In January 2026, the U.S. Department of Health & Human Services (“HHS”) and the Assistant Secretary for Technology Policy / Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) published a Request...more
3/9/2026
/ Artificial Intelligence ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Emerging Technologies ,
Health Care Providers ,
Healthcare ,
Machine Learning ,
ONC ,
Public Comment ,
Public Health ,
Regulatory Requirements
As we close out January 2026, 2025 is firmly in the rearview mirror. And what a roller coaster it was. From AI developments to US state enforcement and legislation, it was a hard one to keep up with! The ground shifted under...more
2/25/2026
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
CIPA ,
Corporate Counsel ,
Data Breach ,
Data Privacy ,
Data Protection ,
EDPS ,
EU ,
General Data Protection Regulation (GDPR) ,
Innovative Technology ,
Machine Learning ,
New Guidance ,
Online Safety for Children ,
Personal Data ,
Personal Information
In January 2026, the State of Utah, acting through its Department of Commerce’s Office of Artificial Intelligence Policy (“OAIP”), launched a first-in-the-nation pilot permitting an autonomous artificial intelligence (“AI”)...more
2/16/2026
/ Artificial Intelligence ,
Data Privacy ,
Data Protection ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Popular ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Risk Management ,
State and Local Government
Artificial intelligence (AI) in healthcare may have reached an inflection point in 2025. After being defined by proofs of concept and isolated pilots for more than a decade, recent advances signal that AI is moving decisively...more
2/9/2026
/ Algorithms ,
Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Critical Infrastructure Sectors ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Emerging Technologies ,
EU ,
Executive Orders ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Healthcare ,
Hospitals ,
Information Technology ,
Innovation ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
OCR ,
OMB ,
Strict Product Liability ,
Whistleblowers
The rapid advancement of artificial intelligence (“AI”) has spurred remarkable innovation for the healthcare industry, while also resulting in swiftly emerging regulatory frameworks. ...more
12/17/2025
/ Artificial Intelligence ,
Bots ,
California ,
Digital Health ,
Electronic Communications ,
Health Care Providers ,
Healthcare ,
Minors ,
New Legislation ,
Regulatory Requirements ,
Reporting Requirements ,
Transparency
For French companies that do business in the United States, understanding the complex privacy and cybersecurity environment is key to managing risk. This is even more important as we face rapid changes and developments under...more
12/16/2025
/ Biden Administration ,
Cross-Border Transactions ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Data Security ,
Federal Data Privacy ,
Federal Trade Commission (FTC) ,
France ,
International Data Transfers ,
Privacy Laws ,
Regulatory Requirements ,
Risk Management ,
State Privacy Laws
In early August, Illinois enacted the Wellness and Oversight for Psychological Resources Act (HB 1806, or the “Act”), making it the first state to pass a law regulating the use of AI in the delivery of therapy and...more
12/2/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Consent ,
Digital Health ,
Health Care Providers ,
Healthcare ,
Illinois ,
Mental Health ,
New Legislation ,
Regulatory Oversight ,
Regulatory Requirements ,
Telehealth
California continues to lead the nation in artificial intelligence (“AI”) regulation with the recent enactment of Senate Bill (“SB”) 53—the Transparency in Frontier Artificial Intelligence Act (“TFAIA” or the “Act”). Signed...more
11/14/2025
/ Artificial Intelligence ,
California ,
Enforcement ,
Machine Learning ,
New Legislation ,
Regulatory Oversight ,
Regulatory Requirements ,
Reporting Requirements ,
Risk Management ,
Transparency ,
Whistleblower Protection Policies
Healthcare organizations of every shape and size are rapidly expanding their use of artificial intelligence solutions from high-risk applications like clinical decision-support interventions, ambient listening, and charting...more
10/22/2025
/ Acquisitions ,
Artificial Intelligence ,
Automation Systems ,
Data Privacy ,
Data Security ,
Disclosure Requirements ,
Due Diligence ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Mergers ,
PHI ,
Regulatory Requirements ,
Risk Management
At the end of June, Texas enacted the “Texas Responsible Artificial Intelligence Governance Act” (the “Act”), adding to the patchwork of growing AI laws. This summary addresses the Act’s most significant provisions....more
On June 10th, Sheppard Mullin partner Carolyn Metnick and associate Esperance Becton, in collaboration with Marsh McLennan, presented the CLE webinar, “Navigating Healthcare Risks in a Rapidly Evolving Patient and Provider...more
Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more
6/10/2025
/ Artificial Intelligence ,
Compliance ,
Enforcement ,
Federal Budget ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government ,
Technology
Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with...more
The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools...more
3/24/2025
/ Artificial Intelligence ,
Compliance ,
Contract Terms ,
Data Privacy ,
Data Protection ,
Data Security ,
Healthcare ,
Healthcare Reform ,
Intellectual Property Protection ,
Machine Learning ,
NIST ,
Risk Management ,
Technology Sector
On October 30, 2023, President Biden signed Executive Order 14110, laying the groundwork for the ethical and secure deployment of AI across industries, including healthcare. This comprehensive directive outlines policy goals...more
1/9/2025
/ Artificial Intelligence ,
Biden Administration ,
Cybersecurity ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Health Technology ,
Healthcare ,
Innovative Technology ,
Machine Learning ,
National Security ,
Public Health
The U.S. Department of Health and Human Services (“HHS”) issued a Notice of Proposed Rulemaking (the “Proposed Rule”) on December 27, 2024, to significantly amend HIPAA’s Security Rule, which sets forth the security standards...more
1/6/2025
/ Business Associates ,
Covered Entities ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Security Rule ,
NPRM ,
Privacy Laws ,
Proposed Rules ,
Regulatory Requirements ,
Rulemaking Process
Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more
12/31/2024
/ Artificial Intelligence ,
Corporate Counsel ,
Distributors ,
Healthcare ,
Legislative Agendas ,
Machine Learning ,
New Legislation ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Management ,
Software Developers ,
State Legislatures ,
Texas
On November 25, 2024, the Illinois State Legislature introduced House Bill 5918 IL HB5918, the Artificial Intelligence Systems Use in Health Insurance Act (“AI Act”). It provides the Illinois Department of Insurance (the...more
12/20/2024
/ Administrative Procedure Act ,
Artificial Intelligence ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Illinois ,
Legislative Agendas ,
New Legislation ,
Regulatory Oversight ,
State Legislatures ,
State Privacy Laws
On September 28, 2024, Governor Gavin Newsom signed into law California Assembly Bill 3030 (“AB 3030”), known as the Artificial Intelligence in Health Care Services Bill. Effective January 1, 2025, AB 3030 is part of a...more
11/19/2024
/ Artificial Intelligence ,
California ,
Governor Newsom ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Machine Learning ,
New Legislation ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology Sector
California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health...more
This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians....more
With technology rapidly evolving and jurisdictions appearing blurred, it is increasingly important to be mindful of data flow and use. This is particularly true where patient data is being accessed by offshore subcontractors....more
On May 17, 2024, Colorado Governor signed into law, Senate Bill 24-205, the Colorado Artificial Intelligence (AI) Act (the “Act”). The law will take effect on February 1, 2026 and the Colorado Attorney General will have...more
At last week’s America’s Physician Group Spring conference in San Diego, California, our team heard firsthand how physicians are leading efforts to integrate Artificial Intelligence (AI) applications in ambulatory and...more
If your organization has not updated its policies to comply with Utah’s Artificial Intelligence Policy Act (the “Act”), now is the time. As we noted in a prior blog post, this law took effect on May 1st. While it imposes...more