| Num | Name | Sponsor/CoSponsor | Description | Project Facilitator | SD Approval | TSC Approval | Status | Next Milestone | Comment | Action | Co-Chair |
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1,687 | Integrated Trial Matching for Cancer Patients and Providers (PSS in Jira) | Sponsor(s):
Biomedical Research and Regulation Work Group | This use case aims to make clinical trial participation equitable and easy for all patients and providers. Our approach is to develop mCODE-based open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching... | Caroline Potteiger | Awaiting Approval | Apr 14, 2021 | Apr 16, 2021Awaiting Approval | Active Project (Resources assigned to pjt) | Sep 1, 2021TBD | OK |
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1,665 | 5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 2: Human Pharmaceutical Reporting Requirements for ICSR, R2 | Sponsor(s):
Biomedical Research and Regulation Work Group | Expiration Date: 2021-06-09 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact | BRR Co-Chairs | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | May 1, 2021 | To be reaffirmed |
| Boris |
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1,664 | Reaffirmation of HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1 | Sponsor(s):
Biomedical Research and Regulation Work Group | Expiration Date: 2021-12-02 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact | BRR Co-Chairs | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | Sept 1, 2021 | To be reaffirmed |
| Boris |
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1,663 | 5-year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1: The Framework for Adverse Event Reporting, R2 | Sponsor(s):
Biomedical Research and Regulation Work Group | Expiration Date: 2021-12-02 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact | BRR Co-Chairs | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | Sept 1, 2021 | To be reaffirmed |
| Boris |
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1,662 | 5-year expiration approaching: HL7 Version 3 Standard: Drug Stability Reporting (eStability), Release 2 (revision of ANSI/HL7 V3 DSR, R1-2005) | Sponsor(s):
Biomedical Research and Regulation Work Group | Expiration Date: 2021-08-22 Work Group CoChairs need to let HL7 HQ know which of the following actions will be taken: - Reaffirm artifact - Begin work on a new version of the artifact - Withdraw artifact | BRR Co-Chairs | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | May 1, 2021 | Withdrawn | NA | WithdrawnWithdrawal requested |
| Boris |
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1,644 | FHIR Implementation Guide for Transfusion and Vaccination Adverse Event Reporting | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Patient Care Work Group, Public Health Work Group | The FHIR Implementation Guide provides a set of profiles for detection, validation, reporting, and ultimately recording/persisting Adverse Events associated with blood transfusions and vaccinations. There are two sets of profiles with the first set intend... | Jean Duteau | Aug 7, 2020 | Sep 7, 2020 | Active Project (Resources assigned to pjt) | May 1, 2021 | OK |
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1,636 | FHIR to CDASH (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group | The overarching goal of this project is to improve interoperability, and facilitate the exchange of data from EHRs to clinical research submission-ready datasets. Building upon previous work on the FDA eSource grant, the PHUSE Research on FHIR projects, a... | Rhonda Facile, Mike Hamidi | Aug 16, 2020 | Aug 31, 2020 | Published | TBDJan 1, 2021 | OK | Feb 2021: Working through ballot comments |
| Hugh |
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1,574 | BRIDG 2020 Update (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group | Changes are made to the BRIDG model based on work planned by FDA and NCI - we know there will be work, but at this point we are unclear what that will be. | Smita Hastak | Oct 29, 2020 | Nov 11, 2019 | Active Project (Resources assigned to pjt) | May 1, 2020 | Inactive |
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1,540 | Single Institutional Review Board Project (sIRB) (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Clinical Interoperability Council Work Group, FHIR Infrastructure Work Group, FHIR Management Group | We will develop, test and evaluate data standards to move data and documents from clinical research sites to a single ethics review board in support of the 'NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research.' The scope o... | Anita Walden and Ed Hammond
James Topping | Nov 22, 2019 | Dec 2, 2019 | Active Project (Resources assigned to pjt) | Jan 1, 2021 | Report due Feb 23rd | Revise dates | Project Complete/Published |
| OK |
| Hugh |
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1,537 | Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC) (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group | The scope of this effort covers the domain of Pharmaceutical Quality/ Chemistry, Manufacturing and Controls (PQ/CMC), e.g., Specification, Stability, Method Validation, Batch, Batch Analysis result, etc. The objective is to develop HL7 FHIR data exchange ... | Mary Ann Slack; Boris Brodsky | Awaiting Approval | June 18, 2021 | June 18, 2021Awaiting Approval | Active Project (Resources assigned to pjt) | Jan 1, 2020TBD | OKGoing for ballot | Revise dates |
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| Smita |
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1,531 | BRIDG 5.4 (BRIDG 5.3 Update) (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group | The scope of this project is to ballot a new release of BRIDG. | Ed Helton (BR&R co-chair, NCI) | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | May 1, 2020 | Inactive |
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1,503 | BRIDG Model Update (BRIDG Release 5.3/HL7 BRIDG r5) (v20190115v2.doc) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Orders and Observations Work Group | The scope of this project is to ballot a new release of BRIDG. | Ed Helton | Feb 3, 2019 | Feb 11, 2019 | Informative - Reconcile | Sep 1, 2019 | Complete | Change status | Smita |
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1,426 | Women’s Health Technology Coordinated Registry Network (CRN) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Clinical Interoperability Council Work Group, Orders and Observations Work Group | The federal Women’s Health Technologies (WHT) Coordinated Registry Network (CRN) project will create a set of linked registries focused on women’s health, using data elements and measures expressed in standard structured definitions with the c... | Nagesh Bashyam / Martha Velezis / Rachael Roan/Richard Ballew | Jul 30, 2018 | Sep 27, 2018 | Informative - Reconcile | Sep 1, 2019 | Needs reconciliation uploading (and its an STU not normative)Inactive | With Dragon - no time until May | Smita |
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1,425 | CDISC Lab Semantics in FHIR (PSS in Confluence) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Orders and Observations Work Group | Biomedical Research and Regulation (BR&R) and Transcelerate Biopharma (TCB)are assessing the use of FHIR resources to exchange clinical trial lab data. The Clinical Data Interchange Standards Consortium (CDISC) Lab Model and LB domain standards curren... | Julie Evans,Hugh Glover | Aug 3, 2018 | Feb 18, 2019 | STU - Test Period/Accepting Comments | Sep 1, 2022 | OK |
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1,424 | Common Data Model Harmonization (CDMH) - FHIR Implementation Guide | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Clinical Interoperability Council Work Group | The nation is reaching a critical mass of Health IT systems (EHRs, Data Warehouses etc.) that comply with data and vocabulary standards. The wide deployment of Health IT systems has created unique opportunities for providers, provider support teams, healt... | Nagesh Bashyam | Jul 24, 2018 | Sep 27, 2018 | STU - Reconcile | Sep 1, 2019 | STU complete - what now? | With Dragon - no time until May | Smita |
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1,416 | Exploration of FHIR resources to support of IDMP 11238/19844 Substances Standard and Technical Specification. | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Orders and Observations Work Group, Pharmacy Work Group | This project will develop FHIR resources to support the content of the revised ISO 11238 IDMP Substance standard and its ISO/TS 19844 Technical Specification, and other domain areas with similar requirements. These cover a very detailed representation of ... | Mary-Ann Slack (FDA), Panagiotis Telonis (EMA), Boris Brodsky (FDA) | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | Sep 1, 2018 | Replace with general MedDef resource development project | Progressing to TSC | Smita |
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1,367 | FHIR resources to support IDMP 11615 Product Standard | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Orders and Observations Work Group, Pharmacy Work Group | This project will commence the development of FHIR work and probably logical models and resources or possibly profiles, to support the content of the ISO 11615 IDMP Product standard, and other domain areas with similar requirements. | Panagiotis Telonis (EMA), Boris Brodsky (FDA) | Dec 29, 2017 | Mar 5, 2018 | Active Project (Resources assigned to pjt) | May 1, 2018 | Replace with general MedDef resource development project | Progressing to TSC | Smita |
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1,339 | Structured Product Labeling (SPL R9) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Orders and Observations Work Group | The scope of this project is twofold: a) to describe the use of SPL Release 9 as the data exchange format to support PQ/CMC (Pharmaceutical Quality (PQ)/Chemistry, Manufacturing and Controls (CMC)) information in Module 3 of the CTD which currently is be... | Vada Perkins (ID), Panagiotis Telonis (EMA), Mary-Ann Slack (FDA) | Awaiting Approval | Awaiting Approval | Active Project (Resources assigned to pjt) | Jan 1, 2018 | Obsolete This was replaced by #1537 | Vote to remove Need O&O to agree Ask Dave Hamil to remove | Boris |
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1,229 | Structured Product Labeling for Food (SPL R8) | Sponsor(s):
Biomedical Research and Regulation Work Group
Co-Sponsor(s):
Patient Care Work Group | The purpose of this project is to ensure that the structured product label V3 artifact includes all of the necessary data elements for food and dietary supplements. The goal is to allow the electronic transmission of foods, branded food products, dietary ... | Vada Perkins and Elaine Ayres | Jan 21, 2016 | Feb 1, 2016 | Active Project (Resources assigned to pjt) | May 1, 2016 | Obsolete This is Food only | Vote to remove Need Patient Care to agree Ask Dave Hamil to remove | Boris |
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