement on AE model at end of HL7 meeting to present at Feb BRIDG harmonization

  13. HL7 ICSR Update • Next steps: • Follow up with all stakeholders to review testing schedule: Establish a formal workgroup: Propose an HL7 workgroup • Continue XFORM development and posting of material on FDA and PSSIG website • Prioritize immediate vocabulary for DSTU testing, conformance and implementation guides: • HL7 ICSR R1 domains • HL7 ICSR R2 domains & value sets

  14. HL7 ICSR Update Next steps continued: • Finalize attributes for MedWATCH Plus Rational Questionnaire • Mandatory, required, optional • Submit an HL7 Project Scope Document for ICSR Release 3: Timeline for final membership ballot by October 2009

  15. HL7 ICSR DSTU Update DSTU Testing Coordination: • Lise Stevens: PSSIG Project Chair • Lise.Stevens@fda.hhs.gov • Mead Walker: Modeling Faciliator • dmead@comcast.net • Jason Rock: ICSR Generation and Transform Tool • jasonrock@globalsubmit.com

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