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HIPAA Complaint Seeks Class Action Status

A complaint filed in the Superior Court of California on March 14, 2014, requested certification as a class action and sought a wide variety of damages arising from a breach of personal information. Doe vs. Sutherland Health...more

No Harm, Still Foul? Florida Court Approves Data-Breach Class Action Settlement

Data-breach class action suits may have just gained significant traction. On Feb. 28, 2014, the U.S. District Court for the Southern District of Florida approved a first of its kind class action data breach settlement that...more

Genentech’s Distribution of Prescribing Information to Physicians is Alleged to Infringe Method Patent

On January 31, 2014, Phigenix, Inc. (“Phigenix”) filed a lawsuit in federal district court in Georgia alleging that the sale and use of the drug Kadcyla by Genentech, Inc. (“Genentech”) infringed U.S. Patent No. 8,080,534B2,...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Calif. Case Limits Health Care Data Breach Claims

The California Court of Appeal recently limited plaintiffs’ ability to state a claim under the California Medical Information Act (CMIA), Cal. Civ. Code §§ 56 et seq., and their ability to get statutory damages under the act....more

Little Harm, Big Damages: AvMed Settlement Could Change the Landscape for Privacy Breach Class Actions

On October 21, Florida-based health insurer AvMed, Inc. (AvMed) settled a data breach class action lawsuit for $3 million, even though no plaintiffs in the class demonstrated that they had suffered identity theft or any other...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases

Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

HHS States That It Will Issue Guidance On HIPAA Regulation For Prescription Refill Reminders

On September 11, 2013, HHS stated in a joint motion filed in the case of Adheris, Inc. v. Sebelius, No. 1:13-cv-1342 (D.D.C.), that it plans to issue guidance on a HIPAA regulation related to prescription drug refill...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Does District Court Dismissal of Declined Qui Tam Threaten Future DOJ False Claims Enforcement?

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more

OCR Settles with Shasta Regional Medical Center for $275,000

The HHS Office of Civil Rights (OCR) recently announced a $275,000 settlement with Shasta Regional Medical Center (SRMC) on the heels of an investigation triggered by a Los Angeles Times article indicating that senior...more

Supreme Court Denies Certiorari in MAO’s Double Damages Case

On April 15, 2013, the United States Supreme Court denied a petition for certiorari brought by GlaxoSmithKline (“Glaxo”) seeking review of a Third Circuit decision in favor of Humana Medical Plan (“Humana”), as a Medicare...more

Court Rules That Supervision and Enrollment Issues Don't Give Rise to False Claims Act Liability

Following the ever-growing progeny of cases holding that Medicare conditions of participation do not give rise to False Claims Act (FCA) liability, the United States Court of Appeals for the Sixth Circuit overturned an $11...more

Preemption: The Cure for the Common Claim?

Although the landscape of the Federal Food Drug and Cosmetic Act (FDCA) preemption of private Surgeon General class action claims continues to shift under our feet in California, first with POM and recently with this case,...more

DOJ Recovers Up To $48 Million in False Claim Act Case Resulting From Whistleblower Report

In yet another large recovery for the DOJ, on December 6, 2012, DFB Pharmaceuticals, and its subsidiary, Healthpoint Ltd., agreed as part of a settlement to pay up to $48 million to resolve allegations that Healthpoint caused...more

U.S. Department of Health and Human Services Announces First HIPAA Breach Settlement Involving Fewer than 500 Patients

On January 2, 2013, the U.S. Department of Health and Human Services ("HHS") settled its first case involving the unauthorized disclosure of the electronic protected health information ("ePHI") of fewer than 500 individuals....more

OCR's Breach Settlement the First Ever Involving Less than 500 Patients

OCR started 2013 with a bang by announcing that it had reached “the first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals” with the Hospice of...more

First OCR Settlement Involving a “Small” Breach Focuses on Mobile Device Security

In what is best understood as a follow-up to both the recent settlement with MEEI and the release of its mobile device security guidance, HHS OCR recently released details of a settlement reached with the Hospice of Northern...more

First State HIPAA Enforcement Action against a Business Associate Returns $2.5 Million Payout

In February, we alerted you to the first HIPAA enforcement action taken against a business associate. The action was pursued by the Minnesota Attorney General against Accretive Health, a service provider that was involved in...more

Alaska Medicaid Settles HIPAA Security Case for $1,700,000

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) has announced the first HIPAA enforcement action OCR has taken against a State agency, and the resolution agreement and related corrective action...more

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

Do you, as a laboratory compliance officer, want to spare your employer the disruption, expense, and burden of a government enforcement action? The answer, of course, is “yes.” The most effective and efficient way of doing so...more

Pharmacies and Suppliers Beware: It Is Not Just the Pill Mills They Are After

DEA’s recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly...more

Ober|Kaler Healthcare Information Privacy, Security and Technology Bulletin: Data Breach in California Results in $20 Million...

The new Director of the HHS Office of Civil Rights (“OCR”) has promised to continue the agency’s trend towards greater HIPAA enforcement, but, following a data breach, OCR may not be a provider’s or contractor’s only concern....more

An Overview of G.I.N.A.

This article describes new protections for employees and new challenges for employers (including specific things to do and not to do) under the Genetic Information Nondiscrimination Act....more

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