2018-04-24 BR&R Conf Call

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Attendees

  • Boris Brodsky (Co-chair)
  • Ed Helton (Co-chair)
  • Hugh Glover (Co-chair)
  • Myron Finseth (Co-chair)
  • Julia Chen
  • Jean Duteau
  • Julie Evans
  • Bill Friggle
  • Norman Gregory
  • Bill Gregory
  • Smita Hastak
  • Wendy Ver Hoef
  • Ulli Wagner
  • Catherine Hosage Norman
  • Robinette Renner
  • Jane Pollack
  • Panagiotis Telonis

Agenda Items and notes

Minutes Approval

  • Approve minutes from conference call on April 10th
  • Motion to approve (Julie E), second (Jean), approved

FHIR

IDMP Substance Resource

  • Background on the IDMP Substance activities (Panagiotis)
  • PSS review (Boris)
  • Motion to approve (Hugh), second (Smita), abstentions (Bill G), approved.
  • Action: Updated PSS to be shared with the listserve.

Lab model (in collaboration with TCB)

  • Report back from last meeting (Julie E)
  • Group to make changes in FHIR regarding the Lab Model, minutes at [[1]]
  • Will be planning for September Connectathon at the WGM

AE Model

  • FDA use cases (Boris)
  • 1) Sponsors and investigators exchanging FHIR AE messages (pre-market)
  • 2) Healthcare professionals submitting voluntary safety reports via FHIR AE messages
  • Patient Care (PC) WG is the present custodian of the FHIR AE resource, proposed to maintain since PC is central to the regulatory use cases
  • PC will be working to progress the resource to the level of Maturity past 0.
  • PC having a discussion of AE resource with FDA to understand the FDA requirements against the present AE resource
  • Action: BR&R representatives to attend PC WG meeting on Thu Q3 to discuss

FHIR Tracker Items

  • Concern with de-identification of subject data, as the ResearchSubject resource is linked to the identifiable Patient resource (Hugo)

See 6.0.5.8 De-Identification, pseudonymization, anonymization for FHIR [[2]] (Julia)

  • Action: Set up a call with Hugo, Hugh, and Julie. Hugo will create and share a sample scenario ahead of the call (Hugh?)

Connectathon

May WGM Agenda

  • Draft is at [[3]]
  • Action: Make changes reflected in the updated WGM agenda on the Wiki:
  • - Move BRIDG Rearchitecture from Mon Q4 to Tue Q3
  • - Put IDMP Substance to Tue Q1
  • - Make Tue Q4 open (overtaken by Thu Q3)
  • - Wed Q3 – don’t need the entire quarter (leave part as a placeholder)
  • - Thu Q2: Clarify that Jeff Lowe will speak on the Sept Connectathon topics relevant to BR&R