Some overarching thoughts

Committees need to have charters

Strategy 1 - Laboratory Interoperability Data Repository (LIDR)

Requirements:

Must be funded and supported for pilot AND long term

Participants:

ALL Lab data creators and users!

Decision Making Needs:

Must be able to make clear decisions, have defined processes for expansion of content and needs strong governance model;

Possible model might be Digital Bridge ()

Strategy 2 - Support dataflow throughout the ecosystem

Requirements:

Participants:

ALL Lab data creators and users!

Ana Szarfman (FDA - CDER)

Decision Making Needs:

Strategy 3 - Tooling

Requirements:

Participants:

Ana Szarfman (FDA - CDER)

Decision Making Needs:

Strategy 4 - IVD Data Hub

Requirements:

Participants:

Ana Szarfman (FDA - CDER)

Decision Making Needs:

Strategy 8 - Communications and Branding

Requirements:

Participants:

Decision Making Needs:

Overarching Strategy: Evaluation and Feedback Loops

Requirements:

Participants:

ALL Lab data creators and users!

Decision Making:

Regulatory Committee

Requirements:

Participants:

Federal agencies, regulated system vendors and users

Decision Making:

Other Ways of organizing:

https://digitalbridge.us/governance/

Uploaded documentation:

Reorganization draft proposal: https://aphlinformatics.atlassian.net/wiki/download/attachments/999161920/SHIELD_Reorganization_Proposal.docx?api=v2

Volunteers for Re-organization committee - SIGN UP BELOW!!!!!:

In case we plan on proceeding with a Collaborative Community, we will need to excuse our federal partners from that part of the work:

Mehdi Nassiri (Indiana University/IUH)

Hung Luu (Children’s Hospital)

Mary Kennedy (CAP)

Riki Merrick (APHL)

Jeff Smith (KP)

Scott Cambell (UNMC)

Stan Huff (Graphite)

Anne Phillips (IMO)

Steven Emrick (IMO)

Nanguneri Nirmala (Tufts Medical Center)

Andrea Pitkus (U Wisconsin)

Pam Banning (3M Health information Systems)

Serge Jonnaert (IICC)

Joe Sapiente (MDIC)

Carolyn Hiller (Regan Udall Foundation)

Joan Kegerize or Freida Hall (American Clinical Laboratory Association [ACLA])

Rob Hausam (Hausam Consulting LLC)

Marjorie Rallins (Regenstrief Institute, LOINC)

Eza Hafeza (Regenstrief Institute, LOINC)

Robyn Temple-Smolkin (AMP)

Federal Partners:

Greg Pappas (FDA - CBER)

Keith Campbell (FDA - CDRH)

Carmela Courderc (ONC)

Jasmine Chaitram (CDC)

Leonie Misquitta (NIH)

Ana Szarfman (FDA - CDER)