What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
5/9/2025
/ Biologics ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Pharmaceutical Industry ,
Regulatory Reform ,
Research and Development ,
Risk Assessment ,
Risk Management ,
Supply Chain
What's Changed? The U.S. Department of Justice (DOJ) published a Data Security Program (DSP), pursuant to a final rule (Final Rule), which became effective on April 8, 2025....more
4/29/2025
/ Covered Transactions ,
Cybersecurity Information Sharing Act (CISA) ,
Data Privacy ,
Data Security ,
Department of Justice (DOJ) ,
Enforcement ,
Final Rules ,
National Security ,
Personal Data ,
Regulatory Requirements ,
Sensitive Personal Information
On April 11, 2025, the Department of Justice's National Security Division (NSD) issued additional guidance to assist U.S. organizations in understanding and complying with the Data Security Program (DSP). As discussed in our...more
4/24/2025
/ Data Security ,
Data Transfers ,
Department of Justice (DOJ) ,
Export Controls ,
Final Rules ,
Foreign Adversaries ,
National Security ,
New Regulations ,
Personal Data ,
Regulatory Requirements ,
Sensitive Personal Information
On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. ยง 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more
1/24/2025
/ Artificial Intelligence ,
Automation Systems ,
Covered Entities ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
OCR ,
Regulatory Requirements ,
Risk Management ,
Section 1557
The HIPAA Privacy Rule to Support Reproductive Health Care Privacy went into effect on June 24, 2024. The 2024 Final Rule strengthens privacy protections for medical records and other health information related to...more
Texas Attorney General, Ken Paxton, (the Attorney General) announced on September 19, 2024, a landmark settlement with Pieces Technologies (Pieces) over allegations of false and misleading claims about the capabilities of its...more