The Food and Drug Administration (FDA) issued final guidance Monday that explains how medical device manufacturers can use a Predetermined Change Control Plan (PCCP) to update AI-enabled device software functions (AI-DSFs)...more
8/22/2025
/ 510(k) RTA ,
Artificial Intelligence ,
Cybersecurity ,
Digital Health ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Manufacturers ,
Marketing Authorization Application ,
Medical Devices ,
Pharmaceutical Industry ,
Premarket Approval Applications ,
Regulatory Oversight ,
Regulatory Requirements ,
Software
The UN General Assembly has adopted a landmark resolution focusing on the safe, secure, and trustworthy use of Artificial Intelligence (AI). This resolution, led by the United States and supported by over 120 Member States,...more
3/28/2024
/ Algorithms ,
Artificial Intelligence ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
International Data Transfers ,
Machine Learning ,
Member State ,
Personal Data ,
Risk Management ,
United Nations
The Securities and Exchange Commission and Federal Trade Commission are on the lookout for unsubstantiated claims surrounding artificial intelligence (AI)....more
The Biden Administration announced a broad Executive Order (Order) on artificial intelligence (AI). The Order, announced just days before an international summit on AI safety, allows the federal government to enforce...more
11/1/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Executive Orders ,
Innovative Technology ,
Machine Learning ,
National Security ,
Regulatory Agenda ,
Regulatory Oversight