Date

​Aug 2, 2023

Attendees

Name

Organization

Role

Nick Decker

Roche

Chair

Steering Committee member

Rebecca McNall

CDC

 

Hubert Vesper (Secondary)

CDC 

 Steering Committee member

Rob Rae

CAP

 

Gyan Penrose-Kafka

Hologic

 

Xavier Gansel

bioMérieux

Steering Committee member

Yue Jin

Roche

 

Walter Sujansky

FDA

Observer


Agenda


  • Team introductions (10 minutes)

  • Align “ways of working” / admin topics (meeting time / cadence, raising awareness for the projects & recruiting others to participate, etc)

  • Review initial proposed projects within the working group; discuss additional proposals

  • Discuss next steps, how to proceed

Discussion topics

Time

Item

Presenter

Notes

10

Intros

All

  • Team introductions

  • Note: Walter Sujansky did not join our call today


30

Scoping Discussion

All

The team has agreed we need to clarify scope of the initiative. Need to level set on the original plans / expectations for the IVD Data Hub

  • create realistic expectations in terms of the level of granularity that can be provided in the IVD data hub, specifically when it comes to cases

  • All team members are not familiar with the SHIELD Roadmap; will share for self-learning in prep for our next call

  • Discussed the possibility of having Keith Campbell join a call with this team to explain more behind FDA’s thoughts on what such an IVD data hub may look like; Riki for LIDR details; + steerco member who is an HCP (perhaps Dr. Luu) → Nick will follow up separately with these colleagues for scheduling

Action items


Review SHIELD Road Map document - See “latest version” on ​https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1107099656
Nick will reach out to the colleagues identified above for scheduling a time to join. We’ll book our next meeting accordingly.

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