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Specification:

Electronic Medicinal Product Information (FHIR)
Raised in Version:

1.0.0-ballot
Work Group:

Biomedical Research & Regulation
Outstanding Negatives:
STU
Related Page(s):

Introduction
Grouping:
- Ready-For-Vote-1
Resolution Description:
Hide

proceed as requested

remove the sentence "This guide will be reviewed annually for active use, obsolescence, and potential need for change."

add qualifications for Co-Lead and Technical co-lead roles in § 1.8
Show
proceed as requested remove the sentence "This guide will be reviewed annually for active use, obsolescence, and potential need for change." add qualifications for Co-Lead and Technical co-lead roles in § 1.8
Change Category:
Correction
Change Impact:
Non-substantive
Applied for Version:

1.0.0-ballot

remove the sentence "FHIR resources: List Bundle Composition Organization Regulated Authorization Medicinal Product Definition Administrable Product Definition Manufactured Item Definition Ingredient Substance Definition Packaged Product Definition Clinical Use Definition Binary" (no added value in this list)
change "to be a common starting point to build region specific profiles"
into
"to be a common starting (Base ePI Profile + link to the 1.5.1 section) point to build region or country specific profiles (Regional or National ePI Profile + link to the 1.5.2 section)"
Remove "The national FHIR ePI profiles were defined by representatives from the health authority for the corresponding jurisdiction, representatives from Gravitate Health, and HL7's Vulcan Accelerator. On behalf of the international community and health authorities, this guide is maintained by HL7's Biomedical Research and Regulation (BR&R) Working Group" there are no national / regional profiles in this guide
revise or remove the sentence "This guide will be reviewed annually for active use, obsolescence, and potential need for change."
Not sure that an annual review is what we should look for. Should we wait one year if an errata should be published ?

is voted on by

BALLOT-46239 Negative - Giorgio Cangioli : 2023-Jan-FHIR IG EMEDICINAL PRODUCT INFO R1 STU