On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
The Nils Svensson v Retriever Sverige AB decision addresses fundamental questions of copyright and Internet use. In essence, the case addresses the question of whether hyperlinking to freely accessible content requires authorization. The original plaintiffs of the Svensson case were Swedish journalists who wrote press articles that were published in the Goteborge-Posten newspaper and on its website, where they were freely accessible ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
As more states adopt anti-SLAPP legislation (i.e., Oklahoma’s passage this Spring and Nevada’s expansion of its anti-SLAPP statute last year), more federal courts must decide whether such laws create a substantive right which should be applied by the federal judiciary ...
The Supreme Court today ruled that Aereo’s system for transmitting over-the-air television broadcasts through the Internet violates copyright law. In a 6-3 decision, with Justice Breyer writing for the majority, the Court ruled that Aereo both “performs” the television broadcasts at issue and does so “publicly.” With these key issues decided, the Court essentially sounded a death knell for Aereo and a similar but unrelated company, FilmOn X ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
New technology is most often associated with telecommunications, IT or robotics. Food is seen as a group of products in which innovation is little important, because it is believed that consumers are mostly concerned with prices and quality, but not innovations. However, the dynamic growth in market share of functional foods calls for a critical review of myths that have arisen around R&D projects in the food sector ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
Who knows why Luis Suarez bit Giorgio Chiellini at the FIFA World Cup 2014. Perhaps it’s a compliment to great Italian defending? Or something to do with the increasing demands of the modern game? Whatever the answer may be, none of us truly believe that this sort of thing is acceptable. But precisely what are the rules that regulate this sort of conduct? Most of us were told not to bite when we were very young - so that we know ...
The draft regulations for OTC derivatives have been released, which means that change is in the air. The government is stepping forward into unchartered territory and is set to regulate an area which has never been regulated before. Following our recent breaking news on the draft regulations, ENSafrica will, over the coming weeks and months, unpack the regulations for you, highlighting all the essentials. What follows is a sneak peak at affected areas and a snapshot of the bigger picture ...
In an unanimous decision dated September 4, 20141 , the Court of Appeal confirmed that the 45-day time limit under the Act Respecting Health Services and Social Services2 (ARHSSS) to allow the medical examiner and the local service quality and complaints commissioner to process a user complaint is not mandatory but rather serves to indicate that the Legislator intends the complaint to be diligently processed ...
In Belgium, although a sportsman is deemed to accept the normal risks linked to the exercise of his sport, he can claim damages for injuries inflicted on him by another player, to the extent that the perpetrator failed to meet the standard of general due diligence.1 The action of the player causing the injury is measured against the behaviour that would have been displayed by another reasonable sportsman placed under the same conditions ...
Last month a USA court found that a hit song performed and co-written by Shakira was in fact copied from an earlier work. So what happened? Shakira had previously collaborated with Dominican rapper El Cata on the song 'Loca'. The song, which sold over 5,000,000 copies worldwide, also featured on her album 'The Sun Comes Out' ...
On August 29, 2014, Normative Resolution N. 112 was published, amending Article 4 of Normative Resolution N. 98 of November 14, 2012. Normative Resolution 112/2014 provides that the temporary visa item V can be granted to foreign nationals who will enter Brazil to work exclusively in the preparation, organization, planning and execution of the 2016 Rio Olympic and Paralympic Games and who do not have a Brazilian sponsoring company or any employment relationship with a Brazilian company ...
On October 3, 2014, the Supreme Court of Canada, by a majority decision of 5 to 4,1 confirmed that a disposition ordering the treatment of an accused who is found unfit to stand trial requires the prior consent of the designated hospital to all the terms of the disposition order, inclusive of the date on which the treatment is to begin ...
On October 3, 2014 the Department of Health and Human Services, Office of Inspector General (“OIG”), released a proposed rule to add new safe harbors to the Anti-Kickback Statute (“AKS”) and to amend the definition of “remuneration” in the Civil Monetary Penalties (“CMP”) regulations. The OIG additionally solicited comments on same which must be submitted no later than 5 pm EST on December 2, 2014 ...
With the recent announcement to extend the waivers of certain fraud and abuse laws for accountable care organizations (ACOs) participating in the Medicare Shared Savings Program (MSSP), ACOs can continue using the waivers in their current form - at least for now ...
On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological products, including all biosimilar and interchangeable biological products. The Purple Book is more formally known as “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.” The Purple Book is meant, at a fundamental level, to be the biological equivalent of the “Orange Book ...
Finding that the taking of photography is entitled to the same First Amendment protection as photographs themselves, the Texas Court of Criminal Appeals struck down the state's "improper photography or visual recording" statute, a statute that made it a crime to photograph or record someone in a place other than a bathroom or private dressing room without their consent and "with the intent to arouse or gratify the sexual desire of any person." Ex Parte Thompson (Tex. Ct. Crim. App. Sept. 17 ...
In an opinion published on November 11, 2014, Connecticut joined a growing number of jurisdictions that have found that state law causes of action based on a health care provider’s unauthorized disclosure of a patient’s medical records are not preempted by the Health Insurance Portability and Accountability Act (“HIPAA”) ...
Just before Americans sat down to enjoy the Thanksgiving holiday with family and friends, with many of them probably choosing to overlook the total calorie count of those meals, the FDA released the long awaited rule on nutritional labeling applicable to chain restaurants and other venues serving restaurant type food (79 FR 71156). The FDA’s final menu labeling rule implements certain amendments to the Food, Drug & Cosmetic Act ("FD&C Act") that were part of the Affordable Care Act of 2010 ...
On December 1, 2014, the Department of Health and Human Services Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that included numerous changes for accountable care organizations (“ACOs”) participating in the Medicare Shared Savings Program (“MSSP”) in light of the experience CMS gained during the first two years of the program ...
