Developing and Implementing Sustainable Real-World Evidence (RWE) Infrastructure for In Vitro Diagnostics (IVDs) Through Systemic Harmonization and Interoperability for Enhancement of Laboratory Data (SHIELD)

  • Overview

    A harmonization and mapping of in vitro diagnostic (IVD) related codes to create infrastructure to support IVDs for future pre-and post-market needs, this project includes pilots planned in antimicrobial susceptibility/resistance, opioid screening and confirmatory testing, testing for acute kidney injury, and diagnosis of sepsis.

  • Impact for NESTcc

    This project could assist in the mapping of relevant codes to improve interoperability of information related to IVDs.

  • Organizations

    The U.S. Food and Drug Administration (FDA)

  • Principal Investigators

    Michael S. Waters, PhD, FDA