Health Care Self-Disclosure Protocols – Is It Worth It To Self-Report?
In recent years the federal government has aggressively investigated and prosecuted pharmaceutical companies and health care providers for possible violations of anti-fraud, anti-kickback and other...
View ArticleNew FinCEN Guidance On Virtual Currency Transactions
Overview - On January 30, 2014, the U.S. Department of the Treasury’s Financial Crimes Enforcement Network (FinCEN) issued two administrative letter rulings that clarify the application of FinCEN’s...
View ArticleGoogle To Get Grilling Before UK Courts for Covert Safari Browser Tracking
High Court Judge Mr Justice Michael Tugendhat has declared in the case Vidal-Hall & Ors v Google Inc. [2014] EWHC 13 (QB) (16 January 2014) that infamous U.S. corporation Google Inc. (‘Google’)...
View ArticleChina Releases Fast Track Approval Process for Innovative Medical Devices
On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1,...
View ArticleReport on the Initial gTLD Launch: Taking a Ride with .BIKE
Despite the attempts of Reed Smith and some others in the intellectual property field to educate the public on the upcoming explosion in the number of global top-level domains (“gTLDs”) (the string to...
View ArticleOIG Reports on Contract Pharmacy Arrangements in the 340B Program
On February 4, 2014, the U.S. Department of Health and Human Services, Office of the Inspector General (OIG) issued a memorandum report regarding contract pharmacy arrangements in the 340B Program. In...
View ArticlePatenting Necessary for Continued Innovation in Biotech/Pharma Industries,...
Most recent academic and some popular assessments of the effects of the Bayh-Dole Act have been critical. This has been due in part to political opposition to licensing university technology (and the...
View ArticleOIG 2014 Work Plan Focuses On Compounded Pharmaceuticals Reimbursed By Medicare
The Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) included two items in its recently-released 2014 Work Plan indicating a new focus on the quality and safety...
View ArticleMBHB Snippets: Review of Developments in Intellectual Property Law - Volume...
The worldwide expansion of data privacy laws and regulations has impacts that are being felt with increasing regularity in the litigation arena. Whenever data collections occur within foreign...
View ArticleCMS Take Steps to Modernize Clinical Lab Policies
Through two recently issued regulations, the Centers for Medicare and Medicaid Services have announced their intention to reform and improve Medicare policies addressing clinical diagnostic laboratory...
View ArticleCMS Releases Long-Awaited Details for Sunshine Act Compliance
The Physician Payment Sunshine Act (the "Act") was enacted as part of the Patient Protection and Affordable Care Act for the purpose of promoting transparency between the medical industry and health...
View ArticleCyber Law Tracker: A Year in the Making, White House Unveils Final...
On Wednesday, February 12, the White House unveiled its new framework for American infrastructure to protect itself against cyberattack. That framework is the result of a yearlong project undertaken by...
View ArticleFINRA Conducting Cyber-Security Sweep Exam
Reacting in part to recent data-breaches and cyber-attacks on larger retailers, the Financial Industry Regulatory Authority (“FINRA”) is conducting a targeted examination of some 20 broker-dealer...
View ArticleA Look at the FDA’s New Social Media Guidance
Draft guidance provides the medical industry with long-awaited boundaries for marketing in the electronic age. On January 13, 2014, the Food and Drug Administration (FDA) released a draft guidance...
View ArticleCyber Espionage And Insurance Coverage
In the United States alone, it is estimated that the cost of “[c]yber-espionage and other malicious cyber crimes...[i s] between $24 billion and $120 billion annually.” In 2008, the U.S. Department of...
View ArticleFDA's Guidance for Industry Concerning Receipt Dates
The U.S. Food and Drug Administration (FDA) on February 10, 2014, published its Guidance for Industry on the receipt date for regulatory submissions. The Guidance applies to submissions that are in...
View ArticleDOJ Files Criminal Charges Against Former Bitcoin Exchange Head
On January 27, 2014, the Department of Justice publicly announced it had filed criminal charges against Charles Shrem for operating an unlicensed money transmitting business, conspiracy to commit money...
View ArticleWas Dumb Starbucks Smart?
Comedian Nathan Fielder created a media stir, and long lines, when he opened a coffee shop called Dumb Starbucks. The establishment was quickly closed down for not having a permit. In the short time...
View ArticleSweden: Latest development regarding the review of the Swedish gambling...
By 30 November 2014, a governmentally appointed investigator shall present his or her view on the necessary amendments of the Swedish prohibition against the promotion of unlicensed gambling. In...
View ArticleFDA Releases Final eMDR Rule and Deadline for Compliance
The Food and Drug Administration (FDA) announced and is promulgating today the Final Rule on Electronic Medical Device Reporting (eMDR). Originally proposed in 2009, the rule is now final and a...
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