Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological product development....more
1/16/2025
/ Artificial Intelligence ,
Bias ,
Biologics ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Premarket Approval Applications ,
Product Development Protocols ,
Regulatory Requirements ,
Risk Management ,
Software ,
Transparency
The use of technology in healthcare services and payment for healthcare is evolving at an unprecedented pace, reshaping how medical services are delivered, managed, and paid for. The use of artificial intelligence systems...more
3/25/2024
/ Algorithms ,
Anti-Discrimination Policies ,
Artificial Intelligence ,
Bias ,
Centers for Medicare & Medicaid Services (CMS) ,
Compliance ,
Consent ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Medicare ,
Medicare Advantage ,
Medicare Advantage Organizations (MAOs) ,
PHI ,
Software