The Food and Drug Administration is sticking its toe in the water of artificial intelligence, providing its first guidance on the emerging development of applications for the technology in healthcare.The FDA released model 1.0 of its software precertification pilot Monday to provide an initial tool to test these programs. The agency noted that with AI and machine learning technology advancing rapidly, the health IT community must move quickly to ensure their safety in practical applications.Software is increasingly used in healthcare to treat and diagnose conditions and diseases, aid clinical decision making and manage patient care, the FDA wrote in its working model (PDF). “Under this program, software developers would be assessed (by FDA or by an FDA-accredited third party) for the rigor of their practices in software design, testing, clinical assessment, and real-world performance monitoring, along with other appropriate capabilities.”

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