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Compliance Department of Health and Human Services (HHS) Today's Popular Updates

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

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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

Health Care Compliance Association (HCCA)

And Then There Were Nine: Disappearing OHRP To Join Enforcement Agency; NIH Cuts Outlined

When it comes to changes roiling the federally supported research landscape, April offered no letup from the first three months of the year; if anything, the pace and magnitude increased. In one instance, an agency—the HHS...more

ArentFox Schiff

Top 10 Issues in the Cannabis Industry for 2025

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It is not all doom and gloom for the cannabis industry this year; positive developments across states and the potential (albeit remote) for federal rescheduling means the cannabis industry can expect ongoing advancements....more

McDermott Will & Schulte

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...more

Gardner Law

FDA Layoffs, RFK Jr. at HHS, and What This Means for FDA-Regulated Companies

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In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

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On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...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

Health Care Compliance Association (HCCA)

Disclosure of Full Record to Employer Results in $35K Fine, Broad CAP; Echoes of 2017 HIV Case

It’s not immediately obvious why someone would want to disclose a health care test result as part of a job application. But one such request spurred a Pennsylvania entity to provide a lot more than that: it sent her whole...more

Lippes Mathias LLP

Hospital Administrators – Is Your Hospital Cyber-Secure?

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On October 2, 2024, New York adopted new regulations requiring general hospitals to implement heightened cybersecurity safeguards. General hospitals, as defined in Article 28 of the NY Public Health Law, generally must begin...more

Health Care Compliance Association (HCCA)

Privacy Briefs: November 2024

Change Healthcare Inc. has amended its initial breach report to the HHS Office for Civil Rights (OCR) to state that 100 million individuals were impacted by its mammoth ransomware attack and breach. However, as of Oct. 24,...more

Holland & Knight LLP

Safeguarding Health Information: Takeaways from HHS and NIST 2024 HIPAA Security Conference

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President Ronald Reagan famously quipped, "I think you all know that I've always felt that the nine most terrifying words in the English language are: I'm from the Government, and I'm here to help."1 At an Oct. 23-24, 2024,...more

Health Care Compliance Association (HCCA)

2nd Settlement Triggered by 2017 Ransomware Attack Costs WA Practice $100K; ‘Not a Breach’

Let’s review for a moment. It’s not a HIPAA violation to be a victim of ransomware. It’s not a HIPAA violation to pay a ransom. It’s up to the covered entity (CE) to determine if a security or privacy incident is a...more

Ankura

Navigating the Fallout: Essential Insights for Healthcare Companies in Light of the Change Healthcare Cyber Breach

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The cyber breach at Change Healthcare in 2024 stands out as one of the most significant cyber-attacks in recent memory. Its repercussions extend far beyond immediate industry disruptions, resonating deeply in regulatory...more

Foley & Lardner LLP

Clinical Trials: FDA Publishes Draft Guidance on Diversity Action Plans

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On June 26, 2024, the U.S. Food and Drug Administration (FDA) released draft guidance addressing use of diversity action plans (Plans) in the conduct of clinical research entitled “Diversity Action Plans to Improve Enrollment...more

ArentFox Schiff

Providers Face HIPAA Compliance Questions After Change Healthcare Cyberattack

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Who will notify the potentially millions of individuals whose information might have been jeopardized by the massive cyberattack on Change Healthcare? Since the affiliate of UnitedHealth Group (UHG) first reported the...more

Health Care Compliance Association (HCCA)

NY Medical College Clashes With OIG After Audit Questions $7.5M, PI Salaries, ‘Illegible Signatures’

New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more

Holland & Hart LLP

New ACA 1557 Non-Discrimination Rules: Checklist For Healthcare Providers

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On May 6, 2024, the Department of Health and Human Services (HHS) published its final rule revamping the non-discrimination regulations issued under § 1557 of the Affordable Care Act.  The revised rules apply to all...more

Holland & Knight LLP

What HIPAA Security Rule Surprises Await Healthcare Providers for the Second Half of 2024?

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The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more

Mintz - Health Care Viewpoints

HHS Health Care Cybersecurity Performance Goals: Proposed Incentives, Penalties and Compliance Standards

As promised in the U.S. Department of Health and Human Services (HHS) concept paper in December 2023, the agency published voluntary health care and public health cybersecurity performance goals (HPH CPGs) in January 2024 and...more

Benesch

Annual Report to Congress on Breaches of Unsecured Protected Health Information

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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

Arnall Golden Gregory LLP

Responding to a Third-Party Data Breach: Practical Legal and Compliance Steps

Cyberattacks and data incidents are rapidly increasing, and third-party services companies are a frequent source of exposure for healthcare providers. Healthcare is a prime target for cybercriminals, with ransomware and...more

NAVEX

Addressing Cybersecurity Expectations in Healthcare

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2024 is shaping up to be a very active year for regulatory and enforcement developments in the healthcare industry – developments that concern not just hospitals and nursing facilities, but many non-healthcare companies as...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

Harris Beach Murtha PLLC

OIG December 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

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - December 2024

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

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