IVD Data Hub

Scope

Developing the requirements for an IVD data hub that would have patient results collected from a network of participating health care systems that can be used for regulatory decision making and post market surveillance and maybe other secondary uses with role based access

Call information

Every Other Thursday starting 2/8/2024 from 11 AM to 12 PM ET

Google Meet joining info
Video call link: https://meet.google.com/hac-xhar-hvw
Or dial: ‪(US) +1 347-773-4204 PIN: ‪111 144 961#
More phone numbers: https://tel.meet/hac-xhar-hvw?pin=6136641232225
Or join via SIP: sip:6136641232225@video.roche.com

Participants

Name

Organization

Role

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

 

Marti Velezis

Sonrisa / FDA

 

Projects

Project Name

[include link to the filled out project template file]

Brief Description

Priority

Project Name

[include link to the filled out project template file]

Brief Description

Priority

 RWE data element requirements

 

 

 Coordination with other domains / projects (research, PH, RWE)