News & Analysis as of

Beware of Phishing Email Disguised as Official OCR Audit Communication

The Office of Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) has posted an alert (and a follow-up alert) warning health plans, health care providers, and their vendors of a mock communication...more

FTC Publishes Data Breach Response Guidelines

Whether resulting from a planned cyberattack or mere carelessness, data breaches are on the rise. In 2015, 781 data breaches were reported across the United States, with the average breach costing $3.8 million. In 2016, the...more

Health Update - November 2016

Post-Election Analysis: Healthcare Antitrust in a Trump Administration - In a Republican sweep of all the elected branches of the federal government, Donald Trump won the presidential election and Republicans retained...more

OCR Guidance Underscores Importance of Authentication under HIPAA

In its tenth OCR Cyber Awareness Newsletter of the year (Newsletter), the Office for Civil Rights (OCR) reminded HIPAA-covered entities and business associates of the importance of selecting an appropriate authentication...more

Three Former Warner Chilcott District Managers Prosecuted for HIPAA Violations

The United States Attorney’s Office for the District of Massachusetts recently announced that three former district managers of the pharmaceutical firm Warner Chilcott have been sentenced for violating the Health Insurance...more

Cloud Service Providers Beware, You May Be Subject to HIPAA Without Knowing It

The use of cloud service providers has exploded in the past several years. According to estimates from Gartner, the market for cloud services is expected to reach $204 billion in 2016. But the use of cloud service providers...more

HHS Designates Cloud Service Providers as Business Associates Under HIPAA

Cloud service providers that process electronic protected health information (ePHI) are business associates under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), even if the PHI is encrypted and the...more

HHS Publishes New Guidance on HIPAA and Cloud Computing

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) has issued a new guidance regarding HIPAA compliance and the use of cloud computing solutions. The guidance is intended to assist covered entities...more

New Tools Help Providers Become Smarter Users of Electronic Health Records Systems

Healthcare providers excel at providing care to their patients, not designing IT strategies. Even so, with the trend toward value-based payments increasing, more healthcare providers have turned to electronic health records...more

OCR Releases HIPAA Guidance on Cloud Computing

On October 6, 2016, the Department of Health and Human Services Office for Civil Rights (OCR) released HIPAA guidance on cloud computing (Guidance). The Guidance is intended to help covered entities and business associates...more

Small-Breach Focus Shows Growing Scope Of HIPAA Probes

Flexing yet more enforcement muscle under the Health Insurance Portability and Accountability Act, on Aug. 18, 2016, the U.S. Department of Health and Human Services Office for Civil Rights announced that it will more widely...more

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

As anticipated, things are getting even more exciting with the case previously covered in Password Protected. Specifically, LabMD is appealing the landmark data security case between it and the Federal Trade Commission...more

Business Associates Beware! OCR Means Business

In June 2016, OCR entered into its first settlement agreement with a business associate, Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”), for potential violations of the HIPAA Laws by failing to...more

MedStar Health Cardiology Associates Employee Emails Patient Information to Personal Account and Gets Fired

MedStar Health Cardiology Associates, (“MedStar Cardiology”) affiliated with MedStar Health, which was recently in the news for a ransomware attack, discovered that an employee sent protected health information of 907...more

OCR Sets Sights on Smaller HIPAA Breaches

Covered entities and business associates can expect increased scrutiny for breaches of unsecured protected health information affecting fewer than 500 individuals. Starting August 2016, the U.S. Department of Health and Human...more

LabMD Seeks Stay of FTC’s Final Order Pending Appeal

Not surprisingly, on August 30, 2016, LabMD filed its Application for a Stay of the Final Order of the Federal Trade Commission (FTC) pending review of the order by the appellate court. But since the matter is still pending...more

FTC Overturns ALJ’s LabMD Decision and Reasserts its Role as a Data Security Enforcer

On July 29, 2016, the Federal Trade Commission (“FTC” or “Commission”) reversed an FTC administrative law judge’s (“ALJ”) opinion which had ruled against the FTC, finding that the Commission had failed to show that LabMD’s...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

$2.75 Million OCR Settlement Underscores the Importance of Risk Management and Analysis

How the theft of a single password-protected laptop turned into an enterprise-wide review of an organization’s data protection practices. Following the announcement of a recent settlement between the U.S. Department of...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

Lessons for Businesses from FTC’s Opinion on LabMD’s Data Security Practices

The Federal Trade Commission (FTC) has issued an Opinion and Final Order finding that the data security practices of LabMD, Inc. were unreasonable, and therefore constituted an unfair act or practice in violation of Section 5...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

FTC Overrules LabMD Dismissal, Finds Unfair Data Security Practices

The FTC issued an Opinion and Final Order reversing the previously dismissed charges against LabMD on July 29. FTC Administrative Law Judge (ALJ) D. Michael Chappell had dismissed the case against LabMD on November 13, 2015...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

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