Operations and Monitoring of Predictive Health AI Solutions

Operations and Monitoring of Predictive Health AI Solutions (CTA-2136) This standard outlines the methodology and requirements of post-market operations and monitoring related to the accuracy of predictive health AI solutions. This standard does not identify real-world metric triggers by which the model might require re-training. Additionally, this standard does not address: • Generative health AI solutions and large language models. • Workflow AI models like scribes. • Natural Language Processing to review unstructured data in Electronic Medical Records (EMR) and transform it into structured data. • How the initial health AI algorithms are trained.