Download a free copy of the Philippine section of Getting the Deal Through: Life Sciences 2015, which was contributed by SyCipLaw partners Rose Marie M. King-Dominguez and Carlos Roberto Z. Lopez with senior associate John Paul V. de Leon and associate Mark Xavier D. Oyales.This chapter is reproduced with permission from Law Business Research Ltd ...
The Minister of Communications and Informatics has issued Regulation No. 18 of 2014 on The Certification of Telecommunication Devices and Equipment. This regulation has been in force since 27 June 2014. All telecommunications devices and equipment that are produced, assembled, and imported in and to Indonesia for commercial purposes uses, must satisfy the prevailing technical requirements including a Telecommunications Devices and Equipment certificate ...
A Ministerial Order (S.I. 541/2014) has been passed commencing Part 3 of the Criminal Justice (Mutual Assistance) Act 2008 (the Act), from last Monday 1 December, 2014. The Act provides for various forms of mutual legal assistance to foreign law enforcement authorities. Part 3 concerns requests for mutual assistance between Ireland and other Member States of the EU for interception of telecommunications messages for the purposes of criminal investigations ...
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 ...
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”) ...
The Federal Communications Commission (“FCC”) is the latest government agency to make a foray into data breach enforcement, proposing a $10 million fine against two telecommunications carriers for failing to protect the personal information of up to 305,000 consumers. In light of this development, companies regulated by the FCC must now be alert to potential liability to the FCC for failing to secure consumers’ “proprietary information” (“PI”) ...
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 ...
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 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 ...
Launch of South African City Domain Name Extensions Three South African city domain names extensions have recently been launched, namely .Joburg, .Durban and .Capetown. It is very important for clients that own co.za domain names, or South African trade marks, to register the matching city domain name extensions. The launch of the city domain name extensions commenced with the Sunrise and land rush phases running concurrently ...
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 ...
As of 23 May 2014, the usage fee for the radio frequency spectrum was increased for Croatian operators. As a result of this increase, three of Croatia's largest operators have announced an increase in the price of their mobile network services, as well as the introduction of additional fees for recipients of public communication services. The announced price increase will range from between 10 and 15% ...
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 ...
In December 2010, the federal Parliament passed the Act to Promote the Efficiency and Adaptability of the Canadian Economy by Regulating Certain Activities1 that Discourage Reliance on Electronic Means of Carrying out Commercial Activities, better known as the “Canada’s Anti Spam Legislation” (the “Act”) ...
In a commentary piece published in Australia’s leading online media law publication, partner and head of our media practice Peter Bartlett argues that Australia already has laws to protect serious invasions of privacy and warns against the effect on reporting that a statutory right to privacy would have. He writes: The reality is that Australia has many laws that already protect an individual’s right to privacy ...
On 1 January 2015, an amendment to the VAT Act is to become valid. Its main objective is to implement EU regulations. The main change concerns the place of performance in the case of telecommunication services, TV and radio broadcasting services and services electronically provided to persons who are not obliged to pay the tax. All these services will be taxed in the country of the recipient of the relevant service ...
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 ...
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 ...
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 ...
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 ...
On March 6, the Plenary Session of the Federal Telecommunications Institute published in the Federal Official Gazette the call of public tender no. IFT-1 that is intended for the development and commercial use of transmission channels for the provision of public service broadcast digital television ("Tender"). This would be, to form two national chains in Mexico for a period of twenty years ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
