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Chair:  Hugh

Scribe:   Boris


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Agenda Topics

Agenda Item

Meeting Minutes from Discussion

Decision Link(if not child)

Approve minutes from April 28th

Accepted by general consent


Draft agenda

Time needs to be finalized for the items in red. 

Hugh suggested BR&R might run a session after the Virtual WGM looking at present pharma thinking in light of COVID-19. 

Project Proposal: Patient Corrections to Errors in the Record

PSS-1599 - Getting issue details... STATUS  

Some interest in BR&R being an INterested Party.  Need to determine if falls under Patient Care.

Regulated Product Jira Issues - Rik Smithies

FHIR-26570 - Getting issue details... STATUS

FHIR-26670 - Getting issue details... STATUS

FHIR-26669 - Getting issue details... STATUS

26570: Proposed to change MedicinalProduct references to CodeableReferences. Rik proposed, Peter second, no objections, no abstentions, 9-0-0.

26670: Proposed to make only status mandatory. Rik/Craig, no objections, no abstentions, 9-0-0.

26669: Proposed to eliminate the "product" tautology from productClassification, Rik/Peter, no objections, no abstentions, 9-0-0.

26989: Proposed to eliminate redundancy by removing dose-form from AdministrableProduct since already recorded under MedicinalProduct. Rik/Craig, no objections, no abstentions, 9-0-0.

Regulatory related JIRA tickets - Peter Bomberg

FHIR-26859 - Expand the allowed values in the Procedure.subject list

FHIR-26860 - Add RegulatedAuthorization to the CodeableReference list in Procedure.reason.Reference.

FHIR-26861 - Usage question relating to basedOn and partOf

FHIR-26862 - statusDate is missing 






FHIR-27005 - Getting issue details... STATUS



26861: Need to clarify the distinction between a partOf multi-stage inspection and a repeated inspection based on the failure of the first one. 

26862: Depending on the duration of the Procedure, it may nor may not need a status variable recorded (e.g. a lengthy rehabilitation.)

26648: Already resolved.

25961: Refers to the authorization of regulatory activities, not medicinal product. Other steps already mapped, only activities and fees left. Need to specify what the fee is associated with (a plan or an authorization). Alternatively, could be done through an extension. 


25943: Not only an Organization but also a practitioner can be a marketing authorization holder. A person would still be treated as a license holding organization. Don't need to change the reference to Organization, but need to clarify that the marketing authorization holder can be a holder (not for drugs but, e.g., for shipping facilities). Change accepted with 9-0-0.


Device Related Issues - Andy Iverson

FHIR-26866 - Getting issue details... STATUS   FHIR-26867 - Getting issue details... STATUS   FHIR-26868 - Getting issue details... STATUS

Postponed until next meeting

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