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Regulatory Oversight Enforcement Actions Health Care Providers

Robinson+Cole Data Privacy + Security Insider

Illinois Enacts Act Prohibiting AI Therapy

On August 4, 2025, Illinois Governor JB Pritzker signed the Wellness and Oversight for Psychological Resources Act into law, which went into immediate effect, and “prohibits anyone from using AI to provide mental health and...more

Kerr Russell

What Causes a LARA Investigation?

Kerr Russell on

Question: Over the years, several of my colleagues and I have been the subject of investigations by the Michigan Department of Licensing and Regulatory Affairs. In most of these cases it’s hard to imagine why LARA is...more

Foley & Lardner LLP

California Agency Cracks Down on High-Cost Hospitals

Foley & Lardner LLP on

California’s Office of Health Care Affordability (OHCA) is moving beyond broader policy-setting and into direct intervention at the provider level — a shift all hospitals and health systems across the state should take...more

Weintraub Tobin

CMS Ramps Up Enforcement of Hospital Price Transparency Rule

Weintraub Tobin on

The Hospital Price Transparency Law, codified at 45 CFR Part 180 and effective as of January 1, 2021, was implemented to provide the public with accessible hospital pricing information, aiming to eliminate hidden fees and...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

McCarter & English, LLP

FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

In January 2025, the US Food and Drug Administration (FDA) finalized its 2023 revised draft guidance Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

McDermott Will & Schulte

This Week in 340B: February 4 – 10, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Quarles & Brady LLP

PE in Healthcare – Recent Governmental Commentary Could Indicate Policy Changes on the Horizon and Time for Increased Vigilance

Quarles & Brady LLP on

Recent reports published by the Senate Budget Committee (the “Committee”) and the U.S. Department of Health and Human Services (“HHS”) highlight what the authors characterize as concerns related to private equity (“PE”)...more

BakerHostetler

DSIR Deeper Dive: Tracking the Crackdown on Tracking/Pixel Technologies: Web Litigation and Regulatory Landscape - Part 1

BakerHostetler on

Regulatory action and class action lawsuits related to pixels and other website technologies continued to surge in 2023 and 2024, particularly in the healthcare industry....more

Dorsey & Whitney LLP

HIPAA on the Horizon in the New Year: Important Lessons from an Active 2023 and Regulatory Initiatives to Watch for in 2024

Dorsey & Whitney LLP on

2023 marked 20 years since the first compliance deadline under the Health Insurance Portability and Accountability Act’s (“HIPAA”) privacy rule. Despite the two decades of experience with HIPAA, compliance continues to remain...more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

McDermott Will & Schulte

[Webinar] 340B… Or Not 340B: Oversight, Compliance and Enforcement - July 15th, 9:00 am - 10:00 am PT

The 340B Program has gained national attention over the last decade, in part due to the opportunities it provides to generate revenue for participating entities without risk of significant enforcement penalties for...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

McDermott Will & Schulte

[Webinar] Telehealth in the Hot Seat: Proactive Compliance in the Face of Heightened Enforcement - April 27th, 12:00 pm - 1:00 pm...

Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more

McDermott Will & Schulte

[Webinar] 2021 +Dx Diagnostics Forum - April 6th, 12:00 pm - 3:30 pm EST

Celebrating its sixth program, McDermott+Consulting’s +Dx Diagnostics Forum is the premier annual program for the laboratory diagnostics community. Gain insight into how the industry addresses regulatory and business...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Regional Healthcare Compliance Conference - Dallas, TX - February 12th, 8:25 am - 4:30 pm CST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Akin Gump Strauss Hauer & Feld LLP

Health Care and COVID – Regulation, Fraud and Enforcement

In this episode, Akin Gump health care partners Kelly Cleary and Robert Salcido discuss the health care industry and how COVID-19 has impacted the industry and affected or driven legislative and regulatory activity. Among...more

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Health Care Compliance Association (HCCA)

[Event] Board & Audit Committee Compliance Conference - February 24th - 25th, Fort Lauderdale, FL

The Office of Inspector General of Health and Human Services expects board members, board audit/compliance committee members, and senior level leaders of organizations to be experienced in compliance oversight. The Board &...more

Mintz - Health Care Viewpoints

Telemedicine Platform Recalled Over Failure to Obtain Pre-Market Clearance or Approval from FDA

On August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more

Bricker Graydon LLP

CMS and the Ohio Department of Health surveys: Active enforcement and increased transparency

Bricker Graydon LLP on

Surveys are an ever-present part of the regulatory oversight of health care entities. The industry continues to see ongoing active enforcement by both the Centers for Medicare and Medicaid Services (CMS) and the Ohio...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

Holland & Knight LLP on

On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Bradley Arant Boult Cummings LLP

'Opioids and Legal Enforcement — A Primer' - HarrisMartin's Drugs & Medical Devices

The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more

Mintz - Health Care Viewpoints

Are HCT/Ps a Dark Spot in the Sunshine Act Requirements?

On February 22, the Wall Street Journal published an article about the tissue graft manufacturer MiMedx Goup, Inc. and its failure to report payments to physicians under CMS’s Open Payments Program established by the Centers...more

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