On 30 January 2020, the World Health Organization declared the existence of a public health emergency of international importance (PHEIC) and classified the virus SARS-CoV2 as a pandemic on 11 March 2020. Around the world, governments and organisations are seeking to introduce contingency rules to deal with the epidemic and the disease (COVID-19) caused by it.This situation has had an enormous effect on football, with the suspension of virtually all football competitions across the globe ...
A state of emergency was declared in Portugal by Decree of the President of the Republic 14-A/2020 of 18 March and this was renewed by Decree of the President of the Republic 20-A/2020 of 17 April. Following this declaration, exceptional and temporary measures have been adopted in relation to the COVID-19 pandemic ...
INFARMED has published a set of exceptional measures – which will remain in force during the period of risk to public health – to be adopted by sponsors, clinical trial sites, and research teams, to guarantee the safety, protection and rights of clinical trial subjects.It has also defined INFARMED’s evaluation of trials intended to treat or prevent the new Coronavirus disease (SARS-CoV-2) as a priority ...
The rapid spread of the new Coronavirus (SARS-CoV-2) and the Covid-19 pandemic have led to a very significant increase in demand for medical devices (MDs) and personal protective equipment (PPE), and there was insufficient supply to meet existing needs during the state of emergency and the period that will immediately follow it ...
INFARMED and the DGS have published a set of guidelines for manufacturers and wholesale distributors of medicinal products for human use. The aim of these guidelines is to ensure supply to the domestic market and, at the same time, to prevent the spread of Covid-19 and protect the employees of these operators ...
There has been an increase in the number of businesses seeking to exploit coronavirus for commercial gain, often in breach of relevant advertising and consumer regulations. What can you do to make sure your advertising practices are above board? Background A surge in the demand for products related to coronavirus, such as facemasks and hand sanitiser gel, has led to a range of issues, particularly in relation to responsible advertising and fair pricing practices ...
Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
Brief notes on Commission Regulation 2021/111 of 29 January 2021 Following the differences that came to light with AstraZeneca at the end of last week, the European Commission approved Implementing Regulation (EU) 2021/111 of 29 January 2021, which came into force on Saturday, 30 January. The Regulation prohibits the unauthorised exportation of vaccines against SARS-CoV-2 outside the European Union ...
The recent accounting frauds and corporate scandals have many in-house counsel, as well as directors and officers, re-examining their responsibilities, obligations, and potential liabilities. New legislation, SEC regulations, stock exchange listing standards and public, media and shareholder scrutiny are imposing new or expanded processes for corporate accountability, financial reporting and business practices ...
By: Carol K. Lucas At a time when many are questioning the continued utility and viability of the corporate practice of medicine ban, California may be doubling down. On May 3, 2021, the California Senate Health Committee approved SB-642, the stated purpose of which is to protect medical decision-making from lay control. The bill is currently pending in the California Senate. Assembly Bill AB-705 is a substantially identical bill in the California Assembly ...
Appeared in Lone Star Express, a puclication of the Lone Star Chapter of the Healthcare Financial Management Association, September 2002. The recent reports of corporate fraud, improper accounting practices, and mismanagement have resulted in new legislation and stock exchange standards for publicly-traded corporations. In order to restore confidence in the nation’s financial markets, President George W ...
2024 By: Melody Mohammadi Since their inception, the Fédération Internationale de Football Association (“FIFA”) in 1904 and the Union of European Football Associations (“UEFA”) in 1955, football’s most important governing bodies, have aimed to promote fairness and act as representative democracies over arguably the most international sport to date ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
That’s the question Shoosmiths and Cornwall Insight’s recent report sought to answer, investigating the role the Battery-as-a-Service (BaaS) model could play as part of the UK’s electric vehicle charging network. In a new video, Jonathan Smart, partner and head of mobility at Shoosmiths, discusses the BaaS model, which enables electric vehicle owners and business fleets to swap out depleted batteries for fully charged ones at a service station via a subscription service ...
The use of telehealth skyrocketed during the COVID-19 public health emergency, as many regulatory barriers restricting its use were temporarily removed at the federal and state level and by private payors. Providers and patients adapted to the changes and are now relying on these flexibilities to deliver and receive high quality virtual care. This rapid expansion of the use of telehealth has ignited the need for permanent telehealth reform ...
The de novo medical device process is a little-used but potentially valuable means of securing approval for your medical device. The pathway was established in 1997 subject to the Federal Food Drug & Cosmetic Act, Section 513 (f) (2). It was designed to employ a risk-based strategy for novel devices that have not yet been classified. Basically, it establishes a new device type including classification, regulation, appropriate controls and product code ...
INTRODUCTION With the increased, Europe-wide focus on countering money laundering and terrorist financing in recent years, it is an anomaly that Irish anti-money laundering and anti-terrorist financing laws have not to date been extended to cover land-based or online bookmakers or gaming operators ...
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 ...
On 7 August 2019 the Federal Administrative Court annulled a Federal Office of Public Health (FOPH) order that had limited the price increase of a medicinal product on the list of specialities to two years. The product manufacturer had requested a price increase under Article 67(2) of the Healthcare Insurance Ordinance (SR 832.102), having incurred higher costs following the loss of two suppliers ...
In a scenario that has played out across the country for nearly a year now, a group of restaurants based in Ohio were ordered by government authorities to close their on-site dining operations to abate the spread of the coronavirus. However, when the restaurants sought insurance coverage for their loss of business income, their insurer, Zurich American Insurance Company, denied coverage. Last week, the U.S ...
Between 2007 and 2009 non-profit association Motor Sports Limes (MSL) hosted motocross races on a piece of land that it owned. It claimed to have taken all necessary safety precautions, including marking and securing circuit, for the races and associated events held there. According to MSL, only accredited photographers had to sign a contract with MSL, which included a clause stating that no commercial use of photos taken at the races could be made without MSL's prior consent ...
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 ...
The U.S. Department of Health and Human Service’s Office of Civil Rights (“OCR”) has announced that several notifications of enforcement discretion issued during the COVID-19 public health emergency (“PHE”) will expire concurrently with the expiration of the PHE on May 11, 2023 at 11:59 PM ...
International trade and shipping play a key role in the transportation of essential supplies, foods and other necessities, a role which becomes even more significant during the ongoing COVID-19 pandemic. Nonetheless, the lockdowns and restrictions on entry imposed by many countries are causing a severe disruption to the industry while reduced manufacturing activity greatly affects shipment volumes and traffic ...
