News & Analysis as of

Risk Management 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

Baker Donelson on

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

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...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

Epstein Becker & Green

Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast

Epstein Becker & Green on

Important changes are unfolding in the vaccine space. How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...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

Warner Norcross + Judd

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

Warner Norcross + Judd on

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

Rivkin Radler LLP

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

Rivkin Radler LLP on

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

Clark Hill PLC

Right To Know - March 2025, Vol. 27

Clark Hill PLC on

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

McDermott Will & Emery

FDA, OHRP Issue Joint Guidance on Collection of Tissue Biopsies in Clinical Trials

McDermott Will & Emery on

On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Paul Hastings LLP

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

Paul Hastings LLP on

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

Bradley Arant Boult Cummings LLP

AI Meets HIPAA Security: Understanding HHS’s Risk Strategies and Proposed Changes

In this final blog post in the Bradley series on the HIPAA Security Rule notice of proposed rulemaking (NPRM), we examine how the U.S. Department of Health and Human Services (HHS) Office for Civil Rights interprets 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

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

Goodwin on

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Bradley Arant Boult Cummings LLP

The Why Behind the HHS Proposed Security Rule Updates

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 justifications...more

Nilan Johnson Lewis PA

Nine Steps Healthcare Entities Should Take to Prevent Cyberattacks

Nilan Johnson Lewis PA on

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

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...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

Bradley Arant Boult Cummings LLP

HHS Security Rule NPRM Proposes Makeover for Administrative Safeguard Compliance for Regulated Entities

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

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

Maynard Nexsen

Changes Proposed by HHS to Strengthen HIPAA Security Rule

Maynard Nexsen on

On January 6, 2025, the US Department of Health and Human Services Office for Civil Rights (“OCR”) issued a notice of proposed rulemaking (“Proposed Rule”) containing significant updates to the Security Rule under the Health...more

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