2018-04-24 BR&R Conf Call

Related Links BR&R Wiki Home Page Conference call agendas and minutes

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
• Hugo Leroux
• 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 F), 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

• [Connectathon activity in Cologne]

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