Last fall at the Safeguarding Health Information: Building Assurance Through HIPAA Security 2024 conference, U.S. Department of Health & Human Services Office for Civil Rights (OCR) promised that before year’s end, it would...more
12/31/2024
/ Compliance ,
Data Breach ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Hackers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
Multi-Factor Authentication ,
OCR ,
Proposed Amendments ,
Proposed Rules ,
Ransomware
The Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) recently held its 2024 Exploratory Workshop titled “The Evolving Landscape of Human Research with AI – Putting Ethics to Practice”...more
10/10/2024
/ Artificial Intelligence ,
Consent ,
Data Collection ,
Data Privacy ,
Data Storage ,
Ethics ,
EU ,
Food and Drug Administration (FDA) ,
GAO ,
General Data Protection Regulation (GDPR) ,
Governance Standards ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Machine Learning ,
Office for Human Research Protections (OHRP) ,
OIG ,
Popular ,
Research and Development
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
6/28/2024
/ Artificial Intelligence ,
Colorado ,
Compliance ,
Consumer Protection Laws ,
Covered Entities ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Medical Devices ,
ONC ,
Risk Assessment ,
Software Developers
The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more
1/9/2024
/ Artificial Intelligence ,
Certifications ,
Department of Health and Human Services (HHS) ,
EHR ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Governance Standards ,
Machine Learning ,
ONC ,
Regulatory Agenda ,
Risk Mitigation ,
Transparency
Governor Newsom signed 890 bills and vetoed 156 bills in 2023. Every year, California passes multiple laws that impact health care practitioners and health facilities and, as further described below, 2023 is no exception....more
11/8/2023
/ California ,
Compliance ,
Department of Justice (DOJ) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Hart-Scott-Rodino Act ,
Healthcare ,
Home Health Care ,
Mental Health ,
New Legislation ,
Pharmacist ,
Skilled Nursing Facility
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