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An Artificially Intelligent Approach to Medical Device Monitoring
No full textThe integration of artificial intelligence (Al) in medical devices, particularly the subset of Al technologies known as machine learning, has sparked a new era of precision and efficiency in healthcare. AI/ML-enabled medical devices are proving to be invaluable as they have already improved patient diagnosis, treatment, and disease prediction. As machine learning continues to be adopted in medical devices, the U.S. Food and Drug Administration (FDA) continues to receive more marketing submissions and pre-submissions for AI/ML-enabled medical devices, a trend that is expected to increase over time. While the FDA has made significant progress in proposing regulatory frameworks that will implement the use of AI/ML-enabled medical devices, it has not considered whether these devices should be monitored based on the level of risk they pose. Therefore, this Comment aims to advance conversations that will promote the safe use of machine learning in healthcare and argues that the FDA should adopt a risk-based approach to the monitoring of AI/ML-enabled medical devices. Adopting such an approach is warranted for several reasons and will provide significant benefits to manufacturers, patients, and the FDA. By tailoring monitoring requirements to device risk levels, the FDA can strike a balance between ensuring patient safety and fostering efficiency in the rapidly evolving field of machine learning in healthcare
Protection of Cultural Property in Armed Conflict and Military Necessity
No full textThe protection of cultural property in armed conflict has been a matter for special consideration by customary and conventional international humanitarian law since its first expressions. The Hague Conventions of 1899 and 1907 already enunciated a principle of protection in this matter, as shown in particular by the Regulations concerning the laws and customs of war on land annexed to the fourth convention, which provided that in sieges and bombardments all necessary steps must be taken to spare, as far as possible, buildings dedicated to religion, art, science, or charitable purposes, historic monuments, hospitals, and places where the sick and wounded are collected, provided they are not being used at the time for military purposes. Additionally, any intentional appropriation, destruction or deterioration of similar institutions, historic monuments and works of art and science were prohibited and had to be criminally repressed. It should be noted, however, that the obligation to respect the buildings forming part of the cultural heritage was limited to the situation in which the mentioned buildings were not used for military purposes at the time of an attack. In practice, therefore, the protection afforded by the conventional rules to cultural objects was not special as compared with the general protection to which any civilian object was entitled
Celebrating Michael Reisman: The Inner World of Others - A Guiding Light for Indigenous Re-Empowerment
No full textMichael Reisman is a beacon of light in the firmament of international law and jurisprudence. His retirement from his faculty position at the Yale Law School affords a welcome occasion to celebrate his work in the quest for a world public order of human dignity. Michael is the cherished leader of the New Haven School of Jurisprudence, an intellectual movement designed to combine the prescriptive purposes of the law with the empirical insights of the sciences to achieve the goal of the flourishing of human beings, through access by all to the processes of shaping and sharing all things humans value. It is the most comprehensive and creative, empowering theory about law and, indeed, its concepts and procedures are uniquely available for securing value-outcomes in situations of disintegrating public order and even the ultimate horror of normative tohu bohu. It is needed even more in this highly conflictual, often violent world
The Future of Law in an Era of Artificial Intelligence Symposium Theme
No full textOn February 9, 2024, the St. Thomas Law Review held its Symposium The Future of Law in an Era of Artificial Intelligence at the St. Thomas University Gus Machado Auditorium. The Symposium committee consisted of Daniel Borges (Articles Solicitation Editor), Lorena Gonzalez (Alumni Relations and Events Editor), and Melissa Betancourt (Editor-in-Chief). The event had a collective attendance of over 150 students and professionals. This Symposium stood as a testament to our Law Review\u27s commitment to staying at the forefront of legal scholarship and engaging in conversations that shape the future of our professions. The intersection of artificial intelligence and the law is a frontier of paramount significance, one that demands our collective attention and intellectual rigor. Artificial intelligence is here, and it has, and will continue to have, a massive impact on all of us-in our careers, and in our lives. The Symposium consisted of two panels encompassing three attorneys in each. The panelists shared their significant contributions to this developing field, and shed light on the ways in which artificial intelligence is reshaping our legal landscape, and, by extension, our society
Financial Regulatory Agency Behavior: Oscillating Priorities
No full textGleaning from political science and economic theories of organizational performance, I propose a theoretical framework positing that financial regulators have multiple, competing goals whose priorities legislators leave ambiguous. Left with organizational goal ambiguity, financial regulatory agencies become information processors that engage in intra-agency coordination and have the broad discretion to transpose these priorities onto their internal agency structure. Precisely which goal the regulator will prioritize hinges on the constraint factors of path dependency, political control, and economic turbulence. We can observe an agency’s goal priorities through its internal organizational choices and its allocation of resources. Through the lens of this theoretical framework, I have analyzed the annual reports of the United States’ prudential regulators (the Fed, the OCC, and the FDIC) from the 1960s to 2006; specifically, I collected data on their internal organization and the examination frequency of prudential regulation vis-à-vis consumer compliance. I show empirically that over the decades, the regulators’ consumer compliance priorities oscillated in response to the internal and external constraints of the agencies’ own history, the political environment, and any financial crises. I argue that these three constraint factors are the critical determinants of prudential regulators’ performance of consumer mandates. The constraint factors’ persistent influence and the agencies’ own ability to shape their internal agency structure challenges the view that regulatory structure has been an important determinant of regulatory failure. During the first stage of my analysis, covering the 1960s to the late 1970s, the prudential regulators first resisted, then accepted, their legislatively assigned roles regarding consumer protection (the “Institution Building Period”). During the 1980s, legislative changes forced the prudential regulators to dismantle some of their consumer-focused functions as the deregulatory political environment and the banking crisis of the 1980s led to radical changes in the U.S. banking industry (the “Deregulation and Banking Crisis Period”). With the conclusion of the banking crisis in the early 1990s, and until 2006, the prudential regulators briefly re-built consumer functions, then slowly de-prioritized them in the years leading up to the subprime mortgage crisis (the “Inter-crisis Period”)
Congressional Incentives and the Administrative State
No full textWhen Judge Douglas H. Ginsburg delivered the Hayek lecture in 2016, his talk was based on an essay that he and Judge Steven J. Menashi co-authored called “Our Illiberal Administrative Law.” That essay argued that even though the Administrative Procedure Act (“APA”) was intended to promote accountability for agency action and to provide “a check upon administrators,” as the Supreme Court once put it, the body of administrative law that had developed around the APA often failed to provide that accountability. Deference to agencies was such that courts were often “relegat[ed] to the correction of procedural errors and of only the most blatant overreaching of an agency’s statutory mandate.” The essay noted the lack of enforcement of the nondelegation doctrine, the extension of Chevron deference from policy-laden judgments to traditional legal questions, and the evasion of the requirements of notice-and-comment rulemaking through adjudications, interpretive rules, and guidance documents.
Since that essay was published in 2016, the Supreme Court has entertained significant changes to our administrative law. The Court has limited the circumstances under which courts must defer to an agency’s interpretation of its own regulations. It has reduced its reliance on Chevron deference, and it is considering this term whether to retain the Chevron precedent at all. The Court has expanded the “major questions doctrine,” which some see as enforcing a nondelegation principle. It has given renewed attention to the requirements of the Appointments Clause and the President’s right of removal. It may have tightened the requirements for surviving arbitrary-and-capricious review. And it is considering other issues this term, such as the accountability promoted by the Appropriations Clause and whether the Seventh Amendment precludes some agency adjudications. So many of the administrative law doctrines that Judges Ginsburg and Menashi discussed in 2016 are being reconsidered.
Given these shifts in the administrative law landscape, it is difficult to sound a pessimistic note. But perhaps it is not so difficult if one addresses the flip side of the debate over administrative policymaking, which is the role of Congress.
Underlying the critique of deferential administrative law doctrines is the belief that administrative policymaking has displaced legislation—that the agencies are making policy decisions that should be made by elected representatives in Congress. And a prominent thought has been that if the courts were less indulgent of agency policymaking, it would force Congress to legislate more frequently, more specifically, and on a wider range of subjects—rather than delegate policymaking discretion to administrative agencies.
We are skeptical that is correct because Congress is not only responding to judicial doctrines. Rather, Congress has structural reasons and incentives for relying on agency policymaking and for engaging in activities such as oversight at the expense of its legislative role. Some proposals aim at bolstering Congress’s legislative capacity, but there are reasons for thinking that enhancing the legislative function of Congress would not address the problems that critics of administrative policymaking identify with the administrative state. Congress can become bureaucratized too. And in many ways, congressional lawmaking looks a lot like administrative policymaking: dominated by an expert, unelected staff, marked by interest group bargaining with little public participation, and involving a correspondingly limited role for the broader public interest that Congress is supposed to represent.
We wanted to offer some thoughts about how we might think about the administrative state even if we do not expect Congress to resume the robust legislative function that its critics claim has been displaced by agency policymaking. In other words, if at least in the short term, Congress is not going to change dramatically, then the administrative state will be with us for better or for worse, and we might consider how to make it better rather than worse.
This Article proceeds in two basic parts. Part I surveys the story of congressional decline and some common proposals for congressional reform, and it provides some reasons for thinking that congressional structure and incentives make it unlikely that we will see a transformation in the short term. Part II addresses the values we may have lost in the decline of congressional lawmaking and the shift toward administrative policymaking. And it suggests that it would be worthwhile to consider how to incorporate those values into the administrative policymaking process that we have. To begin that consideration, we have two main proposals: focusing on congressional oversight, to which Congress is more inclined than legislation, and reforming the administrative process through executive order—that is, in ways that do not depend on congressional or judicial change
Time for Reform, Not Abolition: Balancing Justice and Morality through Amendment of the Federal Death Penalty
No full textIn 1987, President Ronald Reagan addressed Congress, saying it was scandalous and intolerable that federal law did not provide for an enforceable death penalty.\u27 Ten years prior, following a brief moratorium on its application, the death penalty had been ruled constitutional. While thirty-five states had already reinstated the death penalty at the state level and constitutionally executed ninety-three prisoners since 1976, Congress had not yet enacted the rational, objective standards necessary for applying the death penalty constitutionally. In the year following his speech to Congress, President Reagan successfully signed the federal death penalty into law through the Anti-Drug Abuse Act of 1988. Although the federal death penalty is an eligible punishment for over forty capital offenses, there is restraint in usage, as only sixteen executions have occurred since the reinstatement of the federal death penalty in 1988, making up just one percent of all executions in the United States since 1972. However, this restraint of use should not be seen as evidence of a lack of need for the death penalty. The death penalty is imposed in few cases, all of which constitute crimes that profoundly shock the conscience and threaten society to the highest degrees. As such, it would once again be scandalous and intolerable if the proposed Federal Death Penalty Prohibition Act is passed without revision, completely abolishing the federal death penalty.\u27 This Comment aims to return the federal death penalty to a punishment reserved for crimes that threaten the existence of the United States, while managing moral and ethical changes in society. Part II provides a brief background on the history of the federal death penalty in the United States and introduces the Federal Death Penalty Prohibition Act. Part m discusses the Federal Death Penalty Prohibition Act\u27s failure to recognize the crucial role of the death penalty injustice, deterrence, and public safety, and addresses moral and ethical arguments for abolition. Moreover, Part IV proposes a novel solution for reformation of the current federal death penalty. The solution advocates for a nuanced approach that lessens the applicability of the death penalty to a smaller subset of crimes, and increases procedural safeguards. Finally, Part V concludes that the death penalty must be preserved in federal law as punishment for crimes that threaten the existence of the United States of America, but requires amendment to be imposed in a way that considers the moral and ethical opinions of the modem society
40 More Writing Hacks for Appellate Attorneys
No full textScript for Trailer: “40 More Writing Hacks for Appellate Attorneys”
Fade in on aerial view of Washington, D.C.
Zoom in on Supreme Court Building. Chopper sounds. Enter helicopter fleet flying by.
Cut to Chief Justice John G. Roberts, Jr., sitting at his desk, reading. He rubs his forehead. Tired. Anxious. Distraught.
Chief: “What a mess! This brief could have been 10 pages shorter!”
Phone rings. Chief answers on speaker.
Law clerk’s voice through phone: “Chief, turn to Appellee’s brief. You’ve got to see this!”
Chief picks up different brief. Flips it open. Zoom in on face. Eyes widen. Jaw drops. He takes off his glasses and whispers: “Finally!”
Fade to black.
White text fades in on screen: “Make your judge confident.”
Text fades out and new text fades in: “Brian C. Potts, ‘40 More Writing Hacks for Appellate Attorneys,’ 21 Scribes J. Legal Writing 142 (2024).”
Text fades out. Fade back into chambers.
Chief, holding winning brief: “It still could’ve been shorter.”
End.
Reviews of “40 More Writing Hacks for Appellate Attorneys”
“Hack number 73 is worth the price of a subscription to Scribes. Who knew lines could mean so much?” —New Pork Rinds
“The best thing since ‘40 Writing Hacks.’” —People’s Daily Bread
“I’ve read worse.” —Wally’s Street Journey
“‘40 More Writing Hacks for Appellate Attorneys’ is the lamely named sequel to ‘40 Writing Hacks for Appellate Attorneys.’ … You should read ‘40 Writing Hacks’ before reading ‘40 More Writing Hacks.’ Otherwise, the plot won’t make sense.” —The Yomiuri Shimbunny
“If ‘Begs the question’ does not mean what many attorneys think it means, that begs the question: What does it mean?” —US Slay Today
“A style guide should be fun to read. This one was meh.” —Brian A. Gardner
“We weren’t sure we needed the first 40. We certainly didn’t need the second 40. We hope it’s the last 40.” —South Bend Tribulation
“The hacks work! They really work!” —Chicago Spun-Rhymes
“I will never make these mistakes again.” —Boss-Tone Herald
“Mandatory reading in our newsroom.” —Dallas Morning Snooze
“Make it stop!” —Sun Sentimental
“Don’t quote me. But I secretly love it.” —Dr. Terri LawCler
Constitutional Law: Cases and Materials, Custom Edition
No full textThis custom casebook was curated by Christian Lee Gonzalez-Rivera at St. Thomas University College of Law.https://scholarship.stu.edu/faculty_books/1037/thumbnail.jp
Rebooting the Supreme Court
No full textIn 2023, the United States Supreme Court faced its greatest crisis of legitimacy in nearly a century, and one of the most severe in its history. Yet the Roberts Court majority has demonstrated little recognition of the legitimacy crisis or willingness to mitigate or ameliorate it. If the Court continues on its present trajectory, thereby exacerbating its diminishing legitimacy, both demands for reform and the extent of reforms demanded can be expected to continue to increase. Coincidentally, over the same recent timeframe, several prominent media franchises similarly have suffered precipitous collapses in their public standing. In both instances, the dearth of public trust has its origin in the divergence between the actions taken by those exercising the formal authority of interpretation and the normative and empirical consensus of the broader interpretive community. How should the wider interpretive community respond when the interpreters with power fall so far out of alignment with the community as a whole? This question has no simple answer in either context, but the juxtaposition with media franchise management suggests several important considerations in evaluating and responding to the Roberts Court’s legitimacy crisis. The difficult work must begin by carefully and accurately identifying the sources of the divergence so that an appropriately tailored and effective remedy can be implemented. As media franchises have discovered to their detriment, failure to get that first step right all but dooms subsequent remediation efforts, leaving the interpretive legitimacy crisis unresolved—if not worsened. Especially for those calling for a fundamental rebooting of the nature of judicial review in U.S. constitutional law, the comparison to media franchise management provides a cautionary tale about the likelihood of success when a reboot is attempted