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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?
However, for certain DHTs classified as devices or SaMD, ISO 14971:2019 specifies the terminology, principles, and process for application of risk management. Is the product “software” according to the definition of MDCG 2019-11? Is the product “software” according to the definition of MDCG 2019-11? Published 26 September 2019.
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