Project Snapshot

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

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Why is SHIELD important?