Health Level Seven ®

Active Ballot Items for Biomedical Research and Regulation

This report generated on: October 16, 2026

An 'Active' Ballot Item is any ballot item that meets the following criteria.

2027 May Ballot Cycle

HL7 FHIR® Implementation Guide: Transfusion and Vaccination Adverse Event Reporting, Release 1 - US Realm
Standard for Trial Use  2
Ballot Tally Page: FHIR_IG_ICSR_AE_REPORT_R1_D2_TBD Project Insight Reference ID: 1644
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
0   0 + 0 = 0   0
No Reconciliation Package has been posted for this ballot item.

2026 September Ballot Cycle

Retire HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2
Comment  1
Ballot Tally Page: RETIRE_V3_ICSR_PT1_R2_O1_2026SEP Project Insight Reference ID: 1963
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
7   51 + 0 = 51   0
No Reconciliation Package has been posted for this ballot item.
HL7 FHIR® Implementation Guide: FHIR to OMOP, Edition 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_OMOP_E1_S1_2026SEP Project Insight Reference ID: 1774
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
0   60 + 0 = 60   36
No Reconciliation Package has been posted for this ballot item.
Retire HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2
Comment  1
Ballot Tally Page: RETIRE_V3_ICSR_PT2_E_O1_2026SEP Project Insight Reference ID: 1963
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
6   51 + 0 = 51   0
No Reconciliation Package has been posted for this ballot item.

2026 May Ballot Cycle

HL7 FHIR® Implementation Guide: Clinical Study Protocol, Edition 1
Standard for Trial Use  2
Ballot Tally Page: FHIR_IG_PHARM_RESEARCH_PROTOCOL_E1_S2_2026MAY Project Insight Reference ID: 1925
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
3   20 + 0 = 20   14
No Reconciliation Package has been posted for this ballot item.
HL7 FHIR® R6 Implementation Guide: Clinical Study Schedule of Activities, Edition 1
Standard for Trial Use  2
Ballot Tally Page: FHIR_IG_VULCAN_SCHEDULE_R1_S2_2026MAY Project Insight Reference ID: 1761
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
2   14 + 0 = 14   10
Reconciliation Package

2025 January Ballot Cycle

HL7 FHIR® Implementation Guide: Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) Submissions to FDA, Edition 2- US Realm
Standard for Trial Use  2
Ballot Tally Page: FHIR_IG_PQ_CMC_E2_S2_2025JAN Project Insight Reference ID: 1537
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
1   23 + 0 = 23   14
Reconciliation Package

2024 January Ballot Cycle

HL7 FHIR® Implementation Guide: Pharmaceutical Quality (Industry), Edition 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_DX_PQ_E1_D1_2024JAN Project Insight Reference ID: 1800
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
12   30 + 0 = 30   25
Reconciliation Package

2023 September Ballot Cycle

HL7 FHIR® Implementation Guide: Adverse Event Clinical Research, Release 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_AECR_R1_D1_2023SEP Project Insight Reference ID: 1805
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
8   19 + 0 = 19   16
Reconciliation Package
HL7 FHIR® Implementation Guide: Adverse Event Clinical Research R4 Backport, Release 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_AE_RESEARCH_BACKPORT_R1_D1_2023SEP Project Insight Reference ID: 1805
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
7   26 + 0 = 26   20
Reconciliation Package

2023 January Ballot Cycle

HL7 FHIR® Implementation Guide: Retrieval of Real World Data for Clinical Research, Release 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_VULCAN_RWD_R1_D1_2023JAN Project Insight Reference ID: 1762
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
11   50 + 0 = 50   37
Reconciliation Package
HL7 FHIR® Implementation Guide: Electronic Medicinal Product Information, Release 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_EMEDICINAL_PRODUCT_INFO_R1_D1_2023JAN Project Insight Reference ID: 1773
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
2   40 + 0 = 40   25
Reconciliation Package

2021 September Ballot Cycle

HL7 FHIR® Implementation Guide: Single Institutional Review Board Project (sIRB), Release 1- US Realm
Informative  1
Ballot Tally Page: FHIR_IG_SIRB_R1_I1_2021SEP Project Insight Reference ID: 1540
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
4   31 + 0 = 31   21
Reconciliation Package

2021 January Ballot Cycle

HL7 FHIR® Implementation Guide: FHIR to CDISC Mappings, Release 1
Informative  1
Ballot Tally Page: FHIR_IG_CDISC_R1_I1_2021JAN Project Insight Reference ID: 1636
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
1   4 + 13 = 17   11
Reconciliation Package

2019 September Ballot Cycle

HL7 FHIR® Implementation Guide: CDISC Lab Semantics, Release 1
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_CDISC_LAB_R1_D1_2019SEP Project Insight Reference ID: 1425
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
0   32 + 0 = 32   19
Reconciliation Package

2019 May Ballot Cycle

HL7 FHIR® Implementation Guide: Common Data Model Harmonization for Research (CDMH), Release 1 - US Realm
Standard for Trial Use  1
Ballot Tally Page: FHIR_IG_CDMH_R1_D1_2019MAY Project Insight Reference ID: 1424
Tally Summary
Negative   Affirmative   Withdraw   Total Affirmatives   Needed for Passage
3   29 + 0 = 29   19
Reconciliation Package

Total Active Ballot Items: 16

Legend and Additional Information

Important Note Only the last ballot of an item is displayed in this list. If you need to refer to an earlier ballot of any item, you will need to use the Ballot Desktop and navigate to the Tally page of that ballot.
Active In this context, "active" refers to any item that has balloted at least once, but has not been published and has not been withdrawn as a project by the sponsoring WG.
Publication Requests If you feel an item has completed balloting and is ready to be published, you can submit a publication request using the Publication Request Template.
Ballot Tally Page This link will jump you to the Ballot Tally Page for the listed item to allow you to review the ballot tally. The code highlighted in the link is the Unique Ballot ID for the item.
Project Insight Reference ID The Project Insight Reference ID references the HL7 project this ballot item is associated with. More than a single ballot item may reference a single project. The link will jump to the Project Summary page for a project.
Tally Summary The Tally Summary lists the current ballot tally, ignoring any Abstain, No Returns and Removed values as these are not relevant to the final ballot outcome. Withdraws count as Affirmatives, although they are split out to illustrate how the ballot has fared after the ballot close.
Needed for Passage Needed for Passage displays the 'raw' number of votes a ballot needs to pass. If the total number of Affirmatives and Withdraws do not exceed this number, it will display in red. If the total number of Affirmatives and Withdraws do exceed this number, it will display in green. A green number does not necessarily mean that a ballot has passed, but it does mean that a WG should review the ballot and determine whether the actual status of the ballot.
Approval Levels Normative: 75%
Informative and STU: 60%