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 firstname.lastname@example.org. The FDA has recently released its Clinical Decision Support Software Guidance, which will help you assess your algorithm-based decision tool before completing the form. The Office of Regulatory Affairs and Quality and the ABCDS Oversight Committee can help answer any questions project teams may have.