Difference between revisions of "201809 LIVD"
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==Justification== | ==Justification== | ||
| − | Based on [https://ivdconnectivity.org/?ddownload=743 the IICC whitepaper on IVD test code mapping] the HL7 Orders & Observations workgroup set out with IICC to | + | Based on [https://ivdconnectivity.org/?ddownload=743 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. |
| − | + | ||
| + | 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. | ||
| + | |||
| + | The primary objective of the connectathon is to validate that all relevant data is correctly represented using FHIR resources with accurate supporting implementation guidance and can be consumed directly or through an intermediary. | ||
==Proposed Track Lead== | ==Proposed Track Lead== | ||
| Line 30: | Line 35: | ||
* RLNs | * RLNs | ||
** Applicable? | ** Applicable? | ||
| + | * Intermediary third party hosting cross-manufacturer library | ||
| + | ** TBD | ||
Zulip discussions in: https://chat.fhir.org/#narrow/stream/103-Orders-and.20Observation.20WG | Zulip discussions in: https://chat.fhir.org/#narrow/stream/103-Orders-and.20Observation.20WG | ||
| Line 45: | Line 52: | ||
===Middleware/Device Connectivity=== | ===Middleware/Device Connectivity=== | ||
A middelware 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. | A middelware 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. | ||
==Scenarios== | ==Scenarios== | ||
| − | Scenario 1 - The manufacturer creates an LIVD Publication Bundle and makes it electronically available to either of the receivers. The receiver uses the LIVD Publication Bundle to render the content in their preferred format. | + | Scenario 1 - The manufacturer creates an LIVD Publication Bundle and makes it electronically available to either of the receivers. 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 an LIVD Publication Bundle and makes it electronically available to a receivers. The receiver populates a FHIR server and makes APIs available to access these across manufacturer. Another party uses an App to obtain the data from that intermediary. | ||
==TestScript(s)== | ==TestScript(s)== | ||
==Security and Privacy Considerations== | ==Security and Privacy Considerations== | ||
| + | Not during this round, but needs to addressed later as we get into distribution mechanisms more specifically. | ||
==Connectathon Recap== | ==Connectathon Recap== | ||
Latest revision as of 18:02, 29 June 2018
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 the HL7 Orders & Observations workgroup set out with IICC to create an HL7 FHIR based implementation guide to enable exchange of the LIVD Publication.
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.
The primary objective of the connectathon is to validate that all relevant data is correctly represented using FHIR resources with accurate supporting implementation guidance and can be consumed directly or through an intermediary.
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?
- Intermediary third party hosting cross-manufacturer library
- TBD
Zulip discussions in: https://chat.fhir.org/#narrow/stream/103-Orders-and.20Observation.20WG
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
A middelware 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.
Scenarios
Scenario 1 - The manufacturer creates an LIVD Publication Bundle and makes it electronically available to either of the receivers. 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 an LIVD Publication Bundle and makes it electronically available to a receivers. The receiver populates a FHIR server and makes APIs available to access these across manufacturer. Another party uses an App to obtain the data from that intermediary.
TestScript(s)
Security and Privacy Considerations
Not during this round, but needs to addressed later as we get into distribution mechanisms more specifically.
