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 ...
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 ...
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 ...
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 ...
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 ...
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) ...
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 ...
How do we discipline employees that refuse to work due to the Ebola virus? What patient information is protected during an outbreak? How should we communicate with our employees about Ebola? Has OSHA issued new guidelines on Ebola for healthcare providers? These are just a few of the questions we are hearing from our clients ...
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 ...
Last week, Waller launched an Ebola legal resource website. Since then, we have received positive feedback from our clients, follow-up questions and suggestions for additional topics we should cover. As the needs of our clients continue to evolve, we are updating the site regularly ...
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”) ...
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 ...
The Head of the National Agency for Food and Drug Control (BPOM) has issued Regulation No. 11 of 2014 on The Procedure for the Certification of Good Manufacturing Practices, ensuring compliance with the applicable standards for processed food. Regulation 11 has been in force since 5 August 2014 ...
In recent years, the Department of Justice, the FDA and the FBI have stepped up enforcement of the Food Drug and Cosmetic Act’s (FDCA) drug importation, distribution and misbranding requirements particularly with respect to high-priced and difficult-to-obtain drugs used in cancer treatment. Recently, these efforts suffered an unexpected setback in the Sixth Circuit following the United States’ decision to abandon its prosecution against an East Tennessee Oncologist and his wife ...
Under Regulation No. 122/M-IND/PER/12/2014 on Delegation of Authority to Grant Industrial Business Licenses to the Head of the Capital Investment Coordinating Board, the MOT has delegated its authority to issue certain licenses to BKPM. Business licenses delegated consist: 1. Industrial Business License and/or Expansion Licenses as follows: a. alcoholic beverages industry; b. valuable paper industry; c. weapons and ammunition industry; d ...
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 ...
