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Companies Will Need to Embrace Change in Order to Emerge Less Scathed from the Shadow of COVID-19
Shoosmiths LLP, July 2020

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...

EDPB Issues Statement on Restrictions on Data Subject Rights During COVID-19
A&L Goodbody, July 2020

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...

European Commission Releases First Report on Evaluation of GDPR
Hunton Andrews Kurth LLP, June 2020

On June 24, 2020, the European Commission (“the Commission”) submitted its first report on the evaluation and review of the EU General Data Protection Regulation (“GDPR”) to the European Parliament and Council. The report is required under Article 97 of the GDPR and will be produced at four year intervals going forward...

Health Emergency - BCRA Communication "A" 7048: Adjustments to the National Payment System
Beccar Varela, June 2020

Report of the Department of Banks and Financial Institutions Health Emergency - BCRA Communication “A” 7048: adjustments to the national payment system. Yesterday, the Central Bank of the Argentine Republic (BCRA) issued Communication "A" 7048 (the " Communication "), through which certain adjustments were established on the national payment system. The Communication was issued in accordance with the provisions of Decree No...

International Comparative Legal Guides: Fintech 2020
Shearn Delamore & Co., June 2020

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...

Some Going Concerns: A Primer on Intellectual Property Issues in Bankruptcy for Licensors and Licensees
Lowenstein Sandler LLP, June 2020

Westlaw Journal Bankruptcy Much has been written on the myriad of legal issues emanating from the global COVID-19 pandemic: the constitutionality of the lockdowns, liability for stores that open, the process of obtaining PPP loans, and the applicability of force majeure clauses, to name a few. As intellectual property and bankruptcy practitioners, we are fielding more questions regarding the impact of bankruptcies (both actual and potential) on the rights of licensors and licensees...

Privacy Concerns Multiply as Digital Contact Tracing Spreads: U.S. Tech Industry Takes the Lead as Congress Fails to Act
Lowenstein Sandler LLP, June 2020

What You Need To Know: Digital contact tracing (DCT) is a potential game changer in the COVID-19 pandemic. However, the sensitive personal information collected by DCT applications (“DCT apps”) largely falls through the cracks of existing U.S. data protection laws. The California Consumer Privacy Act (CCPA) may be the only current legal model that encompasses the data privacy aspects of digital contact tracing...

COVID-19: Extension of Market Access to Life-Saving and Life-Extending Drugs - Issues Impacting the Life Sciences
YKVN LLC, June 2020

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...

5 Ways Healthcare REIT Sector will Change because of COVID-19
Waller, June 2020

Amid the unprecedented changes wracking the business world in 2020, one certainty remains: many industries will look very different in future years as strategic responses to COVID-19 gain traction and become permanent. In the healthcare REIT sector, we are beginning to see trends that may shape industry norms long after the dust has settled from the chaos of 2020. 1...

FDA Issues Guidance on IRB Review of Non-Emergency Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products to Treat COVID-19
Verrill, June 2020

Prompted by a substantial increase in requests for individual patient access to investigational drugs and biologics to treat COVID-19, the U.S. Food & Drug Administration (“FDA”) issued guidance on June 2, 2020 that outlines key factors and procedures that Institutional Review Boards (“IRBs”) should consider when reviewing such non-emergency requests...

The Perils of Responding to Cyber-Incidents Just Got More Complicated
Bradley Arant Boult Cummings LLP, June 2020

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...

FAQs: Employment Ministry's and DPA's New Positions on Checking Employees' Temperatures
ALTIUS/Tiberghien, June 2020

The controversial issue of whether employers can check their employees' temperatures has been much debated. Both the Employment Ministry and the Data Protection Authority (DPA) have recently changed their positions in this respect...

Impact of Medical Device Regualtions (MDR) Postponement on Swiss Medtech Industry
Walder Wyss Ltd., June 2020

  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...

Introducing the Arendt Insights Mobile App: Instant Access to the Legal Developments Impacting Business in Luxembourg.
Arendt & Medernach, June 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...

Fast-Changing Whisky Industry Can Keep Lifting Spirits in Scotland's Economy
Shepherd and Wedderburn LLP, June 2020

Hand sanitiser production is just one aspect of business that's altered for £5bn industry, writes George Frier of Shepherd and Wedderburn The whisky industry continues to captivate consumers and entrepreneurs. Record exports continue and, within the sector, the emergence of new brands and the rejuvenation of existing brands demonstrate a vibrant sub-set of the Scottish food & drink economy...

CARES Act Questions for the Technology Industry (Updated 06/15/2020)
Schwabe, Williamson & Wyatt, June 2020

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”...

The FCC Funds the COVID-19 Telehealth Program
Schwabe, Williamson & Wyatt, June 2020

  The Federal Communications Commission (“FCC”) established the COVID-19 Telehealth Program (the “Telehealth Program”) on April 2, 2020 in response to the COVID-19 pandemic. The Telehealth Program provides $200 million in funding, appropriated by Congress as part of the CARES Act,[1] to assist certain non-profit and public healthcare providers in making telehealth services available to patients who cannot be seen in person...

FDA Issues Temporary Guidance on Compliance with PDMA for Distribution of Drug Samples During COVID-19
Dinsmore & Shohl LLP, June 2020

Last week, the U.S. Food and Drug Administration (FDA) issued guidance for the health care industry, titled “Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency...

Federal Council Moves Forward in Protection against Cyber Risks
Walder Wyss Ltd., June 2020

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)...

FDA Announces New Updates to its Guidance on Conducting Clinical Trials During COVID-19 and Notes Availability of its COVID MyStudies App
Verrill, June 2020

On June 3, 2020, the U.S. Food & Drug Administration (“FDA”) again updated its guidance on the “Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency” with new information on the use of electronic signatures on clinical trial records and a reference to FDA’s COVID MyStudies App as an option for obtaining electronic informed consent. This follows a prior update released by FDA on May 14, 2020, also described below...

Tech Versus Virus: Remote Diagnostics
Wardynski & Partners, June 2020

This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE...

CARES Act Questions for the Technology Industry (Updated 6/9/2020)
Schwabe, Williamson & Wyatt, June 2020

Congress recently passed the economic stimulus package referred to as the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act1”), the Paycheck Protection Program and Health Care Enhancement Act (“PPPHCE Act”), and the Paycheck Protection Program Flexibility Act (“PPP Flexibility Act”). Together, the CARES Act1, PPPHCE Act, and PPP Flexibility Act are called the “CARES Act”...

DOJ Releases Updated Guidance for Evaluating Corporate Compliance Programs
Lowenstein Sandler LLP, June 2020

Use of Data Analytics and Access to Compliance Resources Among New Considerations On June 1, 2020, the United States Department of Justice (DOJ) updated its “Evaluation of Corporate Compliance Programs,” a guidance document used by prosecutors to assess compliance programs. Prosecutors use the document in making charging decisions pertaining to companies and in imposing obligations such as a corporate monitorship...

HHS Portal Opens for Dentists to Request COVID-19 Provider Relief Funds
Waller, June 2020

The US Department of Health and Human Services (HHS) has announced how dentists who bill Medicaid can now access a $15 billion Provider Relief Fund allocated by the CARES Act to cover COVID-related expenses and losses...

COVID-19 Extensions Set to Expire July 1, 2020 for Patents; Trademark Extensions Ended May 31
Spilman Thomas & Battle, PLLC, June 2020

On May 27, 2020, the U.S. Patent and Trademark Office issued a further extension of certain deadlines that were about to expire on May 31. The latest order provides until July 1, 2020 for certain actions delayed due to COVID-19. For small and micro entities only, filings that would have been accepted if filed by June 1, 2020, will now be deemed timely if filed by July 1, 2020...

 

 

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