The U.S. District Court for the Northern District of Texas vacated key portions of the 2024 updates to the HIPAA Privacy Rule that had strengthened protections for reproductive health care information. HIPAA-regulated...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
1/14/2025
/ Artificial Intelligence ,
Clinical Trials ,
Data Collection ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Popular ,
Regulatory Reform ,
Regulatory Requirements ,
Risk Management
The HIPAA Privacy Rule has been modified by the US Department of Health and Human Services (HHS) to increase privacy protections for reproductive health care information. These changes, which will take effect in early 2026,...more
The FTC continues to scrutinize the privacy practices of consumer health companies. After taking action against patient couponing and mental health companies, the FTC has now turned its attention to genetic testing....more
Sponsors of clinical trials in the United States have a regulatory responsibility under 21 CFR Part 312.50 to monitor the progress of clinical studies. Historically, Sponsors performed in-person monitoring visits of every...more