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.
Read MoreBenjamin 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
Read MoreThe Department of Justice (“DOJ”) recently filed a lawsuit against RealPage Inc. (“RealPage”), a real estate software company, alleging that the company’s algorithmic pricing software violated antitrust laws. (Press Release, U.S. Department of Justice). The DOJ brought the lawsuit under the Sherman Antitrust Act, the “first Federal act that outlawed monopolistic business practices” and prohibited activities restricting competition in the marketplace. (Sherman Antitrust Act, National Archives). Attorney General Merrick Garland stated, “[l[andlords colluding through mathematical algorithms may be new, but it violates the same bedrock principle of a free market fostering competition.” (Jennifer Ludden, NPR). This post explores RealPage’s background, discusses the DOJ’s and RealPage’s arguments for and against the suit, and examines the possible implications for algorithm-driven businesses.
Read MoreThe 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.
Read MoreSeveral 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.
Read MoreOn 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.
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