INSIDE COMPLIANCE – Page 53 – Loyola University Chicago School of Law

Johnson & Johnson COVID-19 Vaccine Awaits Authorization from FDA

February 24, 2021Drugs & Devices, The Marketplace

Recently, the U.S. Food & Drug Administration (“FDA”) announced a scheduled meeting of its Vaccines and Related Biological Products Advisory Committee (“VRBPAC”) to discuss the request for emergency use authorization (“EUA”) for a COVID-19 vaccine from Janssen Biotech Inc. The FDA has just under three weeks to complete its report before the VRBPAC’s meeting to make its recommendation on the vaccine. The review process may be more challenging than the past two reviews for Pfizer and Moderna due to the composition differences and effectiveness.

COVID-19FDAFDA regulationsRegulationVaccines

Facebook Hires Their First Chief Compliance Officer

February 24, 2021Uncategorized

On February 8, 2021, Henry Moniz joined Facebook as their first Chief Compliance Officer. Moniz previously held the position of Chief Compliance Officer and Chief Audit Executive of Viacom after the company merged with CBS. A Chief Compliance Officer is the officer responsible for managing regulatory compliance problems in a company or organization. Facebook already has a compliance group but has never appointed a Chief Compliance Officer. The appointment came after the Federal Trade Commission approved a five billion dollar settlement with Facebook in July of 2019. Facebook has been at the other end of many antitrust lawsuits in connection with their acquisition of potential competitors such as Instagram and WhatsApp. These conflicts likely brought them to hire a Chief Compliance Officer in order to solve issues arising around compliance.

Employment

Safely Getting Back to Work

February 23, 2021Uncategorized

Over 40.3 million Americans have already received at least one dose of the Covid-19 vaccine with a current average of 1.67 million doses administered per day. With a falling infection rate and the vaccine rollout entering a new stage, employers are reexamining their plans to safely return to the office.

EmploymentJournal of Regulatory Compliance

The Clean Water Act: The Broadening of the National Pollutant Discharge Elimination System Permitting Program to Regulate Indirect Discharge Through Groundwater

February 22, 2021Uncategorized

On January 14, 2021, the United States Environmental Protection Agency (“EPA”) issued a Guidance Memorandum (hereinafter “Memo”) addressing the recent decision of the Supreme Court of the United States in the case County of Maui v. Hawai’i Wildlife Foundation, 140 S. Ct. 1462 (2020) regarding the regulation of water pollution under the Clean Water Act (CWA or “the Act”). The Memo outlined how the Court’s recent ruling in the County of Maui applies to the National Pollutant Discharge Elimination System (“NPDES”) permit program created under Section 402 of the Clean Water Act (hereinafter “Section 402”). The intent of the EPA in publishing the Memo is to help clarify the effect of the Court’s ruling in County of Maui for owners and operators of facilities subject to the regulation of the CWA, the primary regulatory framework for governing water pollution in the United States. The ruling in County of Maui expands the types of discharge that are subject to the CWA’s regulatory permit program and illuminates the steps required of facility owners and operators to comply with that framework.

1972 Clean Water ActCounty of Maui v. Hawaii Wildlife Foundationenvironmental regulationJournal of Regulatory ComplianceNPDES PermitRegulationSCOTUSWater Law

Relax, After GDPR’s Schrems II, Some Companies Transferring Personal Data from the EU to the US May Actually Have Less Challenges Than You Thought

February 19, 2021Uncategorized

On December 12, 2020, the European Commission (the “EC”) issued a highly anticipated draft of newly revised standard contractual clauses (“new SCCs”) that may be used by European Union-based companies to safeguard data transfers of personal data to third countries, such as the US, in compliance with GDPR Art. 46(1). The release comes at a decidedly inopportune time as it follows on the heels of the Court of Justice of the European Union’s (CJEU) Data Protection Commissioner v. Facebook Ireland Limited and Maximillian Schrems (“Schrems II”) decision which casts serious doubt on the adequacy of SCCs alone to safeguard against the “high-risks” involved in EU to US data transfers. And for many data protection experts, the language of the revised SCCs only adds to the confusion, raising even more questions. But one question in particular seems to be prominent among others—for transfers to importers, directly subject to GDPR, are SCCs really necessary?

compliance programdata privacydata securityJournal of Regulatory ComplianceprivacyPrivacy & Security

Understanding the Executive Order on Rebuilding and Enhancing Programs to Resettle Refugees and Planning for the Impact of Climate Change on Migration

February 19, 2021The Art of Compliance

Climate change directly and indirectly impacts a range of human rights including the basic rights to life, food, water and housing. Along with all developed countries, the United States has an affirmative obligation to take measures to prevent and address climate change impacts thereby not only mitigating its dire effects, but ensuring that all displaced persons have, at a minimum, their basic needs met. These displaced persons are more often than not those who have contributed the least to climate change and are now disproportionately suffering from its harm.

Climate Changeclimate migrationenforcementenvironmental regulationJournal of Regulatory Compliancerefugee status

Uh Oh Venmo…The CFPB is Cracking Down under the Biden Administration

February 18, 2021Uncategorized

Chandler Wright Associate Editor Loyola University Chicago School of Law, JD 2022 “Can I Venmo you?” is a phrase that many of us find ourselves saying on a weekly basis. Venmo has become not just a money-transfer application, but also a verb. In some ways, Venmo has also become a social media platform among friend …
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Biden AdministrationCFPBConsumer Financial Protection Bureaudodd-frank actfinancial regulationFinancial services complianceJournal of Regulatory CompliancePayment ServicesTrump AdministrationVenmo

Complex Data, Creating Complex Risks for Sports Entities

February 18, 2021Athletic Regulation

Advanced data driven infrastructure is now essential for sports entities to remain competitive, yet few structures are in place to manage the risks inherent in the collection of this sometimes, highly personal information. Data is utilized for virtually every aspect involved in the game, including; to enhance player performance, improve player health, deepen fan engagement, and increase betting predictions. These developments do not come about without risks to the rights of those who the data is extracted from.

Biometricdata privacydata regulationhippaJournal of Regulatory ComplianceprivacySportssports gamblingtechnology

Antitrust & The Competitive Health Insurance Reform Act of 2020

February 17, 2021Uncategorized

The Competitive Health Insurance Reform Act of 2020 (“CHIRA”) was signed into law on January 13, 2020, shifting not only how health insurance markets operate but lowering the bar for federal government agencies to bring successful actions against anticompetitive behavior. Prior to becoming law, health insurance companies retained robust antitrust exemptions under the McCarran-Ferguson Act (the “Act”). While it does not completely eliminate antitrust exemptions, the passage of CHIRA sent a strong signal that the federal government intended to promote competitive conduct in health insurance markets and limit the scope of these antitrust exemptions. While the upshot is that consumers may benefit from increased access and potentially lower cost, the health insurance industry must begin to adjust its conduct or face contentious litigation.

AntitrustHealth Insurance

Robinhood Fined $65 Million for Misleading Customers

February 17, 2021Fraud & Abuse

On December 17, 2020, the Securities and Exchange Commission (“SEC”) charged Robinhood Financial, LLC (“Robinhood”) with material misrepresentation and misleading its users about its revenue sources, specifically Robinhood’s receipt of payments from certain principal trading firms for routing its customer orders to them. The SEC charges against Robinhood also relate to certain statements about the execution quality Robinhood achieved for its customers’ orders and Robinhood’s failure to satisfy its duty of best execution. Robinhood agreed to pay $65 million to settle the charges.

Journal of Regulatory CompliancePrivacy & SecurityRobinhoodSEC