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Compliance Department of Health and Human Services (HHS) Risk Management

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
White & Case LLP

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

White & Case LLP on

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

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...more

Jackson Lewis P.C.

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

Jackson Lewis P.C. on

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

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

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

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

Bradley Arant Boult Cummings LLP

HHS’s Proposed Security Rule Updates Will Require Adjustments to Accommodate Modern Vulnerability and Incident Response Issues

In this week’s installment of our blog series on the U.S. Department of Health and Human Services’ (HHS) HIPAA Security Rule updates in its January 6 Notice of Proposed Rulemaking (NPRM), we are exploring the proposed updates...more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

Baker Donelson on

Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of the...more

Gardner Law

Changes Proposed to HIPAA Security Rules

Gardner Law on

On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more

ArentFox Schiff

Proposed Changes to the HIPAA Security Rule: What Regulated Entities Need to Know

ArentFox Schiff on

In the final days of the Biden Administration, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) issued a notice of proposed rulemaking (NPRM) to modify the Security Rule under the Health...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

McDermott Will & Emery

Human Trafficking Monitoring for Telehealth Providers

Telehealth providers are uniquely positioned to monitor for human trafficking when interacting with patients. Survivor records indicate that health services are among the most common points of access to help trafficked...more

Buchalter

Significant New HIPAA Obligations on Their Way for 2025

Buchalter on

The Department of Health & Human Services (HHS) issued proposed changes to the HIPAA Security Rule (“Proposed Rule”) on January 6, 2025, and is accepting comments from the public until March 7, 2025. The Proposed Rule...more

Paul Hastings LLP

HHS OCR Releases Proposed Updates to HIPAA Security Rule

Paul Hastings LLP on

On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through the Office for Civil Rights (OCR), announced a Notice of Proposed Rulemaking (NPRM) to amend the Security Standards for the Protection of...more

Bradley Arant Boult Cummings LLP

Introducing Bradley’s Series on HHS’s Proposed HIPAA Security Rule Updates

Bradley is launching a multipart blog series on the U.S. Department of Health and Human Services’ (HHS) proposed changes to strengthen cybersecurity protections for electronic protected health information (ePHI) regulated...more

Foley & Lardner LLP

New Artificial Intelligence (AI) Regulations and Potential Fiduciary Implications

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Fiduciaries should be aware of recent developments involving AI, including emerging and recent state law changes, increased state and federal government interest in regulating AI, and the role of AI in ERISA litigation. While...more

Husch Blackwell LLP

OCR Announces Proposed Updates to HIPAA Security Rule, Raises the Bar for Healthcare Cybersecurity

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On December 27, 2024, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), issued proposed changes to the Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

Baker Donelson

Proposed HIPAA Security Rule Updates

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The Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) on December 27, 2024, to update the Health Insurance Portability and Accountability Act...more

Cozen O'Connor

Proposed Changes to the HIPAA Security Rule Will Have a Significant Impact on the Health Care Sector

Cozen O'Connor on

A few days ago, the U.S. Department of Health and Human Services (“HHS”), through its Office for Civil Rights, issued the proposed rule HIPAA Security Rule to Strengthen the Cybersecurity of Electronic Protected Health...more

Akerman LLP - Health Law Rx

New Year, New HIPAA Security Rule Requirements? OCR Proposes Sweeping Changes for HIPAA Security Rule to Bolster Cybersecurity

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently proposed a sweeping rewrite of the HIPAA Security Rule that, if finalized, will require that many Covered Entities and their...more

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

Davis Wright Tremaine LLP

HIPAA Security Rule Resolves To Hit the Gym and Bulk Up

For more than 20 years, the HIPAA Security Rule has been virtually unchanged other than extending its scope beyond covered entities to also include business associates. During that time, technology has changed, cybersecurity...more

ArentFox Schiff

At Long Last, the OIG Issues Its Compliance Program Guidance for Nursing Facilities

ArentFox Schiff on

On November 20, 2024, the US Department of Health and Human Services, Office of Inspector General (OIG) issued its Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (Nursing Facility ICPG)....more

Brownstein Hyatt Farber Schreck

Bipartisan AI Task Force Report Sets the Stage for Health Care AI Action in 2025

The House Task Force on Artificial Intelligence (AI) released a comprehensive 253-page report providing a roadmap for Congress as it develops policies to regulate and optimize the use of this rapidly advancing technology. The...more

Polsinelli

The OIG’s Concerns with Potentially Fraudulent Medicare Advantage Marketing

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The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing...more

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