CLEP NYS AND WSI AI

 Bottom line for companies like Paige, Artera, and PathAI (or hospitals using them):

• If you are offering clinical results on NY specimens, you must operate under a NYS clinical laboratory permit in the relevant categories. wadsworth.org
• Digital pathology/AI use itself does not trigger an LDT submission to CLEP, but you still need proper WSI validation, licensed pathologist sign-out, and you should ensure any AI/viewing software has the needed FDA status for its intended diagnostic use. wadsworth.org+1

https://www.wadsworth.org/regulatory/clep/clinical-labs/obtain-permit/test-approval

CLEP has determined that the use of digital imaging of slides in pathology will not be subject to submission requirements as a laboratory-developed test. This includes digital imaging of slides with subsequent use of artificial intelligence/machine learning. 

 As required in CLEP’s Clinical Laboratory Standards, a licensed pathologist must examine and report out all histopathology cases and all non-gynecologic cytopathology cases; a licensed pathologist must examine and report out all gynecological cases with epithelial cell abnormalities. 

These standards also apply to any digital pathology using artificial intelligence/machine learning. Digital imagining systems and algorithms used in pathology may require approval from the Food and Drug Administration.