ISPE

OCTOBER 27, 2022

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.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

OCTOBER 27, 2022

There are important considerations if the DHTT is classified as a medical device, which may change the level of regulatory controls and evidentiary requirements to support its appropriate use, such as off-label versus on-label use of a device with prior marketing authorization.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

The FDA Law Blog

MAY 26, 2025

The gray box at the top of the document at this link shows the change in position. Were not trying to bury the lead here, but the battle of labeling these surgical and drug treatments is a political one. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.

Labelling 59

Labelling HIPAA Documentation FDA 59