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Latest OCR Enforcement Action: Underbed Storage is Not Appropriate for PHI

Recent enforcement actions by the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) have highlighted that, not surprisingly, Covered Entities should not leave medical records in a...more

Do the Restrictions on Advertising with Nutrition and Health Claims also Apply to Communications Addressed Exclusively to Health...

The Court of Justice of the European Union (ECJ) will soon decide on the issue of whether the restrictions on promoting foodstuffs with nutrition and health claims also apply to communications addressed exclusively to health...more

Historic Moment: Husband Reports Wife’s HIPAA Violation Triggering Six Figure Penalty Against Employer

For the second time in history, the Office for Civil Rights (“OCR”) has imposed a civil monetary penalty (“CMP”) against a covered entity for violations of the Health Insurance and Portability Act (“HIPAA”). Lincare, Inc., a...more

Virginia’s Certificate of Need Laws May Stay, Fourth Circuit Says

On January 21, the U.S. Court of Appeals for the Fourth Circuit upheld Virginia’s Certificate of Need (CON) laws, ruling that the scheme does not illegally discriminate against out-of-state health care providers. See Colon...more

Texas Medical Board Appeals Immunity Ruling

In a notice of appeal filed on January 8, 2016, the Texas Medical Board appealed the Western District of Texas’s ruling that the Texas Medical Board was not entitled to state action immunity in an antitrust suit involving...more

When do healthcare defendants want to be accused of malpractice?

Most injury or wrongful death cases against hospitals, health care facilities, and health care practitioners are governed by the procedures in Fla. Stat. 766, also known as the Medical Malpractice Act. This Act itself is...more

Physician Practices Face Anti-Trust Risks, Too

On December 18, 2015, the Federal Trade Commission (FTC) announced a settlement with Keystone Orthopaedic Associates Specialists and Orthopaedic Associates of Reading, LTD, which were two of six orthopedic practices in Berks...more

FTC files brief in LabMD appeal

We previously reported that the Federal Trade Commission (FTC) lost its case against LabMD alleging that LabMD had inadequate security measures to prevent an alleged data breach....more

Quest Defeats Claims that It Conspired with Health Insurers

On November 25, District Court Judge William Orrick (N.D. Cal.) dismissed all claims in Eastman v. Quest Diagnostics, finding that the plaintiffs, a class of Northern California consumers who had utilized Quest's services,...more

Update on Excellus data breach litigation

Excellus Blue Cross Blue Shield (Excellus) was hit with another proposed class action suit late last week. The case, filed by a New York woman, accuses Excellus BlueCross BlueShield of failing to prevent a massive data...more

Laptop Security Breach Leads to $850,000 HIPAA Settlement Payout

On November 19, 2015, Lahey Hospital and Medical Center (“Lahey”) entered into an $850,000 settlement with the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) for alleged violations of...more

FDA Legal and Regulatory – 2015 Year In Review

Looking back on 2015, it’s apparent that this was another very busy year for the Food and Drug Administration (FDA or Agency), whose oversight responsibilities are estimated to touch 25% of American consumers’ spending on...more

Abbott Secures Preliminary Injunction in Gray Market Case

On November 6, 2015, Abbott Laboratories and its diabetes care units secured a preliminary injunction against multiple pharmacies, distributors and associated individuals engaged in the sale of gray market Abbott FreeStyle...more

HIPAA Fine Underscores OCR’s Focus on Physician Group Compliance

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced a $750,000 fine and resolution agreement, including a Corrective Action Plan (CAP), for Cancer Care Group, P.C. (CCG), a...more

Evolving Litigation of Data Breach Claims

An Illinois circuit court judge has dismissed five of six claims in a consolidated class action against Advocate Health and Hospital Corporation arising from a data breach in July 2013. The judge’s dismissal with prejudice...more

Excellus Blue Cross Blue Shield sued for data breach announced last week

Within days of Excellus Blue Cross Blue Shields’ (Excellus) announcement that its data had been accessed by a hacker through a “sophisticated” cyber-attack, two law firms teamed up to file a proposed class action suit last...more

Advocate Health class action lawsuit trimmed

Last week, an Illinois judge dismissed with prejudice five of the six claims levied against Advocate Health Care in a consolidated case of ten cases filed against it following the data breach it experienced in July of 2013...more

OCR Enters into $750,000 Settlement with Physician Practice for HIPAA Violations

On September 2, the Department of Health and Human Services Office of Civil Rights (OCR) announced a settlement with Cancer Care Group, P.C., a thirteen-physician oncology practice in Indiana related to violations of the...more

Data processing company hit with class action lawsuit for data breach and Judge denies class certification the next day

Advanced Data Processing, Inc. and Intermedix Corp. were sued in federal court in Florida last week for violating the Health Insurance Portability and Accountability Act (HIPAA) for failing to protect the health information...more

Bad News from Europe for Makers of Life-Saving Medical Devices

In over eight years, we’ve never before blogged about a European development in prescription medical product liability. The (relatively) recent decision by the Court of Justice of the European Union (“CJEU”) in Boston...more

Health Care and Legal Services Providers Challenge State Regulatory Boards on Heels of SCOTUS State Action Antitrust Immunity...

On February 25, 2015, the U.S. Supreme Court narrowed the scope of antitrust immunity for state regulatory boards whose members are active market participants in the occupation regulated by the boards. In North Carolina State...more

Advocate Health data breach class action suit dismissal upheld by Appellate Court

In August of 2013, four computers of Advocate Health and Hospitals Corporation (Advocate Health) were stolen from one of its offices. The computers contained the names, dates of birth, Social Security numbers, health...more

Teladoc successful in thwarting new Texas telemedicine rules

We previously reported on the new telemedicine regulations adopted by the Texas Medical Board (Board), which requires that patients be seen face-to-face or in person to establish a physician-patient relationship in order to...more

Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical...

A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. “Product hopping” refers to the practice of changing the form or...more

Decision Highlights Questions Over Substantiation for Weight Loss Claims

The Eleventh Circuit recently issued a decision in an contempt proceeding against Hi-Tech Pharmaceuticals and several individuals. The case highlights the ongoing debate over whether clinical trials are required for weight...more

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