Date

​Mar 7, 2024

Attendees


  • Xavier Gansel

  • Marti James

  • Hubert W Vesper

  • Gyan Penrose-Kafka

  • Rebecca McNall

  • Yue Jin

Discussion topics

Time

Item

Presenter

Notes


Review the slide deck for All SHIELD call update

Yue/Everyone

  • Reviewed the objectives, scope and planned deliverable for the WP

    • Discussion item at All SHIELD call (3/26): given the constraints of time and budget, our planned deliverable is to create a White Paper. However, if we go beyond the White Paper, such as developing a proof of concept, additional budget will be required

  • The WG will review and finalize the slides in the next WG call (3/21)

  • WG will share a draft White Paper at the All SHIELD call

  • Marti proposed to provide an introduction to the WG on the Integrated Knowledge Management (IKM) tool



Review recommended update to SHIELD Roadmap per ONC feedback on IVD Data Hub

Yue

The WG will review and add comments offline

Action items


WG to review and add edits to the attached slides (comments included):
Marti to share the slides that describes SHIELD ecosystem (for Slide 2)
Marti and Xavier to add contents for Baseline Requirements & Use Cases (Slide 3-4)
WG to add relevant resources to Slide 6
WG to review and add comments to the roadmap per ONC feedback
See recommendation provided on https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/2292645948 . GPK proposed a rewrite, Nick amended slightly further. The following is proposed:

The IVD and Clinical Information System (CIS) industries strive to meet the needs of customers and promote the healthcare of the population through the provision of safe and effective products. Addressing the barriers to laboratory interoperability such as lack of standardization by enabling semantic harmonization and standardization will have a profoundly will have a significant positive impact on clinical laboratory operations, as it will significantly reduce the time and cost involved with deploying, connecting, and updating instruments in the laboratory. Such standardization will reduce the need for vendor-customized connectivity implementations and serve as a catalyst and common incentive for stakeholders across the ecosystem to promote interoperability of laboratory data. As such, SHIELD endeavors to promote the use of high-quality data for secondary use purposes. One practical use case would be the establishment of a tool or data system that serves as an IVD Data Hub to facilitate the use of RWD for the purposes of supporting regulatory decision making, improving public health reporting, and development of future innovation. This will eliminate the need for vendor-customized connectivity implementations and favor vendors that adopt the specifications and pass the savings on to their customers. The creation of an IVD data hub provides an incentive for the IVD industry by providing a pathway for using RWE to support regulatory decision making.


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