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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. Journal of the American Medical Association 327, no. 2022.2040.

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Challenges & Opportunities in Emerging Digital Health Technologies

ISPE

Covered by Medical Device Regulations according to decision tree per Medical Device Coordination Group (MDCG) Guidance 2019-11: Covered by Medical Device Regulations according to decision tree per MDCG document 2019-11: 1. Is the product “software” according to the definition of MDCG 2019-11? Published 27 September 2019. MDCG 2019-11.