News & Analysis as of

Department of Health and Human Services (HHS) Risk Management 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

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

Dinsmore & Shohl LLP

Recent OCR Settlements Emphasize the Need for Thorough HIPAA Risk Analysis

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Two settlements recently announced by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) reinforce the agency’s emphasis on promoting thorough risk analysis to help prevent disclosure of...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

2025 Enforcement Trends: Risk Analysis Failures at the Center of HHS’s Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability and Accountability Act (HIPAA) resolution...more

Morrison & Foerster LLP

When Your Life Sciences Are on the Line: False Claims Act

Morrison Foerster partners Kate Driscoll and Nate Mendell, both former federal prosecutors and members of the firm’s Investigations + White Collar Defense Group, hosted the ninth episode of When Your Life Sciences Are on the...more

Warner Norcross + Judd

OCR Enforcement Intensifies: Key Takeaways on Risk Analysis and Right of Access

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services has renewed its focus on two critical areas of HIPAA compliance: risk analysis and individual right of access. These enforcement...more

Jackson Lewis P.C.

Health Fitness, OCR’s Risk Analysis Initiative, and the ERISA Fiduciary Duty to Select Plan Service Providers

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On Friday, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced the fifth enforcement action under its Risk Analysis Initiative. In this case, OCR reached a settlement with Health...more

Clark Hill PLC

Right To Know - March 2025, Vol. 27

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Cyber, Privacy, and Technology Report - Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed....more

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

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In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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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

Nilan Johnson Lewis PA

Nine Steps Healthcare Entities Should Take to Prevent Cyberattacks

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently imposed a $1.5 million civil money penalty against Warby Parker, Inc., a manufacturer and online retailer of eyewear, for...more

Health Care Compliance Association (HCCA)

We’ll Take the Fine: OCR’s ‘Unwarranted,’ Costly Demands Prompted Hospital’s $538K Payment

The saga that led Children’s Hospital Colorado to accept a fine of more than $500,000 imposed by the HHS Office for Civil Rights (OCR) began on July 11, 2017, when a physician’s email account containing details on 3,300...more

BakerHostetler

It’s Officially Enforcement Season: OCR Announces First Penalty Under New Risk Analysis Initiative

BakerHostetler on

On October 31, 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) embraced the end of Spooky Season by announcing two more ransomware-related enforcement actions. ...more

Williams Mullen

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

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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

Benesch

Annual Report to Congress on Breaches of Unsecured Protected Health Information

Benesch on

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

Saul Ewing LLP

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

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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

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Mintz

EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program

Mintz on

2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more

Brooks Pierce

Business Associate Victim of Ransomware Attack Pays $100,000 to HHS OCR

Brooks Pierce on

Is your organization a business associate? You could be subject to enforcement action if you fail to protect health information within your control from ransomware attacks. In October, for the first time, the U.S....more

Harris Beach Murtha PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

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

Harris Beach Murtha PLLC

HHS Office of Inspector General July 2023 Enforcement Activity

Harris Beach invites you to register for its 7 Element compliance program series addressing New York’s 2020 and 2022 updates to Medicaid Compliance Program requirements. Starting on August 16th, each live program will be no...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

[Event] 2023 Board & Audit Committee Compliance Conference - October 23rd - 24th, Fort Lauderdale, FL

Discover today's best practices for your role in healthcare compliance oversight - The Office of Inspector General of Health and Human Services expects healthcare board members, board audit/compliance committee members,...more

Health Care Compliance Association (HCCA)

[Virtual Event] Columbus & Indianapolis Regional Healthcare Compliance Conference - June 2nd, 8:25 am - 4:30 pm ET

General and specialty compliance education from the comfort of your home or office - HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance learning that covers a wide variety of...more

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