Work Group: BR&R

Please record attendance here: 

Joint/Shared sessions are in RED. When hosted by another group entry is italicised


The meeting is being managed in UTC and the full timing grid from HQ is here.  BR&R are meeting at the following times


Eastern US

UTCUKCentral EuropeAustralia







SessionJoint withEventComments/MinutesChair / Minute TakerCo-chairs unavailable
LunchFHIR-IJira balloting, Jira in general, FHIR core maintenance and IG templatesNot a joint, just an interesting open session

Mon Q3

  • R4B & R5 Ballot Comments Overview
  • Tracker Items Overview
  • BR&R Standards for ReviewProduct Status

Smita provided overview of BR&R sponsored projects and Confluence organization

Discussion on overcoming the challenge of two separate groups approaching the same problem with different approaches resulting in differing FHIR IGs for the same problem.

Action Item (Smita) - Determine if FDA sponsored RPS project should be tracked, similar to ECG waveform project

Action Item - Co-chairs to work on new 5 year plan for work group to review. Suggestions and comments can be email to co-chairs.

Review MedDef Jira issues

Hugh / Andy
Mon Q4Patient Care (Host)
  • Adverse Event Profile (are there things to follow up from last time) - with Patient Care
  • Vulcan AE Round Table
  • CDISC Mapping for AE - get their thoughts

Mon Q5Pharmacy
  • Unicom
  • Medication Definition resources / R4B Ballot Comments
  • Pharmacy Quality IG
  • Cumulative medication duration

Unicom presentation by Giorgio Cangioli

1. Focus on Gap Analysis in HL7 - ManufacturedItem and IDMP &FHIR. Proposed change to IDMP 11615; 2. IDMP & FHIR Alignment – resources spread out across BR&R, Pharmacy, Patient Care.  Needs alignment; 3. Other - logical models for patient summary, ePrescription, etc.

2. Proposal for PhPID for COVID vaccines

3. Representing the IDMP req. in FHIR resources – need to distinguish between manufacturer, sponsor and marketing authorization holder.  Proposal to consider the IDMP definition. 

Action item: FHIR-32759Pharmacy to consider changing the name of the Medication.sponsor element to Medication.marketingAuthorizationHolder

R4B Ballot Issues:

Updated Issues:

FHIR-31820 - Getting issue details... STATUS

FHIR-31815 - Getting issue details... STATUS

25th May

Tue Q3Pharmacy
  • Medication Definition resources
  • MedicationKnowledge (MK)/MedicinalProductDefinition (MPD)
  • R4B Ballot Comments

Topic 1:  MPD and MK overlap

Jean presented MPD , MK and Medication resource history and their evolution. The boundary between the 3 resources is fuzzy. Medication is a light resource with limited set of elements.  Not meant to be definational.  MPD is more complete for defining a drug product and can be used for different use cases – regulatory, pharmacy, etc. MK has some definational aspect related to formulary use case.  See Jean's mapping spreadsheet [NEED to get this]

Suggestion - MK would only have those properties (e.g., cost) that are needed for a specific context - like formulary.  While other elements could be removed that are already represented in MPD - dosage, etc.  There maybe few elements that need to be in both MK and MPD.  MK appears to be a catalog entry for formulary in addition to information in MPD.  Cost, local monographs, indication guidelines, etc. are all part of the formulary.

Another proposal - Could we consider the collection of formulary related elements wrapped us a data type for a element in Medication and points to MPD.?  Several use cases suggested this may not be a way forward.

Resolution on MK and MPD overlaps –  Jean – Did we make a decision here?  Smita to follow-up.

Topic 2:  Pharmacy and BR&R engagement on resources of common interest

Discussion on how do the 2 WGs work together since FHIR resources cannot be co-owned.  Need to establish best practices to ensure each WG's input is brought into discussion around the common resources of interest.

Proposals — 1. consider setting up a task force that includes members from BR&R and Pharmacy that together reviews all new use cases and updates that impact MPD, MK and Medication. 2. The 2 WGs need to establish some formal agreement (MOU) that ensures that changes to these resources are discussed as a collective group. 3.  Each WG MUST inform the other WG whenever any changes are being considered for the common set of resources. These must be discussed during the weekly WG calls and the other WG will be informed of the agenda.

Co-ownership resources:

  1. MedicinalProductDefinition (MPD)
  2. PackagedProductDefinition (PPD)
  3. AdministratableProductDefinition (APD)
  4. ManufacturedItemDefinition (MID)
  5. ClinicalParticulars (CP)
  6. Ingredient
  7. MedicationKnowledge (MK)
  8. Medication

Agreement by both WGs that we need to manage updates to these set of resources collectively.   As a first step, start with proposal #3 from above.  If  we are unable to successfully execute on this, we will then consider establishing a more formal relationship. 

BR&R and Pharmacy Action Item– update the missions and charter for both WGs to ensure that the co-ownership is documented for these 8 resources. 

Topic 3: Ingredient as a resource and as a backbone element in FHIR resources

Ingredient as a Resource discussion:  R4B ballot comment suggested that Ingredient should not be a resource, but rather could be considered as a data type.   There is some merit in the comment.  There are new use cases getting identified that suggest that Ingredients of a drug product may need to be authorized.  Jean had made this ballot comment and he agreed that as long as the use case is documented in the comment resolution, he agrees with the decision that Ingredient can stay as a resource.

BR&R Action Item - Resolve the Ballot comment from Jean on Ingredient in Jira and add the use case.  BR&R to first write up the resolution and then vote on this in an upcoming BR&R weekly call. Include Pharmacy members.  

 Ingredient as  a backbone element:  the word "Ingredient" shows up in other places in FHIR resources as a backbone element.  Medication and Substance resources both have Ingredient as a backbone element.  It is confusing for the implementer.  

  • Decision – need to resolve the confusion on the word "ingredient". It applies to both Medication (Pharmacy WG)  and Substance  (BR&R WG) resources, therefore this needs a BR&R and Pharmacy joint call to address the issue.  

BR&R Action Item:  Set up a joint call with Pharmacy WG in June (date TBD) to discuss - 1. Ballot comment on Ingredient, and 2. Ingredient as a backbone element on 2 resources.

Tue Q4
  • PQ/CMC Project Update - Smita
  • SPL resources and profiles Project Update - Jean
  • AE (Transfusion & Vaccinations) Project Update - Jean
  • Gravitate/Capable presentation

PQ/CMC - Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC)

  • Goals - develop the data structure, create FHIR IG
  • Status
    • 100% of Phase 1 requirements mapped to FHIR
    • 180 data elements (31 are extensions)
    • Part of R4B ballot
    • 4 WGs involved, EMA, Health Canada, FDA
    • 6 foundational FHIR profiles developed (next step, will profile the profiles)
      • Drug substance
      • Drug product
      • Batch Formula
      • Quality Specification
      • Batch Analysis
      • Stability
    • Phase 1 controlled terminology published at NCIt EVS


SPL resources and profiles

  • All profiles will not be available in IG due to R4B delays
    • Product submission document section will expand
  • Dual submission supported
  • Next steps
    • Add profiles when R4B published

AE (Transfusion & Vaccinations)

  • Purpose - generate ICSR submission with FHIR
    • Look at data within an EHR to detect AEs
  • Will present subset of AE detection algorithms using CQL
  • Looking at OMOP implementation


  • Giovanna Ferrari, Anne Moen presenters
  • Public/private partnership under innovative medicines initiative in EU
  • Early in journey - working on requirements
  • Mechanism to provide regulatory approved information to patients is critical
Smita / Andy

Tue Q5


  • NCI Data Commons update/NCPI - Ian Fore (maybe others) ??
  • Logical Modelling and FHIR

Project Updates

  • FHIR_I general session


Wed Q4

  • Codex- Trial Matching track (Caroline Potteiger)
  • CDISC Mapping (Rebecca Baker)
  • EBM on FHIR (Brian Alper)

CODEx Presentation --

Overview of CODEx and status of mCODE STU2 (balloted in May 2021)

Trial Matching – challenge to find/match patients to clinical trials. This effort is using the existing matching services and mapping them to mCODE standard. The team defined a subset of elig. criteria for trial matching.  

HL7 ballot planned for September 2021

See details in the slide deck...

FHIR to CDISC Mapping Presentation --

CDISC Overview - various standards, Therapeutic Guides, BRIDG use, etc.

CDASH and SDTM high-level overview and how the domains and variables are related to eCRFs. Summary of the FHIR to CDISC Mapping ballot votes.

See details in the slide deck --

EBM on FHIR Presentation --

Overview of the 5 Resources – Evidence, EvidenceVariable, EvidenceReport, Citation, Group

COVID Knowledge Accelerator (COKA). COKA has developed 2 tools for use

  • MEDLINE to FHIR Converter
  • Citation Viewer and Citation Builder

See details in the slide deck --

Hugh/SmitaBoris, Andy

Wed  Q5

(30 minutes earlier than usual)


Vulcan (general progress and connectathon report back) - Hugh

Note this will be on a different meeting connection look on the agenda for

Birds of a Feather - Vulcan

Note this starts immediately after Q4 - there is no break.  

This is NOT on the BR&R track in whova it is under Birds of a Feather

The Vulcan link is to Jan WG meeting.

Resource development

Thur Q1

O&O (Host)


R4B Healthcare Product resources2021-05-24-28 WGMAndy will join

Thur Q3

  • R4B/R5 Ballot Comments

Thur Q4

  • R4B/R5 Ballot Comments
  • ResearchSubject and ResearchStudy development

FHIR-32317 - Getting issue details... STATUS

FHIR-32316 - Getting issue details... STATUS

FHIR-32315 - Getting issue details... STATUS

FHIR-32314 - Getting issue details... STATUS

FHIR-32313 - Getting issue details... STATUS

FHIR-32312 - Getting issue details... STATUS

FHIR-32310 - Getting issue details... STATUS

FHIR-31659 - Getting issue details... STATUS

FHIR-31652 - Getting issue details... STATUS

FHIR-31682 - Getting issue details... STATUS


Thur Q5

  • R4B/R5 Ballot Comments
  • ResearchSubject and ResearchStudy development

Smita - going to CDS/CQI WG 
Long Term Planning

Fri Q1

O&O (Host)


R4B Healthcare Product resources (if required)
Andy will join

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