All electronic algorithms that could affect patient care at Duke Health fall within the scope of the ABCDS Oversight Committee and must be registered.
Algorithms that support evidence-based standards of care (e.g., TIMI score for the treatment of Acute Coronary Syndrome) may be exempt from checkpoint reviews. A determination will be made after the algorithm is registered.
As a first step, please register your ABCDS model or tool by completing the registration form and e-mailing it to email@example.com. Our SaMD summary guide will help you assess your algorithm-based decision tool before completing the form.
This document provides an overview of the ABCDS Oversight process, the material requested at each checkpoint review, and the principles and criteria for approval.