2023-08-01 SHIELD Steering Committee Meeting notes

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
	SNOMED International	Monica Harry	alternate
	Regenstrief Institute	Marjorie Rallins	primary
	Regenstrief Institute	Eza Hafeza	alternate
	HL7	Julia Skapik	primary
	HL7		alternate
Professional Organization	Association of Public Health Laboratories	Riki Merrick	primary
	Association of Public Health Laboratories	Dari Shirazi	alternate
	Graphite Health	Stan Huff	primary
	Graphite Health		alternate
	CAP	Raj Dash	primary
	CAP		alternate
	AMP	Robyn Temple	primary
	AMP		alternate
Governmental - non Voting	CMS	Serafina Brea	primary
	CMS		alternate
	ONC	Sara Armson	primary
	ONC		alternate
	CDC	Hubert Vesper (/DDNID/NCEH/DLS)	primary
	CDC	Jasmine Chaitram	alternate
	NLM	John Snyder	primary
	NLM		alternate
	FDA		primary
	FDA		alternate

Agenda and Notes

Item	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 Working Groups 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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