The Occupational Safety and Health Administration (“OSHA”) issued a final rule to “Improve Tracking of Workplace Injuries and Illnesses, “ which requires employers to electronically submit their injury and illness records to OSHA. Specifically, establishments with 250 or more employees must annually submit their Forms 300, 300A, and 301. And, establishments with 20 to 249 employees must annually submit their Form 300A ...
The Industrial Court is a creature of statute. In determining a particular dispute, the Industrial Court must act in accordance with the purposes and express provisions of the Industrial Relations Act 1967 (“Act”). The Court must also act according to “equity, good conscience and the substantial merits of the case without regard to technicalities and legal form” [1] ...
"The global healthcare deal frenzy is set to continue for at least another 18 months as technology giants including Amazon, strategic players and private equity firms step up their fight for limited assets ...
In North Midland Building Ltd v Cyden Homes Ltd, the Court of Appeal held that an express contractual term allowing an employer to levy liquidated damages for periods of concurrent delay took precedence over a common law principle known as the prevention principle. Background Cyden Homes Limited (CH) employed a contractor, North Midland Building Limited (NMB), to design and build a large house in the Midlands, under a JCT Design and Build construction contract ...
The European Court of Justice (CJEU) has ruled that Christian Louboutin’s famous red sole does not consist solely of ashape that significantly increases the value of aproduct, and therefore can be registered as atrademark. This is an important victory for the fashion designer in the long-running battle concerning red-soled shoes ...
Resolution number 217/2018 was published in the Brazilian PTO’s Official Bulletin number 2470, and amends Resolution number 80/2013, which refers to the fast-track examination for patent applications related to products, pharmaceutical processes, equipment and materials related to public health, aiming to accelerate patent applications considered strategic to the Brazilian Public Healthcare System ...
On July 11, 2018, then-U.S. Food and Drug Administration Commissioner Scott Gottlieb made a public statement about the agency’s efforts to advance the development of gene therapies.[1] Gottlieb pointed out that the FDA has approved three separate gene therapy products and the agency has issued six scientific guidance documents intended to serve as building blocks of a modern, comprehensive framework for how the FDA can advance the field of gene therapy ...
The Affordable Care Act ("ACA") is alive and well, despite renewed legal challenges and the elimination of the “individual mandate” beginning next year. While the Tax Cuts and Jobs Act reduced the tax penalty for individuals who don’t have health coverage to $0, effective for 2019, employers continue to be subject to penalties for failing to comply with certain ACA rules ...
If you sell your products on Amazon, you can benefit from enrolling your trademarks with the Amazon Brand Registry. The Amazon Registry is a free program accessible to monitor brands on Amazon’s website. This program includes proprietary search tools designed specifically to help online merchants identify trademark infringements on Amazon’s platform. If an infringing product is found, the registered owner can request that Amazon remove the product from its website ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
On June 28, 2018, Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Alex M. Azar III announced the ninth year of the national health care fraud takedown. The takedown resulted in the largest government action against health care fraud, which involved more than 600 defendants from over 50 federal districts. The targeted fraud schemes accounted for more than $2 billion in false billings ...
Artificial intelligence technologies are extremely promising in healthcare.1 By examining, cross-referencing and comparing a phenomenal amount of data.2 AI lets researchers work more quickly at a lower cost3 and facilitates doctors’ decision-making with regard to diagnosis, treatment and choice of prescription. The integration of AI into the healthcare field can take various forms:4 Management of electronic medical records (e.g ...
Earlier this year the U.S. Supreme Court released its much-anticipated opinion inSouth Dakota v. Wayfair, Inc., in which it held that physical presence within a State is no longer a prerequisite to the imposition of liability on out-of-state sellers to collect and remit sales taxes. In doing so, the Court overruled two of its own earlier cases—National Bellas Hess, Inc. v. Department of Revenue of IllinoisandQuill Corp. v. North Dakota ...
This week, the U.S. Department of Labor (DOL) issued final rules to expand access to “Association Health Plans” for small businesses that are unaffiliated, but are in the same line of business or geographic area. An “Association Health Plan” or “AHP” is a group health plan adopted by members of an employer group or association to provide health coverage for their employees ...
On June 5, I wrote about the suspension of the California End of Life Option Act (“EOLOA”) in the wake of Ahn v. Hestrin and several related court proceedings in May. On Friday, June 15, the Fourth District Court of Appeal determined that the EOLOA will in fact remain enforceable pending further proceedings. Thus, eligible Californians who have requested end-of-life drugs in accordance with the EOLOA may continue with the process described in that law ...
In 2016, West Virginia had the highest death rate in the country from drug overdoses—primarily caused by opioids—at 52.0 for every 100,000 people.[1] The state was on track to exceed that number in 2017.[2] Seeking to enact policies that not only curb but reverse this upward trend, the West Virginia Legislature introduced a number of bills during the 2018 Regular Legislative Session that sought to address this disturbing epidemic. One of these, S.B ...
A New Development on the Subject (Update as of June 15th) Click Here to Read » A flurry of rulings during the last two weeks of May has generated enormous confusion regarding the status of California's two-year-old End of Life Option Act ("EOLOA"), the law that allows a terminally ill adult with a six-month prognosis to obtain aid-in-dying drugs from a physician, subject to numerous safeguards ...
Following a tip, the Serbian Competition Commission (the "Commission") recently started investigating the business relationship between GR Sport and Polanik, a Polish company, concerning an alleged infringement of competition – the conclusion of a restrictive agreement which was not notified for prior exemption under the applicable legal framework ...
Getting the Deal Through – Shipbuilding is part of the series of Getting the Deal Through law guides published by Law Business Research that provide an overview of specialist areas of the law in a variety of international jurisdictions. It is published annually and the seventh edition, covers 13 jurisdictions. Leading practitioners from each jurisdiction answer the same key questions ...
The political dispute between Qatar and its neighbors escalated with the announcement by Qatar that it would impose a ban on goods from the four boycotting countries, the UAE, Saudi Arabia, Bahrain and Egypt. As we reported earlier, these four countries imposed a trade embargo on Qatar. The measures that were introduced prohibited the direct shipment of goods and the direct transport of passengers to or from Qatar and closed the land border between Qatar and Saudi Arabia ...
Healthcare Hazards Involving Medical Records During Bankruptcy Companies in the healthcare industry face many unique challenges when undergoing a bankruptcy, including challenges arising due to the federal and state law framework governing the use and disclosure of medical information. In February 2018, the U.S. Department of Health and Human Services (HHS) announced that it had reached a settlement with the receiver appointed to liquidate the assets of Filefax, Inc ...
The manufacturer of a product generally has a duty to warn the end-consumer of any serious risks associated with that product. In the context of prescription drugs and medical devices, however, the “learned intermediary” doctrine holds that the manufacturer need not warn the end-consumer (i.e., patient). Instead, the manufacturer discharges its obligations by warning the prescribing physician ...
The Department for Digital, Culture, Media and Sport (DCMS) has published the Creative Industries Sector Deal aimed at making the UK the best place in the world for businesses in the creative industries. This is the latest sector deal to flow from the government's Industrial Strategy White Paper after sector deals for life sciences and the automotive industry were announced in late 2017/early 2018, respectively ...
This article provides a brief review of MSHA enforcement data and a look at MSHA’s regulatory agenda. MSHA Enforcement Data (data from January 1, 2017 to December 31, 2017) MSHA issued 104,412 enforcement actions to mine operators in 2017, an increase of approximately 11,793 or 11.3 percent from 2016. Of these, 58,083 (or 55.63 percent) were issued to metal/nonmetal operators while 46,329 (or 44.37 percent) were issued to coal operators ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
