Law Commons^™

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 …

Emergencies End Eventually: How To Better Analyze Human Rights Restrictions Sparked By The Covid-19 Pandemic Under The International Covenant On Civil And Political Rights, Eric Richardson, Colleen Devine

Michigan Journal of International Law

In the wake of the COVID-19 pandemic, states have been quick to adopt emergency measures aimed at curbing the spread of the virus. However, poorly constructed restrictions threaten to undermine hard won human rights protections and may in fact erode important elements of international human rights law as a result of overreaching implementation or lack of rigorous analysis in how the restrictions are put, and kept, in place. This article analyzes the International Convent on Civil and Political Rights (ICCPR) standards which apply to emergency regulation in times of public health crisis and the tangled morass of legal tests which …

The Scales Of Reproductive Justice: Casey’S Failure To Rebalance Liberty Interests In The Racially Disparate State Of Maternal Medicine, Mallori D. Thompson

Michigan Journal of Race and Law

Despite the maternal medicine crisis in the U.S., especially for Black women, legislatures are challenging constitutional abortion doctrine and forcing women to interact with a system that may cost them their lives. This Article proposes that because of abysmal maternal mortality rates and the arbitrary nature of most abortion restrictions, the right to choose an abortion is embedded in our Fourteenth Amendment right to not be arbitrarily deprived of life by the State. This Article is a call to abortion advocates to begin submitting state maternal mortality data when challenging abortion restrictions. The call for attention to life was central …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

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

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 …

Medical Violence, Obstetric Racism, And The Limits Of Informed Consent For Black Women, Colleen Campbell

Michigan Journal of Race and Law

This Essay critically examines how medicine actively engages in the reproductive subordination of Black women. In obstetrics, particularly, Black women must contend with both gender and race subordination. Early American gynecology treated Black women as expendable clinical material for its institutional needs. This medical violence was animated by biological racism and the legal and economic exigencies of the antebellum era. Medical racism continues to animate Black women’s navigation of and their dehumanization within obstetrics. Today, the racial disparities in cesarean sections illustrate that Black women are simultaneously overmedicalized and medically neglected—an extension of historical medical practices rooted in the logic …

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

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.

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. …

Reclaiming Access To Truth In Reproductive Healthcare After National Institute Of Family & Life Advocates V. Becerra, Diane Kee

Michigan Law Review

Crisis Pregnancy Centers (CPCs) are antiabortion organizations that seek to “intercept” people with unintended pregnancies to convince them to forego abortion. It is well documented that CPCs intentionally present themselves as medical professionals even when they lack licensure, while also providing medically inaccurate information on abortion. To combat the blatant deception committed by CPCs, California passed the Reproductive FACT Act in 2015. The Act required CPCs to post notices that disclosed their licensure status and informed potential clients that the state provided subsidized abortion and contraceptives. Soon after, CPCs brought First Amendment challenges to these disclosure requirements, claiming that the …

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

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. …

Putting The Fetus First — Legal Regulation, Motherhood, And Pregnancy, Emma Milne

Michigan Journal of Gender & Law

The fetus-first mentality advocates that pregnant women and women who could become pregnant should put the needs and well-being of their fetuses before their own. As this Article will illustrate, this popular public perception has pervaded criminal law, impacting responses to women deemed to be the “irresponsible” pregnant woman and so the “bad” mother. The Article considers cases from Alabama and Indiana in the United States and from England in the United Kingdom, providing clear evidence that concerns about the behavior of pregnant women now hang heavily over criminal justice responses to women who experience a negative pregnancy outcome or …

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

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

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.

Healthy Data Protection, Lothar Determann

Michigan Technology Law Review

Modern medicine is evolving at a tremendous speed. On a daily basis, we learn about new treatments, drugs, medical devices, and diagnoses. Both established technology companies and start-ups focus on health-related products and services in competition with traditional healthcare businesses. Telemedicine and electronic health records have the potential to improve the effectiveness of treatments significantly. Progress in the medical field depends above all on data, specifically health information. Physicians, researchers, and developers need health information to help patients by improving diagnoses, customizing treatments and finding new cures.

Yet law and policymakers are currently more focused on the fact that health …

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.

Redefining Reproductive Rights And Justice, Leah Litman

Michigan Law Review

Review of Reproductive Rights and Justice Stories edited by Melissa Murray, Katherine Shaw, and Reva B. Siegel.

The Intellectual Property Of Vaccines: Takeaways From Recent Infectious Disease Outbreaks, Ana Santos Rutschman

Michigan Law Review Online

In late 2019 and early 2020, a new strain of coronavirus, a family of pathogens causing serious respiratory illness, began infecting populations across the globe. A quick uptick in COVID-19, the disease caused by the novel pathogen, prompted the World Health Organization to declare the outbreak a Public Health Emergency of International Concern on January 30, 2020. By mid-February 2020, with 26 countries reporting cases of COVID-19 infection, the global case count had surpassed 50,000, and had resulted in over 1,500 deaths. The World Health Organization elevated the status of the outbreak to a pandemic in mid-March. As of early …

The Ncaa's Special Relationship With Student-Athletes As A Theory Of Liability For Concussion-Related Injuries, Tezira Abe

Michigan Law Review

The National Collegiate Athletic Association (NCAA) is the primary governing body of college athletics. Although the NCAA proclaims to protect student-athletes, an examination of its practices suggests that the organization has a troubling history of ignoring the harmful effects of concussions. Over one hundred years after the NCAA was established, and seventy years after the NCAA itself knew of the potential effects of concussions, the organization has done little to reduce the occurrence of concussions or to alleviate the potential effects that stem from repeated hits to the head. This Note argues for recognizing a special relationship between the NCAA …

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 …

The Hidden Disability Consensus In The 2020 Campaign, Harold A. Pollack, Samuel R. Bagenstos

Articles

At this writing, the final results of the Iowa caucuses remain unreported. No one yet knows which candidates did well and which did poorly. We do know that health policy is a defining cleavage between left and liberal Democrats this primary season. Much of the press coverage will naturally focus on the implications of this vote for Democrats’ commitment to an incremental public option or a full-throated single-payer plan.

Olmstead V. L.C.: The Supreme Court Case, Samuel R. Bagenstos, Irv Gornstein, Michael Gottesman, Jennifer Mathis

Articles

You have an incredible luxury here at Georgetown Law. You have faculty who are engaged in the world like two of my colleagues on this panel. To my immediate left is Professor Michael Gottesman (Georgetown University Law Center) who argued the case on behalf of Lois and Elaine, and to my next far left, Professor Irv Gornstein (Georgetown University Law Center) who argued the case on behalf of the United States. Between them is Jennifer Mathis (The Bazelon Center for Mental Health Law) who has spent, I think, most of her career at the Bazelon Center litigating, and organizing, and …

Is Obamacare Really Unconstitutional?, Nicholas Bagley

Articles

On December 18, 2019, just 3 days after the close of open enrollment on the exchanges and on the same day the House of Representatives impeached President Donald Trump, a conservative appeals court handed the President a major victory in his crusade against the Affordable Care Act (ACA). Over a stern dissent, the U.S. Court of Appeals for the Fifth Circuit declared that the law’s individual mandate is unconstitutional and that the entire rest of the law might therefore be invalid.

Prescription Restriction: Why Birth Control Must Be Over-The-Counter In The United States, Susannah Iles

Michigan Journal of Gender & Law

This Note argues that it is harmful and unnecessary to require women to obtain prescriptions for access to hormonal birth control. Requiring a prescription is necessarily a barrier to access which hurts women and hamstrings the ability to dictate their own reproductive plans. It is also an irrational regulation in light of the relative safety of hormonal birth control pills, particularly progestin-only formulations, compared to other drugs readily available on the shelves.

Leading medical organizations, including the American College of Obstetrics and Gynecologists, advocate for over-the-counter access to hormonal birth control. While acknowledging that not every woman will have positive …

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

Articles

Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

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

Articles

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 …

Executive Power And The Aca, Nicholas Bagley

Book Chapters

As with any law of its complexity and ambition, the Affordable Care Act (ACA) vests in the sitting president broad implementation discretion. The law is not a blank check: in many ways both large and small, the ACA shapes and constrains the exercise of executive power. But Congress has neither the institutional resources nor the attention span to micromanage the rollout of a massive health program. It has no choice but to delegate.

Naturally, both President Obama and President Trump have drawn on their authority to tailor the ACA to their policy preferences. Neither president, however, has been able to …