Restaurateurs and their employees don’t need anything else to worry about these days. It is challenging enough to operate a restaurant in this time of quarantines, curbside and delivery-only options, and social distancing added to the attendant drops in revenue and worries about making sure employees are cared for. Maybe the absolute last thing any restaurant wants to focus on are food safety regulations such as the Food Safety Modernization Act (FSMA) ...
The FDA revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing COVID-19 pandemic. The FDA acknowledges that companies, and the agency, itself, may be hit with workforce shortages during a pandemic at the same time that adverse event reporting for products deployed for the pandemic may increase ...
The U.S ...
The FDA issued immediately-in-effect guidance to accelerate the development of certain laboratory tests for the urgent need caused by SARS-CoV-2. The FDA provides recommendations, among others, for serological tests, puts forth a policy for states to take responsibility for tests, and announces enforcement discretion for commercial manufacturers using new commercially developed tests prior to the FDA granting an emergency use authorization, under certain circumstances ...
To help prevent disruptions in the food supply-chain during the COVID-19 pandemic, the FDA issued a temporary policy for Food Safety Modernization Act (FSMA) supplier verification onsite audit requirements. The policy states that the FDA will temporarily not enforce FSMA supplier verification onsite audit requirements if other appropriate supplier verification methods are used instead ...
Seemingly overnight, flights and hotels emptied, and state and local governments began ordering restaurants, gyms, bars, and other “non-essential” businesses to close or to significantly curtail operations. Unemployment skyrocketed, and businesses began calling out for relief. In response, the government has proposed multiple initiatives to help stabilize businesses hit hard by current events, especially those in the hospitality industry, many of which are also franchises ...
Will the need to seek state aid due to the COVID-19 pandemic encourage sports unions to implement good governance principles? According to press reports, work is underway at the Ministry of Sport on abill to aid the sports sector, including financial support, as sport is one of the sectors hardest hit by the COVID-19 pandemic. Cancellation of league matches, events and tournaments is causing heavy losses for all participants in the sector ...
The 22 March Decree was anticipated by two ordinances issued on 21 March 2020 by, respectively, the Lombardy Region1, subsequently amended on 22 March 2020 (the “Lombardy Ordinance”), and the Piedmont Region 2 (the “Piedmont Ordinance”). The ordinances provide for even more stringent restrictions for the regions concerned, and will remain in force until 3 April 2020 (for the Piedmont Region) and 15 April 2020 (for the Lombardy Region) ...
As of Monday, March 23, Virginia Governor Northam announced all public K-12 schools will remain closed through the end of the school year and many – but not all – non-essential businesses will be required to close their doors. By the end of Tuesday (11:59 p.m. on March 24) some non-essential services, including all recreation and entertainment services, are to close ...
Special Report "COVID-19 in Central America" on special measures taken in each country of our region prepared by the multidisciplinary team of Consortium. The information contained in this publication is for information purposes only and does not constitute legal advice. The information is constantly updated and issubject to change. Last update: Wednesday 1 April ...
As of March 11, 2020 the World Health Organization declared COVID-19 as an international pandemic, which besides the unfortunate health implications, it will produce a wide range of legal and economic impacts and challenges ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services.Telehealth, telemedicine, and related terms generally refer to the exchange of medical information from one site to another through electronic communication to improve a patient’s health ...
As COVID-19 continues to spread, CMS has issued guidance to various healthcare providers, including, among others, home health agencies, nursing homes, and hospitals that are caring for the nation’s most at-risk patient populations.The guidance is intended to curb transmission and ensure healthcare providers have the information and resources necessary to respond to patient needs ...
Amidst continuing COVID-19 concerns, regulators issued certain waivers of HIPAA requirements and penalties as well as additional guidance applicable during this public health emergency. HIPAA Enforcement Discretion for Telehealth ...
We have been in the UAE helping clients manage and survive crises for 45 years, and these are unprecedented times in our lives. We will have to work together to overcome the challenges brought about by the COVID-19 pandemic, and we at Afridi & Angell are ready to do our part. Until the end of March, we will offer free advice on legal issues affecting companies and employers as a result of the COVID-19 pandemic ...
At LEĜA we are monitoring the measures that are taken to face the crisis generated by COVID-19 and we will be sending updates to our reports and comments divided by practice areas and industry so that you can easily find the information that is relevant to you. Please note that it is our policy to report announced measures only when they are translated into acts published in the Official Gazette ...
On March 18, 2020, Governor Jim Justice suspended the rule prohibiting bars and restaurants from providing beer and wine for off-premises consumption. Restaurants and bars with Class A licenses are now permitted to sell sealed bottles or cans of beer in their original containers and bottles of wine to-go so long as they are accompanied by food orders. The rule does not authorize the sale of beer growlers unless the individual possesses a beer growler license ...
UPDATE - On March 20 in the evening, Governor Wolf issued a revised list classifying businesses as life-sustaining and non-life-sustaining. The press release, list and frequently asked questions can be found here. In addition, Governor Wolf has extended the timeframe for enforcement of the order. The Pennsylvania General Assembly recently completed the Appropriations hearings related to the FY 2020-2021 budget. The plans to resume the legislative session were altered due to COVID-19 ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
The Centers for Medicare & Medicaid Services (CMS) announced during a March 19, 2020 teleconference for physicians and teaching hospitals that it does not have the authority to postpone the statutory timeline for the Physician Payments Sunshine Act (Sunshine Act) ...
The Centers for Disease Control (CDC) reports swimming is the fourth most popular recreational activity in the United States and the most popular recreational activity for children (ages 7 to 17). Statistics further show 36 percent of children and 15 percent of adults go swimming at least six times a year in the United States ...
In the advent of DNA testing, companies such as Ancestry.com and 23andMe have made it easy and convenient to submit DNA samples for testing from your own home. This type of genetic—also known as genomic—testing has been applied to a variety of uses, including paternity determinations and the discovery of genetic ancestors and relatives ...
On March 18, 2020, the State Medical Board of Ohio (“Board”) held a special meeting, which resulted in the temporary suspension of certain regulatory enforcement activities in response to the COVID-19 pandemic. Telemedicine Effective immediately, the Board will suspend enforcement of any regulations requiring in-person visits between providers and patients ...
Introduction While the long-term litigation effects of the COVID-19 pandemic may not materialize for months – or even years – it is important for tort litigation attorneys and their clients to begin preparing now for potential legal issues that may arise. This bulletin is intended to serve as a non-exhaustive list of tort-focused legal considerations for health care providers, product manufacturers, and their attorneys in the new and ever-evolving COVID-19 landscape ...