Biomedical Research and Regulation

Biomedical Research Integrated Domain Group (Archived)

Below is a list of the current projects this work group is sponsoring. Visit Project Insight to see the full project details. Visit the searchable project database to find projects sponsored by other work groups.

1-25 of 25
Num Name
Sponsor(s)/
Co-Sponsor(s)
Description Project Facilitator
SD
Approval
Date
TSC
Approval
Date
Status
1,865
5- year expiration approaching: HL7 Version 3 Standard: Context- Aware Retrieval Application (Infobutton); Knowledge Request, Release 2 (revision of ANSI/HL7 V3 INFOB, R1- 2010) Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2024- 08- 12 Work Group Co- Chairs 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 CDS WG Co- Chairs Awaiting Approval Awaiting Approval Active Project (Resources assigned to pjt)
1,864
5- year expiration approaching: HL7 Version 3 Standard: Regulated Studies - Annotated ECG, Release 1 Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration Date: 2024- 08- 01 Work Group Co- Chairs 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 BR&R WG Co- Chairs Awaiting Approval Awaiting Approval Active Project (Resources assigned to pjt)
1,847
Medication Risk Evaluation and Mitigation Strategies (REMS) FHIR Implementation Guide (Jira PSS- 2295) Sponsor(s):
Pharmacy Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Clinical Decision Support Work Group
The aim of this effort is to develop a FHIR Implementation Guide focused on the US jurisdiction for integrating medication- related Risk Evaluation and Mitigation Strategies (REMS) into provider workflows. A REMS is a drug safety program that the U. S. Food. . . Kelee Petzelt Awaiting Approval Nov 14, 2023 Active Project (Resources assigned to pjt)
1,805
Adverse Event Clinical Research Implementation Guide (Jira PSS - 2171) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Devices Work Group, Patient Care Work Group
Adverse events (AE) are tracked and evaluated as part of the clinical research process in a research study, as the occurrence of an adverse event may surface a potential confounder or a potential side- effect of the study treatment. In the research setting. . . Michelle Casagni Awaiting Approval Apr 24, 2023 STU - Preparing Ballot
1,800
Data exchange industry – Pharmaceutical Quality (d X- PQ) PSS (Jira PSS- 2145) Sponsor(s):
Biomedical Research and Regulation Work Group
The objective of this project is to develop a universal realm Implementation Guide and profiles that will allow for the creation and exchange of CMC data internationally within biopharmaceutical companies; and between the company and its stakeholders. Thi. . . Craig C. Anderson Awaiting Approval Jan 27, 2023 STU - Reconcile
1,799
FHIR Representation of Eligibility Criteria for Clinical Trials (Jira PSS- 2127) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group, Clinical Interoperability Council Work Group, Clinical Quality Information Work Group
This project will develop implementation guidance to support FHIR representation of Eligibility Criteria for Clinical Trials. The BR&R WG has been working on this use case for several months and has done extensive work discussed during weekly BR&R call. . . Brian Alper Awaiting Approval Nov 22, 2022 Active Project (Resources assigned to pjt)
1,774
Vulcan FHIR- to- OMOP (Jira PSS- 2909) Sponsor(s):
Biomedical Research and Regulation Work Group
Project Scope and deliverables The project aims to support selection of a canonical gold standard for only the US Core Data for Interoperability and the SNOMED CT International Patient Summary sub- ontology. Analysis and selection of the exact version o. . . Davera Gabriel Awaiting Approval Awaiting Approval Active Project (Resources assigned to pjt)
1,773
Electronic Product Information FHIR Implementation Guide (Jira PSS- 2102) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Structured Documents Work Group
Electronic Product Information (e PI) is the online version of the "product label" or "package insert" or "patient information" that is supplied with every medication package. By expressing this in FHIR the information can be structured which in turn allow. . . Craig Anderson Awaiting Approval Aug 16, 2023 STU - Test Period/Accepting Comments
1,762
Vulcan Real World Data FHIR Implementation Guide (Jira PSS- 2008) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Pharmacy Work Group
This project aims to develop a FHIR Implementation Guide that defines FHIR profiles that can be used to retrieve relevant research data from Real World Data sources – specifically Electronic Health Record (EHR) systems - and ultimately transform that data. . . Jean Duteau Awaiting Approval May 23, 2022 STU - Test Period/Accepting Comments
1,761
Vulcan Schedule of Activities FHIR Implementation Guide (Jira PSS- 2003) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group
This project intends to produce a set of FHIR Profiles that will allow for a schedule of activities of a clinical study to be represented as FHIR resources. The initial phase of the project will restrict itself to the initial definition of the activities . . . Jean Duteau Awaiting Approval Nov 15, 2022 STU - Test Period/Accepting Comments
1,704
FHIR Implementation Guide: Migrate from Structured Product Labeling V3 to a FHIR- based submission (PSS in Confluence) Sponsor(s):
Biomedical Research and Regulation Work Group
IBM and FDA are partnering to produce a FHIR Implementation Guide that will allow stakeholders to migrate from the current Structured Product Labeling (SPL) V3 document architecture to a FHIR- based submission architecture. The Implementation Guide will pr. . . Jean Duteau Apr 19, 2021 Apr 26, 2021 Active Project (Resources assigned to pjt)
1,702
BR and R FHIR Resource Maintenance Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Quality Information Work Group, Orders and Observations Work Group, Pharmacy Work Group
This project is an umbrella project for the maintenance and development work to be done on all current and future FHIR Resources. in BRR WG. As of Q1 2021, there are 16 FHIR resources that are in active development. The list and status of each is managed . . . BRR Co Chairs Awaiting Approval Mar 21, 2022 Active Project (Resources assigned to pjt)
1,687
Integrated Trial Matching for Cancer Patients and Providers (Jira PSS- 1686) 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 m CODE- based open data standards and open APIs that enable interoperable, scalable, and accessible clinical trial matching. . . Caroline Potteiger Apr 14, 2021 Apr 16, 2021 Active Project (Resources assigned to pjt)
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 Aug 31, 2020 STU - Reconcile
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 e Source grant, the PHUSE Research on FHIR projects, a. . . Rhonda Facile, Mike Hamidi Aug 16, 2020 Aug 31, 2020 STU - Test Period/Accepting Comments
1,540
Single Institutional Review Board Project (s IRB) (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 . . . Anita Walden and Ed Hammond Nov 22, 2019 Dec 2, 2019 STU - Test Period/Accepting Comments
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 Jun 18, 2021 Jun 18, 2021 Active Project (Resources assigned to pjt)
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 Active Project (Resources assigned to pjt)
1,433
Patient Reported Outcomes (PRO) Sponsor(s):
FHIR Infrastructure Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Orders and Observations Work Group, Patient Care Work Group
Patient Reported Outcomes (PROs) can be used to inform the clinical management of individuals, shared decision- making, patient self- management, care planning, goal setting and attainment, and to inform patient- centered outcomes research. However, health s. . . FHIR- Infrastructure Aug 9, 2018 Sep 27, 2018 STU - Reconcile
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 capability to. . . Nagesh Bashyam / Martha Velezis / Rachael Roan/Richard Ballew Jul 30, 2018 Sep 27, 2018 Active Project (Resources assigned to pjt)
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 (BRR WG) 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 currentl. . . Julie Evans, Hugh Glover Aug 3, 2018 Feb 18, 2019 STU - Expired Test Period
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 - Test Period/Accepting Comments
1,422
FHIR Resources for Evidence- Based Medicine Knowledge Assets (EBMon FHIR) Sponsor(s):
Clinical Decision Support Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Clinical Quality Information Work Group
The project will gather input from broad communities producing, analyzing, synthesizing, disseminating and implementing clinical research (evidence) and recommendations for clinical care (clinical practice guidelines) to determine the data exchange needs . . . Brian Alper Jun 4, 2018 Jun 22, 2018 Active Project (Resources assigned to pjt)
1,390
Structured Data Capture Update (SDC) Sponsor(s):
FHIR Infrastructure Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group, Financial Management Work Group, Orders and Observations Work Group, Patient Care Work Group
This project will involve updating the existing Structured Data Capture (SDC) Implementation Guide. Specific objectives include: - Aligning the implementation guide with the forthcoming R4 version of FHIR - Updating profiles to reflect the experi. . . Lloyd Mc Kenzie Jan 29, 2018 Mar 5, 2018 STU - Reconcile
1,292
Specimen DAM Update Sponsor(s):
Orders and Observations Work Group

Co-Sponsor(s):
Biomedical Research and Regulation Work Group
Comparison of conceptual model components defined in the first release of the Specimen DAM (http://www. hl7. org/implement/standards/product_ brief. cfm?product_ id=394)were compared to the biologic specimen part (and its ancestor classes) of the BRIDG 4. 0 mod. . . Riki Merrick Oct 25, 2016 Nov 17, 2016 Comment - Considering Comments
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