View the February 2017 Health Law Vitals Newsletter PDF. Final Guidance Sheds Light on Medical Device Reporting Requirements In November 2016, the U.S. Food and Drug Administration issued a final guidance on medical device reporting for manufacturers ("Final MDR Guidance") ...
'Close of business' is a term many people use in their day to day working life without much thought. But what does it actually mean and should the term be used in contractual documentation? Agreeing to get something done by 'close of business' is a phrase often used when flexibility is required as to the time a task will be completed. It makes it clear the task will be done that day, but not by a particular time ...
Membership substitution transactions are the most common form of business combination transaction in the nonprofit hospital industry. They are also widely misunderstood and the source of many mistakes. Many large 501(c)(3)s have become more acquisitive as a result of economic pressures of the ACA. Nonprofit health systems have been getting much better at participating in and winning competitive sale processes, resulting in an increased use of this business combination form. http://www ...
In a decision rendered on December 1, 2016, the Superior Court of Québec had to rule on a situation which, until that time, was completely novel, and to determine whether lawyers can act in a court action against former employees of a client whom they still have to work with in connection with another related proceeding. The Court declared that the lawyers were disqualified ...
Just weeks into the new Administration, perhaps the only certain thing is that there will be uncertainty as the Administration makes its mark and works to fulfill campaign promises. Meanwhile, restaurant chains and food companies are trying to allocate resources to best address business priorities and hot legal issues ...
The SEC’s Office of Compliance Inspections and Examinations recently announced its 2017 examination priorities for broker-dealers, investment advisers, and investment funds. OCIE, which serves as the “eyes and ears” of the Commission, identified the current staff’s priorities as a focus on (i) matters of importance to retail investors, (ii) risks specific to elderly and retiring investors, and (iii) assessing market-wide risks ...
The superintending and reforming power of the Superior Court of Québec over the decisions of the Court of Québec is indisputable. It is furthermore confirmed by article 34 of the Code of Civil Procedure1, which grants to the Superior Court powers to judicially review decisions made by the Québec courts, with the exception of the Court of Appeal ...
In its recent judgment of 21 December 2016, the Tournai Commercial Court (‘Court’) declared it did not have jurisdiction to deal with a dispute concerning the termination of an exclusive distributorship that the parties had agreed to submit to arbitration. This judgment was based on the new definition of arbitrability in the Belgian Judicial Code, which entered into force in 2013, and marks a new era for the arbitrability of Belgian distributorship law disputes ...
On January 20, 2017, in a case of first impression among the appellate courts, a panel of the Ninth Circuit concluded in Syed v. M-I, LLC (Case No. 14-17186) that an employer violates the Fair Credit Reporting Act (FCRA) when its background check disclosure/authorization document includes a sentence that releases the employer, the consumer reporting agency (the vendor), and their agents from liability for any violations of the FCRA ...
The False Claims Act, 31 U.S.C. §§ 3729, et seq. (FCA) continued to be a significant focus of government and whistleblower activity in 2016. ThisYear in Review highlights several key developments, including: The U.S. Department of Justice is continuing its strong enforcement of the FCA, including recovering more than $4.7 billion in settlements and judgments in FCA cases in 2016, as well as continuing its focus on individual culpability ...
Disclosure is an essential part of litigation and arbitration under English law as it usually provides both parties with access to the contemporaneous documents which support or adversely affect a party’s case. The exponential growth in recent years of the number of electronic documents created during the course of a project has increased the size and, as a result, the cost of the disclosure exercise ...
It is becoming increasingly common to see allegations of misrepresentation made in shipbuilding and offshore construction disputes ...
The Affordable Care Act (ACA) has been one of the most sweeping, and most divisive, pieces of legislation related to healthcare in a generation. More ink has been spilled over enactment, constitutionality, and repeal than any other government healthcare program. With the election of Donald Trump, and a Republican-controlled Congress, the repeal of the ACA is all but assured ...
The Board of Supervisors unanimously approved legislation on December 13, 2016 to provide developers of market rate projects with 24 or fewer dwellings with the option of contributing the required fees for off-site affordable housing (under the Inclusionary Housing Program) to a Small Sites Fund administered by the Mayor's Office of Housing and Community Development ("MOHCD") ...
accounts throughout Europe with one single order. EU Regulation 655/2014 of 15 May 2014 establishing a European Account Preservation Order procedure to facilitate cross-border debt recovery in civil and commercial matters (‘EAPO Regulation’) came into force on 17 July 2014 and applies from 18 January 2017 ...
The current EU regulations for medical devices and in vitro diagnostics are from the 1990s. The rapid technical developments in the health care system in recent years as well as the increased cross-border trade urgently require a modernization of the current legal framework. Now the adoption of new EU legislation is imminent. This article provides a brief overview of the planned content and the likely entry into force of the Regulations ...
As the American press focuses on the dismantling of the Affordable Care Act, the wheels have been set in motion to implement new health care legislation that enjoys strong bipartisan support. The 21st Century Cures Act (the “Act”), signed by President Obama on December 13, addresses a broad range of health care priorities, including drug innovation, biomedical research, and mental health reform ...
November 2016: In the recent Singapore High Court decision of The Enterprise Fund II Ltd v JongHee Sen [2016] SGHC 259, Judicial Commissioner Hoo Sheau Peng (the "Judge") considered whether “withoutprejudice” privilege ("WP Privilege")applied to certain communications between the parties and, consequently,whether those communications could be received into evidence ...
Under the Affordable Care Act (“ACA”), large employers (generally those with 50 or more full-time employees or full-time equivalents) must report annually to the IRS information about the health coverage offered to their full-time employees during the prior year. Employers also must provide copies of the reports to their full-time employees ...
The December/January issue of the International Financial Law Review (IFLR) included an international briefing article entitled “Philippines: Competition Law Updates”. The article was contributed by SyCipLaw partners Franco Aristotle G. Larcina and Arlene M. Maneja. The article discussed the new merger form issued by the Philippine Competition Commission on August 31, 2016. Read the article online at the IFLR website ...
On January 1, 2017, most public works projects in California will be subject to new procedural requirements applicable to claims from contractors ...
On December 22, 2016, in Augustus v. ABM Security Services, Inc., Case No. S224853, the California Supreme Court issued a split decision on rest periods. In a decision in which four justices concurred, and two concurred and dissented, in part, the Court held that employers “must relieve their employees of all duties and relinquish any control over how employees spend their break time ...
The Serbian Parliament has recently adopted amendments to the Criminal Code. The amendments include a significant overhaul of the legal framework for white collar crimes, touching upon the rules relevant for antitrust enforcement as well. While the Serbian Criminal Code previously penalized antitrust infringements spearheaded by the responsible managers, the relevant provision was relatively vague and targeted chiefly dominance abuse ...
Karanovic & Nikolic provided complete legal support to Affidea, a largest European medical service provider with respect to opening the first foreign hospital located in Belgrade. Our services consisted of extensive regulatory and corporate advice related to formation and start of operations of Affidea&s first hospital in Serbia. Affidea is one of the largest healthcare investors and operates over 180 Diagnostic and Cancer Treatment Centers in 15 countries across Europe ...
After a remarkable year in both merger control and antitrust, the Serbian Competition Commission (the "Commission") is already starting to look ahead. The announcements made on the Commission's website during November and December of this year suggest that the Commission's focus in the year ahead will be directed at several industries in particular. Firstly, the Commission published on its website the Report on the Sectorial Analysis of Aftermarkets ...
