As we reflect on the flurry of activity in the health care data privacy and security space in 2023 and look ahead to what will continue to be a busy 2024, we are seeing the early stages of federal agency movement to align the...more
1/26/2024
/ Artificial Intelligence ,
Cybersecurity ,
Data Breach ,
Data Security ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
HIPAA Privacy Rule ,
Information Blocking Rules ,
Mental Health ,
Notice of Proposed Rulemaking (NOPR) ,
OCR ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Reproductive Healthcare Issues ,
Request For Information ,
SAMHSA ,
Substance Abuse ,
Transparency
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
In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history...more