2024-07-18 Meeting notes

Date

Jul 18, 2024

Attendees:

Yue Jin, Xavier Gansel, Hubert Vesper, Gyan Penrose-Kafka, Muktha Natrajan (joined on behalf of Rebecca McNall)

Notes

1. We aligned on objectives for a call with Dr. Crawford from Northwell (presented in the June All SHIELD call). Link to the meeting notes and his presentation is below for reference.

2024-06-11 ALL SHIELD Call #2 Meeting Minutes

• Goals for the meeting:

  1. Learn from Experience: Gain insights from Dr. Crawford's experience with the Covid-19 RWD Infrastructure (CRWDi).

  2. Understand Use Cases: Explore the potential use cases Dr. Crawford has in mind for this project.

  3. Infrastructure Details: Learn about the infrastructure used (federated infrastructure vs. other infrastructure)

  4. Data Elements: Identify which data elements were available and which were not in the database. Any challenges in obtaining different data elements?

  5. Lessons Learned: Discuss the lessons learned from the CRWDi project. Understand the challenges Dr. Crawford encountered when building the CRWDi.

2. The group also discussed what’s needed for the IVD Data Hub working group as next steps

• Generic applications/use cases:

  • Need to develop generic applications or use cases to demonstrate how the IVD Data Hub can be utilized.

• Partnership with agencies

  • Establish partnership with agencies (FDA, CDC, MDIC etc.) is needed to gain clarity on how IVD Data Hub can benefit various stakeholders

  • Determine specific scenarios where data from the IVD Data Hub can support regulatory submissions.

    • Would be helpful to achieve consensus with agencies on the types of submissions or circumstances under which data from the IVD Data Hub can be used.

Action items