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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. Is the software MDSW according to MDCG 2019-11?
The application of risk management principles for DHTs is not clearly defined and depends on whether the technology is classified as a medical product based on its intended use. However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management.
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