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) ...
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 ...
The global health alert triggered by the spread of the new coronavirus known as SARS-CoV-2, which causes the disease COVID-19, is creating great challenges for companies. Governments around the world are tackling the situation by approving drastic measures to try to mitigate the effects of the health crisis first and the economic crisis second ...
I. Regulation In the context of the declaration of a State of Catastrophe, the National Customs Service (“NCS”) issued Exempt Resolution No. 1,179 dated March 18, 2020, by means of which the NCS adopted 13 measures to facilitate foreign and domestic trade operations electronically, and to protect the health of people involved in such operations ...
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 ...
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 ...
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 ...
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 ...
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 ...
Introduction COVID-19 poses great challenges, especially for cross-border M&A transactions and capital market deals. In the last five years or so, the M&A sector has seen a strong seller's market in which sellers have been able to generate high selling prices and enforce contractual arrangements in their favour. This will likely change rapidly now ...
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 ...
