News & Analysis as of

Risk Assessment Department of Health and Human Services (HHS)

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

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

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What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

Morgan Lewis on

On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Epstein Becker & Green

A Closer Look at Proposed Changes to Medicare Advantage in the “No UPCODE Act”

On March 25, 2025, U.S. Senators Bill Cassidy, M.S. (R-LA) and Jeff Merkley (D-OR) introduced the No Unreasonable Payments, Coding, or Diagnoses for the Elderly (No UPCODE) Act (the “Bill”)....more

Bradley Arant Boult Cummings LLP

Top 10 takeaways from the new HIPAA security rule NPRM

On Jan. 6, 2025, the U.S. Department of Health and Human Services (HHS) proposed new regulations to enhance cybersecurity protections for electronic protected health information (ePHI) under the Health Insurance Portability...more

Foley & Lardner LLP

Key Takeaways: 7th Annual “Let’s Talk Compliance” Conference

Foley & Lardner LLP on

Editor’s Note: PYA and Foley & Lardner hosted the 7th Annual “Let’s Talk Compliance” two-day virtual conference on January 23 and 24, 2025. Panelists included Foley attorneys and PYA subject matter experts. The event was...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

Dickinson Wright

‘Security! Security!’ HHS Proposes Updates to HIPAA’s Security Rule

Dickinson Wright on

Can you remember healthcare security 20+ years ago? It seems like a different world from now. Believe it or not, the HIPAA Security Rule has barely changed since it was first enacted in 2003 and has been long overdue for a...more

Groom Law Group, Chartered

Biden Administration Proposes Beefed-Up HIPAA Security Rule… But Prognosis Uncertain

On January 6, 2025, the Biden Administration issued a new proposed rule updating the HIPAA Security Standards ( “Proposed Rule”). The original HIPAA Security Standards were issued in 2003 and updated in 2013 and require that...more

McCarter & English, LLP

Season of Enforcement: OCR Announces Its Sixth Enforcement Action of 2025

With 2025 barely three weeks old, the US Department of Health and Human Services Office for Civil Rights (OCR) has already announced six enforcement actions for the new year. Particularly significant is the advancement of...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

Robinson+Cole Health Law Diagnosis

What to Know About the HHS HIPAA Security Standards Proposal

At the close of 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (the Proposed Rule) to amend the Security Rule regulations established...more

Fisher Phillips

PEOs Need to Prepare for Increased Cybersecurity Requirements Thanks to Proposed HIPAA Security Rule Revisions

Fisher Phillips on

With the HIPAA Security Rule set to undergo a massive overhaul to boost cybersecurity protections, PEOs need to take note. After all, as stewards of worksite employee and client company data – and as sponsors of group health...more

Fox Rothschild LLP

New Year, New HIPAA Security Rules Headed Your Way

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What better way to welcome the new year than with proposed new HIPAA Security Rules? As 2024 came to an end, the U.S. Department of Health and Human Services announced new proposed regulations to strengthen cybersecurity and...more

Jackson Lewis P.C.

OCR Proposed Tighter Security Rules for HIPAA Regulated Entities, including Business Associates and Group Health Plans

Jackson Lewis P.C. on

As the healthcare sector continues to be a top target for cyber criminals, the Office for Civil Rights (OCR) issued proposed updates to the HIPAA Security Rule (scheduled to be published in the Federal Register January 6). It...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

ArentFox Schiff on

Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Arnall Golden Gregory LLP

OCR Announces Risk Analysis Initiative

The U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”), which enforces HIPAA, recently announced a new enforcement initiative, the Risk Analysis Initiative, in conjunction with OCR’s seventh...more

Holland & Knight LLP

NY Department of Health Bolsters Hospital Cybersecurity Regulations

Holland & Knight LLP on

New York hospitals have less than a year to dust off their Health Insurance Portability and Accountability Act (HIPAA) compliance programs and update them to comply with more stringent and detailed state regulations. Last...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

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

BakerHostetler

6 Important Takeaways for HIPAA Covered Entities and Business Associates from 2024 NIST HHS OCR Conference

BakerHostetler on

On October 23-24, 2024, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) Information Technology Laboratory hosted the Safeguarding...more

Clark Hill PLC

The Value of an Effective HIPAA Compliance Program Amid OCR HIPAA Audits

Clark Hill PLC on

In 2024, the U.S. Department of Health and Human Services Office of Civil Rights (“OCR”) Director Melanie Fontes Rainer announced that OCR will resume auditing Health Information Portability and Accountability Act (“HIPAA”)...more

Baker Donelson

The Office for Civil Rights Recently Settled Two Ransomware Related Investigations

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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

Ankura

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

Ankura on

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

Jackson Lewis P.C.

Exploring AI Risks Reported in SEC Filings Can Be Helpful For Many Organizations, Including SMBs

Jackson Lewis P.C. on

One of our recent posts discussed the uptick in AI risks reported in SEC filings, as analyzed by Arize AI. There, we highlighted the importance of strong governance for mitigating some of these risks, but we didn’t address...more

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