Court Report - December 29, 2013
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Pharmaceuticals Inc. et al. v. Alkem Laboratories Limited 1:13-cv-09227; filed December 26, 2013...
View ArticleOIG Extends Electronic Health Records AKS Safe Harbor
The Office of Inspector General (OIG) has amended the Safe Harbor Regulation regarding electronic health record (EHR) items and services. The primary purpose of the amendment is to extend the Safe...
View ArticleComing Next: Mexico to tender 2 D-TV broadcasting networks
Last December 20, 2013, the IFT, Telecom regulator, published the tender program for two TV broadcasting networks with the location of the TV stations and frequencies to be granted under license. The...
View ArticleCrowns and Coins for QuizUp
New stuff that spreads really fast never ceases to amaze me. Remember the viral music video from Norway earlier this year? The What Does the Fox Say video amassed another 200 million views since my...
View ArticleHealth Care Law Update: Anti-Kickback Safe Harbor Rule for Electronic Health...
The anti-kickback safe harbor concerning electronic health records (EHR) items and services, which defines certain conduct that is protected from liability under the federal anti-kickback statute...
View ArticleCyber Risk Is The “New Normal”
Introduction - Make no mistake, all companies—big or small—are vulnerable to a privacy breach or a network security incident. Cyber liability is the “new normal.” Cyber liability can be attributable to...
View ArticleHHS Closes Out 2013 with 6th Resolution Agreement
Throughout 2013, HHS OCR has stated that covered entities of all sizes need to give priority to securing ePHI. In addition, HHS OCR has recommended that covered entities identify and mitigate risks...
View ArticleThe Long Sunset: EHR Donations May Continue Until 2021 (With a Few Changes)
Under long-awaited final rules recently published by the federal government, hospitals and other “protected donors” may continue to “donate” interoperable electronic health record items and services...
View ArticleMedical practice agrees to payment due to HIPAA data breach
One day after Christmas, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) announced that a Massachusetts-based dermatology practice (Practice) agreed to a $150,000...
View ArticleU.S. Court of Appeals for the Ninth Circuit Rules There Is No Cause of Action...
On December 4, the Ninth Circuit ruled that the 1999 Anticybersquatting Consumer Protection Act (ACPA), 15 U.S.C. § 1125(d) does not provide a cause of action for contributory cybersquatting. In...
View ArticleThe McKesson Case – A Holiday Gift From Justice Boyle Of The Tax Court Of...
On Friday, December 20th, the Tax Court of Canada released the long-awaited and lengthy decision of Justice Patrick Boyle in McKesson Canada Corporation v. The Queen, a case involving transfer pricing...
View ArticleMexico to launch tender on 2 geostationary orbital positions in 2014
Yesterday, the IFT, Mexican telecom regulator, published the Program for launching a tender on 2 geostationary orbital positions (GOP) with coverage on Mexican territory for fixed satellite service....
View ArticleAdvertising Law - December 31, 2013
FTC Shines a Light on Flashlight App’s Geolocation Data Sharing - In the agency’s first action involving geolocation data, Goldenshores Technologies, LLC, settled charges with the Federal Trade...
View ArticleCalifornia Appellate Court Holds That Federal Law Preempts Unfair Competition...
In a case of first impression in the state courts, a California appellate court delivered an early Christmas present Dec. 23 to beleaguered food and beverage companies facing an avalanche of lawsuits...
View ArticleA New Year’s Resolution (And Corrective Action Plan) From OCR: Physician...
The Office for Civil Rights (OCR) is closing out 2013 with a reminder of the importance of an effective HIPAA compliance program. On December 26, 2013, OCR announced a resolution agreement with a...
View ArticleRegulatory Landscape For Mobile Medical Apps (MMAs)
On December 6, 2013, I delivered a presentation on the FDA’s policy on mobile medical apps (MMA) to the Bar Association of Erie County. The event was well attended by attorneys practicing in diverse...
View ArticleAstraZeneca AB v. Hanmi USA, Inc. (Fed. Cir. 2013)
A classic example of product "evergreening" is how AstraZeneca used its experience with its omeprazole franchise (sold for over a decade as Prilosec®) to promote an alternative form of the drug,...
View ArticleFinal EHR Donation Rules Issued in Time for the New Year
On December 27, 2013, the U.S. Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules revising...
View ArticleE-Discovery in 2013 – Waiting for Godot, Closing Kimonos, and Your World...
In some respects, 2013 seemed like a conversation between Vladimir and Estragon. Some commentators likened it to a simple, unified message that finally had E-Discovery practitioners, litigators in...
View ArticleBe It Resolved: Identify an Opportunity and Make a Change
If there is one thing I look forward to about New Year’s, it’s making resolutions. I think much of life is about continuous improvement; every day is a chance to do something better than the day...
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