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 ...
The COVID-19 pandemic has disrupted every sector of the economy in multiple ways. For businesses whose operations are subject to environmental requirements, including waste management, storage, and disposal laws, these coronavirus-related disruptions may impact a facility’s ability to comply with mandatory reporting and submission deadlines or waste storage time limits ...
Data protection and privacy laws are relevant to current responses aimed at preventing the spread of the coronavirus. An important response to limit the spread of the infection is the practice of identifying and monitoring anyone who may have been in contact with an infected person ...
Many organizations are these days in a phase of reorganizing their operations and establishing alternative solutions to ensure continued business work capacity. Meanwhile numerous hackers and other cyber criminals around the world are mobilizing themselves to take advantage of the extraordinary situation. All business should therefore be aware of a significant increase of cyber risk in relation to the current corona crisis ...
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 ...
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 ...
On March 19, 2020 the Superintendence of Environment (“SOE”) issued the Exempt Resolution No. 497 (“Res. 497”), which is referred to a number of general instructions within the sanitary context caused by the coronavirus (COVID-19). I. Purpose. Carry out a permanent monitoring of the status of projects or activities and of the compliance with their applicable obligations given the current sanitary context. II. Recipients ...
Given the increased number of local COVID-19 cases in Malaysia, the Malaysian Government issued a Movement Control Order ("Order") which takes effect between 18 March 2020 to 31 March 2020. The Order imposes on all government and private sector business premises to be shut down for the duration of the Order and only businesses which carry out certain essential services are able to continue to function ...
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 ...
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 ...
In accordance with the CDC’s guidance on social distancing, more and more companies are increasing the number of employees working from home. As the number of employees working from home increases, so do the related cyber risks. Sophisticated hackers have developed a game plan for exploiting weaknesses unique to the remote workforce employment model ...
With the outbreak of the coronavirus (COVID-19), many businesses have taken the decision to request that employees work from home. To work from home, employees will either be using their own personal devices or company-issued equipment to either access the company network remotely or to transmit data and information through their own personal network. There are a few inherent information security risks that are posed by these arrangements ...
With the Corona crisis, countries such as Germany, France and the Czech Republic have already announced bans on exports of protective gear to avoid shortages at their countries. But is this in conformity with the principle of free movement of goods as provided for in articles 34-36 TFEU? This principle is one of the cornerstones of the European Union's internal market which implies that national barriers to the free movement of goods within the EU need to be removed ...
In this challenging period of the Coronavirus outbreak, your organisation might currently be taking strong internal measures to protect its employees while ensuring work continuity. Such measures could have data protection implications and therefore you might be wondering how to take them in accordance with the GDPR. We have answered the most important GDPR questions below ...
EUIPO On 16 March 2020, the Executive Director of the European Union Intellectual Property Office (EUIPO) has issued Decision No EX-20-3 extending all time limits expiring between 9 March 2020 and 30 April 2020, that affect all parties before the Office, to 1 May 2020. In principle, the new deadlines will not be communicated to the parties on a case-by-case basis ...
The new virus COVID-19, also known as coronavirus, is spreading exponentially all over the world, also in Brazil. The outbreak is affecting the way in which our clients and their clients conduct their businesses, and the behavior of each and every one of us drastically. The virus is not only tragic for those, whose health is being affected, but also for large parts of the economy, such as the tourism industry, airlines and general retail (other than nutrition-related) ...
Overview and Outlook for Fintech in 2020 Technology continues to redefine our expectations in almost every area of our lives and shape the way we interact with the world ...
How do you protect the privacy of people who have been infected by Covid-19, while still usefully informing those who have been put at risk? At a time of public health emergency, shouldn't GDPR take a back seat? As companies struggle to get new processes in place to cope with the potential ramifications of Covid-19, the aim of this note is to highlight how EU data protection law applies to this unusual set of circumstances ...
We regularly work with financial institutions to navigate the challenges of implementing, maintaining, and using security procedures for commercial customers’ use of treasury management services. Security procedures are an integral part of the relationship between the financial institution and its commercial customers ...
Federal and state occupational safety and health regulations require employers to record and report certain work-related injuries and serious illnesses, including work-related fatalities and in-patient hospitalizations. While Cal/OSHA has stated that the common cold or flu are exempt from reporting and recording requirements, even if the employee became ill at work, this exemption does not apply to COVID-19 ...
In response to the outbreak of COVID-19, the Occupational Safety and Health Administration (OSHA) and the California Department of Occupational Safety and Health (Cal/OSHA) have issued guidance for employers. The guidelines provide guidance on how to determine if COVID-19 is a hazard in the workplace and employer obligations. Is COVID-19 a Workplace Hazard? Employers should determine if COVID-19 infection is a hazard in their workplace ...
