Less than two days after an enforcement moratorium expired, U.S. and EU officials in transatlantic data transfer talks have reached a new “Privacy Shield” framework to replace the Safe Harbor regime struck down in the Schrems case last year. The new framework, also known as Safe Harbor 2.0, is expected to increase obligations on U.S. companies that handle the personal data of Europeans, while bringing stronger privacy enforcement by the U.S. Federal Trade Commission (“FTC”) ...
As part of its effort to eliminate the risk of taxpayer-funded bail-outs of European banks, the European Union undertook a new “bail-in” regime beginning on January 1, 2016, implementing rules which require banks and some other market participants in EU member states to write-down, cancel, convert into equity or otherwise modify certain unsecured liabilities if such steps are required to recapitalize the institution.To red the full alert, click here ...
Effective on April 6, 2020, an Order was published to establish the technical guidelines (the “Technical Guidelines”) for the activities described in Article 1, Section II, sub-sections (c) and (e) of the order that adopted extraordinary measures to deal with the health emergency caused by the SARS-CoV2 virus” (the “Order”). (We published an article on the Order, which may be foundhere ...
The Department of State (“DOS”) published in the Federal Register a Notice to implement the presidential initiative for extreme vetting of visa applicants. Emergency review of the DOS proposal has been requested from the Office of Management and Budget (“OMB”). The DOS has requested approval. If granted, the emergency approval would be valid for 180 days, although permanent approval could still be sought ...
In May 2016, the Division of Corporation Finance of the Securities and Exchange Commission (“SEC”) added new Compliance & Disclosure Interpretations (“C&DIs”) to the existing catalog of C&DIs that addresses disclosures of“non-GAAP financial measures ...
In response to the economic impact of the COVID-19 pandemic, the federal government has passed several new laws to provide trillions of dollars of funding to affected businesses and individuals. But this also means there are new compliance considerations for entities receiving federal funds, especially as it relates to the False Claims Act’s “false certification” theory of liability ...
The False Claims Act, 31 U.S.C. §§ 3729, et seq. (FCA) continued to be a significant focus of government and whistleblower activity in 2016. ThisYear in Review highlights several key developments, including: The U.S. Department of Justice is continuing its strong enforcement of the FCA, including recovering more than $4.7 billion in settlements and judgments in FCA cases in 2016, as well as continuing its focus on individual culpability ...
Even before COVID-19, the Foreign Corrupt Practices Act (FCPA) was becoming increasingly tricky to navigate and was actively enforced. But in light of the pandemic, which is forcing rapid changes to the global marketplace and causing unique supply chain challenges, the risk of a costly misstep has only increased ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was re-evaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities ...
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 ...
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 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 ...
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 ...
On January 8, 2018, the U.S. Court of Appeals for the Federal Circuit issued itsen bancdecision inWi-Fi One, LLC v. Broadcom Corp., Appeal 2015-1944 (Fed. Cir. Jan. 8, 2018) (en banc) holding that Patent Trial and Appeal Board (“PTAB”) time-bar determinations under 35 U.S.C. § 315(b) in aninter partesreview (“IPR”) proceeding are appealable. Theen bancdecision overrules a panel’s earlier decision inAchates Reference Publishing Inc. v. Apple Inc.803 F ...
The U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”), in In re Simon Shiao Tam, held the seventy-year old disparagement clause of Section 2(a) of the Lanham Act unconstitutional on December 22, 2015. Under Section 2(a), a trademark shall be refused registration if it consists of “matter which may disparage…persons, living or dead… or bring them into contempt, or disrepute ...
California Assembly Bill 1687 (“AB 1687”) requires certain entertainment websites to remove a paid subscriber’s date of birth or age information upon request. This law applies to IMDb, the world’s largest online database of information about the entertainment industry ...
On April 13, 2020, Federal OSHA implemented its nterim Enforcement Response Plan for Coronavirus Disease 2019 (COVID-19)(“Enforcement Plan”), which provides instructions and guidance to Area Offices and OSHA investigators for handling COVID-19-related complaints, referrals, and severe illness reports ...
On April 9, 2020, the Board of Governors of the Federal Reserve System (the “Board”) announced the establishment of the Main Street Lending Program (“Main Street Loan Program”), an up to $600 billion lending program for mid-size businesses ...
The Federal Reserve ’s Main Street Lending Program has recently been expanded to add two potential loan options, which will enable nonprofit organizations such as educational institutions, social service organizations and hospitals to receive financial support in addition to the previously announced programs benefiting for-profit entities ...
On May 21, 2020, the Federal Energy Regulatory Commission’s Offices of Energy Policy and Innovation and Electric Reliability jointly published and released their 2020 Summer Energy Market and Reliability Assessment. The report provides an overview of key market events and data for the nation’s ISOs/RTOs as well as a discussion on reliability in the various power regions for summer 2020. The report includes the following key items that are summarized below ...
The Internal Revenue Service (“IRS”), the Department of Treasury, and the Department of Labor (“DOL”) recently issued preliminary guidance on the Families First Coronavirus Response Act (“FFCRA” or the “Act”) regarding (i) a temporary non-enforcement period during the first thirty (30) days of the Act; and (ii) more detail on how the employer payroll tax credit will work for the employer funding portion of the paid sick and child
Recent statistics from London’s Commercial Court and major arbitration institutions confirm London’s reputation as an international hub for dispute resolution, with English law remaining the most popular choice for the resolution of international disputes ...
Whether you are a garage tinkerer or an engineer at a technology company, you probably have considered obtaining a patent to protect one of your ideas or innovations. There is an allure to a government issued document declaring that you are the inventor of a patent that grants you exclusive right to your innovation. However, the next time that light bulb goes off above your head, here are five things you should consider before calling your patent lawyer. 1 ...
In a major departure from over 20 years of practice, the EPA announced on January 25 that it is withdrawing the “once in, always in” (OIAI) interpretation of the hazardous air pollutants (HAPs) program. The OIAI required sources of HAPs to permanently comply with Maximum Achievable Control Technology (MACT) standards applicable to major sources of HAPs, even when those sources’ emissions are below major source levels ...
