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”) ...
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 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 ...
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 ...
The Energy Law is to permit industrial users to obtain certificates of origin and present them for redemption for only a portion of the electricity they purchase. But the future of this support mechanism has been called into question. The rule introduced by the 26 July 2013 act amending Poland’s Energy Law limits the obligation imposed on industrial users to support the generation of electricity from renewable energy sources (RES) and high-efficiency cogeneration (CHP) ...
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 ...
The trade mark laws of the world are, by and large, fairly well harmonised, or at least well on their way to becoming so. Which makes perfect sense in an era where multinational companies operate in a global village – a multinational should ideally get the same protection for its brand in all the countries where it operates. It is for this reason that South African trade mark law offers the same sort of protection to trade mark owners that many other countries offer ...
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 ...
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 ...
According to the Council Regulation (EC) No 6/2002 on Community designs (CDR), you can protect a design without registering it. But here is the catch: the unregistered design must be new and have an “individual character”. So, what is individual character? A recent court case gives insight. It specifically addresses the fashion industry, but the ideas are useful for any company that does not register all of its designs ...
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 ...
The high cost threshold system or public procurement: The Swedish pharmaceutical subsidy system is based on a high cost threshold system for consumer products such as prescription medicines sold to end consumers via pharmacies. The relatively generous system also includes some medical devices; certain consumption articles prescribed for self-care use are included, as these in practice for the patient are considered to fulfill a similar function to prescription medicines ...
For the purpose of reducing the time of creation of new companies and helping medium-sized and small companies in their organization, the Ministry of Economy (Mineco) submitted a proposal to make modifications to the Mercantile Register. Such modifications include changes in tariffs, online inquiries concerning the names of companies, reduction of terms and improvements in procedures ...
New regulations that ban businesses from imposing excessive fees on consumers making payments will extend to small businesses from 12 June 2014. The Consumer Rights (Payment Surcharges) Regulations 2012 (the 'regulations') - the first of many legislative changes that form part of the major ongoing overhaul of consumer protection legislation - came into force for most businesses on 6 April 2013 ...
With international marketers readying for the upcoming FIFA World Cup, the Global Advertising Lawyers Alliance (GALA) has released Ambush Marketing: A Global Legal Perspective, which summarizes laws and other rules governing ambush marketing in 52 countries around the world ...
Our clients from outside the province of Quebec often ask us the following questions: what are the linguistic labelling requirements in Canada, and particularly Quebec? There are several statutes and regulations governing labelling in Quebec and Canada. The following is a summary of some of the major points relating to the use of the French language ...
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 ...
For the second time this year, the Constitutional Tribunal has considered a challenge to the court fees for appeals against rulings by the National Appeals Chamber in public procurement cases. The maximum fee of PLN 5 million was held to be disproportionately high. Earlier this year, in Case No. SK 25/11 (14 January 2014), Poland’s Constitutional Tribunal upheld the constitutionality of one aspect of Art ...
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 ...
In a surprise announcement on 21 March 2014, the Zambian government with immediate effect abolished exchange control regulations introduced in 2012 and 2013 in an attempt to halt the rapid devaluation of the Kwacha. When the Movement for Multiparty Democracy (MMD) came to power in Zambia in 1991, the new government’s priorities were the restoration of economic future growth and employment through liberalising the economy and allowing market forces a greater role ...
On 14 February 2014 the South African Department of Trade & Industry (DTI) gave notice of its intention to prohibit the use of a large number of European food and drinks names in terms of section 15 of the Merchandise Marks Act (MMA) - confusingly the notice also makes reference to section 13 of the MMA, a section that no longer exists ...
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 ...
New Regulations Governing Consumer Claims and Language Use in Consumer Information The Croatian Consumer Protection Act has recently updated how customer claims are to be handled. The receipt of complaints must now be confirmed in writing without delay ...
