Device Approval 2 device approval Decision Support Systems, Clinical 1 Electronic Health Records 1 Food and Drug Administration 1 Humans 1 Note 1 Product Surveillance, Postmarketing 1 Software 1 United States 1 United States Food and Drug Administration 1 adverse event 1 artificial intelligence 1 clinical decision support system 1 clinical practice 1 electronic health record 1 health care planning 1 human 1 learning algorithm 1 machine learning 1 postmarketing surveillance 1 sepsis 1 software 1