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201809 LIVD

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Return to September 2018 Proposals

LIVD

Submitting WG/Project/Implementer Group

The LIVD Project Team within the OO workgroup is made of representatives of device manufacturers, LIS vendors, FDA, CDC, and other interested parties.

Justification

Based on the IICC whitepaper on IVD test code mapping..... Created FHIR draft profile/IG. Ready to start connectathon to validate....

Proposed Track Lead

  • TBD (candidates: Hans, Ed, others?)

See Connectathon_Track_Lead_Responsibilities

Expected participants

  • Manufacturer:
    • Abbott
  • Lab
    • TBD
  • Middleware/Device connections between device and LIS
    • TBD
  • LIS
    • TBD
  • RLNs
    • Applicable?

Roles

Device Manufacturer

The Device Manufacturer creates a Bundle for their LIVD Publication and make that available at least as a file (e-mail, Direct, CD, website link) or FHIR server (although latter is not expected to be interacted with current state).

Laboratory

The Laboratory, LIS or separate system, will receive the LIVD Bundle and present the content in a readable form, which may be a spreadsheet, online view, or otherwise.

Reference Network

Applicable??

Middleware/Device Connectivity

Scenarios

TestScript(s)

Security and Privacy Considerations

Connectathon Recap