Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with...more
DTC Telehealth Platforms -
Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
1/31/2025
/ Acquisitions ,
Anti-Kickback Statute ,
Artificial Intelligence ,
Cannabis Products ,
Clinical Trials ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Fraud ,
Hart-Scott-Rodino Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Laboratory Developed Tests ,
Life Sciences ,
Marijuana ,
Marketing ,
Medical Devices ,
Medical Marijuana ,
Mergers ,
Non-Compete Agreements ,
Pharmaceutical Industry ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Section 340B ,
Technology Sector ,
Telehealth ,
Telemedicine
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
1/9/2025
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
National Security ,
Public Health
Last month, the U.S. Department of Justice (“DOJ”) quietly updated its March 2023 guidance on the evaluation of corporate compliance programs. Of course, DOJ did not conduct a major rewrite, but interestingly, the updated...more
10/30/2024
/ Acquisitions ,
Artificial Intelligence ,
Compliance ,
Corporate Governance ,
Department of Justice (DOJ) ,
Emerging Technologies ,
Guidance Update ,
Mergers ,
Policies and Procedures ,
Risk Assessment ,
Technology Sector
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure