The Second Circuit Court of Appeals recently granted a petition for interlocutory review to decide whether a violation of the FCA’s first-to-file rule can be cured by filing an amended pleading. Both the D.C. Circuit and Fourth Circuit1 recently addressed this issue, concluding that the plain language of the first-to-file rule precludes amending around the rule ...
The Health Insurance Portability and Accountability Act (“HIPAA”) contains minimum security standards that Covered Entities and Business Associates must employ to safeguard protected health information (“PHI”). As part of HIPAA’s security standards, Business Associates are obligated to report all security incidents to the Covered Entity ...
As Hurricane Harvey continues to cause far-reaching disruptions, it is important to understand how to effectively assert or respond to assertions of force majeure. This summary outlines the steps to take to assert force majeure, and initial considerations for those who have received several notices of force majeure from counterparties ...
Hurricane Harvey has radically impacted every industry in southeastern Texas, including healthcare providers, who continue to analyze potential next steps in ensuring operations can resume so that they can further assist those in need of healthcare services. Below are several links to resources that may be helpful for healthcare providers attempting to navigate through their options ...
In recent months, the South African Minister of Transport gave notice that Cabinet had approved the Comprehensive Maritime Transport Policy, 2017 (“CMTP”). The CMTP makes certain policy statements in order to develop South Africa’s maritime industry. Below, we summarise certain policy statements that relate to the more commercial aspects of shipping, in the order in which they are dealt with in the CMTP ...
Unmanned vessels are no longer a futuristic concept, but a reality. In Norway, several projects involving the testing of unmanned vessels are currently ongoing. It is only a question of time before we see unmanned vessels operating in international waters. In this article we will first look at ongoing projects in Norway and the challenges faced from a national law perspective ...
Few medical issues are as significant to an employee and an employer as major back surgery. The procedure incapacitates the injured worker for months and leaves the employer short staffed while the employee recovers. Additionally, these surgeries often do not result in the expected outcome, which leads to further impairment and expense ...
According to the advocate general’s opinions in C-434/15 Elite Taxi and C-320/16 Uber France, Uber does not provide information society services, but local transport services which may be regulated by EU member states. It has been more than ayear since we signalled that the Court of Justice of the European Union would need to resolve the legal classification of the services provided by Uber ...
Medical Cannabis approvals in the City have been the subject of intense negotiations, hearings, and appeals in the last two months. First, our law firm assisted the Apothecarium - Sunset (an additional location in the Sunset District for the medical cannabis dispensary called The Apothecarium currently near the Castro), in obtaining an approval at the Planning Commission ...
We previously reported that on March 30, 2017, Ohio Gov. John Kasich and the executive directors of Ohio’s health care licensing agencies announced new standards for prescribing opiates for acute pain ...
It has been four months since the changes to 42 CFR Part 2, the confidentiality regulations that apply to all substance abuse treatment records, became effective. Ensure your policies and forms have been updated. The finalized changes to 42 CFR Part 2 by the Substance Abuse and Mental Health Services Administration (SAMHSA), an agency within the U.S. Department of Health and Human Services (HHS), took affect March 21, 2017 ...
In recent months, in a unanimous decision authored by Justice Thomas, the Supreme Court issued its much-awaited decision in Sandoz Inc. v. Amgen Inc. et al., No 15-1039, considering two critical questions in the biosimilar approval mechanisms adopted in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Long-term care (LTC) facilities received a boost last week when the Centers for Medicare and Medicaid Services (CMS) reversed its position regarding the use of arbitration agreements in this setting. On June 8, 2017, CMS published a proposed rule amending LTC facilities’ conditions of participation in the Medicare and Medicaid programs to remove prohibitions on binding pre-dispute arbitration agreements ...
“It is a treasured value in humanity … that no parent would want her child to grow up thinking that she (the child was) a mistake." - Justice Choo Han Teck In 2010, a Chinese woman, trying to conceive a child with her Caucasian husband, underwent an in vitro fertilisation (“IVF”) procedure at a clinic. Like the previous time she bore a child through IVF at that clinic in 2006, no third party’s gametes were meant to be used ...
The Ministry of Transport and Public Works (Ministerio de Obras Públicas y Transporte) of Ecuador, which is entitled of the management of the ports had issued the invitation to the public bidding process ...
Following recommendations from a working group formed by the Ministry of Transportation, Ports and Civil Aviation (MTPAC) and discussions with representatives of different interested parties, President Michel Temer recently signed a decree changing the regulations of (Ports Law) ...
The Croatian Competition Agency (the "Agency") initiated proceedings against Grand Auto – an authorised dealer of Land Rover and Jaguar cars for Croatia, after an initiative by the Auto Dealership "Karlo", a former authorised repairer of the said cars for Croatia ...
On Wednesday, April 26, 2017, the Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. et al., a landmark case that many hope will provide clarity and guidance for consumers and the pharmaceutical industry on the regulatory approval pathway for biosimilar drugs under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA” or “Biosimilars Act”) ...
Autonomous cars have really taken off in the last few years, particularly due to the interest of both consumers and the businesses who develop and improve them. In this context, on April 5 and 10, 2017, the City of Montréal and the Government of Québec respectively announced significant investments in the electrification and intelligent transportation sector to make the Province of Québec a pioneer of that industry ...
Upon reconsideration in Gerard v. Orange Coast Memorial Medical Center, Case No. G048039 (March 21, 2017) (Gerard II), the Fourth Appellate District decided that IWC Wage Order 5 is valid and that healthcare employees may waive one of their two required meal periods on shifts longer than 8 hours ...
In March 2017, the Montenegrin Agency for the Protection of Competition carried out an unannounced inspection (dawn raid) at the business premises of Sava Trans d.o.o. Cetinje, a company engaged in freight transport, in order to collect data necessary for undertaking further actions carried out by the Agency ...
The Treasury Department has announced further extensions for medium-sized and large-sized employers for compliance with the “employer mandate” of the Affordable Care Act (“ACA”). The employer mandate requires employers with a threshold level of employees to provide affordable health insurance to 95% of their full-time employees. Under the ACA, a full-time employee is defined as any employee who works on average 30 or more hours per week ...
Few areas of law have proven more dynamic over the last few years than the interplay between state tort laws and the federal regulation of pharmaceutical drugs and medical devices. During its last two terms, the United States Supreme Court has issued three separate opinions addressing federal preemption of state law claims under the Federal Food, Drug, and Cosmetic Act ...
The Patient Protection and Affordable Care Act ("ACA") has significantly changed the healthcare industry in the United States. Among the many changes is the new requirement that healthcare providers must provide all "Food and Drug Administration approved contraceptive methods, sterilization procedures, and patient education counseling for all women with reproductive capacity."77 Fed. Reg. 8725 (Feb. 15, 2012); see 42 U.S.C. 300gg-13(a)(4), 45 C.F.R. § 147.130(a)(1)(iv) ...
The September 23, 2013 deadline for covered entities, business associates and their subcontractors to implement the new HIPAA rules is approaching quickly. In case you missed it, on January 25, 2013, the U.S. Department of Health and Human Services issued an omnibus final rule modifying the Health Insurance Portability and Accountability Act of 1996 ...
