Law Commons^™

Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs

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Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …

The Case For Banning (And Mandating) Ransomware Insurance, Kyle D. Logue, Adam B. Shniderman

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Ransomware attacks are becoming increasingly pervasive and disruptive, resulting in ransom demands becoming more exorbitant. Payments for ransom costs are increasingly being covered by insurance, which may offer coverage for a variety of cyber-related losses. Some commentators have expressed concern over this market phenomenon. Specifically, the concern is that the presence of insurance is making the ransomware problem worse based on the following theory: because there is ransomware insurance that covers ransom payments, and because paying the ransom is often far cheaper than paying the restoration and business interruption costs covered under the policy, there is an increased tendency to …

Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii

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Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those related to liability. Well-designed AI liability insurance can mitigate predictable liability risks and uncertainties in a way that is aligned with the interests of health care’s main stakeholders, including patients, physicians, and health care organization leadership. A market for AI insurance will encourage the use of high-quality AI, because insurers will be most keen to underwrite those products that are …

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

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In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

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Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

The Orkney Slew And Central Bank Digital Currencies, Jeffery Y. Zhang, Gary B. Gordon

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This Article on central bank digital currencies is motivated by a parable, The Orkney Slew, which is set in an archipelago. Based on the parable, we point out a significant economic market failure that exists in the cross-border payments realm. The analysis then focuses on real-world examples and the national security concerns, including for Anti-Money Laundering/Combatting the Financing of Terrorism (AML/CFT) and the continued efficacy of U.S. sanctions, associated with the rapidly evolving digital payments landscape.

Many central banks around the world are now cooperatively experimenting with cross-border interoperability of digital currencies. These efforts are driven by the idea of …

The Promise And Limits Of Lawfulness: Inequality, Law, And The Techlash, Salomé Viljoen

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In response to widespread skepticism about the recent rise of “tech ethics”, many critics have called for legal reform instead. In contrast with the “ethics response”, critics consider the “lawfulness response” more capable of disciplining the excesses of the technology industry. In fact, both are simultaneously vulnerable to industry capture and capable of advancing a more democratic egalitarian agenda for the information economy. Both ethics and law offer a terrain of contestation, rather than a predetermined set of commitments by which to achieve more democratic and egalitarian technological production. In advancing this argument, the essay focuses on two misunderstandings common …

How Much Can Potential Jurors Tell Us About Liability For Medical Artificial Intelligence?, W. Nicholson Price Ii, Sara Gerke, I. Glenn Cohen

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Artificial intelligence (AI) is rapidly entering medical practice, whether for risk prediction, diagnosis, or treatment recommendation. But a persistent question keeps arising: What happens when things go wrong? When patients are injured, and AI was involved, who will be liable and how? Liability is likely to influence the behavior of physicians who decide whether to follow AI advice, hospitals that implement AI tools for physician use, and developers who create those tools in the first place. If physicians are shielded from liability (typically medical malpractice liability) when they use AI tools, even if patient injury results, they are more likely …

Clearing Opacity Through Machine Learning, W. Nicholson Price Ii, Arti K. Rai

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Artificial intelligence and machine learning represent powerful tools in many fields, ranging from criminal justice to human biology to climate change. Part of the power of these tools arises from their ability to make predictions and glean useful information about complex real-world systems without the need to understand the workings of those systems.

Regulatory Responses To Medical Machine Learning, Timo Minssen, Sara Gerke, Mateo Aboy, W. Nicholson Price Ii, Glenn Cohen

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Companies and healthcare providers are developing and implementing new applications of medical artificial intelligence, including the artificial intelligence sub-type of medical machine learning (MML).MML is based on the application of machine learning (ML) algorithms to automatically identify patterns and act on medical data to guide clinical decisions. MML poses challenges and raises important questions, including (1) How will regulators evaluate MML-based medical devices to ensure their safety and effectiveness? and (2) What additional MML considerations should be taken into account in the international context? To address these questions, we analyze the current regulatory approaches to MML in the USA and …

Are Litigation Outcome Disparities Inevitable? Courts, Technology, And The Future Of Impartiality., Avital Mentovich, J.J. Prescott, Orna Rabinovich-Einy

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This article explores the ability of technology—specifically, online judicial procedures—to eliminate systematic group-level litigation outcome disparities (i.e., disparities correlated with the visible identity markers of litigants). Our judicial system has long operated under the assumption that it can only be “impartial enough.” After all, judges, like all human beings, harbor implicit biases that are often sizable, unconscious, and triggered automatically, and research indicates that strategies to curb implicit biases in human decision making may be ineffective, especially in the face of the resource and caseload constraints of modern-day adjudication. The recent emergence of online court proceedings, however, offers new hope …

Potential Liability For Physicians Using Artificial Intelligence, W. Nicholson Price Ii, Sara Gerke, I Glenn Cohen

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Artificial intelligence (AI) is quickly making inroads into medical practice, especially in forms that rely on machine learning, with a mix of hope and hype. Multiple AI-based products have now been approved or cleared by the US Food and Drug Administration (FDA), and health systems and hospitals are increasingly deploying AI-based systems. For example, medical AI can support clinical decisions, such as recommending drugs or dosages or interpreting radiological images.2 One key difference from most traditional clinical decision support software is that some medical AI may communicate results or recommendations to the care team without being able to communicate the …

Medical Ai And Contextual Bias, W. Nicholson Price Ii

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Artificial intelligence will transform medicine. One particularly attractive possibility is the democratization of medical expertise. If black-box medical algorithms can be trained to match the performance of high-level human experts — to identify malignancies as well as trained radiologists, to diagnose diabetic retinopathy as well as board-certified ophthalmologists, or to recommend tumor-specific courses of treatment as well as top-ranked oncologists — then those algorithms could be deployed in medical settings where human experts are not available, and patients could benefit. But there is a problem with this vision. Privacy law, malpractice, insurance reimbursement, and FDA approval standards all encourage developers …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, Will Nicholson Price Ii

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Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its own challenges, and an understanding of the four roles …

Grants, Nicholson Price Ii

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Innovation is a primary source of economic growth and is accordingly the target of substantial academic and government attention. Grants are a key tool in the government’s arsenal to promote innovation, but legal academic studies of that arsenal have given them short shrift. Although patents, prizes, and regulator-enforced exclusivity are each the subject of substantial literature, grants are typically addressed briefly, if at all. According to the conventional story, grants may be the only feasible tool to drive basic research, as opposed to applied research, but they are a blunt tool for that task. Three critiques of grants underlie this …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii

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Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …

Targeting Poverty In The Courts: Improving The Measurement Of Ability To Pay Fines, Meghan M. O'Neil, J.J. Prescott

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Ability-to-pay determinations are essential when governments use money-based alternative sanctions, like fines, to enforce laws. One longstanding difficulty in the U.S. has been the extreme lack of guidance on how courts are to determine a litigant’s ability to pay. The result has been a seat-of-the-pants approach that is inefficient and inaccurate, and, as a consequence, very socially costly. Fortunately, online platform technology presents a promising avenue for reform. In particular, platform technology offers the potential to increase litigant access, reduce costs, and ensure consistent and fair treatment—all of which should lead to more accurate sanctions. We use interviews, surveys, and …

Lawyer As Soothsayer: Exploring The Important Role Of Outcome Prediction In The Practice Of Law, Mark K. Osbeck

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Outcome prediction has always been an important part of practicing law. Clients rely heavily on their attorneys to provide accurate assessments of the potential legal consequences they face when making important decisions (such as whether to accept a plea bargain, or risk a conviction on a much more serious offense at trial). And yet, notwithstanding its enormous importance to the practice of law (and notwithstanding the handsome legal fees it commands), outcome prediction in the law remains a very imprecise endeavor. The reason for this inaccuracy is that the three principal tools lawyers have traditionally relied on to facilitate outcome …

Universities: The Fallen Angels Of Bayh-Dole?, Rebecca S. Eisenberg, Robert Cook-Deegan

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The Bayh-Dole Act of 1980 established a new default rule that allowed nonprofit organizations and small businesses to own, as a routine matter, patents on inventions resulting from research sponsored by the federal government. Although universities helped get the Bayh-Dole Act through Congress, the primary goal, as reflected in the recitals at the beginning of the new statute, was not to benefit universities but to promote the commercial development and utilization of federally funded inventions. In the years since the passage of the Bayh-Dole Act, universities seem to have lost sight of this distinction. Their behavior as patent seekers, patent …

Outcome Prediction In The Practice Of Law, Mark K. Osbeck, Michael Gilliland

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Business forecasters typically use time-series models to predict future demands, the forecasts informing management decision making and guiding organizational planning. But this type of forecasting is merely a subset of the broader field of predictive analytics, models used by data scientists in all manner of applications, including credit approvals, fraud detection, product-purchase and music-listening recommendations, and even the real-time decisions made by self-driving vehicles. The practice of law requires decisions that must be based on predictions of future legal outcomes, and data scientists are now developing forecasting methods to support the process. In this article, Mark Osbeck and Mike Gilliland …

Fourth Amendment Constraints On The Technological Monitoring Of Convicted Sex Offenders, Ben A. Mcjunkin, J. J. Prescott

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More than forty U.S. states currently track at least some of their convicted sex offenders using GPS devices. Many offenders will be monitored for life. The burdens and expense of living indefinitely under constant technological monitoring have been well documented, but most commentators have assumed that these burdens were of no constitutional moment because states have characterized such surveillance as ‘‘civil’’ in character—and courts have seemed to agree. In 2015, however, the Supreme Court decided in Grady v. North Carolina that attaching a GPS monitoring device to a person was a Fourth Amendment search, notwithstanding the ostensibly civil character of …

The Future Of Law And Mobility, Daniel A. Crane

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With the launch of the new Journal of Law and Mobility, the University of Michigan is recognizing the transformative impact of new transportation and mobility technologies, from cars, to trucks, to pedestrians, to drones. The coming transition towards intelligent, automated, and connected mobility systems will transform not only the way people and goods move about, but also the way human safety, privacy, and security are protected, cities are organized, machines and people are connected, and the public and private spheres are defined.

Controlling The Jury-Teaching Function, Richard D. Friedman

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When evidence with a scientific basis is offered, two fundamental questions arise. First, should it be admitted? Second, if so, how should it be assessed? There are numerous participants who might play a role in deciding these questions—the jury (on the second question only), the parties (through counsel), expert witnesses on each side, the trial court, the forces controlling the judicial system (which include, but are not limited to, the appellate courts), and the scientific establishment. In this Article, I will suggest that together, the last two—the forces controlling the judicial system and the scientific establishment—have a large role to …

Scientific Trials--In The Laboratories, Not The Courts, Nicholas Bagley, Aaron E. Carroll, Pieter A. Cohen

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In 2015, one of us published a peer-reviewed study, together with colleagues at the University of California, San Francisco, replicating prior research from the US Food and Drug Administration (FDA) detecting a designer stimulant, β-methylphenylethylamine, in sports, weight loss, and “cognitive function” supplements sold in the United States. The confirmatory study prompted the FDA to take enforcement action against companies selling the stimulant as a dietary ingredient. One of the companies that received an FDA warning letter sued the study’s authors for $200 million in damages for libel, claiming, without supporting scientific evidence, that multiple statements in the article were …

Assessing Access-To-Justice Outreach Strategies, J. J. Prescott

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The need for prospective beneficiaries to “take up” new programs is a common stumbling block for otherwise well-designed legal and policy innovations. I examine the take-up problem in the context of publicly provided court services and test the effectiveness of various outreach strategies that announce a newly available online court access platform. I study individuals with minor arrest warrants whose distrust of courts may dampen any take-up response. I partnered with a court to quasi-randomly assign outreach approaches to a cohort of individuals and find that outreach improves take-up, that the type of outreach matters, and that online platform access …

Risk And Resilience In Health Data Infrastructure, W. Nicholson Price Ii

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Today’s health system runs on data. However, for a system that generates and requires so much data, the health care system is surprisingly bad at maintaining, connecting, and using those data. In the easy cases of coordinated care and stationary patients, the system works—sometimes. But when care is fragmented, fragmented data often result. Fragmented data create risks both to individual patients and to the system. For patients, fragmentation creates risks in care based on incomplete or incorrect information, and may also lead to privacy risks from a patched together system. For the system, data fragmentation hinders efforts to improve efficiency …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

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Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …

Contracts Ex Machina, Kevin Werbach, Nicolas Cornell

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Smart contracts are self-executing digital transactions using decentralized cryptographic mechanisms for enforcement. They were theorized more than twenty years ago, but the recent development of Bitcoin and blockchain technologies has rekindled excitement about their potential among technologists and industry. Startup companies and major enterprises alike are now developing smart contract solutions for an array of markets, purporting to offer a digital bypass around traditional contract law. For legal scholars, smart contracts pose a significant question: Do smart contracts offer a superior solution to the problems that contract law addresses? In this article, we aim to understand both the potential and …

Improving Access To Justice In State Courts With Platform Technology, J. J. Prescott

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Access to justice often equates to access to state courts, and for millions of Americans, using state courts to resolve their disputes—often with the government—is a real challenge. Reforms are regularly proposed in the hopes of improving the situation (e.g., better legal aid), but until recently a significant part of the problem has been structural. Using state courts today for all but the simplest of legal transactions entails at the very least traveling to a courthouse and meeting with a decision maker in person and in a one-on-one setting. Even minimally effective access, therefore, requires time, transportation, and very often …

Factors In Fairness And Emotion In Online Case Resolution Systems, Youyang Hou, Cliff Lampe, Maximilian Bulinski, J. J. Prescott

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Courts are increasingly adopting online information and communication technology, creating a need to consider the potential consequences of these tools for the justice system. Using survey responses from 209 litigants who had recently used an online case resolution system, we investigate factors that influenced litigants’ experiences of fairness and emotional feelings toward court officials. Our results show that ease of using the online case resolution system, the outcome of the case, and a litigant’s perceptions of procedural justice are positively associated both with whether the litigant views the process as fair and whether the litigant ultimately feels positive emotions toward …