Patient consent over data post processing in USA

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Imagine you have a new AI device that takes the output from another FDA cleared sensor device, feeds it into an AI prediction network, and provides a prediction to a clinician or to the patient themselves.. Is there a requirement to notify the user thats being done behind the scenes? I know in the EU GDPR probably addresses explicit consent but does the FDA require some patient notification of this processing of their personal health data?
 
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