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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

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. Wireless medical devices. IMDRF SaMD Risk Categorization.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Category I: SaMD that provides information to inform clinical management for a disease or condition in a nonserious situation or condition is a Category I and is considered to be of low impact.