INSIDE COMPLIANCE – Page 16 – Loyola University Chicago School of Law

Exploring the Ramifications of the Department of Justice’s Withdrawal from Health Care Antitrust Guidelines

March 23, 2023Healthcare Compliance

On February 3, 2023, the Department of Justice (DOJ) formally withdrew its support for three policies that created longstanding safe harbors from antitrust enforcement, relied upon by the healthcare industry for nearly thirty years. Assistant Attorney General, Jonathan Kanter, of the DOJ’s Antitrust Division stated that these changes were “long overdue”, and that the, “[DOJ] will continue to work to ensure that its enforcement efforts reflect modern market realities.” In striking these guidelines, the DOJ notably left no new guidelines in its place, leaving many healthcare providers and purchasers uncertain of whether they will face litigation or even criminal prosecution under the Sherman Act.

Department of JusticeHealth Insurance

Justice Department Hitting Corporate Executive Lawbreakers Where it Hurts

March 22, 2023Uncategorized

The Justice Department introduced a new pilot program last week that encourages companies to center their compensation policies around rewarding good behavior and punishing those partaking in criminal activity. Deputy Attorney General, Lisa Monaco, previewed the program at an American Bar Association conference in Miami.

ceosclawbackscomplianceDepartment of JusticefinanceprosecutorsRegulationSEC

Infant Formula Shortage: How has the FDA Altered Regulations to Help?

March 21, 2023Uncategorized

Over the past year, the nation has been concerned over an infant formula shortage that has become a crisis for many families in the United States. The Food and Drug Administration (FDA) is responsible for offering support and relief to families affected by this shortage in any way they can. Accordingly, the FDA loosened infant formula regulations. Specifically, the FDA allowed for an increased supply of infant formula by the announcement to infant formula manufacturers of the agency’s intention to temporarily exercise enforcement discretion. Enforcement was on a case-by-case basis, for specific infant formula requirements. This went into effect from May 16, 2022, through November 14, 2022, and was specifically designed to protect infants’ health. Essentially, selective enforcement would allow the FDA to grant permission for formulas despite not meeting all the regulations.

Baby formula shortageFDA

Off the Rails: the Norfolk Southern Train Derailment and its Aftermath

March 17, 2023Uncategorized

On February 3, 2023, Ohio was suddenly and unexpectedly rocked by an accident whose long-term consequences are still unfolding. A Norfolk Southern-operated freight train carrying toxic chemicals derailed in the village of East Palestine. This accident, which poses severe threats to the environment and safety of the local community, has raised significant concerns about the environmental implications of train accidents and the safety of transporting hazardous materials through residential areas.

chemical spillenvironmental regulationEPAFederal Railroad AdministrationJournal of Regulatory ComplianceNational Transportation Safety Boardtrain derailment

HIPAA Violations Hurting Americans

March 17, 2023Uncategorized

Taelor Thornton Associate Editor Loyola University Chicago School of Law, JD 2024 The Health Information Portability and Accountability Act (HIPAA) complaints and breaches increased from 2017 to 2021, yet the Department of Health and Human Services Office for Civil Rights (HHS OCR) stated that they did not perform any audits due to financial resources in …
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Journal of Regulatory Compliance

Biden Administration to Knock “Chip” off China’s Shoulders: Proposed Export License Revocation Seeks to Remove Huawei’s Access to the US Market

March 16, 2023Uncategorized

The Biden administration has considered not only ending all future export licenses between US microchip producers and Huawei, but also revoking existing licenses to sell microchips to the Chinese tech company. This move is just one section of increasing tensions between China and the United States but could have long-reaching consequences for the United States and the global tech market.

big techChinaRegulationtechnology

Capitol Attack Aftermath: The 65 Project files Complaint Against Trump-Aligned Attorney

March 16, 2023Fraud & Abuse

Monday, March 6, 2023, marks two-and-one-quarter years since the notorious attack on the U.S. Capitol. Since then, the unprecedented insurrection’s aftermath has thrust Trump-aligned supporters and politicians into the political limelight. As the House of Representatives continues its comprehensive investigation, Cassidy Hutchinson, former White House aide and standout witness of the House’s Jan. 6th committee investigation, recently accused President Trump’s former White House attorney Stefan Passantino of unethical legal maneuvering. On Wednesday February 15, 2023, nearly three months after her allegations were brought, bipartisan U.S. legal advocacy group ‘The 65 Project’ filed an informal ethics complaint against Passantino.

attorney ethicsAttorney RegulationEthicsprofessional misconduct

Investors in NFTs find Potential Protection through Real Estate Investment Trusts

March 16, 2023Uncategorized

Cryptocurrency’s lack of regulation has been a major focus in the news recently. Furthermore, there is a lack of regulation over non-fungible tokens (NFTs) as well, which is a further concern for consumer safety. Although the first known NFT was established in May of 2014, NFTs didn’t really take-off until 2017. Due to the unique nature of NFTs (being either jpegs, real estate, etc.) the Securities and Exchange Commission (SEC), along with other regulatory authorities, still haven’t clearly laid out if NFTs are securities or what rules/regulations will apply. Unless securities are clearly at issue it is unclear if NFTs will fall under securities laws at this point in time. However, there is a potential way consumers can invest in NFTs related to real estate and still find protection through the SEC.

consumer protectionNFT RegulationNFTsREITsSEC

Proposal to Change TULA Late Fee Maximum on Credit Cards: Is it Beneficial or Burdensome?

March 15, 2023Uncategorized

Megan Aldworth Associate Editor Loyola University Chicago School of Law, JD 2023 The Truth in Lending Act (TILA), established 1968, is aimed to protect consumers against unfair credit practices and billing by lenders. Under TILA, lenders must provide consumers (borrowers) with information that allows them to compare loan terms given by various lending institutions. …
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American Banking AssociationBankingCFPBCredit Card FeesRegulationTruth in Lending Act

FDA Restrictions, State Action, and Pharmaceutical Responses to the Abortion Pill

March 15, 2023Food and Drug Law

As of March 3, 2023, Walgreens, the second-largest pharmacy store in the United States, has announced that it will not offer mifepristone, the abortion pill, in twenty-one states. This decision followed letters written by Republican attorneys generals in the twenty-one states urging Walgreens not to stock the product, and even threatening legal action against Walgreens if they did decide to move forward with stocking mifepristone in those twenty-one states. Rite Aid and other pharmacies have not yet made a decision on whether they will sell mifepristone.

FDAMifepristonepharmacy regulationWalgreens