OVERVIEW

2024 ICBE-B: Artificial intelligence (AI)/Predictive Model Verification is organized by College of American Pathologists (CAP).

Start Date: 05/20/2024
End Date: 05/19/2027

Description:
Artificial intelligence and machine learning have become increasingly central to clinical laboratories, offering the potential to improve patient care efficacy and quality. Despite this promise, there is a noticeable lack of guidance for the implementation and validation of machine learning (ML)-enabled In Vitro Diagnostic (IVD) devices. At present, a clear need exists for detailed guidelines on validating and verifying these emerging technologies.

Objectives:
After completing this activity, you should be able to:
• Identify what the manufacturer claims for a given In Vitro Diagnostic (IVD) device are and among those, which require validation/verification prior to use in the clinical laboratory.
• Generate the steps required to properly verify a machine learning (ML)-enabled IVD assay.
• Discuss approaches to verifying qualitative and quantitative claims that are associated with ML-enabled IVD assays.