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
|UTC||UK||Central Europe||Australia |
|Session||Joint with||Event||Comments/Minutes||Chair / Minute Taker||Co-chairs unavailable|
|Lunch||FHIR-I||Jira balloting, Jira in general, FHIR core maintenance and IG templates||Not a joint, just an interesting open session|
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 Q4||Patient Care (Host)||Andy|
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:
- FHIR-31820Getting issue details... STATUS
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.
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.
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.
PQ/CMC - Pharmaceutical Quality (PQ) and Chemistry & Manufacturing Controls (CMC)
SPL resources and profiles
AE (Transfusion & Vaccinations)
|Smita / Andy|
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
See details in the slide deck --
(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
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.
|R4B Healthcare Product resources||2021-05-24-28 WGM||Andy will join|
- FHIR-32317Getting issue details... STATUS
- FHIR-32316Getting issue details... STATUS
- FHIR-32315Getting issue details... STATUS
- FHIR-32314Getting issue details... STATUS
- FHIR-32313Getting issue details... STATUS
- FHIR-32312Getting issue details... STATUS
- FHIR-32310Getting issue details... STATUS
- FHIR-31659Getting issue details... STATUS
- FHIR-31652Getting issue details... STATUS
|Smita - going to CDS/CQI WG|
|Long Term Planning|
|R4B Healthcare Product resources (if required)||Andy will join|