News & Analysis as of

Department of Health and Human Services (HHS) Settlement Enforcement Actions

Paul Hastings LLP

At the Crossroads: Illumina Settlement Reflects the Intersection of Cybersecurity and Healthcare Law

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On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more

Goodwin

CCPA Settlement Signals Focus on Web Tracking Health Data

Goodwin on

In June 2025, California Attorney General Rob Bonta filed a proposed settlement with Healthline, a health information website, for its handling of personal information under the California Consumer Privacy Act (CCPA)....more

Kilpatrick

Healthcare Fraud in the False Claims Act Enforcement Crosshairs: Why Now is the Time to Strengthen Compliance Efforts

Kilpatrick on

The U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) have announced that they are revitalizing the DOJ-HHS False Claims Act Working Group. The primary focus of the working group will be...more

Rivkin Radler LLP

OCR Announces $800,000 HIPAA Settlement with Florida Health System

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The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced another settlement for alleged violations of HIPAA. OCR investigated BayCare Health System, which serves central Florida, after a...more

Harris Beach Murtha PLLC

Scrutiny of Hospital–Physician Relationships Continues

Despite changes in many priorities, the federal government’s scrutiny of relationships between hospitals and physicians continues well into 2025. Last month, Community Health System (CHS) in California and its affiliate,...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

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The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Private Equity Throws FCA Enforcement Off-Kilter

Over the last 15 years, private equity (“PE”) firms have invested hundreds of billions of dollars in the healthcare sector, infiltrating every corner of the industry from emergency rooms and labs to billing providers and...more

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more

Mintz - Health Care Viewpoints

EnforceMintz — Long Tail of Pandemic Fraud Schemes Will Likely Result in Continued Enforcement for Years to Come

In last year’s edition of EnforceMintz, we predicted that 2024 would bring an increase in False Claims Act (FCA) enforcement activity related to COVID-19 pandemic fraud. Those predictions proved correct. The COVID-19 Fraud...more

Saul Ewing LLP

Two CMPs and One Settlement Close Out 2024 HIPAA Enforcement

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December 2024 was an active month for the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR"). OCR announced (i) a $1.19 million civil monetary penalty ("CMP") against Gulf Coast Pain...more

Quarles & Brady LLP

HHS Office for Civil Rights Reaffirms Interest in Enforcement Related to Reproductive Health Information

Quarles & Brady LLP on

On December 2, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (HHS OCR) announced a settlement with Holy Redeemer Family Medicine, a Pennsylvania covered entity, regarding an alleged violation...more

Saul Ewing LLP

Emergency Medical Service Provider Agrees to Pay a $90,000 HIPAA Settlement Following Ransomware Attack

Saul Ewing LLP on

On November 1, 2024, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced a $90,000 settlement with Bryan County Ambulance Authority (“BCAA”), a provider of emergency medical...more

Saul Ewing LLP

No “Trick”: Plastic Surgery Practice Agrees to Pay a $500,000 HIPAA Settlement Following Ransomware Attack

Saul Ewing LLP on

On October 31, 2024, the U.S. Department of Health and Human Services (“HHS”), Office of Civil Rights (“OCR”) announced a $500,000 settlement with Plastic Surgery Associates of South Dakota (“PSA”) concerning potential...more

Bass, Berry & Sims PLC

HHS-OIG Set To Intensify Scrutiny of Grants and Contract Compliance: How to Prepare

Bass, Berry & Sims PLC on

As we detailed in a previous blog, on October 3, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a strategic plan to “safeguard[] the integrity of HHS grants and contracts.” The...more

Baker Donelson

The Office for Civil Rights Recently Settled Two Ransomware Related Investigations

Baker Donelson on

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently settled two ransomware cases with covered entities. These cases signal the government's growing concern with health care...more

Saul Ewing LLP

Medical Practice Agrees to Pay $250,000 HIPAA Settlement Following Ransomware Attack

Saul Ewing LLP on

In late September 2024, the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) announced a settlement with Cascade Eye and Skin Centers, P.C., a health care provider in the state of...more

Saul Ewing LLP

HIPAA Security Rule Settlement Results in $950,000 Payment by a Mid-Atlantic Health System

Saul Ewing LLP on

On July 1, 2024, the U.S. Department of Health and Human Services (“HHS”) Office For Civil Rights (“OCR”) announced a $950,000 settlement with Heritage Valley Health System (“Heritage Valley”) and a three-year Corrective...more

Skadden, Arps, Slate, Meagher & Flom LLP

HHS Office for Civil Rights Reaches Second Health Care Ransomware Settlement

The Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently announced its second settlement in four months growing out of a ransomware attack on a health care business. Maryland-based Green Ridge...more

Saul Ewing LLP

HHS OCR Issues Its Most Recent HIPAA Annual Report and a Second Ransomware Settlement

Saul Ewing LLP on

On February 14, 2024, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued two reports to Congress as required by the Health Information Technology for Economic and Clinical Health...more

Health Care Compliance Association (HCCA)

News Briefs: January 8, 2024

H. Lee Moffitt Cancer Center & Research Institute Hospital Inc. in Tampa, Florida, has agreed to pay $19.564 million to settle false claims allegations over claims submitted to federal health care programs for items and...more

Saul Ewing LLP

NYC Hospital Agrees to Pay $4.75 Million as Part of a HIPAA Settlement

Saul Ewing LLP on

On February 6, 2024, the HHS Office for Civil Rights (“OCR”) announced a settlement with Montefiore Medical Center (“MMC”) for alleged HIPAA Security Rule violations and MMC agreed to pay $4.75 million and enter into a...more

Harris Beach Murtha PLLC

OIG January 2024 Enforcement Summary

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

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