INSIDE COMPLIANCE – Page 55 – Loyola University Chicago School of Law

Politicizing a Pandemic: Emergency Use Authorizations for COVID-19

February 8, 2021Drugs & Devices

The Food and Drug Administration (“FDA”) is one regulatory agency that has been on the forefront of the American fight against COVID-19. Historically, the agency has been highly respected for its success in apolitical operation despite its mission of (1) protecting the public health and (2) innovating in the development of medical products. One of its most important tools in the face of a public health crisis is the once obscure regulatory mechanism called the Emergency Use Authorization (“EUA”). But as public trust in the FDA falters, Americans are surely wondering how effective a protective measure can be when it seems to be used as political ammo.

COVIDEUAFDAJournal of Regulatory Compliance

Bitcoin, Tesla, and GameStop: Regulatory Challenges Posed by the New Retail Investor

February 2, 2021Finance & Banking

GameStop started 2021 with a stock price below $20 but saw its stock price skyrocket to well above $300 a share towards the end of January. The rally would be hard to explain by solely relying on the company’s financial reports or underlying fundamentals. Instead, the rally has to be explained through a combination of external factors involving a popular fintech company’s app, manic speculation by retail investors, and Reddit. Although at first glance this may seem like a new phenomenon, the same factors have been at play for years with a huge interest in Tesla and Bitcoin – and they pose a risk to the markets that regulators and Wall Street together can’t ignore.

BitcoinGameStopJournal of Regulatory ComplianceRegulationRobinhoodSECstock marketTesla

Vertical Healthcare Companies Merging Compliance Programs

February 1, 2021Uncategorized

Vertical Healthcare Companies Merging Compliance Programs Perri Nena Smith Senior Editor Loyola University Chicago School of Law, JD 2021 In 2020, The Federal Trade Commission (“FTC”) and the Department of Justice (“DOJ”) released guidelines for vertical mergers to give clarity to companies so they can avoid harmful mergers. Healthcare companies are an industry that has been …
Read more

Antitrustcompliance programsenforcementFTCFTC enforcementHealth Insurancehealthcare antitrusthealthcare antitrust compliancehealthcare compliance programsJournal of Regulatory Compliancemergers and acquisitionsOIGRegulationvertical mergers

Federal Relief of Regulatory Oversight Burdens in Medicaid Final Rule

December 2, 2020Uncategorized

he Centers for Medicare & Medicaid Services (“CMS”) refined the Medicaid and Children’s Health Insurance Program (“CHIP”) Managed Care final rules. CMS originally released the final rules in 2016 and another revision in 2018. After several cumulative comments on 2016 and 2018 final rules, CMS attempted to create more flexibility for States with managed care delivery methods. CMS’s third version of the final rules is more of an attempt to clarify and fix technical errors than giving States more flexibility to operate their managed care organizations.

Centers for Medicare and Medicaid ServicesCMS regulationHealth InsuranceJournal of Regulatory Compliancemanaged careManaged Care Final Rulemanaged care organizationMedicaidMedicaid Final Rule

Investing in Income Sharing: Why Regulators Should Pay Attention to the Innovative Set Up Now

November 28, 2020Finance & Banking

As of November 8, 2020, the student debt crisis reached $1,769,280,155,524. There’s no easy way to address a $1.7 trillion problem and the increasing cost of higher education, coupled with the necessity of a four-year degree, will only exacerbate the issue. From 2000 to 2016, the average annual cost of college more than doubled, from around $15,000 a year to nearly $32,000. The New York Fed most recently identified a phenomenon acknowledging that when you flood the marketplace with subsidies, like grants, loans, etc., it enables higher education to continue to raise prices. For every dollar of new public subsidy, prices for college have risen between 60 and 70 cents. There are a number of proposals as to how to address this crisis – from federal statutes to private intervention – but income sharing agreements (ISAs) have largely been left out of the conversation. ISAs are not without criticism, particularly because of concerns about excessive interest. However, many of the criticisms could and should be addressed by comprehensive regulation, as any other type of lending has been. ISAs will likely be part of the future solutions of financing education and, as a result, regulators need to pay attention.

Journal of Regulatory ComplianceRegulation

Journal of Regulatory Compliance Call for Papers: Spring 2021 Issue – Employment Issues in the Time of COVID-19

November 23, 2020Uncategorized

As the world grapples with the COVID-19 pandemic, the legal community has ramped up efforts to identify challenges and manage risks. In recognition of the employment implications of the COVID-19 pandemic, the Journal of Regulatory Compliance invites original submissions for publication in our Spring 2021 issue. The official Journal of Regulatory Compliance is a bi-annual …
Read more

EmploymentJournal of Regulatory Compliance

How Federal Data Privacy Regulation Could Help Curb the COVID-19 Pandemic

November 20, 2020HIPAA & Health Information

It cannot be denied that the COVID-19 pandemic has led to many novel legal and regulatory issues. One topic of major concern both domestically and abroad is how to manage the massive amounts of consumer data being collected in the attempt to quell the spread of the virus. This issue is especially complicated to address in the United States, where a convoluted patchwork of state and federal laws interact to create a relentlessly fragmented data regulation system. Now, as state and local governments, along with tech giants like Apple and Google, continue to roll out contact tracing applications, the need for comprehensive data privacy regulation is more pressing than ever.

Consumer Data Protection Actcontact tracingCOVID-19datadata collectiondata privacydata regulationdata securityExposure Notification Privacy Acthealth dataPrivacy & SecurityPublic Health Emergency Privacy ActRegulation

Understanding Circuit Splits Regarding Article III Standing in Data Breach Litigation

November 19, 2020Uncategorized

Complex litigation in data breach disputes is not surprising due to the reliance on information technology infrastructure. The Identity Theft Resource Center defines a data breach as “an incident in which an individual name plus a Social Security number, driver’s license number, medical record or financial record is potentially put at risk because of exposure.” However, the issue that challenges most plaintiffs’ in a data breach lawsuit is the ability to establish an injury-in-fact sufficient to support Article III standing. Injury-in-fact is harm that is concrete and particularized, and actual or imminent. Currently, the United States Court of Appeals fails to uniformly decide this issue, creating “splits” in the Circuits regarding Article III standing in data breach litigation. The Supreme Court ruled in fact-distinguishable cases concerning standing, but not in the data breach litigation context. Until the Supreme Court renders guidance, Americans face significant judicial patchwork in privacy protection.

Constitutiondata privacyLitigationPrivacy & Security

Business Interruption Insurance Coverage During COVID-19 Era

November 19, 2020Uncategorized

Due to the COVID-19 pandemic, state and local municipalities have issued emergency proclamations requiring small businesses to either shut down or limit their business operations. This has caused small businesses to suffer substantial profit losses. In response, small businesses have filed business interruption claims with their insurance providers to recover their profit losses. However, insurance companies have mostly rejected their insureds’ business interruption claims because there has not been a direct physical loss or damage to the insureds’ properties, which is required to grant business interruption coverage. Businesses have been forced to file lawsuits against their insurers, hoping that the courts will compel insurance companies to provide business interruption coverage to their insureds during the pandemic. Business owners have also asked their elected officials to intervene and help them by passing legislation that would require insurance companies to provide business interruption coverage.

Business InterruptionEmploymentInsuranceJournal of Regulatory ComplianceRegulation

Is Zoom Doomed?

November 18, 2020Uncategorized

There is no doubt that working from home has become a new normal for millions of employees worldwide, and for some, this may be the future of their employment. When the workforce made the shift to remote work and online meeting navigation, Zoom Video Communications, Inc. (“Zoom”) quickly became the frontrunning platform. Many companies flocked to Zoom because of its alleged higher levels of security and encryption capabilities. However, a recent lawsuit against Zoom, by nonprofit group Consumer Watchdog, reveals that Zoom may not actually be as safe for users as it once claimed to be. Other lawsuits allege privacy concerns including Zoom sending user data to Facebook. Most recently, the FTC filed a suit against Zoom on November 9th for allegations of unfair, deceptive, or abusive acts or practices (“UDAAP”) related to encryption, cloud storage, third-party safeguards, and failure to disclose information to users. Though various privacy concerns arise, the platform’s popularity continues to increase given its newfound necessity.

COVID-19FTCJournal of Regulatory CompliancePrivacy & SecuritySECUDAAP