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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

OCTOBER 27, 2022

Given the public health emergency, health authorities offered greater flexibilities in the use of digital health platforms and technologies such as: Enhanced HIPAA (Health Insurance Portability and Accountability Act of 1996) flexibilities in the use of telemedicine services 3. IMDRF SaMD Risk Categorization. Framework 26. doi:10.1001/jama.2022.2040.

Health and Personal Care Stores 52
Health and Personal Care Stores FDA HIPAA Communication 52
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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

OCTOBER 27, 2022

There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization. IMDRF SaMD Risk Categorization. Framework 26.

Health and Personal Care Stores 52
Health and Personal Care Stores FDA Communication Clinic Management 52
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