The FDA Law Blog

OCTOBER 10, 2022

Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information. Here again, FDA’s novel interpretation of statutory terms effectively narrows the scope of information that a software product can display, analyze, or print and still be considered Non-Device CDS.

FDA 52

FDA Labelling Documentation Communication 52

ISPE

OCTOBER 27, 2022

DHTs may include mobile medical applications, health information technology, wearable devices, wireless sensors, telemedicine, electronic health records (EHRs), digital therapeutics, software as a medical device (SaMD), and artificial intelligence and machine learning (AI/ML) technology. Health information technology (IT).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

DHTs may include mobile medical applications, health information technology, wearable devices, wireless sensors, telemedicine, electronic health records (EHRs), digital therapeutics, software as a medical device (SaMD), and artificial intelligence and machine learning (AI/ML) technology. Health information technology (IT).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52