2025-07-02 Steering Committee Meeting Notes

Stakeholder group

SHIELD organization

Name of SHIELD member

organization designation

Industry Entity

Labgnostic, Inc.

Steve Box

primary

alternate

Epic

Dan Rutz- regrets

primary

alternate

Biomerieux

Xavier Gansel

primary

alternate

Roche

Nick Decker

primary

Roche

none currently

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

Longtime Lab Professional

Carmen Pugh

primary

Sonic Healthcare

Eric Crugnale

primary

Former Quest Diagnostics

Collom, Craig D

primary

Patient Advocate

 OPEN

OPEN

individual

Standards Organization

SNOMED International

Jim Case

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- regrets

primary

Christina Gallegos

alternate

Logica

Stan Huff

primary

alternate

CAP

Raj Dash

primary

alternate

AMP

Robyn Temple

primary

alternate

Governmental - non Voting

CMS

Michael Smalara

primary

Open

alternate

ASTP/ONC

Sara Armson

primary

alternate

CDC

Hubert Vesper (/DDNID/NCEH/DLS)

primary

Jasmine Chaitram

alternate

NLM

 John Snyder

primary

alternate

FDA

 Keith Campbell

primary

Victoria Derbyshire

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 (2 open slots), 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

12:06 PM ET No quorum

Conferences/Time critical things / FYI

AMIA November 15 - 19 in Atlanta, GA https://amia.org/education-events/amia-2025-annual-symposium/call-participation was accepted

ADLM reached out to request a webinar about SHIELD later this year to be scheduled in August or later

SHIELD Charter Updates

Proposed Charter Updates To Article Three - March 2025Preview - Review the updated Article Three of the Charter as a whole

Discuss:

Motion to approve the Charter updates as noted by those on the call, with a request for e-vote for those not on the call. (Craig/Hung, votes for approval, 0 abstentions, 0 nays. Motion passes.) (4 non voting members.)

Note: Changes to the Charter require unanimous approval by the Steering Committee!!

https://grants.nih.gov/grants/guide/notice-files/NOT-LM-25-002.html

Due by Jul 14, 2025

Will have to read for relevance to SHIELD before we decide if we want to respond - If anyone has bandwidth, please make a note here:

May not have bandwidth, but overal sentiment is to try to submit something supporting standards, etc.

Consider a summary response that SHIELD supports continued Extramural Funding for

1: Training programs in Health Informatics across a variety of clinical areas as shortages of informaticists in areas as the data and informatics needs continue to grow.

2. Research grants across informatics and data science areas especially as informatics uses (e.g, Artificial Intelligence, Machine Learning) expand.

• utilizing machine learning applications to extract valuable clinical information from narrative pathology report; could be used to better identify cancer-related trends and diagnosis

3. Support for codesystem development either by NLM for SNOMED CT, RxNorm, etc. or in supporting other standards development organizations (LOINC)

4. Additional resources needed to create concepts for increased data, which is expanding for AI/ML needs.

LIDR White PaperPreview

Motion to approve the white paper with understanding the formatting of references will be finished. (Stan/ Hung) (8 in favor, 0 abstentions, 0 against) - will need to follow up with email vote

plan to publish in white paper and manuscript for publication.

Standards WG Vocab Follow up - NEXT TIME

LRI Review Summary DocumentPreview

Please review and provide comments - will take this up in early August 2025

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

Reviewing Updated Roadmap: https://aphlinformatics.atlassian.net/wiki/download/attachments/3214147628/DRAFT_UpdatedSHIELD_Community Roadmap_20250402.docx?api=v2

Changes are highlighted with markup addressing these ONC comments:

1. Aligning the roadmap scope to the mission scope

2. Addressing the concern that all standards need training and education

• Still need to review this one: Reviewed 2Jul25 see page 5 added text.

3. There are several solutions proposed, including repositories and tools, which need to be further evaluated before ONC could fully support the roadmap.  ONC suggests the roadmap be updated to include details around feasibility, scalability and how the proposed changes can be integrated into the current laboratory ecosystem (e.g., regulation and industry).

Identify components that could improve the ecosystem infrastructure, and then highlight the places where these components can be advanced / sustained or made easier to implement. Would SHIELD be willing to consider to provide an example implementation - create the structures and bound terminologies to showcase how each element would be properly represented be working.

(Action plan of which solutions would improve intereoperability. Why were these solutions chosen for the path forward. What is needed? How do you know this is the right path forward? Where’s the evidence this will work? )

For each of the Consideration sections we could certainly add a section on feasibility / requirements (e.g. continued funding for LIDR, better describing the intended use of ANY data element added, overall goal of LIDR, clearly delineate what is commonly used and is minimum, provide best practice and alternatives (non-preferred) - example would be metadata around the value sets in VSAC (curation / usage etc) to be able to ascertain quality) and highlight that other mechanisms are needed to achieve for adoption.

Discuss:

Review Working Groups progress - NEXT TIME

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

Setting milestones for deliverables should be NEXT for WGs: they will be captured here: SHIELD WG Deliverables and Milestone Grid

• Laboratory Interoperability Data Registry (LIDR) Working Group

  • Waiting for SC review of the LIDR White paper (see below)

  • Working on a pilot project with KOMET and Biomerieux

  • 4th Tuesday Cadence of meeting once a month

• IVD Data Hub

  • Exploring finding funding opportunities - current talks with Truveta (https://www.truveta.com/ )

    • No update since last time. Been holding with limited attendance. Looking to pilot use of their systems. Unclear what can be done without funding. Federal folks haven’t been able to participate.

• Standards Updates and Vocabulary Working Group

  •  

• Communications and Branding Working Group

  • SHIELD Membership Survey summary results

  • Continuing to review survey results. Had to move meetings that overlap with Steering Committee.

Placeholder to get back to later - NEXT TIME

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext AMP paper - do we need to do something with this as the Steering Committee?

• Antimicrobial result reporting

  • Related work at HL7 Europe:

• https://www.jmdjournal.org/article/S1525-1578(21)00327-5/fulltext

• Other presentations to folks at FDA?

  • Data Standards Review Committee of the FDA – work with Helena Sviglin

  • FDA Scientific Computing Board (SCB)

  • Compass group lab

Next calls

All SHIELD Calls

• Jul 22, 2025

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

Special Topic:

• Let us know if you have topics or speakers of interest

Steering Committee:

• Jul 16, 2025

Adjourned

 1: 57 PM ET