Pharma Marketing Network

MARCH 26, 2025

Misinformation and Hallucinations : Generative AI platforms may create content that is inaccurate, outdated, or off-labelviolating FDA regulations. Misuse or insufficient anonymization can trigger HIPAA or GDPR violations. Documentation and Version Control : Keep detailed records of how AI content is created, reviewed, and approved.

HIPAA 64

HIPAA FDA Documentation 64

Pharma Marketing Network

MAY 22, 2025

These include: Pre-approved content libraries for AI models to select from Human-in-the-loop review of high-risk recommendations Explainable AI (XAI) protocols that document why a model made a decision Consent-based targeting, particularly in DTC campaigns involving patient data Additionally, data security and HIPAA compliance remain non-negotiable.

HIPAA 52

HIPAA Documentation FDA 52

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.

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In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical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. Table 3: Example classification of DHTs. .

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. 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.

Labelling 59

Labelling HIPAA Documentation Pharmaceutical Companies 59