News & Analysis as of

Enforcement Actions Risk Management Health Care Providers

Warner Norcross + Judd

Escalating ICE Presence in Health Care Settings — What Providers and Administrators Must Know Now

On July 8, a routine enforcement action by Immigration and Customs Enforcement (ICE) agents at a surgery center in California escalated into criminal charges for two health care workers. ICE agents were attempting to detain...more

Baker Donelson

EKRA's Application to Marketing Arrangements: Laboratories and Other Providers

Baker Donelson on

The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Morgan Lewis

AI in Healthcare: Opportunities, Enforcement Risks and False Claims, and the Need for AI-Specific Compliance

Morgan Lewis on

The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more

Warner Norcross + Judd

Insights from the Largest DOJ Health Care Fraud Enforcement Effort in U.S. History

On June 30, the Department of Justice (DOJ) announced the largest coordinated health care fraud enforcement effort in U.S. history, involving criminal charges against over 300 defendants and over $14.6 billion in health care...more

Blake, Cassels & Graydon LLP

New Guidance From Ontario’s Information and Privacy Commissioner on Privacy Management for Small Healthcare Organizations

Ontario’s Information and Privacy Commissioner (IPC) has released a new Privacy Management Handbook (Handbook) aimed at assisting small healthcare organizations to meet their privacy obligations under Ontario’s health...more

Ropes & Gray LLP

Navigating TRAIGA: Texas’s New AI Compliance Framework

Ropes & Gray LLP on

On June 22, 2025, Texas enacted the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), putting it at the forefront of state-level AI regulation in the United States. TRAIGA becomes effective January 1, 2026....more

Baker Donelson

Insider Threats Are Just as Dangerous as Ransomware – Lessons from the Latest OCR HIPAA Settlement

Baker Donelson on

What's New? On May 28, 2025, the U.S. Department of Health and Human Services' Office for Civil Rights (OCR) announced an $800,000 settlement with a large Florida-based health care provider over potential violations of the...more

Husch Blackwell LLP

False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation

Husch Blackwell LLP on

Host Jonathan Porter welcomes to the show Husch Blackwell partner Bryan Nowicki, a Madison-based member of the firm’s Healthcare group, to discuss payment suspensions involving the Centers for Medicare & Medicaid Services...more

Dentons

Ep. 61 – Three Compliance Lessons from a False Claims Act Verdict

Dentons on

In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more

Roetzel & Andress

ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations

Roetzel & Andress on

Join us on the HealthLawHotSpot as host Ericka Adler and Michael Brohman, shareholder and member of Roetzel’s Employment Litigation Group, discuss ADA compliance for medical and dental practices. In this episode, you'll learn...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Shook, Hardy & Bacon L.L.P.

OCR Enforcement Activity: Trends and Insights From a Limited Sample

Arecent report put the odds of an asteroid hitting the earth in December 2032 at 3.1%—which is 3,100 times more likely than an organization resolving an enforcement action with the U.S. Department of Health and Human...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

Dentons on

Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Morrison & Foerster LLP

China Issues First Compliance Guidelines to Combat Commercial Bribery Risks - UPDATED February 2025

On January 10, 2025, China’s State Administration for Market Regulation (“SAMR”) put into effect its Compliance Guidelines for Healthcare Companies to Prevent Commercial Bribery Risks (“Compliance Guidelines”)....more

Goodwin

Texas AG Reaches First-of-its-Kind Settlement With Healthcare AI Company Over Hallucination Rate Claims

Goodwin on

In a recent settlement, the Texas attorney general resolved allegations that Pieces Technologies, Inc. (Pieces), a healthcare generative AI company, misrepresented the hallucination rate of its generative AI product to...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 6th, Lafayette, CA

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - December 6th, Houston, TX

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - November 15th, Nashville, TN

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Williams Mullen

Ransomware Hat Trick: OCR Scores Three Major Enforcement Actions in 2024

Williams Mullen on

Ransomware attacks are a growing threat in the health care sector due to the value of personal health information (PHI). In addition to being expensive, these attacks can cripple health care operations, delay patient care,...more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - November 8th, Philadelphia, PA

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - November 8th, Philadelphia, PA

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - November 1st, Scottsdale, AZ

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 11th, Denver, CO

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

Hackers Increasingly Leveraging Threats to Patients to Pressure Health Organizations to Pay Ransom

Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more

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