Week in Review

IN THE NEWS

• The European Union reached an agreement on a landmark law to regulate artificial intelligence (AI). The law, which is expected to pass early next year and is expected to take effect in 2026, is the first comprehensive AI regulation. The new law would require the largest general-purpose AI systems, such as ChatGPT, to comply with transparency and disclosure requirements, conduct “systemic risk” evaluations on their product, assess and mitigate those risks, and report serious incidents to the EU. The law—which includes penalties for violations—also bans the untargeted scraping of online images to create a facial recognition database and limits the use of facial recognition software by police and governments, except in cases of serious safety and national security threats.
• The U.S. Court of Appeals for the Second Circuit upheld parts of New York’s gun law, holding that the state can ban guns in “sensitive locations,” such as schools, parks, and theaters, and can deny gun licenses to those who local officials determine lack “good moral character.” The court also rejected parts of the law, including a requirement that concealed carry permit applicants disclose their social media accounts and bans on guns in places of worship and on private property open to the public, such as gas stations. The ruling is the first federal appellate court ruling on where licensed owners can carry guns since the U.S. Supreme Court’s ruling in Bruen, which held that gun laws must “be consistent with the nation’s historical tradition of firearm regulation.”
• The U.S. Food and Drug Administration (FDA) issued its first-ever approval to gene-editing treatments for human illness. The approved treatments are available to individuals aged 12 and older who have sickle cell disease. Both approved treatments involve taking a patient’s own blood stem cells, modifying them using the gene-editing technology, and then administering a one-time infusion of a large amount of modified blood cells back into the patient. Lewis Hsu, Chief Medical Officer of the Sickle Cell Disease Association of America, noted that the approval “is something that we’ve been waiting for in the sickle cell community for basically 70 years.”
• The U.S. Supreme Court said it will decide on the availability of the abortion pill mifepristone, marking the first abortion case on its docket since Dobbs. In April, a federal trial judge in Texas mandated that FDA suspend its approval of the pill, but the U.S. Court of Appeals for the Fifth Circuit then ruled that the drug can remain available with restrictions, including prohibiting the pill from being mailed, and shortening the cutoff for obtaining the pill from 10 to seven weeks into pregnancy. The Supreme Court will not hear a separate challenge to FDA’s initial approval of the pill in 2000, meaning its ruling would not ban mifepristone, but could make it more difficult to obtain.
• The Texas Supreme Court overturned a lower court’s order permitting a pregnant woman to get an emergency abortion. The lower court had ruled that the woman, Kate Cox, whose fetus has been diagnosed with an often-fatal genetic abnormality, qualified for a medical exemption to the state’s near-total abortion ban after Cox’s doctor testified. The Texas Supreme Court held that the doctor’s testimony did not establish the proper level of medical emergency required by the state’s laws. The court warned that “judges do not have the authority to expand the statutory exception” to abortions. Cox has since left the state to receive a legal abortion.
• The Federal Trade Commission issued a new rule targeting two illegal practices that car sellers employ: bait-and-switch tactics and hidden junk fees. Under the rule, car sellers cannot lure consumers into their lot with misrepresentations about the cost of the vehicle or any add-ons, the availability of discounts, pre-approvals, or the value of trade-in vehicles. In addition, the rule requires dealers to disclose offering prices, financing terms, and add-on fees in advertisements. The rule also prohibits charging for “bogus” add-ons that provide no actual benefit, such as warranty programs that duplicate the manufacturer’s warranty.
• Several EU agencies published a list of “critical medicines,” which identifies the medicines that treat serious disease and cannot be substituted easily. The list includes insulin, morphine, and amoxicillin, as well as vaccines for measles and hepatitis B. The list does not reflect current or predicted shortages. Rather, the list is intended to highlight where supply chains should be strengthened and prevent future shortages of these medicines. The move is part of the EU’s broader attempts to overhaul pharmaceutical laws and encourage drug companies to introduce their products in all EU member states.
• A bill introduced in the U.S. House of Representatives would require agency heads to identify two regulations to be rescinded for every one regulation passed. The 2 for 1 Act would codify President Donald J. Trump’s executive order with the same mandate. President Joseph R. Biden revoked that executive order on his first day in office. Representative Mike Gallagher (R-Wis.), who introduced the bill, claimed that the Biden Administration now “rules by regulation.”

WHAT WE’RE READING THIS WEEK

• In an article in the Loyola Consumer Law Review, Matthew A. Bruckner, a professor at Howard University School of Law, and Christopher J. Ryan, professor at the University of Louisville Louis D. Brandeis School of Law, analyzed the most common types of complaints about student loan servicers that are submitted to the U.S. Consumer Financial Protection Bureau’s database. Bruckner and Ryan explained that many complaints can be grouped into the same category, such as complaints about customer service after a borrower’s payment obligations change with little explanation. Brucker and Ryan concluded that greater investments in customer service and clearer rules surrounding payment processing could alleviate many of these complaints.
• In an article in the Yale Journal on Regulation, Amelia Fletcher, a professor at the University of East Anglia, and several coauthors argued that consumer law is out-of-touch with modern, digital marketplaces. The Fletcher team highlighted how websites that retain personal data about its users often use the data to monetize their services with targeted advertising and sales. Fletcher and her authors claimed that companies’ efforts to be transparent with consumers about the use of their data have largely failed. The Fletcher team recommended that regulators simplify and standardize privacy choices for consumers and require the largest platforms to report on breaches of users’ privacy.
• In an article in the Harvard Journal of Law & Public Policy, Supreme Court of Pennsylvania Justice David N. Wecht and Lawrence McIntyre, a law clerk, discussed the nondelegation doctrine—which bars legislatures from allocating their authority to other branches of government—in Pennsylvania. Justice Wecht and McIntyre noted that although the U.S. Supreme Court has struck down federal law on nondelegation grounds only twice in history, the Supreme Court of Pennsylvania has done so twice in the last six years alone. Justice Wecht and McIntyre argued that Pennsylvania does not have a particularly strict nondelegation doctrine, but rather that its recently lively nondelegation docket is “mere coincidence.”

EDITOR’S CHOICE

• In an essay in The Regulatory Review, Philip Rubin, the Chief Executive Officer Emeritus of Haskins Laboratories, explained recent developments in the regulation of research that involves human subjects. Rubin noted that the federal government recently updated its policy on this kind of research—known as the “Common Rule”— for the first time in almost 30 years. Rubin applauded these updates, which included heightened consent requirements and decreased oversight for some minimal-risk research. Rubin concluded that an interagency group on research ethics is necessary to ensure that constant conversation continues on the topic as new technologies emerge.