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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.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Table 3: Example classification of DHTs. .