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.

Organization(s): The U.S. Food and Drug Administration (FDA)

Collaborators Include: 5 government offices, 7 IVD manufacturers, 5 healthcare systems, and 10 professional organizations and standards developers

Principal Investigator(s): Michael S. Waters, PhD (FDA)