News & Analysis as of

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

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Rivkin Radler LLP

DOJ and HHS Announce FCA Working Group

Rivkin Radler LLP on

On July 2, the U.S. Department of Justice (DOJ) and Department of Health and Human Services (HHS) announced the formation of the DOJ-HHS False Claims Act Working Group to strengthen “their ongoing collaboration to advance...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

Health Care Compliance Association (HCCA)

Former OCR Director Fontes Rainer Reflects On ‘Imperfect’ RSP Law, Urges Final Security Reg

In October, the HHS Office for Civil Rights (OCR) fined Providence Medical Institute (PMI) $240,000, an amount that reflected a 20% discount for having “recognized security practices” (RSPs) in place. But many more covered...more

BakerHostetler

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

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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

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

Health Care Compliance Association (HCCA)

Revised Privacy Rule May Not Emerge for Two Years; Info Blocking Penalty Regulation Published

Report on Patient Privacy Volume 23, no 7 (July 2023) In two public talks this spring, Melanie Fontes Rainer, director of the HHS Office for Civil Rights (OCR), said completing the 2021 proposed regulation extensively...more

DarrowEverett LLP

A HIPAA Privacy Notice A Day Keeps The Doctor Away (And Out Of Trouble)

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The start of 2023 has brought with it significant changes to data privacy – new state laws concerning data privacy came into effect January 1 (the California Privacy Rights Act and the Virginia Consumer Data Protection Act),...more

Robinson+Cole Health Law Diagnosis

Fifth Circuit Overturns “Arbitrary and Capricious” $4.3 Million HIPAA Penalty Against Hospital

On January 14, 2021, the U.S. Court of Appeals for the Fifth Circuit overturned a $4.348 million penalty for alleged HIPAA violations assessed by the U.S. Department of Health & Human Services (HHS) against the University of...more

Holland & Hart - Health Law Blog

Encrypt Your Devices or Face HIPAA Penalties

This week, the Office for Civil Rights (“OCR”) announced a $3,000,000 HIPAA settlement arising from a medical center’s loss of an unencrypted laptop and flash drive. This is simply the latest of many HIPAA settlements based...more

Hogan Lovells

HIPAA Penalty Caps to Be Reduced and Tied to Culpability Level

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In a dramatic turn, the US Department of Health and Human Services (HHS) has announced that effective immediately, penalties for many HIPAA violations will be subject to substantially reduced limits. ...more

Snell & Wilmer

2017 HIPAA Enforcement – Appears Not To Be Slowing Down

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To state the obvious, there has been some uncertainty regarding how the Trump Administration will affect federal agency enforcement efforts. However, at least, in regard to HIPAA Privacy and Security, the U.S. Department of...more

Mintz - Health Care Viewpoints

OCR Delays Required Changes to Notices of Privacy Practices for Laboratories

The HHS Office of Civil Rights (OCR) has granted certain clinical laboratories a temporary reprieve from the requirement to update their Notices of Privacy Practices (NPPs) by September 23, 2013, the deadline imposed by the...more

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