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. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. General wellness apps.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

The FDA Law Blog

MAY 26, 2025

And the memo goes one step more arguing that, even if otherwise truthful, promotion of off-label uses of hormones can run afoul of FDA prohibitions on misbranding and mislabeling. Nevertheless, individuals and organizations could be in receipt of grand jury or HIPAA subpoenas requesting records, or they could be visited by federal agents.

Labelling 59

Labelling HIPAA Documentation Pharmaceutical Companies 59