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Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
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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. IMDRF SaMD Risk Categorization. Framework 26. doi:10.1001/jama.2022.2040.
The FDA describes these products under enforcement discretion if they are intended to inform clinicalmanagement for nonserious situations or conditions, help patients self-manage their disease or conditions without providing specific treatment, or automate simple tasks for health care providers. IMDRF SaMD Risk Categorization.
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