The Norwegian Ministry of Trade, Industry and Fisheries has adopted a new regulation exempting the transport sector from the prohibition in Section 10 of the Norwegian Competition Act; cf. FOR-2020-03-18-340. Section 10 is the national equivalent to Article 101 TFEU and 53 EEA. The new rules are set to apply for three months but may be prolonged or shortened, depending on how the ongoing covid-19 pandemic evolves ...
The aviation industry came to a standstill this month due to the outbreak of the Covid-19 virus, and this has hit the airlines worldwide. With the majority of the fleet on the tarmac, we could potentially see a number of airlines defaulting on their lease agreements and loan facilities. The question of how to enforce security or repossess an aircraft could sadly turn out to be something the lessors and the lenders would have to look into more closely in the time to come ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) released an FAQ on Medicare provider enrollment relief, noting several key changes aimed at streamlining and expediting provider enrollment in light of COVID-19. Physicians and non-physician practitioners may now enroll and receive temporary billing privileges without certain fingerprint-based criminal background checks and site visits ...
“One ought never to turn one’s back on a threatened danger and try to run away from it. If you do that, you will double the danger. But if you meet it promptly and without flinching, you will reduce the danger by half.” - Winston Churchill As responses to the COVID-19 pandemic have evolved over the course of the first quarter, you and your business have reacted swiftly to ensure the health and safety of your customers, partners and employees ...
Regarding the State of Catastrophe and sanitary alert decreed in Chile in the face of the COVID-19 pandemic, on Sunday 22 March 2020, the Chilean Government announced the following 12 measures: Strict quarantine for the extreme-South city of Puerto Williams (except for essential cargo freighting). Strict sanitary customs in the aerial and maritime crossing to the city of Puerto Williams ...
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 ...
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 ...
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 ...
A range of legislative and legal initiatives have been taken in recent days to control the spread of the SARS-CoV-2 coronavirus epidemic. How will temporary closing of borders and mandatory hospitalisation impact carriers’ liability in international transport of goods by road? Legal solutions adopted Faced with the SARS-CoV-2 coronavirus epidemic, the Polish government has decided to take drastic legal measures ...
In the midst of the coronavirus outbreak, the Centers for Medicare & Medicaid Services (CMS) has taken steps to make healthcare services more accessible through telehealth, particularly for those who are at high-risk of complications from the virus. CMS and commercial payors have opened a viable path for healthcare providers to continue to provide care to high risk patients and other patients and receive reimbursement for services to current and new patients ...
On March 23, 2020, the Centers for Medicare & Medicaid Services (CMS) announced updates to its survey process in response to COVID-19 (press release,press release, andmemo). Specifically, as authorized pursuant to section 1135(b)(5) of the Social Security Act, CMS is prioritizing certain surveys and exercising enforcement discretion for all certified provider and supplier types for the next three weeks ...
FDA Takes Action to Increase U.S. Supplies in Response to COVID-19. The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The FDA is engaging the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S ...
FDA Warns Consumers About Unauthorized Fraudulent COVID-19 Products.The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. The FDA has seen unauthorized fraudulent test kits for COVID-19 being sold online. Currently, the FDA has not authorized any test that is available to purchase for testing yourself at home for COVID-19 ...
This news alert includes information on the way in which the authorization for safe passage permits shall be granted on account of the nighttime curfew that stands in Chile as of the evening of this Sunday 22 March 2020, as an additional measure to face the Covid-19 pandemic: Individual safe-passage permit Collective safe-passage permit Permanent authorization for emergency personnel Authorization for companies and people who carry out transport of goods Airport Staff Passengers
An article establishing a procedure for the procurement of medical supplies was recently introduced. This new provision (Resolution No 53960) amended Resolution No 38941-2006-JD of February of 2006, which is the general procurement regulation for the Social Security Administration (CSS for its initials in Spanish) ...
INVIMA adopts measures aimed at efficiently facing the current health situation related to COVID-19, optimizing the processes that allow the commercialization of products necessary for the prevention of the virus and the evaluation of protocols to prevent it. 1. Declaration of products as Vital Unavailable. Due to the shortage of some supplies in general, the authority has declared that masks, antibacterial gel and disinfecting solutions as Vital Products Not Available ...
The Ministry of Health and Social Protection dictates measures tending to guarantee the prevention, diagnosis and treatment of Covid-19 The Ministry of Health and Social Protection has issued Decree 476 of 2020 by which it has decided to make the necessary changes for regulatory requirements to have flexibility in all proceedings related with Pharmaceutical, Phytotherapeutics, Medical Devices, Biomedical Equipment, In-Vitro Diagnostic Reagents, cosmetics and products of Domestic hygie
The U.S. Environmental Protection Agency has announced its temporary policy regarding environmental enforcement activities during the COVID-19 pandemic. The policy is retroactive to March 13, 2020, and will apply for the foreseeable future, until seven days after EPA gives notice that the policy will terminate. The policy applies to actions for which EPA has federal enforcement authority ...
