Project Overview

Provide cross cutting support for articulating the role of industry in the various parts of the strategic plan.​

High-Level Scope

IVD Industry Connectivity Consortium’s (IICC) mission is to advance the continued development, enhancement, and adoption of semantic interoperability standards for In Vitro Diagnostics (IVD) data aggregation, transmission, and analysis, critical to build the national infrastructure to improve epidemiological surveillance and response to COVID-19 and future pandemics. IICC members include Abbott Laboratories, A&T, Beckman Coulter, Beckton Dickinson, bioMérieux, Data Innovations, Hitachi, IZASA SA, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Samsung, Siemens Healthcare Diagnostics, Sunquest Information Systems, and Systelab Technologies, SA. IICC specifically brings expertise to:

Items in scope: (my sense is that these are too broad. I added some suggestions below)

• Develop semantic interoperability standards that are secure, well-structured, and easy to implement and maintain by IVD manufacturers

• Drive adoption of standards by IVD manufacturers through concerted effort of continued evangelization and education

• Support the development and adoption of LIVD on FHIR

• Expand LIVD and LAW functionality, including Value Set, UDI, and Specimen Mapping, as well interface improvements

• Support integrations with emerging interoperability frameworks (e.g. Solor)

• Added

• Create agreements with a list of IVD manufacturers what will initially agree to implement SHIELD (i.e., develop harmonized coding on their products in ways that will be useful to their customers

• Develop training material and implementation guides along with a training schedule

• Coordinate with IVD Data Hub efforts as a strategy to get manufacturers to see value of promoting SHIELD harmonized standards

Items out of scope:

• Text

Timeline

Insert timeline <guys, I am winging this. Does this make sense to you???>

1. Development of finalize like of SHIELD partner IVD manufactures - date first 3 months of new fiscal year

2. Development of materials to communicate needs of LIVD Expansion to manufactures. Develop campaign, Seminars, meetings, training. - date, Second 3 months of fiscal 2022

3. Launch campaign to get manufactures to adopt recommendations of LIVD Expansion Committee for production of SHIELD harmonized coding standards and provide them as a serve to their customers - date Jan 2022.

4. Complete half of work with companies - July 2022

Interested Parties

• Committee Co-Chairs: Ed Heierman and Serge Jonnaert.

• Committee Members: Carolyn Hiller, Flora Siami, Daniel Rutz, Cornelia Felder, Xavier Gansel, Laurent Lardin, Rajeev Sehgal, John Wilkinson, Michael Berman, Devon Snedden, and Ana Szarfman.

Value Metrics

How does the project or team work align with APHL Informatics value metrics?

DRAFT metric : 50% of SHIELD partner IVD manufacturers are providing coding instructions, electronically to customers in 3 years.

100% of SHIELD partner IVD manufacturers are providing coding instructions, electronically to customers in 5 years.

SHIELD Partner IVD manufactures: List TBA. This committee can develop a list.

How to monitor the metric: Because of the small number of manufacturers we are addressing, this can be done by IICC, perhaps

How would be get a more comprehenisvre view of he success? Like the % of all IVD manufacturers? IS that needed. Waht percent of tests are produced by the SHIELD partner manufacturers???