In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry. According to Ceresney, the SEC is continuing to focus on pharmaceutical companies because their operations typically pose a high risk for FCPA violations ...
Understanding the Texas Attorney General’s efforts on enforcement of healthcare fraud and abuse matters often is challenging. Recent activities, however, give physicians and other providers insight into the agency’s priorities ...
On March 10, 2015, the Centers for Medicare & Medicaid Services (CMS) Innovation Center released its newest model in alternative care delivery: the Next Generation ACO Model. This new version of accountable care organization (ACO) builds upon the experiences from the Pioneer ACO Model and the Medicare Shared Savings Program (MSSP) to set more predictable financial targets, enable providers and beneficiaries to better coordinate care, and provide overall high quality care ...
In an opinion that will certainly cause Texas hospitals, physicians, nursing home operators and other healthcare providers to consider whether they should insert standard arbitration clauses into their pre-treatment agreements, the Texas Supreme Court held last week that the Federal Arbitration Act (“FAA”) preempts the more stringent arbitration requirements set forth in the Texas Medical Liability Act (“TMLA”).The Fredericksburg Care Co., L.P. v. Juanita Perez et al, No. 13-0573, 2015 Tex ...
When copyright has been infringed online, what court is competent to hear and decide the case? The EU top court’s recent ruling provides clarity and states that online infringement cases can be heard where the infringing content is accessible. The content right holders will be able to take legal action against the infringer in their home countries, but only regarding damage that occurred there ...
On February 26, 2015, the Supreme Court of Canada dismissed Dr. Gilbert Liu's application for leave to appeal a Court of Appeal decision concerning the time limit for handling complaints from users of health institutions ...
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 ...
This week, I caught up with patent attorneys Jonathan D’Silva and Bryan Walker of MacDonald Illig Jones & Britton, LLP to hear their perspectives on some key strategic intellectual property (IP) legal issues ...
The Minister of Communications and Informatics issued Regulation No. 19 of 2014 on Controlling Internet Websites Containing Negative Content (Regulation 19). Regulation 19 has been in force since 17 July 2014. This regulation aims to implement “the safe and healthy use of the internet” by all social groups by blocking access to websites that contain pornographic or unlawful material (negative content) ...
As noted in our previous client update, judicial rulings on the patent-eligibility of software and business method patents under section 101 of the U.S. Patent Act have run heavily against patent owners since Alice Corp. v. CLS Bank International, 573 U.S. ___, 134 S. Ct. 2347 (2014). (See 11/17/2014 Client Update). On Friday December 5, 2014, however, the U.S ...
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 ...
Every day seems to bring word of a new data breach, and given the stakes of these breaches, it would be easy to assume that dealing with the damage they cause would be a top government priority. Unfortunately, a myriad of conflicting state laws, as well as the lack of one over-arching federal law, creates legal and compliance nightmares for companies that these breaches affect. For example, in late February and early March 2014, hackers successfully targeted eBay’s corporate network ...
Nowadays, we live in an information age (also known as the computer age, digital age or new media age) and the advancement of technologies has facilitated information flow and communication through social media. On one hand, people have easy and quick access to others’ information, enabling interaction with one another. However, the free flow of information and wide participation in social media networks also exposes a person to various risks or dangers ...
Judicial rulings on the patent-eligibility of software and business method patents under section 101 of the U.S. Patent Act have run heavily against patent owners since the U.S. Supreme Court’s June 19, 2014 ruling in Alice Corp. v. CLS Bank International, 573 U.S. ___, 134 S. Ct. 2347 (2014). (See Client Update here ...
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 Richemont Group, owner of a number of luxury brands including Cartier, Montblanc and IWC, has secured a landmark website blocking order against the five main retail internet service providers (ISPs) in the UK (SKY, BT, EE, Talk Talk, and Virgin). Building upon the website blocking orders available to copyright holders, Richemont applied to the Court for orders requiring the ISPs to prevent subscribers' access to six websites (including www.cartierloveonline.com, and www.ukmontblancoutlet.co ...
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 ...
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 ...
Aside from a passing reference to data protection in the Electronic Transactions Ordinance (see below), TCI has no data protection statute. However, a number of other areas of local law are applicable or, in the context of the advice sought, ought to be considered in relation to data protection, confidentiality and privacy matters. In that respect:- a. Data protection, privacy and confidentiality at common law TCI is a British Overseas Territory and is a common law jurisdiction ...
The rise of social media in recent years has had a significant impact on people's private lives and an increasing number of companies are now using social media for business purposes. However, the opportunities and advantages offered by social media platforms also represent its greatest challenges. Companies often forget that such services do not exist in a legal vacuum – the normal legal framework is still applicable ...
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 ...
