On October 6, 2025, after multiple rounds of amendments, California Governor Gavin Newsom signed into law Senate Bill 351 (SB 351), a significant measure that strengthens restrictions on the corporate practice of medicine...more
Federal oversight of Remote Patient Monitoring (“RPM”) is increasing, as agencies like the OIG, CMS and DOJ shift from issuing warnings to actively enforcing regulations. This includes standardized audit metrics and the first...more
10/13/2025
/ Audits ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medical Devices ,
Medicare ,
OIG ,
Regulatory Oversight ,
Telehealth
On June 27, 2025, the Centers for Medicare & Medicaid Services (“CMS”) announced the introduction of the Wasteful and Inappropriate Service Reduction (“WISeR”) Model, a six-year Medicare Part B pilot program that will...more
On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the CY 2026 Medicare Physician Fee Schedule (“PFS”) Proposed Rule. Published in the Federal Register on July 16, 2025, the rule outlines...more
8/26/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Comment Period ,
Department of Justice (DOJ) ,
Digital Health ,
False Claims Act (FCA) ,
Health Care Providers ,
Medicare ,
Medicare Part B ,
Physician Fee Schedule ,
Proposed Rules ,
Telemedicine ,
Value-Based Care
January saw activity in the copyright infringement lawsuit filed by a group of authors led by comedian Sarah Silverman against OpenAI. A magistrate judge ordered the AI pioneer to produce its datasets, which are used for...more
The adoption of artificial intelligence (AI) in healthcare has ushered in a new era of innovation that is transforming diagnostics, treatment planning and operational efficiencies. However, with great potential comes...more
It was a busy year for AI in 2024, and the Benesch AI Commission continued to follow the headlines and stay on top of legal developments. We wanted to take a look back at the year while also looking forward with some...more
1/29/2025
/ Amazon ,
Artificial Intelligence ,
China ,
Emerging Technologies ,
EU ,
Innovation ,
Legal Technology ,
Machine Learning ,
New Legislation ,
Partnerships ,
Pending Litigation ,
Proposed Legislation ,
Regulatory Agenda ,
Regulatory Oversight ,
Risk Management ,
Technology Sector
A pivotal decision by a New York Appellate Division court holding that earnouts based on the future revenue of a dental practice violated the NY Fee Splitting Prohibition could substantially impact the structuring of health...more
8/14/2024
/ Acquisitions ,
Appeals ,
Asset Purchase Agreements ,
Breach of Contract ,
Buyers ,
Contract Terms ,
Corporate Practice of Dentistry ,
Earn-Outs ,
Fee-Splitting ,
Mergers ,
Sellers ,
Unjust Enrichment
The AI sector continues to experience regulatory growing pains. Tech companies are struggling to comply with the EU’s new AI laws, which require more transparency in their model training. Meta, in particular, had to halt its...more
7/18/2024
/ Analytics ,
Artificial Intelligence ,
Big Tech ,
Consumer Financial Protection Bureau (CFPB) ,
Copyright Infringement ,
EU ,
Google ,
Machine Learning ,
Microsoft ,
Minors ,
NAD ,
Regulatory Agenda
The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more
7/12/2024
/ Artificial Intelligence ,
Compliance ,
Executive Orders ,
Federal Trade Commission (FTC) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Machine Learning ,
OCR ,
OMB ,
Personalized Medicine ,
Regulatory Standards
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
4/5/2024
/ Annual Reports ,
Compliance ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Enforcement Actions ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
OCR ,
PHI ,
Popular ,
Risk Management ,
Security and Privacy Controls
The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more
4/4/2024
/ Annual Reports ,
Breach Notification Rule ,
Business Associates ,
Compliance ,
Covered Entities ,
Department of Health and Human Services (HHS) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach Notification Rule ,
HITECH Act ,
OCR ,
PHI ,
Regulatory Authority