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.
Based on the IICC whitepaper on IVD test code mapping the HL7 Orders & Observations workgroup set out with IICC to create an HL7 FHIR based implementation guide to enable exchange of the LIVD Publication (LOINC to Vendor IVD results).
Although the initial interest of the manufacturers who provide the source LIVD Publication is not to provide a server based access point, rather access to a web-page, included in device package, via, e-mail, a intermediary third-party may be interested to collect the data and make it available through a FHIR server.
The final recipient in the Laboratory environment would access the data through either mechanism and make it available to the user performing device configurations in a format suitable to them, e.g., spreadsheet, App query, in-line with the configurator.
With feedback from the September 2018 connectathon and ballot we need to progress improvements to the guide and complete the availability of a LIVD Bundle that is then successfully consumed through an application a-synchronously.
Clinical input requested
LIVD expects to work with the Order Catalog track, as the Catalog profile is used in the LIVD specification.
Proposed Track Lead
- TBD (candidates: Hans, Ed, others?)
- Middleware/Device connections between device and LIS
- Intermediary third party hosting cross-manufacturer library
Zulip discussions in: https://chat.fhir.org/#narrow/stream/103-Orders-and.20Observation.20WG
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 in the current state).
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.
A middleware solution may be used to configure the test analyte mappings on behalf of an LIS as results flow from device to LIS. This role is therefore expected to be very similar, if not that same as that of a Lab/LIS, but separated for now to validate whether that is correct.
Intermediary Third Party Library
A third party collecting all manufacturer's data and making it available through a FHIR server for others to access. This could be completely independent (e.g., a standards organization or terminology library), as part of an LIS or Middleware/Device Connectivity.
Scenario 1 - The manufacturer creates a LIVD Publication Bundle and makes it electronically available to a receiver. The receiver uses the LIVD Publication Bundle to render the content in their preferred format (e.g., spreadsheet, in-line with configurator, UI display).
Scenario 2 - Multiple manufacturers create a LIVD Publication Bundle and make it electronically available to a receiver. The receiver populates a FHIR server and makes APIs available to access these across manufacturers. Another party uses an App to obtain the data from that intermediary.
Security and Privacy Considerations
Not during this round, but needs to addressed later as we get into distribution mechanisms more specifically.