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Articles 1 - 30 of 162
Full-Text Articles in Law
Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen
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 …
Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin
Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin
Articles
Disruptive social events such as the COVID-19 pandemic can have a significant impact on sex trafficking and the working conditions of victims, yet these effects have been little understood. This paper examines the effect of the COVID-19 pandemic on sex trafficking in the United States, based on analysis of over one million sexual service advertisements from the online platform Rubratings.com, using indicators of third-party management as potential proxies for trafficking. Our results show that there have been measurable changes in online commercial sexual service advertising, both with and without third-party management indicators, in the United States, with a significant decrease …
Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price
Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel Sachs, Nicholson Price
Law & Economics Working Papers
If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (IRA) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …
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 …
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
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
Articles
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 …
Distributed Governance Of Medical Ai, W. Nicholson Price Ii
Distributed Governance Of Medical Ai, W. Nicholson Price Ii
Law & Economics Working Papers
Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference …
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
Articles
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 …
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.
Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii
Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii
Reviews
Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …
Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price
Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price
Articles
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.
Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley
Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley
Articles
Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1
Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii
Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii
Articles
Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …
California V. Texas — Ending The Campaign To Undo The Aca In The Courts, Nicholas Bagley
California V. Texas — Ending The Campaign To Undo The Aca In The Courts, Nicholas Bagley
Articles
On June 17, 2021, the U.S. Supreme Court, by a 7-to-2 vote, rejected what will probably be the last major case seeking to uproot the Affordable Care Act (ACA). Although skirmishes over the law and its implementation will persist, the Court’s decision most likely marks an end to Republicans’ efforts to achieve in the courts what they have been unable to achieve in Congress.
Preventing Child Maltreatment Through Medical-Legal Partnership, Debra Chopp
Preventing Child Maltreatment Through Medical-Legal Partnership, Debra Chopp
Book Chapters
There has been significant attention in recent years to health care delivery models that address social determinants of health. One such model is medical-legal partnership (MLP). MLPs join health care providers with lawyers to address health-harming legal needs in the lives of vulnerable patients. Research on MLPs has demonstrated their success in reducing stress and increasing health and well-being in the patients they serve and in their families. This chapter explores the possibility of using MLP as a tool to prevent child maltreatment.
Suicide Prevention And Mood Disorders: Self-Exclusion Agreements For Firearms As A Suicide Prevention Strategy, Melvin G. Mcinnis, Stephen B. Thompson, Sofia D. Merajver, Carl E. Schneider
Suicide Prevention And Mood Disorders: Self-Exclusion Agreements For Firearms As A Suicide Prevention Strategy, Melvin G. Mcinnis, Stephen B. Thompson, Sofia D. Merajver, Carl E. Schneider
Articles
Suicide involves a complex set of behaviors and emotions that lead up to actions that may be based on planning and forethought or the result of impulse. While there are a host of antecedent circumstances the presence of a mood disorder, primarily depression, is the most common factor in suicide. While management of depression is recognized as important prevention strategy in depression, the means by which suicide occurs must be a critical element of prevention. Policies that lower access to the means for suicide will decrease the fatality. Guns are associated with half of suicides and the case fatality rate …
Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii
Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii
Law & Economics Working Papers
The interaction of artificial intelligence (“AI”) and health privacy is a two-way street. Both directions are problematic. This Article makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set of entities, the process of data collection while following privacy rules, and the use of …
The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds
The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds
Articles
Incarcerated people are excluded from Medicaid coverage due to a provision in the Social Security Act Amendments of 1965 known as the Medicaid Inmate Exclusion Policy (“MIEP”). This Article argues for the elimination of the MIEP as an anachronistic remnant of an earlier era prior to the massive growth of the U.S. incarcerated population and the expansion of Medicaid eligibility under the Patient Protection and Affordable Care Act of 2010. It explores three reasons for eliminating the MIEP. First, the inclusion of incarcerated populations in Medicaid coverage would signify the final erasure from the Medicaid regime of the istinction between …
New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg
New Innovation Models In Medical Ai, Nicholson Price Ii, Rachel Sachs, Rebecca S. Eisenberg
Law & Economics Working Papers
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those which 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 that relate 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 …
Workers' Comp And Contagious Disease: History And Future, Kate E. Britt
Workers' Comp And Contagious Disease: History And Future, Kate E. Britt
Law Librarian Scholarship
Modern workers’ compensation schemes set out to provide financial relief to employees who contract an occupational disease during employment, like miners contracting black lung or contractors exposed to asbestos. Certain professions are understood to stand a particular risk of exposure to contagious diseases. Health-care workers interact with persons carrying contagious disease as a matter of course. What workers’ compensation does not cover are diseases which are so prevalent they are considered an “ordinary disease of life.” These diseases, like the common cold, influenza, or pneumonia, could be contracted by persons regardless of their profession, and workers’ compensation acts generally limit …
How Much Can Potential Jurors Tell Us About Liability For Medical Artificial Intelligence?, W. Nicholson Price Ii, Sara Gerke, I. Glenn Cohen
How Much Can Potential Jurors Tell Us About Liability For Medical Artificial Intelligence?, W. Nicholson Price Ii, Sara Gerke, I. Glenn Cohen
Articles
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 …
The New Eugenics, Samuel R. Bagenstos
The New Eugenics, Samuel R. Bagenstos
Articles
During the first third of the Twentieth Century, the eugenics movement played a powerful role in the politics, law, and culture of the United States. The fear of “the menace of the feebleminded,” the notion that those with supposedly poor genes “sap the strength of the State,” and other similar ideas drove the enthusiastic implementation of the practices of excluding disabled individuals from the country, incarcerating them in ostensibly beneficent institutions, and sterilizing them. By the 1930s, with the rise of Adolf Hitler in Germany, eugenic ideas had begun to be discredited in American public discourse. And after the Holocaust, …
Opioid Settlement Funds: Do Not Neglect Patients With Pain, Mark C. Bicket, Barbara Mcquade, Chad M. Brummett
Opioid Settlement Funds: Do Not Neglect Patients With Pain, Mark C. Bicket, Barbara Mcquade, Chad M. Brummett
Articles
The opioid crisis has escalated in the setting of the COVID-19 pandemic to new extremes and has claimed more than half a million lives in the US since 2000. Lawsuits to address the civil and criminal liability of drug companies and other groups have originated from federal, state, local, and tribal jurisdictions. When successful, there will likely be billions of dollars and significant discretion as to how these funds are spent. Several groups have produced reports with principles to address the toll of addiction using settlement funds. However, they lack actionable strategies to address the needs of patients with pain, …
Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.
Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.
Articles
Tax policy can play important roles in limiting the spread of communicable disease and in managing the economic fallout of a pandemic. Taxes on business activities that bring workers or customers into close contact with each other offer efficient alternatives to broad regulatory measures, such as shutdowns, that have been effective but enormously costly. Corrective taxation also helps raise the revenue required to cover elevated government expenditure during a pandemic. Moreover, the restricted consumer choice that accompanies a pandemic reduces the welfare cost of raising tax revenue from higher-income taxpayers, making it a good time for deficit closure. Current U.S. …
What Will (Or Might?) Law School Look Like This Fall?: Teaching In The Midst Of A Pandemic, Ted Becker
What Will (Or Might?) Law School Look Like This Fall?: Teaching In The Midst Of A Pandemic, Ted Becker
Articles
January 2020 marked the start of a new semester for Michigan law schools. There was little reason to suspect it wouldn’t be a semester like any other: for 3Ls, the start of the stretch run to graduation; for 1Ls, a chance to begin anew after the stress of their first set of law school final exams; for law school faculty, administrators, and staff, a return to the excitement and activity of crowded hallways and classrooms after the brief interlude of winter break. Classes began and proceeded as normal.
What's Left Of The Affordable Care Act?, Helen Levy, Andrew Ying, Nicholas Bagley
What's Left Of The Affordable Care Act?, Helen Levy, Andrew Ying, Nicholas Bagley
Articles
We assess the progress of the Affordable Care Act a decade after it became law. Although most of it remains intact, some parts have been repealed and others have not been implemented as expected. We review how and why the law has aged. Legal challenges have done less damage than is commonly appreciated, with the exception of the Supreme Court case that thwarted full expansion of Medicaid. Most of the important changes have other sources. Some parts were born to fail. Others were dismantled in response to interest-group pressure. Still others have failed to thrive for any number of reasons. …
Medical Marijuana, Taxation, And Internal Revenue Code Section 280e, Douglas A. Kahn, Howard J. Bromberg
Medical Marijuana, Taxation, And Internal Revenue Code Section 280e, Douglas A. Kahn, Howard J. Bromberg
Articles
Congress enacted § 280E of the Internal Revenue Code in 1982 to punish businesses engaged in illegal drug trafficking, including marijuana. Section 280E denies all credits and deductions, including ordinary business expenses, from gross income of businesses illegally trafficking in a Schedule I or II controlled substance. This provision violates the principle that the tax code should foster a consistent treatment of income, regardless of source; and that the income tax is ill-used for punitive measures. Now that marijuana has been legalized in some form in at least 46 states for therapeutic purposes, this federal tax penalty transgresses principles of …
Who Gets The Ventilator? Disability Discrimination In Covid-19 Medical-Rationing Protocols, Samuel Bagenstos
Who Gets The Ventilator? Disability Discrimination In Covid-19 Medical-Rationing Protocols, Samuel Bagenstos
Articles
The coronavirus pandemic has forced us to reckon with the possibility of having to ration life-saving medical treatments. In response, many health systems have employed protocols that explicitly de-prioritize people for these treatments based on pre-existing disabilities. This Essay argues that such protocols violate the Americans with Disabilities Act, the Rehabilitation Act, and the Affordable Care Act. Such explicit discrimination on its face violates these statutes. Nor can medical providers simply define disabled patients as being “unqualified” because of disabilities that do not affect the ability to ameliorate the condition for which treatment is sought. A proper interpretation of the …
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Importing Prescription Drugs From Canada — Legal And Practical Problems With The Trump Administration's Proposal, Rachel E. Sachs, Nicholas Bagley
Articles
As Americans report ever-growing difficulty affording their prescription drugs, President Donald Trump has come under increasing pressure to act. To date, the Trump administration has attempted to advance a number of policy initiatives by means of executive action, but it has not yet adopted a program that would meaningfully assist patients. Most recently, the administration proposed a rule that, if finalized, would allow states to develop programs to import lower-priced prescription drugs from Canada, with the intent of reducing spending on drugs by U.S. patients and states and increasing access for patients.
The Coronavirus And The Risks To The Elderly In Long-Term Care, William Gardner, David States, Nicholas Bagley
The Coronavirus And The Risks To The Elderly In Long-Term Care, William Gardner, David States, Nicholas Bagley
Articles
The elderly in long-term care (LTC) and their caregiving staff are at elevated risk from COVID-19. Outbreaks in LTC facilities can threaten the health care system. COVID-19 suppression should focus on testing and infection control at LTC facilities. Policies should also be developed to ensure that LTC facilities remain adequately staffed and that infection control protocols are closely followed. Family will not be able to visit LTC facilities, increasing isolation and vulnerability to abuse and neglect. To protect residents and staff, supervision of LTC facilities should remain a priority during the pandemic.
May Hospitals Withhold Ventilators From Covid-19 Patients With Pre-Existing Disabilities? Notes On The Law And Ethics Of Disability-Based Medical Rationing, Samuel R. Bagenstos
May Hospitals Withhold Ventilators From Covid-19 Patients With Pre-Existing Disabilities? Notes On The Law And Ethics Of Disability-Based Medical Rationing, Samuel R. Bagenstos
Law & Economics Working Papers
Thanks to the coronavirus pandemic, the threat of medical rationing is now clear and present. Hospitals faced with a crush of patients must now seriously confront questions of how to allocate scarce resources—notably life-saving ventilators—at a time of severe shortage. In their protocols for addressing this situation, hospitals and state agencies often employ explicitly disability-based distinctions. For example, Alabama’s crisis standards of care provide that “people with severe or profound intellectual disability ‘are unlikely candidates for ventilator support.’” This essay, written as this crisis unfolds, argues that disability-based distinctions like these violate the law. The Americans with Disabilities Act, the …