Law Commons^™

Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen

Articles

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed …

Humans In The Loop, Nicholson Price Ii, Rebecca Crootof, Margot Kaminski

Articles

From lethal drones to cancer diagnostics, humans are increasingly working with complex and artificially intelligent algorithms to make decisions which affect human lives, raising questions about how best to regulate these “human in the loop” systems. We make four contributions to the discourse.

First, contrary to the popular narrative, law is already profoundly and often problematically involved in governing human-in-the-loop systems: it regularly affects whether humans are retained in or removed from the loop. Second, we identify “the MABA-MABA trap,” which occurs when policymakers attempt to address concerns about algorithmic incapacities by inserting a human into decision making process. Regardless …

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 …

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 …

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 …

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.

An Agent-Based Model Of Financial Benchmark Manipulation, Gabriel Virgil Rauterberg, Megan Shearer, Michael Wellman

Articles

Financial benchmarks estimate market values or reference rates used in a wide variety of contexts, but are often calculated from data generated by parties who have incentives to manipulate these benchmarks. Since the the London Interbank Offered Rate (LIBOR) scandal in 2011, market participants, scholars, and regulators have scrutinized financial benchmarks and the ability of traders to manipulate them. We study the impact on market quality and microstructure of manipulating transaction-based benchmarks in a simulated market environment. Our market consists of a single benchmark manipulator with external holdings dependent on the benchmark, and numerous background traders unaffected by the benchmark. …