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Difference between revisions of "2018-04-24 BR&R Conf Call"

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=Attendees=
 
=Attendees=
* Boris Brodski (Chair)
+
* Boris Brodsky (Co-chair)
* Ed Helton (Chair)
+
* Ed Helton (Co-chair)
* Hugh Glover (Chair)
+
* Hugh Glover (Co-chair)
* Myron Finseth (Chair, scribe)
+
* Myron Finseth (Co-chair)
 
* Julia Chen  
 
* Julia Chen  
 
* Jean Duteau  
 
* Jean Duteau  
Line 41: Line 41:
 
=Agenda Items and notes=
 
=Agenda Items and notes=
  
===1. Minutes Approval===
+
==Minutes Approval==
 
* Approve minutes from conference call on April 10th
 
* Approve minutes from conference call on April 10th
Motioned to approve:??  Seconded: ??
+
* Motion to approve (Julie E), second (Jean), approved
  
===2. May WGM Agenda===
+
==FHIR==
* Draft is at [[wc 2018-05-14  BR&R WG Meeting
 
On Thursday, a member from BR&R to go to Patient Care to discuss Adverse events (developing use cases for pre-approval AND/OR post approval)
 
  
===3. IDMP Substance Resource===
+
===IDMP Substance Resource===
* PSS Review and Approval (Boris, Panagiotis)
+
* Background on the IDMP Substance activities (Panagiotis)
* Motioned to approve: Hugh, Second: Smita
+
* PSS review (Boris)
* Bill Friggle asked to have the PSS sent over the list serve.
+
* Motion to approve (Hugh), second (Smita), abstentions (Bill), approved.
 +
* '''Action:''' Updated PSS to be shared with the listserve.
  
===4. FHIR===
+
===Lab model (in collaboration with TCB)===
====4.1 Lab model (in collaboration with TCB)====
 
 
* Report back from last meeting (Julie E)
 
* Report back from last meeting (Julie E)
* Group to make changes in FHIR regarding the Lab Model.
+
* Group to make changes in FHIR regarding the Lab Model, minutes at [[http://wiki.hl7.org/images/f/f6/TCB_Lab_Model_to_FHIR_Team_Meeting_18_April_2018.pdf]]
 +
* Will be planning for September Connectathon at the WGM
  
====4.2 AE Model====
+
===AE Model===
 
* FDA use cases (Boris)
 
* FDA use cases (Boris)
* need further notes here
+
*   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
  
====4.3 FHIR Tracker Items====
+
===FHIR Tracker Items===
* Are there any outstanding?
+
* 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 [[https://build.fhir.org/secpriv-module.html#deId]] (Julia)
 +
* '''Action:''' Set up a call with Hugo, Hugh, and Julie. Hugo will create and share a sample scenario ahead of the call (Hugh?)
  
====4.4 Connectathon====
+
===Connectathon===
* [http://wiki.hl7.org/index.php?title=201805_Clinical_Research_Track Connectathon activity in Cologne]
+
* [[http://wiki.hl7.org/index.php?title=201805_Clinical_Research_Track Connectathon activity in Cologne]]
  
===5. Action Item List===
+
==May WGM Agenda==
* Initial draft (Hugh)
+
* Draft is at [[http://wiki.hl7.org/index.php?title=Wc_2018-05-14_BR%26R_WG_Meeting]]
 
+
* '''Action:''' Make changes reflected in the updated WGM agenda on the Wiki:
===6. AOB===
+
* - Move BRIDG Rearchitecture from Mon Q4 to Tue Q3
* The use of BR&R Wiki
+
* - 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

Revision as of 14:15, 27 April 2018

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
  • 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), 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