Covered Entities

News & Analysis as of

Client Alert: OCR Blitzkrieg: Wider Investigation of Smaller Breaches

On the heels of its first business associate settlement with a business associate and a hat trick of multi-million dollar settlements with covered entities involving electronic Protected Health Information (“PHI”), on August...more

HIPAA Phase 2 Audits: What Has OCR Requested from Auditees to Date?

In our April 8, 2016, advisory, we discussed the U.S. Department of Health and Human Services’ (HHS) Office of Civil Rights (OCR) “Phase 2” audit program. Then, we could only make educated guesses about what documents OCR...more

HRSA Proposes Administrative Process to Resolve Disputes Between 340B Program Covered Entities and Drug Manufacturers

Taking a step toward completing a requirement imposed by the Affordable Care Act, the federal government has proposed regulations that would create an administrative dispute resolution (“ADR”) process to resolve disputes...more

HHS Issues Final Non-Discrimination Rules for Healthcare Providers

Healthcare providers and others who receive federal financial assistance are now subject to new non-discrimination rules and notice requirements under the Affordable Care Act. The new regulation prohibits discrimination in...more

HRSA Releases Proposed Rule Governing the Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more

A Closer Look at the OCR’s Guidance on Ransomware

In the wake of several high-profile ransomware infections targeting hospitals and health care organizations, the Department of Health and Human Services Office for Civil Rights (OCR) has issued guidance on the growing threat...more

OCR Plans to More Widely Investigate HIPAA Breaches Affecting Fewer than 500 Individuals

This month the HHS Office for Civil Rights (OCR) has launched an initiative “to more widely investigate the root causes” of HIPAA breaches affecting fewer than 500 individuals, according to an August 18, 2016 OCR email...more

Ransomware May Be a Reportable HIPAA Breach

In 2016, more than 4000 ransomware or other malware attacks are occurring daily, a 300% increase since 2015. There have been reports of six hospitals that have been victims of ransomware in 2016. Ransomware is a type of...more

Now is a Good Time to Review Your HIPAA Policies

The HHS Office for Civil Rights (OCR) has announced it is increasing its investigations of breaches of unsecured protected health information (PHI) affecting fewer than 500 individuals. As a reminder, the HIPAA Breach...more

FTC Finds Laboratory Security Practices Caused Consumer Harm

On July 28, 2016, a panel (the “FTC Panel”) of three acting Federal Trade Commission (“FTC”) commissioners issued an opinion that found that LabMD, Inc. (“LabMD”) failed to implement reasonable security measures to protect...more

OCR to Increase Efforts to Investigate Breaches Affecting Fewer Than 500 Individuals

The Department of Health and Human Services Office for Civil Rights (OCR) is the federal agency tasked with investigating data breaches involving protected health information (PHI) under the Health Insurance Portability and...more

Smaller HIPAA Breaches To Get More Attention by Office for Civil Rights

The HIPAA breach notification rule has two buckets for classifying data breaches – those that involve “protected health information” (PHI) of 500 or more individuals and those that involve fewer than 500 individuals. Since...more

Section 1557 of the Affordable Care Act Requires Healthcare Providers to Take Certain Steps in 2016 to Promote Equity

Section 1557 of the Affordable Care Act aims to advance healthcare equity. This statutory provision provides that current non-discrimination laws, such as the Civil Rights Act of 1964, will now apply to individuals and...more

HHS Proposes Administrative Dispute Resolution Process for 340B-Related Claims

On August 12, 2016, the US Department of Health and Human Services (HHS) Health Resources and Services Administration issued a notice of proposed rulemaking that establishes an administrative dispute resolution process for...more

It’s Not the Olympics, but OCR Sets New HIPAA Settlement Records

Athletes at the Rio Olympics aren’t the only ones setting records this year. Hoping to send a “strong message” about the importance of safeguarding electronic protected health information (PHI) and conducting mandated risk...more

Got Data? Actual Harm Not Required for FTC Enforcement Action for Lax Security Measures

While much of Washington, D.C. is enjoying the slow and hazy days of summer, the Federal Trade Commission (FTC) is staying busy solidifying its presence as the go-to authority for data security. Most recently, on July 29,...more

Record-Breaking HIPAA Settlement Sends Strong Message to Covered Entities

This month marked the largest HIPAA settlement to-date for a single entity. Advocate Health Care Network (“Advocate”) agreed to pay $5.5 million and adopt a corrective action plan after an investigation by the Department of...more

Latest OCR HIPAA Settlement Provides Lessons for Covered Entities

Capping off a busy month of HIPAA settlements, on August 4, the Office for Civil Rights (“OCR”) announced a $5.55 million settlement with Advocate Health Care Network (“Advocate”), the largest fully-integrated healthcare...more

On the Trail for Pokémon – and HIPAA Compliance

Pikachu, Alakazam, Bulbasaur, Charmander, and Squirtle can teach us a few things about HIPAA privacy. Pokémon GO is a recent craze encouraging people to try to catch’em all. As a result, employees, clients, and patients are...more

Blog: Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health...more

Largest HIPAA Settlement Announced Against A Single Entity: $5.55 Million

On August, 4, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced that Advocate Health Care Network (Advocate) agreed to pay a settlement amount of $5.55 million and adopt a...more

Client Alert: The Government Enters into Largest HIPAA Settlement to Date; What HIPAA Covered Entities and Business Associates...

Advocate Health Care Network, which operates 12 hospitals and more than 200 other treatment centers in Chicago and central Illinois, has agreed to the largest settlement to date with the Office for Civil Rights (“OCR”) for...more

HSS Issues New Guidance on Ransomware Attacks Against HIPAA-Covered Entities

Ransomware attacks at hospitals and other healthcare facilities have dramatically increased over the last several years, putting healthcare providers in the uncomfortable position of having to consider paying thousands of...more

Guidance on Ransomware Attacks under HIPAA and State Data Breach Notification Laws

The US Department of Health and Human Services (HHS) has recently issued guidance under the Health Insurance Portability and Accountability Act (HIPAA) on what covered entities and business associates can do to prevent and...more

Advocate Health Care Network Agrees to Pay $5.55 Million to Settle Potential HIPAA Penalties

On August 4, 2016, the Office of Civil Rights (“OCR”) announced that Advocate Health Care Network (“Advocate”), Illinois’ largest fully-integrated health care system, has agreed to pay a record-breaking $5.55 million to...more

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