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Fact Sheet
Regulatory Assessment Tool for Clinical Decision Support Software
Feb 12, 2024
Clinical Decision Support (CDS) Software can help healthcare providers make treatment decisions and interpret patient data. The increasing development of CDS tools with AI-functionality have spurred the US FDA to develop new regulatory frameworks around the oversight of AI driven software used as medical devices. However, the agency's newest guidance on CDS tools leave a lot of questions for clients as they try to make sense of, and comply with, regulations.
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