News & Analysis as of

Risk Management 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

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

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

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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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

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

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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

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

BakerHostetler

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

BakerHostetler on

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

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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

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

Paul Hastings LLP

HHS’ Civil Rights Office Reaches Second-Ever Ransomware Settlement

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The Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently announced a settlement under the Health Insurance Portability and Accountability Act (HIPAA) with Green Ridge Behavioral Health, LLC...more

Paul Hastings LLP

Data Breaches Exposing Protected Health Information Are Surging

Paul Hastings LLP on

The number of large data breaches, those involving 500 or more people, exposing protected health information has increased exponentially in the last few years, and ransomware and hacking are the primary cyber threats in...more

Rivkin Radler LLP

Montefiore Medical Center Settles HIPAA Breach for $4.75 Million

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On February 6, the U.S. Department of Health and Human Services (HHS) announced a $4.75 million settlement with Montefiore Medical Center (MMC) for a breach of unsecured electronic protected health information (ePHI). The...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Federal Regulators Unveil Revised Final Guidance for Healthcare Cybersecurity and HIPAA Compliance

On February 14, 2024, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and the National Institute of Standards and Technology (NIST) published a new, final version of their guidance for...more

Health Care Compliance Association (HCCA)

‘An Unknown Individual Walked In’: Protecting Against Telehealth Risks Includes Non-IT Threats

The HHS Office for Civil Rights (OCR) and other government agencies aren’t just worried that providers understand—and mitigate—the privacy and security risks of telehealth. In fact, in 2022, the Government Accountability...more

Health Care Compliance Association (HCCA)

Privacy Briefs: October 2023

Report on Patient Privacy 23, no. 10 (October, 2023) Kaiser Foundation Health Plan Inc. and Kaiser Foundation Hospitals will pay California $49 million to resolve allegations that they unlawfully disposed of hazardous waste,...more

WilmerHale

HHS OCR Settles with iHealth Solutions Over Alleged HIPAA Violations

WilmerHale on

On June 28, the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement (resolution agreement and corrective action plan) with iHealth Solutions (also known as Advantum Health)...more

Health Care Compliance Association (HCCA)

[Virtual Event] Columbus & Indianapolis Regional Healthcare Compliance Conference - June 2nd, 8:25 am - 4:30 pm ET

General and specialty compliance education from the comfort of your home or office - HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance learning that covers a wide variety of...more

Butler Snow LLP

Telehealth in a Post-Pandemic World

Butler Snow LLP on

As we enter the third year of the pandemic, life with COVID-19 has become the new “normal” for many Americans. While debate can be had about when a pandemic ends or becomes endemic, there is no dispute that more and more...more

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

Ballard Spahr LLP

HIPAA Guidance and Enforcement: A New Alignment?

Ballard Spahr LLP on

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) announced that it has entered into a settlement with a business associate that provides electronic medical records services to health...more

Stoel Rives - Health Law Insider®

HHS Issues Practical New Cybersecurity Guidance for Healthcare Businesses of all Sizes

In late January, the U.S. Department of Health and Human Services’ Healthcare & Public Health Sector Coordinating Council issued a new cybersecurity guidance document for healthcare businesses of all sizes. The guidance...more

Mintz - Health Care Viewpoints

Gone Phishin’: Hack Leads to HIPAA Settlement

Earlier this week, the HHS Office for Civil Rights (“OCR”) announced a $400,000 settlement with Metro Community Provider Network (“MCPN”) related to a 2012 HIPAA breach caused by a phishing scam. The phishing scam, carried...more

Orrick, Herrington & Sutcliffe LLP

What Did They Say About Cybersecurity in 2016? 8 Proclamations from Regulators and the Courts

There is no such thing as compliance with the NIST Cybersecurity Framework (FTC). In September, the FTC dispelled a commonly held misconception regarding the NIST Framework: It “is not, and isn’t intended to be, a standard or...more

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