AI/ML Models to Aid in the Diagnosis of COVID-19 Illness from Forced Cough Vocalizations: Good Machine Learning Practice and Good Clinical Practices from Concept to Consumer for AI/ML Software Devices

From a comprehensive and systematic search of the relevant literature on signal data signature (SDS)-based artificial intelligence/machine learning (AI/ML) systems designed to aid in the diagnosis of COVID-19 illness, we identified the highest quality articles with statistically significant data sets for a head-to-head comparison to our own model in development. Further comparisons were made to the recently released “Good Machine Learning Practice (GMLP) for Medical Device Development: Guiding Principles” and, in conclusions, we proposed supplemental principles aimed at bringing AI/ML technologies in closer alignment GMLP and Good Clinical Practices (GCP).