The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. The guidance advises vaccine development and licensure following the standard trial progression but on an accelerated timeline ...
With federal privacy legislation stalled and indefinitely delayed, states have moved forward to push an impressive number of privacy laws forward over the last several years. Some of these laws are still relatively obscure, but are being increasingly enforced by state regulators and through litigation ...
On 22 July 2020, data protection authorities from Australia, Canada, Gibraltar, Hong Kong, Switzerland and United Kingdom (together the Authorities), issued an open letter (Letter) on global privacy expectations of video teleconferencing companies (VTC companies)[1]. Why there is such a Letter? As a result of the COVID-19 pandemic, the Authorities have witnessed an increasing use of VTC tools, both in social and business contexts ...
In April 2019, with the introduction of House Bill 904, a bi-partisan effort was made to strengthen cyber security in North Carolina. H.B ...
Thursday 16 July 2020 saw the Court of Justice of the European Union (“CJEU”) issue its decision on the validity of two international data transfer mechanisms - the “Privacy Shield” mechanism, which allowed for transfers between the EU and the US, and the Standard Contractual Clauses (“SCCs”) which are of more general application. Both of these mechanisms were confirmed by decisions of the European Commission ...
In Japan, the Act on the Protection of Personal Information (APPI) is the primary law that regulates data protection issues ...
On Thursday, July 16, 2020, the European Union's top court issued a landmark ruling that will immediately transform how companies can lawfully transfer EU personal data to the United States. The court invalidated the EU-U.S. Privacy Shield, one of the most common mechanisms used by U.S. companies in connection with cross-border data transfers ...
As of July 1, the Russian requirements on digital labelling of medications and transmitting the data on medications’ turnover to the Chestny ZNAK system have become mandatory.Start of mandatory digital labellingFrom 1 July, all market participants of the pharmaceutical industry (manufacturers, distributors, pharmacies, etc.) must reflect information on all operations made with medications in the monitoring system ...
An application software (app) is a program designed to help customers perform particular activities. These apps, which are usually on our electronic devices, are used to control several things ranging from health & fitness, music, movies, online shopping, gaming to mobile money transfers and even household appliances. In this article, our Davidson Oturu, breaks down the IP considerations app developers should note ...
With the implementation of the Movement Control Order (MCO) since 18 March 2020, the Conditional Movement Control Order (CMCO) as well as the Recovery Movement Control Order, the Government has issued a number of Standard Operating Procedures (SOPs) to control the spread of the Covid-19 pandemic ...
The impact on human health of the global pandemic of the SARS-CoV-2 virus and the resulting disease termed COVID-19 cannot be overstated. Not since the influenza pandemic of 1918 have so many regions of the world been so acutely impacted by a single pathogen. Society in 2020 has the advantage of a more sophisticated biotechnology industry. Testing is considered crucial in controlling (or at least mitigating) the pandemic, and tests from several companies have become widely available ...
How successfully a business emerges following this pandemic will depend to a great extent on how quickly it identifies and implements long term necessary changes. Nobody is yet clear what the post-Covid-19 world will look like. It is possible that things revert back to the way they were quicker than anyone imagines. That said, it is very difficult to imagine no lasting or consequential changes to the way we work or live ...
The European Data Protection Board (EDPB) has adopted a statement on restrictions on data subject rights in connection with the state of emergency in Member States. The EDPB emphasises that, despite the international crisis, the GDPR remains applicable and allows an efficient response to the pandemic, while still protecting fundamental rights and freedoms. The EDPB’s statement was made in response to a Hungarian government decree dated 4 May 2020 ...
On June 16, 2020 the German government released its Corona-Warn-App. There are some key points employers should be aware of concerning the app: NO OBLIGATION FOR EMPLOYEES TO USE THE APP ON THEIR PERSONAL SMARTPHONES An employer may be thinking about instructing its employees to install and use the Corona-Warn-App on their own devices to reduce the infection risk among its employees. That is not permitted ...
Under the Decree of the Moscow Mayor No. 68-UM dated June 8, 2020 (available only in Russian here), a phased removal of restrictions caused by the spread of coronavirus infection began from June 9. This includes the return to work of a large number of organizations. Starting from June 16, 2020 organizations and in-dividual entrepreneurs carrying out operations with real estate, activities in the area of rent, leas-ing, law, accounting, etc. are able to resume work ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
The Fintech LandscapeDevelopments in 2019 in terms of sectors were:Payments: Remittance was an area of significant growth in 2019, with a number of notable non-bank payments service providers receiving Remittance (Class B) Licences from Bank Negara Malaysia (BNM). MoneyMatch, the first graduate from BNM’s Regulatory Sandbox programme for incubating and ensuring the sustainability and regulatory compliance of fintech start-ups, was the first to receive a licence at the start of the year ...
Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
It’s 8 am, and you just learned that a material cyber-incident occurred in your organization. You fire up your Incident Response Plan. You engage outside counsel, and outside counsel engages a forensic firm. Your company, your outside counsel, and your forensic firm all sign an agreement that the forensic firm will work at the direction of outside counsel ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
“At a time when the flow of information is always expanding, this app is a smart alternative for users to stay informed about these topics without a flood of emails.”(Jean-Marc Ueberecken, Managing Partner). The CoVid-19 crisis as a trigger Arendt Insights is the only app dedicated to Covid-19 crisis management in Luxembourg. The first version of the app has been designed to give insight from Arendt experts, using the Covid-19 Solutions platform ...
Congress recently passed the economic stimulus package referred to as the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), the Paycheck Protection Program and Health Care Enhancement Act (“PPPHCE Act”), and the Paycheck Protection Program Flexibility Act (“PPP Flexibility Act”). Ttogether, the CARES Act1, PPPHCE Act, and PPP Flexibility Act are called the “CARES Act” ...
On 27 May 2020 the Federal Council adopted the Ordinance on Protecting against Cyber Risks (OPCy, available in French and German), which is set to enter into force on 1 July 2020. This move is the next step in a series of measures taken by the Federal Council to adopt a new organisational structure and implement a national strategy to protect Switzerland against cyber risks (NCS, available in German, French, Italian and English) ...
