On October 30, 2023, the Biden Administration released and signed an Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (Executive Order) that articulates White House...more
11/3/2023
/ Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Data Collection ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
LEAP ,
Non-Discrimination Rules ,
Policies and Procedures ,
Privacy Laws ,
Transparency
A spurt of letters from California Attorney General Rob Bonta to leaders of hospitals and other health care facilities sent on August 31, 2022 signaled the kickoff of a government probe into bias in health care algorithms...more
9/13/2022
/ Algorithms ,
Artificial Intelligence ,
California ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Costs ,
Hospitals ,
Machine Learning ,
Non-Discrimination Rules ,
Software ,
State Attorneys General
In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop), we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more...more
In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently,...more