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  • The Brussels Effect –The EU’s Digital Strategy Goes Global

    On February 19, the European Commission laid out its ambitious plans for regulating data, AI, and the digital sphere. These set the stage for the next five years’ work for President von der Leyen’s Commission in this critically important, and ever expanding, domain. Crucially, in its plans the Commission is making a concerted attempt to...

  • Tenth Circuit Provides New Material on FCA’s Materiality Standard

    Earlier this month, the United States Court of Appeals for the Tenth Circuit issued a decision that provided further clarity on the False Claims Act’s standard for materiality.  The decision, United States ex rel. Janssen v. Lawrence Memorial Hospital, further demonstrated that materiality should be viewed through the eyes of the government customer rather than...

  • Drug Pricing Investigations in the 116th Congress

    Consistent with popular predictions and our prior posts, Congress made drug pricing a key item on its investigative agenda in the first year of the 116th Congress. Several factors contributed to the uptick in congressional drug pricing oversight activity, including the elevation of new Democratic chairs in the House with longstanding interests in drug pricing issues, and...

  • Seventh Circuit Adopts Narrow Interpretation of TCPA Autodialer Definition, Deepening Circuit Split

    The Seventh Circuit has issued a unanimous decision in Gadelhak v. AT&T Services, adopting a narrow interpretation of a key definitional term in the Telephone Consumer Protection Act (TCPA).  This decision is in line with a recent ruling from the Eleventh Circuit (which we analyzed here) but departs from the Ninth Circuit’s approach—deepening a circuit...

  • FDIC Seeks To Clarify Procedures for Non-traditional Banks

    On February 10, 2020, the Federal Deposit Insurance Corporation (FDIC) issued supplementary guidance intended to clarify existing procedures for deposit insurance applications for non-traditional banks. The FDIC released three updated documents. The first is a supplement to the FDIC’s Deposit Insurance Application Procedures Manual. It specifically addresses applications for “non-bank and other...

  • Drug Pricing Investigations in the 116th Congress

    Consistent with popular predictions and our prior posts, Congress made drug pricing a key item on its investigative agenda in the first year of the 116th Congress.  Several factors contributed to the uptick in congressional drug pricing oversight activity, including the elevation of new Democratic chairs in the House with longstanding interests in drug pricing...

  • European Commission Presents Strategies for Data and AI (Part 1 of 4)

    On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers...

  • AI Update: European Commission Presents Strategies for Data and AI (Part 1 of 4)

    On 19 February 2020, the European Commission presented its long-awaited strategies for data and AI.  These follow Commission President Ursula von der Leyen’s commitment upon taking office to put forward legislative proposals for a “coordinated European approach to the human and ethical implications of AI” within the new Commission’s first 100 days.  Although the papers published this...

  • The French telecoms regulator has entered the fray “prevailing digital platform”

    In his speech in Austin, Texas in 2019[1] and subsequent interviews,[2] the Chairman of the French Electronic Communications and Postal Regulatory Authority (ARCEP) and former general rapporteur at the French Competition Authority, Sébastien Soriano, suggested that it is no longer appropriate to apply the “Schumpeterian paradigm” to technology companies that he characterised as having reached...

  • The French telecoms regulator has entered the fray “prevailing digital platform”

    In his speech in Austin, Texas in 2019[1] and subsequent interviews,[2] the Chairman of the French Electronic Communications and Postal Regulatory Authority (ARCEP) and former general rapporteur at the French Competition Authority, Sébastien Soriano, suggested that it is no longer appropriate to apply the “Schumpeterian paradigm” to technology companies that he characterised as having reached...

  • California Introduces Bill to Regulate Automated Decision Systems

    On February 14, 2020, California State Assembly Member Ed Chau introduced the Automated Decision Systems Accountability Act of 2020, which would require any business in California that provides a person with a program or device that uses an “automated decision system” (“ADS”) to establish processes to “continually test for biases during the development and usage...

  • Sen. Kirsten Gillibrand Proposes New Digital Privacy Agency

    On February 12, 2020, Senator Kirsten Gillibrand (D-NY) announced a plan to create a new Data Protection Agency through her proposed legislation, the Data Protection Act of 2020 (S.3300). Under the proposal, the new agency would replace the Federal Trade Commission (FTC) as the “privacy cop on the beat.” As such, the FTC’s current authority...

  • The Week Ahead in the European Parliament – February 14, 2020

    Summary Next week, Members of the European Parliament (“MEPs”) will gather in Brussels for Committee Meetings.  Many interesting votes and debates are scheduled to take place. On Wednesday, during a joint meeting of the Committee on Industry, Research and Energy (“ITRE”) and the Committee on the Internal Market and Consumer Protection (“IMCO”), Commissioner for the...

  • French Supervisory Authority Publishes Guidance for Website and App Developers

    On January 27, 2020, the French Supervisory Authority (“CNIL”) issued a guidance for developers of websites and applications which sets out the main principles of the General Data Protection Regulation (“GDPR”), expounds on their application in the online environment, and gives practical tips to help developers respect users’ privacy when deploying websites and apps. The...

  • IOSCO Issues Report on Risks Relating to Crypto-Asset Trading Platforms

    On February 12, 2020, the Board of the International Organization of Securities Commissions (“IOSCO”) released a report titled Issues, Risks and Regulatory Considerations Relating to Crypto-Asset Trading Platforms.  The report describes the risks associated with crypto-asset trading platforms (“CTPs”) and sets forth key considerations for regulators in addressing such risks.  IOSCO is an...

  • IRS Releases Proposed Regulations on the Mechanics of Income Tax Withholding

    Today, the IRS published proposed regulations addressing changes made by the Tax Cuts and Jobs Act of 2017 (the “TCJA”) to how an employee instructs an employer to withhold income taxes on his or her Form W-4 (Employee’s Withholding Certificate). The Form W-4 was redesigned for 2020 to reflect the TCJA changes to how income...

  • A Closer Look at Version 1.0 of DoD’s Cybersecurity Maturity Model Certification

    On January 31, the Department of Defense (“DoD”) released Version 1.0 of its Cybersecurity Maturity Model Certification (“CMMC”).  This is the fourth iteration of the CMMC that DoD has publicly released since it issued the first draft in October, and it is intended to be the version that auditors will be trained against, and that...

  • A New Path to TAA Compliance: U.S.-Made End Products in Acetris

    On Monday, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Acetris Health, LLC v. United States, No. 2018-2399 (Fed. Cir. Feb. 10, 2020) (“Acetris”), that would permit pharmaceutical manufacturers to source a drug’s active pharmaceutical ingredient (“API”) from India, China and other non “designated countries” and yet still offer the...

  • Justice Department Continues Criminal Prosecutions in Employment Tax Cases

    Over the last few years, the Justice Department has worked with the IRS to more aggressively prosecute cases involving employment tax noncompliance and the failure to remit trust fund taxes to the U.S. Treasury.  Trust fund taxes are taxes withheld from the wages of employees such as federal income tax withholding and FICA tax withholding. ...

  • U.S. Government Seeks Industry Solutions in Novel Coronavirus Response

    As of February 10, 2020, the World Health Organization (WHO) reported that 40,554 cases of the Novel Coronavirus (2019-nCoV) have been confirmed globally, with twelve cases confirmed in the United States.  The WHO has been issuing situation reports on a daily basis since January 21, and each report in February alone has identified more than...

  • DOL Issues Final “Joint Employer” Rule

    The U.S. Department of Labor (“DOL”) has published a final rule, which takes effect on March 16, 2020, outlining the new four-factor approach DOL will use to determine whether, under the Fair Labor Standards Act (“FLSA”), a business is a “joint employer” of another company’s employees and thus jointly and severally liable for wage and...

  • The CJEU clarifies the test to determine when a general, non-specific health claim is “accompanied” by a specific health claim

    Article 10(3) of Regulation 1924/2006 on nutrition and health claims made on foods (the “NHC Regulation”) permits references to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being, if such a claim is “accompanied” by a specific health claim included in the Union lists. In Case C-524/18, Dr. Willmar...

  • California AG Releases New Draft CCPA Regulations

    The California Attorney General has released both clean and redlined versions of proposed modifications to the draft implementing regulations for the California Consumer Privacy Act (“CCPA”). Below is a high-level overview of some key changes: Service Providers. The modified draft restricts a service provider from processing the personal information it receives from a business except...

  • Kids’ Privacy Bill Allowing for Private Suits Introduced in House

    On January 30, House Rep. Kathy Castor (D-FL) introduced the Protecting the Information of our Vulnerable Children and Youth (“PRIVCY”) Act, a bill that promises to be a significant overhaul of the Children’s Online Privacy Protection Act (“COPPA”). Currently, COPPA applies only to personal information collected from children under 13 years old. The PRIVCY Act...

  • IRS Launches New Tax Withholding Estimator

    Earlier this year, the IRS issued IR-2020-09, in which it announced the launch of a new and improved Tax Withholding Estimator. The Tax Withholding Estimator (the “Estimator”) is designed to help employees adjust their federal income tax withholdings by performing a “Paycheck Checkup.”  The process also helps employees  target the refund they want by adjusting...

  • IoT Update: FCC Raises the Benchmark for Rural Broadband Deployments

    Last week, the Federal Communications Commission (FCC) formally adopted a draft order aimed at supporting the buildout of robust wired broadband networks in underserved rural areas. The Commission created the Rural Digital Opportunity Fund, which targets up to $20.4 billion over ten years for investment in high-speed broadband networks. In addition to narrowing the digital...

  • CCPA Cited for the First Time in Litigation

    In a complaint filed on Monday involving an alleged data breach, Barnes v. Hanna Andersson, the California Consumer Privacy Act (CCPA)—the State’s comprehensive privacy law that went into effect on January 1, 2020—was cited for what appears to be the first time in a lawsuit.  Importantly, however, the plaintiff in this case has not asserted...

  • Proposal Would Simplify Volcker Rule’s “Covered Funds” Provisions

    On January 30, 2020, five federal financial regulators jointly issued a proposed rule that would modify existing regulations implementing the Volcker Rule’s general prohibition on banking entities investing in, sponsoring, or having certain relationships with hedge funds or private equity funds (collectively, “covered funds”).  The proposal, which follows a 2019 final rule revising the Volcker...

  • DoD Announces the Release of CMMC Version 1.0

    Last Friday, the Department of Defense announced the release of Version 1.0 of its Cybersecurity Maturity Model Certification (“CMMC”), which sets forth the cybersecurity requirements that contractors and suppliers must meet to participate in the Department’s supply chain.  A new post on Covington’s Inside Government Contracts blog discusses the release of Version 1.0 of the...

  • DoD Announces the Release of CMMC Version 1.0

    On Friday January 31, 2020, Ellen Lord, Under Secretary of Defense for Acquisition and Sustainment, Kevin Fahey, Assistant Secretary of Defense for Acquisition, and Katie Arrington, the Chief Information Security Officer for the Department of Defense (“DoD”), briefed reporters on the release of the Cybersecurity Maturity Model Certification (“CMMC”) Version 1.0.  We have discussed draft...

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