Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
4/29/2025
/ AI Act ,
Algorithms ,
Artificial Intelligence ,
EU ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Healthcare ,
ONC ,
Regulatory Requirements ,
Transparency
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a major initiative to voluntarily phase out “petroleum-based synthetic dyes” (i.e., synthetic...more
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F....more
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
1/22/2025
/ Artificial Intelligence ,
Cybersecurity ,
Draft Guidance ,
Emerging Technologies ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more
1/17/2025
/ Artificial Intelligence ,
Compliance ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management
On January 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance establishing action levels for lead in processed food intended for babies and young children. This is the first FDA guidance directly...more
1/13/2025
/ Baby Products ,
Class Action ,
Compliance ,
Consumer Protection Laws ,
Enforcement Actions ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Safety ,
Lead ,
Liability ,
Manufacturers ,
Product Defects ,
Public Health ,
Regulatory Requirements ,
Risk Mitigation ,
Toxic Chemicals