EXIM Turns Stateside

Tomer D. Elkayam Associate Editor Loyola University Chicago School of Law, JD 2024   In 2021, the Biden administration conducted a 100-day supply chain assessment in the midst of a global supply shock. The assessment specifically looked at four critical products that were being severely impacted by reverberating supply chain issues – semiconductors, large capacity …
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Peculiar Alliances Responding to the FDA v. Alliance for Hippocratic Medicine

The Supreme Court is currently reviewing a 5th Circuit decision to roll back 2016 and 2021 expanded indications of mifepristone, a drug originally approved by the Food and Drug Administration (FDA) in 2000. Given the Supreme Court’s hostility toward administrative agencies in the current term, a judge from a United States District Court may substitute their knowledge for that of agency scientific experts in United States FDA v. Alliance for Hippocratic Medicine.

Mass Shootings and the Things We Miss

  Noor Abdelfattah Associate Editor Loyola University Chicago School of Law, JD 2025   With the recent mass shooting in Maine that has left nearly twenty dead, discussions regarding  how we could avoid such atrocities continue. Mass shootings are commonly defined as, “any incident in which four or more people are shot and wounded or …
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The Potential Impacts of Artificial Intelligence in the Environmental Context

The use of artificial intelligence (AI) has been quickly evolving over the past few years, satisfying unexpected needs and allowing for innovative solutions to different problems. More recently, environmental organizations are increasingly interested in potential AI solutions for environmental issues. AI has the potential to streamline regulatory compliance in the environmental context by switching the approach of environmental regulation from responding to current problems into prevention of future problems through data analysis, predictive analysis, and easier reporting procedures for violations of environmental regulation.

EPA Re-Defines “Waterways” in New Rule Following Sackett v. EPA

EPA Re-Defines “Waterways” in New Rule Following Sackett v. EPA Amanda Lane Associate Editor Loyola University Chicago School of Law, JD 2025 The U.S. Environmental Protection Agency (EPA) and Department of the Army (together, Agencies) issued an amended final rule in August of 2023 revising the definition of “waters of the United States” following the …
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Biden Ties Medicare Reimbursement to Sepsis Treatment

The Centers for Medicare and Medicaid Services (CMS), under the Department of Health and Human Services (HHS), finalized CMS-1785-P in August, a rule that links Medicare reimbursement to the treatment of sepsis. Previously, hospitals were required to report on their sepsis treatment patients, but there was no penalty for not adhering to treatment guidelines. Beginning in Fall 2024, hospitals must meet the specific treatment benchmarks integrated into Medicare’s Hospital Value-Based Purchasing Program (MHVBPP) specifically the provisions outlined in the Severe Sepsis/Septic Shock Management Bundle (SEP-1). Failing to meet these benchmarks could result in significant financial losses for hospitals, ranging from thousands to millions of dollars for larger entities. While hospitals should presently be aware of these requirements and implement plans to meet them, there are concerns about whether the proposed rule is the optimal solution for improving outcomes for sepsis patients.

Regulating AI Used to Predict and Prevent Sports Injuries: A Crucial Need

The use of Artificial Intelligence (AI) in sports could revolutionize the way athletic injuries are predicted and managed. Notably, a variety of AI companies have developed software that forecasts potential injuries, possibly prolonging athletes’ careers. This technology analyzes data about the biomechanics of players, their frequency of play or training, and past injuries to identify patterns, find potential causes, and predict future injuries. There is immense value in preventing injuries in athletics for players, teams, and fans alike. It would therefore make sense that everyone is eager to utilize the findings of AI, but without regulation this could cause more harm than good.

No “Moore” Realization Events?

In June 2024, the Supreme Court will decide on a case that may completely upend one third of the Internal Revenue Code (IRC). Moore v. United States calls into question whether the 16th Amendment authorizes Congress to tax unrealized gains without apportionment among the states.

U.S. Auditing Watchdog’s Inspections Program Needs Work

The Public Company Accounting Oversight Board (PCAOB) inspects the audits of U.S public companies, and according to former inspectors for the PCAOB the inspection process needs improvement. The SEC and the Sarbanes-Oxley Act empower the PCAOB to establish auditing standards through inspections and compliance reports. The former inspectors criticized the reports produced and call for a wider scope in the process, more details, and for the reports to be released in a timely manner. While the PCAOB is in the middle of a transformation under current PCAOB Chair Erica Williams, the transformation is largely focused on making inspections more efficient. Hopefully, the call to action by former inspectors will result in improved reports by inspectors. For investors, having more context on how the inspection went and being able to review how the PCAOB measures audit quality would allow them to make more informed decisions.

Global Tech Regulation: The Impact of the E.U.’s Digital Markets Act on Big Tech Giants and the Potential Shift in U.S. Policies

Big tech companies in the United States are largely subject to fewer and less restrictive regulations than those found in other parts of the world. The E.U., however, is rapidly becoming one of the most “assertive regulators” of big tech, which consequently affects American companies that participate in the global market, such as Amazon, Apple, and Google. In response to the growing need for stricter antitrust and data privacy laws, the E.U. adopted the Digital Markets Act (“DMA”) in September of 2022. The DMA’s obligations are set to be fully applicable in March of 2024.