Project Overview

Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD) is a public-private partnership of over 70 organizations representing federal agencies, in vitro diagnostics (IVD) organizations, standards development organizations , medical associations, and other professional laboratory organizations.

SHIELD’s mission is to “Describe the SAME test the SAME way ANYWHERE in the Healthcare ecosystem”

SHIELD strives to create laboratory data interoperability (describing the same test the same way, everywhere in the healthcare ecosystem) because such data interoperability allows accurate public health surveillance and response; provides confidence by patients and doctors in laboratory results; and ensures medical researchers that their studies can be reproduced.

The FDA has been working with the SHIELD community since its inception, and now has a webpage: https://www.fda.gov/medical-devices/diagnostic-data-program/systemic-harmonization-and-interoperability-enhancement-laboratory-data-shield

One pager for more details:

Want to learn more / Connect? SHIELDLabCodes@gmail.com

ALL SHIELD calls are the fourth Tuesday of every month 12 - 1 PM ET - call coordinates: https://aphl.zoom.us/j/85881872295?pwd=SzlvakVHaGE2WTlxcUNVV0l6WmVyUT09

Special Topic SHIELD calls are on the second Tuesday of every month 12 - 1 PM ET - call coordinates: https://aphl.zoom.us/j/85881872295?pwd=SzlvakVHaGE2WTlxcUNVV0l6WmVyUT09

All Working Group calls are listed in the Call calendar: https://aphlinformatics.atlassian.net/wiki/spaces/SC/calendars

Roadmap:

Charter:

Standing Rules:

Steering Committee: - Chair: Riki Merrick, Vice-Chair: Andrea Pitkus

Working Groups Overview:

FROM PRIOR WORK

Steering Committee:

Co-Chairs: Micky Tripathi (ONC), Sara Brenner (HHS), Wendy Rubinstein (FDA) and Greg Pappas (FDA).Ensure that planning efforts are not duplicated, and that committee work fits together in an overall plan.

Other SHIELD Committees' Confluence Page - from 2021:

Communication: SHIELD Communication, Ed., Training Committee - APHL Informatics (atlassian.net)

Effectiveness: SHIELD Effectiveness - APHL Informatics (atlassian.net)

Implementation: SHIELD Implementation - APHL Informatics (atlassian.net)

IVD Industry: SHIELD IVD Industry - APHL Informatics (atlassian.net)

LIVD File: SHIELD LIVD Committee - APHL Informatics (atlassian.net)

Strategic Alignment: SHIELD Strategic Alignment - APHL Informatics (atlassian.net)

Tooling/Tech: SHIELD Tooling, Tech - APHL Informatics (atlassian.net)

FROM PRIOR WORK Timeline

Due date Nov 1 for the strategic plan to go into clearance

To be developed (3 year plan) TBD - image showing original timeline)

Interested Parties

SHELD Master List (7/7/21) and Coordination Committee Roster