In response to the changes in the transmission of COVID-19, both domestically and across the globe, the UK government has announced that passengers from all international destinations will now be required to present a negative COVID-19 test result before departing for England.
States and localities across the country are continuing to respond as quickly and effectively as possible to the coronavirus (COVID-19) outbreak. These responses include guidance for taxpayers on numerous topics, such as providing tax relief through filing and payment deadline extensions.
The European Data Protection Board (EDPB) has finally released its much anticipated guidance following the Schrems II decision in July 2020, which invalidated the "Privacy Shield" system that allowed the transfer of personal data to the United States. EDPB also released draft new Standard Contractual Clauses (SCCs) that allow for data transfers from processors who are exporters as well as new SCCs for controllers who are exporters.
Medical device companies should be prepared for an increase in FDA enforcement activity with the incoming Biden administration, in addition to changes in agency leadership and repeals of regulatory reform.
The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and flexibilities, in particular with regard to value-based enterprise (VBE) arrangements. While hospices have not been frequent parties to many of the burgeoning risk-based, value-based payment arrangements within the healthcare sector, with the anticipated Medicare Advantage carve-in, this will likely change and consequently hospices and their legal counsel are well advised to familiarize themselves with how hospices may benefit from the OIG’s revised AKS safe harbors.
Coinciding with the end of the UK-EU Brexit transition period, the United Kingdom has dramatically reduced the scope of DAC 6 reporting obligations in the United Kingdom.
Morgan Lewis partners Baird Fogel and Alexander Reid and associate Elizabeth Polido authored a Law360 article about the issues regarding the compensation of college athletes, which the US Supreme Court is expected to hear in a 2021 case.
Morgan Lewis senior attorney Brooke McGlinn and associates Pejman Moshfegh and Arjun Ramadevanahalli authored a Pratt’s Energy Law Report article on the growth of microgrid installation in the energy sector.
Morgan Lewis partner Melissa Hill spoke with Law360 for an article about the outlook for Employee Retirement Income Security Act (ERISA) disputes in 2021.
Morgan Lewis partner Mark Krotoski was quoted in a Legaltech News article about what the privacy and cybersecurity industry will likely see in 2021.
The Food and Drug Administration (FDA or the Agency) spent the remaining weeks of 2020 issuing Emergency Use Authorizations (EUAs) for the first over-the-counter (OTC) COVID-19 test to be performed at home and the first OTC home sample collection kit for COVID-19 testing, as well as additional prescription at-home tests and sample collection kits.
The Criminal Antitrust Anti-Retaliation Act establishes new federal protections for whistleblowers who report violations of antitrust laws. This may impact enforcement efforts and litigation on labor mobility issues, including no-poaching and wage-fixing agreements. Companies can prepare for the new legal standards by updating or enhancing their whistleblower programs and taking a holistic view of their compliance programs to meet new US Department of Justice Antitrust Division standards.
Morgan Lewis partner Daniel Skees was quoted in a Utility Dive article about the US Federal Energy Regulatory Commission’s (FERC’s) proposed rule regarding incentives for utilities that elect to make voluntary security investments. Dan noted that FERC’s approach "could expand the scope of facilities receiving heightened cybersecurity protections" and it "allows FERC to use a carrot approach, to bring more facilities into CIP compliance."
Morgan Lewis partners Daniel Tehrani and Robin Nunn and associate Bryan Woll authored a Law360 Expert Analysis about the potential implications of the Corporate Transparency Act (CTA), found within the National Defense Authorization Act for fiscal year 2021.
Morgan Lewis partner Katie McDermott spoke with Bloomberg Law about the potential policy agenda of President-elect Joseph Biden’s pick to lead the US Department of Health and Human Services (HHS). In the article, she discussed potential coronavirus (COVID-19) related claims.
Morgan Lewis partners and co-heads of the firm’s privacy and cybersecurity practice Mark Krotoski and Reece Hirsch spoke with Law360 about the major privacy and cybersecurity developments that occurred in 2020. In the article, Reece discussed the California Consumer Privacy Act and Mark outlined the oral arguments in US Supreme Court cases that addressed robocalls.
The California attorney general released a fourth set of proposed modifications to the California Consumer Privacy Act regulations; notable regulatory changes include a new opt-out button for websites and an offline notice of the right to opt out.
As part of a modernization of the nation’s anti-money laundering regime, the Anti-Money Laundering Act of 2020 creates enhanced whistleblower rewards that are likely to lead to increased enforcement action.
Partner Matt Miner and BDO partner Paul Peterson sat down with Risk & Compliance to discuss the Foreign Corrupt Practices Act (FCPA), including recent enforcement activity and key trends on how companies should respond if they are subject to an FCPA-related investigation.
Lawyers from our London practice have contributed to Lexology’s Getting the Deal Through (GTDT) – Distressed M&A 2021 guide. The UK chapter features insight from lawyers in our corporate, finance, tax, and antitrust practices.
Businesses in the United Kingdom which engage contractors through intermediaries should prepare now for changes to the “IR35” rules that will take effect in April 2021.
President-elect Joseph Biden announced on December 15 that he intends to nominate former Michigan Governor Jennifer Granholm to serve as secretary of energy in his new administration. Ms. Granholm previous served as the attorney general of Michigan and as Michigan’s governor from 2003 to 2011.
The Internet of Things Cybersecurity Improvement Act of 2020 was signed into law on December 4, resulting in the first federal regulation of the Internet of Things (IoT).
From 1 January 2021 the United Kingdom will cease to follow EU rules, bringing significant changes to trademark law in the United Kingdom and European Union that are relevant to all owners of UK and EU trademarks.
The Brexit “transition period” will come to an end on 31 December 2020, and from 1 January 2021, the United Kingdom will cease to follow EU rules. This brings significant changes to design law in the United Kingdom and European Union, relevant to all owners of Registered
A LawFlash authored by Morgan Lewis partner Duke McCall and associates Douglas Hastings and Meredith Compton was cited in an AgriPulse article about the US Environmental Protection Agency’s draft guidance regarding implementation of a US Supreme Court decision regulating pollutions in US waterways. The Lawflash details the implications of the guidance.
Morgan Lewis partner Sandra Moser spoke with the Anti-Corruption Report about Foreign Corrupt Practices Act (FCPA) enforcement efforts in 2020 and the impact of the coronavirus (COVID-19) pandemic. In the article, she discussed two of the largest settlements of the year and what they mean for an ongoing trend.
Morgan Lewis partner Baird Fogel spoke with Law360 about the US Supreme Court agreeing to review a case regarding limits on compensation and benefits for college athletes. In the article, he discussed the implications of the case, Alston v. NCAA.
The US Congress passed S.2258, the Criminal Antitrust Anti-Retaliation Act of 2019, on December 8 and presented the bill to the president on December 11 – almost a year-and-a-half after Senator Chuck Grassley (R-IA) introduced the bill in the Senate.
The Corporate Transparency Act, found within the National Defense Authorization Act, directs the Financial Crimes Enforcement Network to establish and maintain a national registry of beneficial ownership information.
A federal grand jury in Texas indicted the owner of a therapist staffing company on wage-fixing charges on December 9. Although this is the US Department of Justice’s first criminal wage-fixing prosecution, the indictment underscores that enforcement agencies remain focused on policing these types of anticompetitive agreements that restrict competition in labor markets.
Morgan Lewis partner Reece Hirsch was quoted in a MedCity News article about the US Department of Health and Human Services’ proposed changes to the HIPAA privacy rule. “[The proposed change] is more flexible than the current standard,” said Reece in the article.
Our tax team published a LawFlash on the recently released Internal Revenue Service Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program (PPP).
The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects industry calls for broader protections.
The coronavirus (COVID-19) pandemic has made the development and use of drug and device products to diagnose, treat, or prevent COVID-19 essential.
With coronavirus (COVID-19) vaccines on the horizon amid the surging pandemic, critical extensions expand the scope of liability immunity under the PREP Act.
In this NSI Live podcast addressing the findings and recommendations of the US Congress’s US-China Economic and Security Review Commission Annual Report, partner Giovanna Cinelli, leader of Morgan Lewis’s international trade and national security practice and National Security Institute (NSI) fellow, discussed how the US-China relationship may evolve or stay the same under President-elect Joseph Biden’s administration.
Members of the US Congress announced on December 2 the proposal of a new consumer protection bill to increase the oversight and regulation of existing stablecoin issuers, potential stablecoin issuers, and stablecoin-related service providers.
We invite you to join us for a webinar series where we discuss our views on the enforcement priorities expected from the incoming Biden-Harris administration.
Morgan Lewis’s insurance practice is profiled in a Law360 feature celebrating its recognition as a 2020 Practice Group of the Year. In the piece, practice leader Paul Zevnik noted that “the firm secured around $1 billion for its clients in 2020 and about $15 billion for its clients over the last 17 years.”
The Internal Revenue Service recently released Revenue Ruling 2020-27 and Revenue Procedure 2020-51, which provide guidance on the deductibility of certain expenses paid or incurred in a taxpayer’s business using loan proceeds from a “covered loan” provided under the CARES Act’s Paycheck Protection Program.
Associate Jacob Harper spoke with Modern Healthcare about the need for congressional action as the coronavirus (COVID-19) pandemic continues to increase the use of telehealth services.
The Centers for Disease Control and Prevention (CDC) issued new guidance to public health agencies on December 2 to provide options to reduce the duration of quarantine periods for asymptomatic individuals who were exposed to coronavirus (COVID-19).
The NRC held a public meeting with industry on November 2 to discuss approaches for performing supplier oversight during the coronavirus (COVID-19) pandemic.
Morgan Lewis partner Mark Krotoski spoke with Law360 about a cybersecurity and privacy case before the US Supreme Court that seeks to resolve a longstanding circuit split about the circumstances under which companies, organizations, and government agencies can enforce access restrictions on information and data under the Computer Fraud and Abuse Act.
Morgan Lewis partner Mark Krotoski and associate Jonathan Justl authored a Law360 article about the oral arguments recently heard by the US Supreme Court in Van Buren v. United States, a case that is expected to clarify under what circumstances insiders "exceed authorized access" to a computer that may result in a federal crime under the Computer Fraud and Abuse Act (CFAA). In the piece, they discuss the background of the CFAA and the potential implications of the case.
Partner Jonathan Snare and associate Alana Genderson spoke with HR Magazine for an article about what employers may expect regarding enforcement by the Occupational Safety and Health Administration (OSHA) under a Biden administration.
Morgan Lewis partners Susan Harthill, Jennifer Breen, and Kenneth Polite authored a Law360 article about the pace of personnel changes that could result in federal agencies under a Biden administration.
A LawFlash authored by Morgan Lewis partners Sharon Perley Masling and Kathy Sanzo, and associates Alana Genderson, Christopher Jaynes, and Maria Kalousi-Tatum was quoted in an EHS Today article about the potential for employers to establish policies related to a COVID-19 vaccine.
The NRC held a public meeting on November 17 to review regulatory relief currently available to medical and other materials licensees, and to identify potential additional relief that the Staff is currently considering.
The EU Parliament has approved the EU Council’s position on representative actions. By doing so, it has paved the way for consumers in Europe to be able to sue companies collectively.
Morgan Lewis partner Jeffrey Boujoukos spoke with Law360 for an article about the likely impact of the COVID-19 pandemic and a Biden administration on the US Securities and Exchange Commission’s (SEC’s) enforcement priorities.
Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) have finalized rules that will alter critical healthcare fraud and abuse regulations to remove or diminish obstacles to value-based enterprises that meaningfully embrace patient care coordination.
While workplace safety standards have been thrust into the national conversation since the coronavirus (COVID-19) pandemic began, Occupational Safety and Health Administration (OSHA) enforcement has been relatively quiet. That will likely change under a Biden administration.
Morgan Lewis partners Sandra Moser and Kenneth Polite authored a Law360 article about what a Biden administration will likely mean for white collar enforcement actions under the US Department of Justice (DOJ).
Here’s what we know: After the November 3 US election, the Biden-Harris ticket has 290 electoral votes, 20 more than what is needed to win (with one state, Georgia, undecided). Senate Republicans hold a two-seat advantage (50-48) with the two Georgia seats undecided, and House Democrats maintain control with a current advantage of 221-205 (218 is needed to retain the majority) and 9 races undecided.
Morgan Lewis partner Douglas Baruch was quoted in a Bloomberg Law article following the announcement that the 2018 policy on whistleblower case dismissals, known as the Granston memorandum, would continue under the incoming presidential administration.
Morgan Lewis partner Sandra Moser spoke with Law360 about a recent Organization for Economic Cooperation and Development (OECD) report on US enforcement of the Foreign Corrupt Practices Act (FCPA).
With only weeks until the US presidential administration changes hands, companies and consumers alike are anticipating what a Biden presidency will mean for consumer financial protection and for the Consumer Financial Protection Bureau (CFPB), the agency charged with overseeing it. Partner Robin Nunn and of counsel Eamonn Moran outline some of the changes that may lie ahead.
There was a perception in 2017 when then President-elect Trump took office that white collar enforcement actions under the US Department of Justice (DOJ) might drop dramatically. Many expected the Republican administration to effect policy changes or resourcing decisions that would keep corporations out of the spotlight when it came to major investigations and massive penalties.
A new US presidential administration brings new priorities across various areas and industries, including regulation and enforcement of activities that affect the environment. With President-Elect Joe Biden expected to assume the presidency on January 20, 2021, there are a number of considerations for companies tracking potential changes to the law governing the use of chemicals and antimicrobials.
Morgan Lewis partners Giovanna Cinelli and Kenneth Nunnenkamp contributed to “The U.S. Defense Industrial Base: Can It Compete in the Next Century?”, a collaboration between NSI (National Security Institute) and Duco.
Partner John McGahren spoke with Law360 for an article about what a Biden administration may mean for environmental policy.
The new Executive Order (EO or the Order) bans transactions by US persons in publicly traded securities of companies identified as “Chinese military companies,” and includes a ban on trading in derivatives of those securities and any securities designed to “provide investment exposure” to such securities, thereby capturing Exchange Traded Funds and arguably extending to funds that rely on those companies’ securities in any manner. The EO provides an 11-month wind down for divestiture of covered securities and positions.
Morgan Lewis partner Matt Miner spoke with Compliance Hots Spots for an article about the implications of the 2020 election outcomes on congressional oversight and investigations.
MedTech Dive featured comments from Morgan Lewis partner Dennis Gucciardo in an article about the US Department of Health and Human Services directive to the US Food and Drug Administration to review requests for emergency use authorization for COVID-19 laboratory developed tests "in a timely manner.”
Morgan Lewis partner and co-leader of the firm’s privacy and cybersecurity practice Reece Hirsch spoke with Politico about potential changes the Biden administration might bring to the digital health landscape.
Morgan Lewis partner Susan Feigin Harris spoke with Fierce Healthcare about California v. Texas, a recent US Supreme Court case regarding the Affordable Care Act’s (ACA’s) individual mandate and overall constitutionality. In the article, she discussed the oral argument presented by the House.
The UK’s Competition and Markets Authority (CMA) on 6 November published draft updates to two of its merger guidance documents (CMA2 and CMA56) in preparation for the end of the Brexit Transition Period on 31 December 2020.
Morgan Lewis partner Susan Feigin Harris discussed the oral arguments in California v. Texas, which was heard by the US Supreme Court Wednesday, regarding the Affordable Care Act’s (ACA’s) individual mandate and overall constitutionality, with Fierce Healthcare.
Last week’s state attorney general races brought little change on the surface, but change in Washington significantly increases the risk of enforcement and litigation by the states. If it seems counterintuitive, it is. But this Washington changeover heightens the complexity of the relationship between Washington and state capitols.
A majority of California voters approved the California Privacy Rights Act of 2020 (CPRA) on November 3. The CPRA expands provisions of the California Consumer Privacy Act (CCPA), creates new consumer privacy rights, establishes the California Privacy Protection Agency as California’s privacy regulator, and removes the ability of businesses to fix violations before being penalized for violations. The CPRA becomes effective on January 1, 2023, with enforcement commencing on July 1, 2023. This article summarizes a few notable aspects of the CPRA and highlights practical steps that businesses should take to ensure compliance.
The Securities and Exchange Commission (SEC) on August 26 adopted amendments (Amendments) to the “accredited investor” definition , which is one of the principal tests for determining who is eligible to participate in certain private securities offerings and if an issuance of securities is exempt from registration under Regulation D of the Securities Act of 1933 (Securities Act).
As the dust settles on the 2020 presidential election, autonomous and self-driving vehicles could receive a long-awaited federal regulatory framework under President-elect Joe Biden and Vice President–elect Kamala Harris’s administration.
Morgan Lewis partners Susan Feigin Harris and David Salmons and of counsel Saghi Fattahian authored a Law360 article previewing California v. Texas
As the nation has turned its attention to fighting a global pandemic and the very real, human cost associated with that fight, the decade-old battle over the Affordable Care Act (ACA) is once again in the limelight. On November 10, right after the election, the US Supreme Court will hear arguments in California v. Texas, S. Ct. Nos. 19-840 & 19-1019.
Morgan Lewis partner Reece Hirsch spoke with Bloomberg Law about California Proposition 24, which has been approved by voters in the state.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including surface sanitizing products) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use in the United States.
Morgan Lewis partner Jeff Boujoukos spoke with Investment News about the US Securities and Exchange Commission’s (SEC’s) enforcement report for fiscal year 2020. In the article, he discussed what the report shows lies ahead for the SEC.
The shift to a remote working environment as a result of the coronavirus (COVID-19) pandemic has drawn attention to data security and business continuity risks. With increased demand for technology services comes increased scrutiny, which may include False Claims Act investigations and litigation targeting providers of hardware, software, and other technology products and services to the government.
While an SEC proposal to exempt “finders” from broker-dealer registration requirements is promising, potential hazards remain and interpretive questions may persist.
Partner Reece Hirsch spoke with Law360 about California’s Proposition 24, a ballot measure that, if adopted, would build on the California Consumer Privacy Act (CCPA).
The Environmental Protection Agency will expedite review of certain types of applications for new and amended registrations of pesticide products intended for use against the coronavirus (COVID-19).
An August 31 memorandum issued by the Office of Information and Regulatory Affairs (OIRA), an arm of the Office of Management and Budget (OMB) within the Executive Branch, could dramatically change the way agencies handle civil and administrative enforcement proceedings. The memorandum directs covered agencies to provide greater due process to individuals and companies under investigation and reemphasizes the principle that the burden of proof of a violation rests solely with the government. The memorandum was issued to implement the directives contained in Section 6 of Executive Order 13924, Executive Order on Regulatory Relief to Support Economic Recovery (issued May 19, 2020). In relevant part, the executive order directed agency heads to revise agency procedures and practices in light of “the principles of fairness in administrative enforcement and adjudication.”
The Financial Crimes Enforcement Network (FinCEN) issued a final rule that requires minimum standards for anti-money laundering (AML) programs for banks lacking a federal functional regulator (the Federal Reserve Board, OCC, FDIC, OTS, NCAU, and SEC), i.e., banks and similar financial institutions that are subject only to state regulation and supervision, and certain international banking entities (collectively, “covered banking entities”).
This White Paper presents a high-level overview of the current cybersecurity legislation in force or proposed at the European Union (EU) level as well as in a selection of EU member states.
As environmental, social, and governance (ESG) considerations continue to gain traction with investors, asset managers are confronted with varying levels of regulation that they must balance with the wide array of ESG demands being made by investors. Our global investment funds team has prepared a White Paper as a regulatory framework to navigate such considerations across the United States, United Kingdom, European Union, Hong Kong, and Singapore.