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HL7 Searchable Project Database

 

301-325 of 333
NumName
Sponsor(s)/
Co-Sponsor(s)
DescriptionProject Facilitator
TSC
Approval
Date
Status
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Date
1,644
FHIR Implementation Guide for Transfusion and Vaccination Adverse Event Reporting (PSS in Confluence) 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 31, 2020 STU - Reconcile
Jan 15, 2027
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 Feb 18, 2019 STU - Test Period/Accepting Comments
Sep 1, 2027
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 11, 2019 Active Project (Resources assigned to pjt)
Jan 1, 2024
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 Apr 24, 2023 STU - Test Period/Accepting Comments
May 1, 2028
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 Mar 21, 2022 Active Project (Resources assigned to pjt)
Sep 1, 2033
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 Sep 27, 2018 Active Project (Resources assigned to pjt)
Jan 15, 2027
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 Dec 2, 2019 STU - Test Period/Accepting Comments
May 1, 2027
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 Sep 27, 2018 STU - Test Period/Accepting Comments
Jan 15, 2027
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 Nov 22, 2022 Active Project (Resources assigned to pjt)
Sep 1, 2023
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 Nov 15, 2022 STU - Reconcile
May 15, 2028
1,925
IG for Utilizing a Digital Protocol for Clinical Trials (Jira PSS- 2526) Sponsor(s):
Biomedical Research and Regulation Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group
An initial use looked at a simple document based transfer and was tested at the May 2024 connectathon. The September 2024 connectathon tested representation of protocol meta data. This initial work has provided sufficient groundwork to begin building a dr. . . Hugh Glover Apr 7, 2025 STU - Reconcile
May 15, 2028
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 STU - Test Period/Accepting Comments
Jan 1, 2027
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 31, 2020 STU - Test Period/Accepting Comments
Sep 1, 2027
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 26, 2021 On Hold
May 1, 2027
1,774
Vulcan FHIR- to- OMOP (Jira PSS- 2099) 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 Mar 3, 2025 Informative - Reconcile
May 15, 2028
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 Jan 27, 2023 STU - Test Period/Accepting Comments
Jan 15, 2027
1,963
5- year expiration approaching: HL7 Version 3 Standard: Pharmacovigilance - Individual Case Safety Report, Part 1 and Part 2 Sponsor(s):
Biomedical Research and Regulation Work Group
Expiration date: 2026- 12- 09 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 Co- Chairs Awaiting Approval
Sep 25, 2026
1,984
Standardization of Patient- Generated Health Data Recorded on Smartphones (PSS- 2560) Sponsor(s):
Arden Syntax Work Group

Co-Sponsor(s):
Patient Empowerment Work Group
The project aims to develop the Patient- Generated Health Data Implementation Guide for health data collected via Apple Health Kit and Google Health Connect. This guide will provide standardized data structure and code for capturing data in Apple Health Kit. . . Awaiting Approval Active Project (Resources assigned to pjt)
Sep 1, 2025
1,175
Clinical Decision Support Big Picture Implementation Guide Sponsor(s):
Arden Syntax Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group; Clinical Quality Information Work Group
2017 Sept: PSS with updated target dates submitted. Clinical decision support (CDS) is increasingly viewed as a vital health information technology for supporting and maintaining good health outcomes. However, a proliferation of health information tech. . . Robert Jenders Mar 5, 2018 Active Project (Resources assigned to pjt)
May 1, 2026
1,118
Arden Syntax for Medical Logic Systems v3. 0 Sponsor(s):
Arden Syntax Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group
Arden Syntax v3. 0 will be an updated successor to Arden Syntax v2. 10 in the universal realm. The primary change in v3. 0 over v2. 10 will be incorporation of a standard data model for external data mappings in order to address the “curly braces” problem. Th. . . Robert Jenders Nov 26, 2018 STU - Test Period/Accepting Comments
May 15, 2028
2,005
Bidirectional OMOP phenotype and FHIR CQL Data Requests (PSS- 1981) Sponsor(s):
Arden Syntax Work Group

Co-Sponsor(s):
Clinical Decision Support Work Group
This project will create guidance for bidirectional flow of queries and responses written in OMOP with Atlas expressions to FHIR with CQL and FHIR CQL expressions to OMOP Atlas expressions. The initial activity will use Digital Quality Measure (d QM) as an. . . Awaiting Approval Active Project (Resources assigned to pjt)
Jan 1, 2023
1,853
Arden Syntax on FHIR Implementation Guide R1 (Jira PSS- 2279) Sponsor(s):
Arden Syntax Work Group
The recently approved v3. 0 of Arden Syntax includes for the first time a standard data model (FHIR) for representation of data being used in Arden Syntax medical logic modules (MLMs) to provide clinical decision support as well as constructs for manipulat. . . Robert Jenders Awaiting Approval STU - Test Period/Accepting Comments
May 1, 2027
1,949
HL7 Arden Syntax: Implementation Guide, Release 4 (Jira PSS- 2703) Sponsor(s):
Arden Syntax Work Group
The Arden Syntax for Medical Logic Systems is a structured, executable formalism for the explicit representation of scientific, clinical, administrative and other knowledge used in clinical decision support systems. Despite the relative ease of use and fu. . . Robert Jenders Dec 8, 2025 Informative - Reconcile
Jan 15, 2027
1,966
Arden Syntax for Medical Logic Systems v3. 0 (web) STU (PSS- 2788) Sponsor(s):
Arden Syntax Work Group
Based on Arden Syntax for Medical Logic Systems v3. 0 STU, produce a web- based documentation of the standard main published materials. The web page will be hosted under an official HL7 domain and finally replace older publication formats. Currently the . . . Andreas Csarmann Aug 4, 2026 Active Project (Resources assigned to pjt)
Jan 1, 2027
1,974
PDex IG Observation: Prior Authorization Resource Naming Inconsistency (PSS- 2765) Sponsor(s):
Arden Syntax Work Group
I wanted to share an observation regarding the Da Vinci Payer Data Exchange (PDex) Implementation Guide, specifically the *Data Retrieval Methods* section ([https://hl7. org/fhir/us/davinci- pdex/Payer To Payer Exchange. html#data- retrieval- methods]). The *[. . . Awaiting Approval Active Project (Resources assigned to pjt)
301-325 of 333
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