Page Comparison

Quorum evaluation (two-thirds (2/3) of the Voting Representatives shall be necessary to constitute a quorum for the transaction of business)

Currently we have 18 named members, so 2/3 = 12 (excluding chair and government members).

Open Meeting

Updates

• Proposed new members for the SC:

  • Patient Advocate position: Stacy Lange has been in patient advocacy for over 10 years - Synensis sent her our way

  • FDA representative coming soon

  • FDA now has a SHIELD website: https://www.fda.gov/medical-devices/diagnostic-data-program/systemic-harmonization-and-interoperability-enhancement-laboratory-data-shield

• Members leaving the SC

  • Serafina Brea will move to different branch in CMS effective 8/25 - will notify us of replacement member as soon as possible

• New group enggement engagement for SHIELD:

  • Sedning invites to the min calls to Pfizer (their Riki met with Pfizer’s evidence creation team) -

    • they may be joining hte ALL SHIELD calls and also let them know about the working groups

    • they are working on feedback on package inserts that are patient facing https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information#:~:text=Patient%20Medication%20Information%20would%20be,drug%20products%20safely%20and%20effectively. - this might push the FDA towards a more structured data approach in other package inserts, too

Established SHIELD Calendar

Thanks to Eric for coming up with the idea - we now have calendar of all the calls, including call info for all the open calls (not the SC call)

Goal of the outreach to IVD vendors

Review Working Groups progress

LOINC Conference presentation

• Other SHIELD member presentations

  • Christine Spisla, W. Scott Campbell, PhD, MBA, Stephen Powell, DHA, MSc, and Raja Cholan, MS - Deloitte
    Thinking Outside the Box: Using an Integrated Knowledge Management Environment to model LOINC terms

  • John Snyder - National Library of Medicine
    Automating the curation of reference terminologies

  • Pamela Banning - 3M Health Information Systems
    In-roads: Advancing LOINC Adoption in Clinical Trials Data

  • Stanley Huff - Graphite Health
    Semantic Interoperability: The Vision of What Could Be

  • Stephen Powell - Synensys, LLC
    Results from a System Safety Analysis of the U.S. Laboratory Data Ecosystem: How LOINC Impacts System Safety?

  • Christina Gallegos & Ed Heierman, Ph.D - Association of Public Health Laboratories & IICC
    Collaborative Development of LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2

• Andrea Pitkus, Riki Merrick - SHIELD
  SHIELD as a mechanism to support the adoption of LOINC and SNOMED CT standards for laboratory data interoperability:

  • Submitted abstracts bios and headshots

  • Discuss outline (will not be shared here, so we don’t publish before the conference)

Roadmap section updates in response to ONC comments on the SHIELD roadmap

We will talk about approach to updates in general and these specific comments in particular next call - sorry - Riki didn’t get the prep done related to the ONC comments

Next call

Sep 5, 2023 - so far Riki not available, and have 10 confirmed attendees (Andrea, Nick, Julia, Eric, Robyn, Scott, Stan, Aaron, Nirmala, Xavier)

Sep 19, 2023 12 -1 PM EDT

Adjourned