Date

Aug 1, 2023

Attendees (bolded = present), (Green=Approval via email)

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Aaron Green

primary

 

 

alternate

Epic

Dan Rutz

primary

 

 

alternate

Biomerieux

Xavier Gansel

primary

 

 

alternate

Roche

Nick Decker

primary

Roche

 Yue Jin

alternate

Healthcare Provider

Indiana University/Indiana University Health/Association for Molecular Pathology

Mehdi Nassiri, MD

primary

University of Wisconsin-Madison

Andrea Pitkus, PhD, MLS(ASCP)CM, FAMIA

primary

UT Southwestern Medical Center

Hung Luu

primary

UNMC

Scott Campbell

primary

Tufts Medical Center

Nanguneri Nirmala

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Standards Organization

SNOMED International

 

James T. Case

primary

Monica Harry

alternate

Regenstrief Institute

 

Marjorie Rallins

primary

Eza Hafeza

alternate

HL7

 

Julia Skapik

primary

 

alternate

Professional Organization

Association of Public Health Laboratories

 

Riki Merrick

primary

 Dari Shirazi

alternate

Graphite Health

 

Stan Huff

primary

 

alternate

CAP

 

Raj Dash

primary

 

alternate

AMP

 

Robyn Temple

primary

 

alternate

Governmental - non Voting

CMS

Serafina Brea

primary

 

alternate

ONC

Sara Armson

primary

 

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

 

alternate

FDA

 

primary

 

alternate

Agenda and Notes

Item

Notes

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

  • Have reached out to a few patient advocates - Andrea and Riki will have a meeting with one of them next week, hopefully she will want to join

  • FDA CDRH Senior Leadership unanimously approved FDA/CDRH participation in the community - waiting for name of designes to invite

    • most questions were around the IVD Datahub

IVD vendor engagement

  • Need to figure out how to get more IVD vendor engagement

    • now that we are a FDA Collaborative Community, will that help?

    • IICC is also working on getting more vendor engagement

    • ask LOINC to get some help in getting a shortlist of vendors to reach out to specifically

    • ask the communications WG to take the lead here

Review https://aphlinformatics.atlassian.net/wiki/spaces/SC/pages/1887437089 progress

  • Communications WG

    • needs more members - reach out specifically to MDIC, AACC

    • created meeting minutes page for first meeting tomorrow 12-1 ET

  • RWD WG

    • created meeting minutes page for first meeting tomorrow 2-3 ET

  • Standard Vocab WG

    • created meeting minutes page for their first meeting from July 24 - will copy in from Raj’s email

  • For all WGs Riki will send reminder to ALL SHIELD call group with dates / times and call info

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 - Riki will prep something related to the ONC comments

LOINC Conference presentation

No updates

Next call

Aug 15, 2023 12 -1 PM EDT

Adjourned

 

Recording:

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