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Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs
Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs
Articles
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 …
Biometrics And An Ai Bill Of Rights, Margaret Hu
Biometrics And An Ai Bill Of Rights, Margaret Hu
Faculty Publications
This Article contends that an informed discussion on an AI Bill of Rights requires grappling with biometric data collection and its integration into emerging AI systems. Biometric AI systems serve a wide range of governmental purposes, including policing, border security and immigration enforcement, and biometric cyberintelligence and biometric-enabled warfare. These systems are increasingly categorized as "high-risk" when deployed in ways that may impact fundamental constitutional rights and human rights. There is growing recognition that high-risk biometric AI systems, such as facial recognition identification, can pose unprecedented challenges to criminal procedure rights. This Article concludes that a failure to recognize these …
Assessing Automated Administration, Cary Coglianese, Alicia Lai
Assessing Automated Administration, Cary Coglianese, Alicia Lai
All Faculty Scholarship
To fulfill their responsibilities, governments rely on administrators and employees who, simply because they are human, are prone to individual and group decision-making errors. These errors have at times produced both major tragedies and minor inefficiencies. One potential strategy for overcoming cognitive limitations and group fallibilities is to invest in artificial intelligence (AI) tools that allow for the automation of governmental tasks, thereby reducing reliance on human decision-making. Yet as much as AI tools show promise for improving public administration, automation itself can fail or can generate controversy. Public administrators face the question of when exactly they should use automation. …
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Other Publications
Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally …
Moving Toward Personalized Law, Cary Coglianese
Moving Toward Personalized Law, Cary Coglianese
All Faculty Scholarship
Rules operate as a tool of governance by making generalizations, thereby cutting down on government officials’ need to make individual determinations. But because they are generalizations, rules can result in inefficient or perverse outcomes due to their over- and under-inclusiveness. With the aid of advances in machine-learning algorithms, however, it is becoming increasingly possible to imagine governments shifting away from a predominant reliance on general rules and instead moving toward increased reliance on precise individual determinations—or on “personalized law,” to use the term Omri Ben-Shahar and Ariel Porat use in the title of their 2021 book. Among the various technological, …
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Other Publications
It may seem counterintuitive to open a book on medical devices with chapters on software and data, but these are the frontiers of new medical device regulation and law. Physical devices are still crucial to medicine, but they – and medical practice as a whole – are embedded in and permeated by networks of software and caches of data. Those software systems are often mindbogglingly complex and largely inscrutable, involving artificial intelligence and machine learning. Ensuring that such software works effectively and safely remains a substantial challenge for regulators and policymakers. Each of the three chapters in this part examines …
Algorithm Vs. Algorithm, Cary Coglianese, Alicia Lai
Algorithm Vs. Algorithm, Cary Coglianese, Alicia Lai
All Faculty Scholarship
Critics raise alarm bells about governmental use of digital algorithms, charging that they are too complex, inscrutable, and prone to bias. A realistic assessment of digital algorithms, though, must acknowledge that government is already driven by algorithms of arguably greater complexity and potential for abuse: the algorithms implicit in human decision-making. The human brain operates algorithmically through complex neural networks. And when humans make collective decisions, they operate via algorithms too—those reflected in legislative, judicial, and administrative processes. Yet these human algorithms undeniably fail and are far from transparent. On an individual level, human decision-making suffers from memory limitations, fatigue, …
Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen
Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen
Law & Economics Working Papers
While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.
Antitrust By Algorithm, Cary Coglianese, Alicia Lai
Antitrust By Algorithm, Cary Coglianese, Alicia Lai
All Faculty Scholarship
Technological innovation is changing private markets around the world. New advances in digital technology have created new opportunities for subtle and evasive forms of anticompetitive behavior by private firms. But some of these same technological advances could also help antitrust regulators improve their performance in detecting and responding to unlawful private conduct. We foresee that the growing digital complexity of the marketplace will necessitate that antitrust authorities increasingly rely on machine-learning algorithms to oversee market behavior. In making this transition, authorities will need to meet several key institutional challenges—building organizational capacity, avoiding legal pitfalls, and establishing public trust—to ensure successful …
From Negative To Positive Algorithm Rights, Cary Coglianese, Kat Hefter
From Negative To Positive Algorithm Rights, Cary Coglianese, Kat Hefter
All Faculty Scholarship
Artificial intelligence, or “AI,” is raising alarm bells. Advocates and scholars propose policies to constrain or even prohibit certain AI uses by governmental entities. These efforts to establish a negative right to be free from AI stem from an understandable motivation to protect the public from arbitrary, biased, or unjust applications of algorithms. This movement to enshrine protective rights follows a familiar pattern of suspicion that has accompanied the introduction of other technologies into governmental processes. Sometimes this initial suspicion of a new technology later transforms into widespread acceptance and even a demand for its use. In this paper, we …