The U.S. Food & Drug Administration (“FDA”) is looking to elbow its way into the medical testing business by mandating stricter regulations that would slow the process of bringing lab-developed tests (“LDTs”) to market. LDTs are common medical diagnostic tests that have led to both diagnostic advances and setbacks that affect the everyday consumer. (FDA News Release, U.S. Food and Drug Administration). The FDA’s regulation was previously opened for a 60-day comment period and was met with vigorous discussion. Regardless, the FDA moved forward with the regulations on April 29, 2024, and has been met with legal push back and Congressional commentary that could threaten the future of the proposed rule. (Chair Rogers, U.S. House Energy and Commerce Committee).  This post examines the current structure of LDT regulations, their marketability, and how this regulation change will affect small startups and patient experiences.

Benjamin Franklin once said, "Nothing is certain except death and taxes." (Benjamin Franklin, Letter to Jean-Baptiste Le Roy).  In a recent United States Supreme Court (“SCOTUS”) decision, the tax portion is more certain than ever. (Richard Rubin, Wall Street Journal). On June 20, 2024, SCOTUS rejected a challenge to a 2017 tax law (“Tax Law”) on certain foreign investments. (Moore v. United States, 144 S. Ct. 1680, 1697 (2024)). The decision keeps the foreign investment tax intact, while avoiding addressing a 16th Amendment interpretation. (Richard Rubin, Wall Street Journal). This article explores the case's background, the Court's reasoning, and how this decision will ultimately discourage individuals from investing in foreign companies

The U.S. Consumer Financial Protection Bureau (“CFPB”) recently introduced a new proposed rule change that will expand its regulatory oversight to “‘general-use digital consumer payment apps.’” (Jessie Chang, ABA). The Consumer Financial Protection Act allows the CFPB to supervise nonbank entities in the mortgage, payday loan, and private student loan sectors, as well as service providers to banks and credit unions, but the CFPB can also oversee companies that pose consumer risks or are “larger participants in other markets.” (Consumer Financial Protection Bureau). While the CFPB has used its power to regulate “larger participants” in markets involved with consumer financial products and services before, this proposed rule will expand its oversight to a brand-new height by including more non-traditional banking companies. (A&O Shearman). CFPB Director Rohit Chopra stated the proposed “rule would crack down on one avenue for regulatory arbitrage by ensuring large technology firms and other nonbank payments companies are subjected to appropriate oversight.” (Consumer Financial Protection Bureau). This article examines the need for and the positive effects of this proposed rule, as well as the potential dangers.

Several prominent news organizations, including The New York Times, The Intercept, Raw Story, and Alternet, have filed lawsuits against OpenAI, an artificial intelligence research organization. (Yiwen Lu, The New York Times)​​. The lawsuits allege that OpenAI used their journalists’ copyrighted content to train its artificial intelligence (“AI”) system, ChatGPT, without proper authorization or accurate citation. Id. They allege that OpenAI unlawfully used their copyrighted content to train its AI system, ChatGPT, violating the Digital Millennium Copyright Act (“DMCA”), which prohibits the “removal of information like author and title from protected works” thereby infringing upon their copyrights. Id.(Cade Metz, et al. & Katie Robertson, The New York Times). As a result of the training, ChatGPT can potentially produce similar content to the copyrighted material which would be grounds for a DMCA violation. Id. This article describes how OpenAI has responded to these lawsuits, how OpenAI has responded to news organizations’ claims, other stakeholders suing AI platforms, and possible outcomes of the lawsuits.

On August 23, 2023, the Securities and Exchange Commission (“SEC”) adopted New Rules under the Investment Advisers Act for private fund advisers to increase investor protection, transparency, and oversight. (Securities and Exchange Commission). The New Rules apply to all private fund advisers and restrict activities that are contrary to the public interest, while increasing the visibility of practices that could harm investors. Id. Under the New Rules, all private fund advisers are subject to the Restricted Activities Rule and the Preferential Treatment Rule. Id. While the New Rules are poised to protect investors, opponents argue the cost of compliance will negatively affect private fund advisers and stifle entrepreneurialism. (O’Melveny). This article reviews the New Rules, the arguments for and against the New Rules, and the potential impact they will have on private fund advisers moving forward.

The U.S. grocery industry witnessed a significant development with the proposed merger of two of its largest players: Kroger and Albertsons. Announced in October 2022, this merger aims to create a powerhouse capable of competing with giants like Walmart and Amazon. (Phil Lempert, Forbes). However, the Federal Trade Commission (“FTC”) pursued legal action to block Kroger's bid for Albertsons, citing concerns over potential harm to competition, which could lead to higher prices and lower wages. (Georgetown University). This article explores the FTC's challenge to the Kroger-Albertsons merger, detailing the FTC's competition concerns, Kroger’s perspective on the matter, strategic store divestitures, and the potential effects on the grocery industry and consumers.

Do the new SPAC regulations mean the end of SPAC IPOs? It sure seems that way. Earlier this year, the United States Securities and Exchange Commission (“SEC”) adopted new regulations to enhance disclosures and provide additional investor protections in initial public offerings (“IPO”) by Special Purpose Acquisition Companies (“SPAC”) and in subsequent business combination transactions between SPACs and target companies (“de-SPAC transactions”). (SEC; U.S. National Archives and Records Administration: Federal Register). The new SPAC regulations, which will go into effect on July 1, 2024, are designed to close many of the loopholes that allowed companies to “go public” through SPAC and de-SPAC transactions without the time, cost, and reporting requirements of traditional IPOs. (SEC; Brian Breheny et al., Skadden, Arps, Slate, Meagher & Flom LLP). This article provides a high-level overview of what led to the SPAC craze from 2019-2022, why the SEC adopted new SPAC regulations, and a prediction on the future of SPACs.

In 2023, the threat of cyberattacks continued to escalate. (Kim Nash, Wall Street Journal). Reports of cyberattacks, such as the cyberattack on Cisco IOS XE devices, dominated the news cycle. (Kyle Alspach, CRN). In response, the Securities and Exchange Commission (“SEC”) implemented new regulations which heightened disclosure requirements for corporate cybercrime risk management. (James Rundle, Wall Street Journal). As of December 15, 2023, the SEC is requiring companies to disclose management of cyber risk in their annual reports, also known as 10-Ks. Id. Additionally, companies must report significant cyberattacks to the SEC in a Form 8-K within four calendar days of discovering a “material” cyberattack. (James Rundle, Wall Street Journal). Federal case law has defined “material” as any potential harm that has a “substantial likelihood” that an investor thinks would have “significantly altered” the information made available. (Kate Azevedo, Bloomberg Law).  Ultimately, the SEC’s new requirements for company disclosures on cybersecurity represent an outstanding strategy to enhance companies’ awareness and readiness against cybercrime.

In a financial world where every move seems to echo with the clink of coins and the rustle of bills, a seismic shift has rocked the securities market. On February 6, 2024, the U.S. Securities and Exchange Commission (“SEC”) adopted two new rules with a 3-2 vote along party lines. (SEC; Sidley). These rules aim to further define what it means to be a “dealer” and “government securities dealer” under the Securities Exchange Act of 1934. Id. The regulatory scheme requires implicated market participants to register with the SEC as “dealers” and conform to various regulatory requirements. Id. Despite the SEC’s good-faith attempt to curtail de facto market makers and promote fairness among market participants, the new rules have been met with harsh criticisms due to their various impracticalities. (Fluhr, et al., DLA Piper; SEC).