2026-05-13 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box - regrets

primary

alternate

Epic

Dan Rutz - regrets

primary

alternate

Biomerieux

Xavier Gansel - regrets

primary

alternate

OPEN

OPEN

primary

OPEN

OPEN

alternate

Healthcare Provider

Quest Diagnostics, Seattle, WA

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

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare / ACLA

Eric Crugnale - regrets

primary

Harvard

Li Zha - regrets

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case - regrets

primary

Monica Harry

alternate

Regenstrief Institute

Marjorie Rallins - regrets

primary

Eza Hafeza - regrets

alternate

HL7

Julia Skapik

primary

alternate

Professional Organization

Association of Public Health Laboratories

Riki Merrick

primary

Christina Gallegos

alternate

Logica

Stan Huff - regrets

primary

alternate

CAP

Raj Dash - regrets - regrets

primary

alternate

AMP

Robyn Temple - regrets

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ONC

Sara Armson

primary

 OPEN

alternate

CDC

Hubert Vesper - regrets (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

OPEN

primary

OPEN

alternate

FDA

OPEN

primary

alternate

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 17 named members (1 open slot, future 3 openings), so 2/3 = 11 is quorum (excluding chair and government members).

# of voting member per charter: 13 - 21

# of non-voting members per charter: 7

Open Meeting

12:09 PM ET - no quorum

Follow up items

• SHIELD flyer passed eVotes after the call - it is uploaded here: SHIELD Collaborative Community

• eVote for Charter passed eVotes after the call - the current version is here: SHIELD Community Charter (as of 5/14/2026)

• NLM and FDA participation:

  • John Snyder is asking about decision for NLM

  • Reached out to contacts for FDA Collaborative Community and lead in OHT7 - they are working on finding a resource

Review SHIELD WG Deliverables and Milestone Grid

THANK YOU to all the WG Chairs for their effort in moving SHIELD work forward!!!

Julia will schedule the Standards and Vocab WG calls soon

• would be good to give guidance to LOINC Committee and USCDI (where LOINC is listed for LabOrders) what to include when there are one-click panels like the stroke panel, which in itself has many panels in it - how to deal with “exploding panels” and maybe also set this up for a Topic #2 call

• Dealing with panels in reflex testing (susceptibility testing panel as part of the reporting per organism)

FDA Interoperability Roadmap Updates

Nick Decker sent this email:

UPDATE ON ANTICIPATED ‘INTEROPERABILITY ROADMAP’: Last week (April 30), Center for Devices and Radiological Health Director MICHELLE TARVER said at a meeting hosted by the Medical Device Manufacturers Association that the device center was working on a “roadmap” for interoperability in the medtech and consumer tech sectors. At the Food and Drug Law Institute Annual Conference yesterday (May 6), she offered more detail, noting that the roadmap would be a discussion paper document. “We plan to put out a discussion paper about interoperability that shows the landscape of all the different standards that exist, not only in the medical device space or in the electronic health record space, but also in the consumer tech space,” Tarver said. She also indicated that the agency would seek comment on the topics to be addressed in the paper. The move comes as medtech and consumer tech increasingly intersect. Issues related to health information technology interoperability are top of mind as devices integrate with HIT products, and their generated data sets, such as electronic health record data, are considered for regulatory use as real-world evidence.

Discussion today:

nothing new to add

Update from HITACH meeting

• Mainly presentations about
  prior authorization CMS rule - Hung mentioned that lab tests that require those need to be included

• LEAP and Ignite Challenge by ONC

• https://healthit.gov/event/health-information-technology-advisory-committee-2/

HL7 WGM in Bethesda joint meeting with FDA, ONC and CMS or other participants that are in the area possible?

Sep 19-25th HL7 is at Marriott in Rockville - in person meeting for SHIELD members? Potentially another DC area site.

Consider if part of WG quarter (if OO can sponsor that; need to have permission for virtual participants, which would mean folks might need to register for the day?) or one-off outside of HL7

Update from brainstorming email:

• Suggested to open up to all SHIELD members

• have agenda posted

  • inviting federal folks who are local to DC area to introduce them to SHIELD

• Thursday or Friday most popular

• 1 quarter = 1.5 hours or longer?

• Offer for other meetings in the future by Regenstrief (Indiana) and by Stan (UT)

• HL7 registration fees could be a barrier (could we find sponsors?):

  • before Aug 21, 2026 member/non member $420/$560

  • after Aug 21, 2026 member/non member $630/$840

  • student: $210

Vision 2030 work

https://docs.google.com/document/d/11A9VyhtSGm9dCjJNOi7_eJzz3gPDMYhkmNCoQNVbxuo/edit?tab=t.0#heading=h.yp9lsvo5yvsf

Follow up from last call - see minutes: 2026-04-29 Steering Committee Meeting Notes

Need to find date to re-invite Serge

Discussion today:

Next calls

All SHIELD Calls

• Jun 9, 2026

General Updates: 2024 - WG Chairs please make sure we have material for updates (at least notes we can link to)

Special Topic:

• May 12, 2026 - LOINC Updates

Steering Committee:

• Jun 3, 2026

Call adjourned

12:32 PM ET

Ideas for the longevity of SHIELD Community and work

Placeholder to get back to later

• Antimicrobial result reporting - CAP Informatics Commitee will request feedback from Standards and Vocab WG

  • Any updates from CAP?

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

• Next HTI rule (whenever it comes out)