Update on discussion with K.Campbell

Nick

• Discussed feedback from K.Campbell on IVD Data Hub considerations. FDA SHIELD Program is heavily focused on data quality as a foundational element which will enable other uses of collected data

• Team discussed at length “Cart before the horse” thought of IVD Data Hub: agreed that the requirements for an IVD Data Hub must be considered in the development of Knowledge Mgmt tools (e.g. LIDR, etc). White Paper outline was updated accordingly. See below

White Paper Next Steps

All

Intro (what is SHIELD, how did we get here)
<Use intro from Community Roadmap executive summary)

IVD Data Hub Vision (What is it? why does it matter? why now?) (Nick & Hubert)

• Research other repositories (e.g. Cancer Registries)

• Highlight efforts ex-US (e.g. UK, Israel, EHDS, …)

Envisioned baseline requirements (Xavier & Marti)

• improved data quality from knowledge mgmt tools (e.g. delivery of LIDR, etc)

• Robust / appropriate standardization for things like UDI format for transmission from Mfg Instrument to LIS

• Additional standards, solutions needed from HL7

• Others…

Envisioned use cases for IVD Data Hub (Expanded upon by those who offered the proposals)

• Broaden description beyond EUA transitions (Gyan)

• Instrumentation and Ancillaries (Gyan)

• Public Health Reporting (Rob)

• Research & Innovation

• infrastructure

Dependencies (Yue & Rob) → Xavier / Marti will provide input based on requirements