2022-04-04 SHIELD Leadership Call Notes

Ana Szarfman

FDA

Frank Weichhold

FDA

Andrea Pitkus

UW

Haley Flores

FDA

Carmela Courderc

ONC

Joe Sapiente

MDIC

Kevin Schap

CAP

Leonie Misquitta

NIH

Mary Hasan

CMS

Molly Pollen

AACC

Serge Jonnaert

IICC

Ed Heierman

Abbott / IICC

Keith Campbell

FDA

Stan Huff

Intermountain Healthcare

Hung Luu

Children’s Hospital

April Voukas

Abbott

Andrew Northrup

ONC

Avinasha Shanbhag

HHS

Michael Glickman

CNA INC

Serafina Brea

CMS

Rob Hausam

MITRE

Marion Peyton

Deloitte (FDA suport)

Riki Merrick

APHL

Welcome and Agenda Review

Riki Merrick

• Have set up leadership team calls for every other week 12:30 - 1 PM on Mondays

• When to start the big SHIELD call back up?

  • Once a month Tuesdays 1 – 1:30 PM EDT
    on the week we don’t have leadership call

  • First call 4/26

• Any other agenda Items?

Update on the strategic plan

Riki Merrick

• Send to editor this week (sorry for the delay)

• Create a short overview video to share with partners

  • 10 minutes ppt slides with more background

  • video of current state and then after SHIELD implementation

Organizational Structure

Riki Merrick / Keith Cambell

Reviewing the confluence pages
SHIELD Re-Organization
Organization of Committees for Implementation Rightsizing operations

• informal has advantage of being more flexible - works well until we have disagreement of what to do first, but harder to make official statements, then may only be able to generalize

• For starters we had SHIELD be the open platform to build consensus around the problem of laboratory interoperability and then there are projects that come out of that, that will need specific structures

• May also need more outreach to more stakeholders - like patient advocacy?

• Will the endproduct(s) be part of the ISA / certification program / a tool?

• Keith has engagement contract and can use part of these resources to be helpful, without taking this over, but having funded resources to have folks give ideas to get a faster outcome may be a good thing

Hybrid approach

• What parts of SHIELD have to have formal organization?

• In order to decide consider:

  • What will be the end product - value add to existing work - where will this reside?

  • For whom?

  • For what purpose?

LIDR specifically

• are we defining this for the long term (commercial or otherwise), or just continue to have the plan that then gets handed over to an entity that will run LIDR

• Goal should be able to harmonize the results of the tests - this begs the question under which this work should be done?

From Chat

From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone 12:39 PM

What's the timeline for the strategic plan?

From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone 12:45 PM

"terms “collaborative communities” is used in a specific context (=specific definitional requirements by the FDA)."-(picc)

From Riki to Everyone 12:46 PM

I am hoping for end of April 2022

From Leonie Misquitta to Everyone 12:50 PM

We can likely have a hybrid structure for formal and informal organization.

Formal for strategic goals, end products and the like.

From Keith.Campbell@fda.hhs.gov to Everyone 12:50 PM

I think the question of long term funding is critical.

From Leonie Misquitta to Everyone 12:50 PM

Informal org can be around outreach, education and the like

From Keith.Campbell@fda.hhs.gov to Everyone 12:56 PM

For long term funding, one question is how FDA User Fees might relate...

https://energycommerce.house.gov/committee-activity/hearings/rescheduled-hearing-on-fda-user-fee-reauthorization-ensuring-safe-and

From Andrea Pitkus PhD, MLS(ASCP)CM to Everyone 12:59 PM

What will be outcome of feedback?  A proposal to vote upon in the future?