Health Science, Computers & Technology

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The Federal Circuit Found Direct Infringement Attributable to Physicians Where “No Single Actor Performs All Steps of a Claim"

Can a patient’s action in taking a generic drug be attributable to a physician such that it can support a finding of the physician’s direct patent infringement? According to a recent precedential opinion of the Court of...more

Your Cyber Minute: Current GDPR regulatory and enforcement landscape  [Video]

The conversation continues with Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran as they go deeper into what clients need to know when it comes to compliance around the...more

Medical Device Alert – Finalised texts of the new EU Regulations on medical devices and in-vitro diagnostic medical devices are...

On 22 February 2017, the Council of the European Union issued the final versions of the draft texts of the European Union (“EU”) Medical Device Regulations (“MDR”) and the In Vitro Diagnostics Regulation (“IVDR”)....more

W2 Phishing Scam Hits Citizens Memorial Hospital

We continue to see all industries hit with W2 phishing scams, including the health care industry. Citizens Memorial Hospital, located in Bolivar, Missouri, was hit with the scam when one of its employees believed that an...more

Sixth Circuit Affirms Branded Drug Preemption and Trial Win

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a...more

Ethicon To Acquire Torax Medical, Inc

Ethicon Inc. announced on February 17 that it reached an agreement to acquire Torax Medical, Inc. According to its website, Torax Medical is a privately held medical device company developing a minimally invasive surgical...more

Health Law Insights: February Newsletter

ALERT: Technical Noncompliance with HIPAA Can Lead to Big Penalties- As discussed in prior client alerts, the Office of Civil Rights (OCR), the agency charged with HIPAA enforcement, has increased HIPAA compliance...more

$3.2M Fine for Failure to Protect Electronic Records

The Department of Health and Human Services Office of Civil Rights (“OCR”) fined a Texas hospital $3.2 million for its impermissible disclosure of unsecured electronic protected health information (ePHI) and non-compliance...more

CMS Recommendations Regarding Protection from Cybersecurity Risks

On January 13, 2017, the Centers for Medicare & Medicaid Services (CMS) issued Recommendations to Providers Regarding Cyber Security. In general, the Recommendations are intended to remind providers and suppliers to keep...more

RxIP Update - February 2017

Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a significant...more

Celltrion Healthcare and Pfizer Present Data on Infliximab Trial

As we reported last November, the NOR-SWITCH Phase IV study concluded that patients could be safely and effectively switched from originator infliximab (Remicade®) to Celltrion’s biosimilar product CT-P13 (Remsima®). On...more

Florida Supreme Court Rejects More Rigorous Expert Testimony Standard

The federal court system and 36 states have adopted the so-called Daubert standard in place of the Frye standard when it comes to qualifying expert witnesses under the rules of evidence. In 2013, the Florida Legislature...more

Lessons Gleaned From Recent HIPAA Settlements: An Ounce of Prevention is Worth a Pound of Cure: How Recent OCR Enforcement...

HIPAA enforcement has been on the rise during the last several years, and the dollar impact of those settlements has continued to grow significantly. The Department of Health and Human Services, Office of Civil Rights (OCR)...more

Your Cyber Minute: The Implications of the GDPR for Cybersecurity [Video]

Partner Harriet Pearson and Head of our Privacy and Cybersecurity practice in Europe Eduardo Ustaran discuss the Global Data Protection Regulation and what companies need to know now. ...more

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

Report Lists Health Care Data Breaches by State

A new report issued by Safetica USA has organized data breaches affecting over 500 individuals that were self-reported to the Office for Civil Rights (OCR) in 2016 into a list by state and records exposed....more

Health Care Fraud and Abuse in the Middle District of Florida in 2016 - a Year in Review

The United States Attorney’s Office (USAO) for the Middle District of Florida (USAO-MDFL) prosecuted several civil health care fraud matters in 2016 and issued related press releases. A review of the USAO-MDFL’s criminal and...more

Spoiler Alert: Florida Appellate Court Upholds PMA Preemption and Rejects Parallel Claim

Over the years, comedian Adam Carolla has played the “Germany or Florida” game on his various radio and tv programs and podcasts. The game is based on the observation that many of the most bizarre stories of human ineptitude...more

Health Update - February 2017

Securing the Safety Net for America's Vulnerable Populations - Editor's Note: America's population is aging rapidly. By 2029, 75 million baby boomers will have reached age 65 and older, and older adults will represent...more

Insider Trading Around Private Placements: Was Tom Price’s Investment Down Under Above Board?

On February 10, the Senate confirmed Representative Tom Price (R-GA) as Secretary of Health and Human Services, where he will oversee the U.S. Food and Drug Administration (FDA). His nomination has not been without...more

FDA Changes Warning For Fluoroquinolones

Fluoroquinolones is a drug used to treat respiratory and urinary infections. Fluoroquinolones include these drugs: - Avelox (moxifloxacin); - Cipro (ciprofloxacin); - Cipro extended-release (Cirpofloxacin...more

OIG Publishes Online Portfolio Highlighting its Body of Work on Drug Pricing and Reimbursement

For several years now, the public outcry over the issue of drug pricing and reimbursement has increased in frequency and fervor. At least one government agency wants you to know that it has been listening and wants to help...more

Employment Law Navigator – Week in Review: February 2017 #3

Over the weekend, a female Uber employee published a blog post that accuses the company of systemic sex discrimination and harassment. Uber quickly reacted, hiring former Attorney General Eric Holder to perform an “urgent...more

$5.5 Million HIPAA Settlement Underscores Importance of Audit Controls

On February 16, 2017, the HHS Office for Civil Rights (OCR) disclosed a $5.5 million settlement with Memorial Healthcare Systems (MHS) for HIPAA violations affecting the protected health information (PHI) of 115,143...more

What's "Hidden" in the 21st Century Cures Act for Health Care Entities

The 21st Century Cures Act (Cures) was signed into law December 13, 2016. While the primary focus of the 996-page Act centered on biomedical innovation, several components of Cures have significant implications for health...more

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