Quality & Governance News

FDA Releases Guidance on AI-Driven Clinical Decision Support Tools

The FDA has released new guidance recommending that some artificial intelligence-powered clinical decision support tools, like sepsis prediction devices, should be regulated as medical devices.

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Source: Getty Images

By Shania Kennedy

- The Food and Drug Administration (FDA) has released new guidance stating that some artificial intelligence (AI) tools should be regulated as medical devices as part of the agency’s oversight of clinical decision support (CDS) software.

The new guidance includes a list of AI tools that should be regulated as medical devices, including devices to predict sepsis, identify patient deterioration, forecast heart failure hospitalizations, and flag patients who may be addicted to opioids, among others.

In recent years, AI and machine learning (ML) have been increasingly incorporated into medical devices because these algorithms are capable of “learning” from experience and improving performance over time.