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Welcome

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Perspectives chat: Dr. Luu

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Perspectives (Dr. Luu): Need for accurate coding so that we can use results from real patients. Use for research, regulatory clearance, reporting to agencies.

• Felt things most acutely where we are part of various consortiums (e.g. cancer registries) where the data gathering is extremely cumbersome and often the data are not usable.

• Quantitative values are often different between manufactures. Example: Institution contracted with 3rd party to implement SW that auto pulls lab data from EHR into cancer registry…but we can only make partial use because there are various conditions that have to be met for auto transfer to occur e.g. LOINC code has to match with what is in cancer registry…example where they did not is in UoM.

• LIDR would need to be the source of truth for the coding so that the data is in fact useable in the IVD Data Hub…enable accurate mapping of the data. Can help the industry move forward to get indication expansion

The team discussed what our deliverable is out of this team. Need to reference MDIC framework on our WG page.

Deliverables:

• White Paper as first output that discusses detailed vision, intended use, value proposition, and ‘roadmap’

Next Steps

1. propose use cases for IVD Data Hub (goal will be to take to All SHIELD call to get input) → Will be used for the white paper

2. Nick will connect with MDIC on support for drafting.

Next call in two weeks…main agenda item will be to go through proposed use cases

Broaden description beyond EUA transitions.

Suggest broadening the description to include RWE to supplement 510(k)s or PMAs (reduce burden or help bridge studies, lots of examples that have got FDA approval this way) and RWE to support claims expansion (e.g. new specimen type) for 510(k) or PMA devices.

Gyan Penrose-Kafka

There are examples of using RWE to generate evidence that can go through EUA, but how is it envisioned that an IVD Data Hub makes this better, higher quality, etc.?

Instrumentation and Ancillaries

what instrumentation an assay is run on, that would be really helpful.

I am not sure it is possible to collate specimen collection kit/swab/collection device but I can see scenarios where that could help expand claims.

Gyan Penrose-Kafka

Data could come from LIDR or from the device itself…discussion in white paper about sourcing data

Public Health Reporting

The ability for the organization that houses the data hub to be able to report results on behalf of laboratories to local, state and federal public health agencies

Rob Rae

Research

The ability to use the data hub data for clinical research

Rob Rae

Research

Use the data hub data for post-market surveillance (may also help with claims extension) or clinical utility studies

Yue Jin

Innovation

Site / patient identification for enrollment in clinical studies - supportive of increasing diversity in clinical trials

Nick Decker

infrastructure

enable a decentralized approach enabling local usage of the data hub (i.e. at the source of production) for local needs as well as global usage accros all sites using a CDM & vocabularies

Xavier Gansel

this may translate into a federated nature for the IVD data hub, associating lab data & some relevant patient data.