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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. IMDRF SaMD Risk Categorization. Framework 26. doi:10.1001/jama.2022.2040.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

The FDA describes these products under enforcement discretion if they are intended to inform clinical management 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.