Decoding U.S. Tort Liability in Healthcare\u27s Black-Box AI Era: Lessons from the European Union

The rapid development of sophisticated artificial intelligence (“AI”) tools in healthcare presents new possibilities for improving medical treatment and general health. Currently, such AI tools can perform a wide range of health-related tasks, from specialized autonomous systems that diagnose diabetic retinopathy to general-use generative models like ChatGPT that answer users’ health-related questions. On the other hand, significant liability concerns arise as medical professionals and consumers increasingly turn to AI for health information. This is particularly true for black-box AI because while potentially enhancing the AI’s capability and accuracy, these systems also operate without transparency, making it difficult or even impossible to understand how they arrive at a particular result. The current liability framework is not fully equipped to address the unique challenges posed by black-box AI’s lack of transparency, leaving patients, consumers, healthcare providers, AI manufacturers, and policymakers unsure about who will be responsible for AI-caused medical injuries. Of course, the United States is not the only jurisdiction faced with a liability framework that is out of tune with the current realities of black-box AI technology in the health domain. The European Union has also been grappling with the challenges that black-box AI poses to traditional liability frameworks and recently proposed new liability Directives to overcome some of these challenges. As the first to analyze and compare the liability frameworks governing medical injuries caused by black-box AI in the United States and European Union, this Article demystifies the structure and relevance of foreign law in this area to provide practical guidance to courts, litigators, and other stakeholders seeking to understand the application and limitations of current and newly proposed liability law in this domain. We reveal that remarkably similar principles will operate to govern liability for medical injuries caused by black‑box AI and that, as a result, both jurisdictions face similar liability challenges. These similarities offer an opportunity for the United States to learn from the European Union’s newly developed approach to governing liability for AI-caused injuries. In particular, we identify four valuable lessons from the European Union’s approach. First, a broad approach to AI liability fails to provide solutions to some challenges posed by black-box AI in healthcare. Second, traditional concepts of human fault pose significant challenges in cases involving black-box AI. Third, product liability frameworks must consider the unique features of black-box AI. Fourth, evidentiary rules should address the difficulties that claimants will face in cases involving medical injuries caused by black-box AI

Video Endoscopy as Big Data: Balancing Privacy and Progress in Gastroenterology

Tens of millions of gastrointestinal (GI) endoscopy videos and images are generated annually in the United States (1). A single 15-minute endoscopic procedure, recorded at 30 frames per second, generates approximately 27,000 high-definition images, representing a treasure trove of potential data. In the era of artificial intelligence (AI) and machine learning (ML), this data stream will not only fuel innovative and clinically impactful research in gastroenterology for both academic and commercial purposes, but also introduce ethical and legal concerns that merit consideration. Gastroenterologists are now faced with navigating new questions around data privacy and data ownership that have previously not been central to the endoscopy suite

A Theory of Federalization Doctrine

The doctrine of federalization—the practice of the U.S. Supreme Court consulting state laws or adopting state court doctrines to guide and inform federal constitutional law—is an underappreciated field of study within American constitutional law. Compared to the vast collection of scholarly literature and judicial rulings addressing the outsized influence Supreme Court doctrine and federal constitutional law exert over state court doctrines and state legislative enactments, the opposite phenomenon of the states shaping Supreme Court doctrine and federal constitutional law has been under-addressed. This lack of attention to such a singular feature of American federalism is striking and has resulted in a failure by scholars and jurists to articulate the historical origins of and theoretical rationales for federalization doctrine. Constitutional theory ought not only to produce doctrine, but to validate the application of existing doctrine—or interpretive practices—as well. This Article explores this constitutional lacuna by studying several historical developments of pre-Republic state courts, state constitutions, and state laws to trace the theoretical origins of federalization. Further, it sets forth a justificatory theory of federalization doctrine by arguing that the doctrine emanates from the founding generation’s practices of consulting and borrowing the pre-Republic states’ judicial opinions, constitutions, and statutes to draft and interpret the federal Constitution and its Bill of Rights. These practices of consultation and borrowing should be recognized as the theoretical antecedent for the practical application of the Supreme Court’s modern-day doctrine of federalization. The Article concludes by discussing Chief Justice John Roberts’ special application of the theory of federalization doctrine in the Court’s Moore v. Harper landmark ruling discarding of the independent state legislature doctrine

The Paradox of The Paradox of Democracy

In The Paradox of Democracy: Free Speech, Open Media, and Perilous Persuasion, authors Zac Gershberg and Sean Illing argue that democracies contain the capacity for their own destruction because they promote open communication but such communication can be manipulated by authoritarian forces. They argue further that with contemporary communications technologies the descent into fascism is even more likely. The authors argue that in order to confront these threats, democratic nations must increase media literacy within the citizenry and strengthen local journalism. Given the grave nature of the threats the authors have exposed, these solutions do not appear up to the task of defending democracy. Indeed, a deeper analysis of The Paradox of Democracy suggests that it is not just the solutions, but the analysis itself, that leaves some stones unturned, glossed over, or completely ignored. Although the work is a useful complement to other works addressing the present threats to democracy, like some of those other works, it, too, fails to provide a complete picture of these threats or offer viable options for resisting them. When read together, however, a more complete picture of not just the threats, but also the tactics and strategies necessary to oppose them, comes into view

Using the Common Law of Contracts to Police Abusive Terms in Hospital Admissions Agreements: Balancing Freedom of Contract with Fairness

Standard hospital admissions contracts (“HACs”) often contain provisions that are shockingly unfair, but are easily overlooked or misunderstood by patients. Hospitals rely on the common law of contracts, especially the doctrine of freedom of contract, to claim that these provisions should be enforced. Many courts have accepted the freedom of contract argument and enforced some or all of these provisions. This Article suggests that courts are in error to enforce these harsh provisions against patients. This Article focuses on four harsh provisions commonly found in HACs. First is the payment provision which is opaque, misleading, and designed to allow hospitals to price gouge self-pay patients by charging an exorbitant price. Second is the pernicious pre-dispute binding arbitration clause, which provides that patients waive their constitutional right to sue in court when they have been the victim of medical negligence. Third is the independent contractor provision that requires patients to acknowledge that the doctors treating the patient are independent contractors and thus prevents the patient from suing the hospital in the event of medical professional negligence. The fourth is the overly broad assignment of benefits provision that requires patients to assign not just health insurance benefits, but all other insurance benefits that may cover the patient’s losses related to an accident, including medical expenses and the proceeds of any claim the patient may have against any person that caused the patient’s injuries. This provision allows hospitals to exploit patients who have been the victim of an accident by charging, even for insured patients, the hospital’s exorbitant list price for the care provided. Moreover, because the hospital uses this provision to take a grossly excessive fee, there is less money available to reimburse the patient for other losses resulting from the accident. The gross unfairness of these provisions, the latent dangers they create for patients, and standardized nature of HACs provide more than enough justification for courts to use existing common law doctrines to refuse enforcement of these harsh provisions. In particular, common law contract requirements of mutual assent and capacity to contract, as well as doctrines concerning contracts of adhesion and unconscionable contracts can and should be used to limit or eliminate the enforceability of these provisions

Childist Objections, Youthful Relevance, and Evidence Reconceived

Evidence rules are written by and for adults. As a result, they largely lack the vantage point of youth and are rooted in arm’s-length assumptions about the lives and legal interests of young people. Moreover, because children have been mostly treated as evidentiary afterthoughts, they have been patched into the justice system and its procedures in a piecemeal fashion. Yet, to date, there has been no comprehensive scholarly critique of evidence principles and practices for failing to meaningfully account for youth. And the evidentiary intersection of youth and race has been almost entirely overlooked in legal scholarship. This Article, in part drawing from a range of contemporary examples including the Derek Chauvin trial, begins to provide such analysis. It suggests that evidence law and practice are not only steeped in gender and race bias but unduly adult-centric—and childist—in their orientation. Further, it recommends a more humanist reconception of court proceedings to account for all individuals as whole persons with strengths, weaknesses, vulnerabilities, and complexities in the here and now—regardless of their age or stage in life

The Feminist-Neutrality Paradox

This Symposium asks us to contemplate women’s role in the judiciary. Female judges are vital to a well-functioning third branch of government given the long-documented link between diversity and judicial legitimacy. Beyond appearances, however, the Article explores the reasons why so many empirical studies have shown that judges do not decide cases differently on account of their gender. This Article describes how women must act like men to gain acceptance into the male-dominated judicial sphere and then are expected to apply precedent that has been overwhelmingly decided by men. In other words, the decisions of female (and feminist) judges are largely the same as those of their male counterparts because of systemic pressures on female judges to conform to the unstated male norm under the guise of neutrality and the rule of law. These observations are not new. But in the wake of Dobbs v. Jackson Women’s Health Organization— the case that erased the constitutional right to abortion with little concern for the appearance of judicial neutrality or stare decisis—this Article asks whether feminists should stop playing by the rules

Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article is not meant to be comprehensive but rather thought-provoking. The goal is to engage clinical neuroradiologists in the debate and equip them to actively shape these topics in the future