Health Law and Policy Commons^™

Not So Private, Stacey A. Tovino

Faculty Articles

Federal and state laws have long attempted to strike a balance between protecting patient privacy and health information confidentiality on the one hand and supporting important uses and disclosures of health information on the other. To this end, many health laws restrict the use and disclosure of identifiable health data but support the use and disclosure of de-identified data. The goal of health data de-identification is to prevent or minimize informational injuries to identifiable data subjects while allowing the production of aggregate statistics that can be used for biomedical and behavioral research, public health initiatives, informed health care decision making, …

Worth A Shot: Encouraging Vaccine Uptake Through "Empathy", Jody L. Madeira

Articles by Maurer Faculty

Pro- and anti-vaccine organizations and individuals have frequently invoked empathy as a strategy for increasing uptake of COVID-19 precautions, including vaccinations. On one hand, vaccine supporters deployed empathy to defuse conflict, prioritize safeguarding the collective welfare, and avoid government mandates. On the other hand, vaccine opponents used empathy to emphasize the alleged individual effects of pandemic precautions, mobilize public voices, and stress the importance of medical freedom in policy-making contexts.

This Article first defines empathy and reviews empathy scholarship, paying particular attention to its relationship with narrative and the contexts where empathy can be difficult or dangerous. It then applies …

The Limits Of Regulation By Insurance, Kenneth S. Abraham, Daniel Benjamin Schwarcz

Indiana Law Journal

Insurance is an enormously powerful and beneficial method of spreading risk and compensating for loss. But even insurance has its limits. A new and misleading aspiration for insurance—that it also can and often does substitute for or significantly complement health and safety regulation—is increasingly in vogue. This vision starts from the uncontroversial recognition that insurers typically adopt measures designed to counteract “moral hazard,” the tendency of insurance to blunt policyholders’ incentives to take care. But proponents of this vision go on to contend that the risk-reducing potential of insurance is significantly more extensive than is traditionally imagined, because insurers are …

The Next Pandemic Might Be A Petdemic, Hillary Greene

Indiana Law Journal

A new scientific study shows that COVID-19 can be transmitted from cats to humans. Luckily, this channel of transmission seems extremely rare, at least thus far. But next time—and there will be a next time—we may not be so fortunate. This Article addresses this underappreciated risk of what I term a “petdemic”—a pandemic or epidemic that involves significant disease transmission between pets and humans. With nearly 70% of U.S. households owning pets, a petdemic could be catastrophic. One of our go-to responses for even perceived petdemics, honed over the last century, is to slaughter our pets. This pioneering Article proposes …

Delusions, Moral Incapacity, And The Case For Moral Wrongfulness, Lea Johnston

Indiana Law Journal

Responsibility is a legal—not medical—construct. However, science can be useful in exposing faulty assumptions underlying current doctrine or practice, illuminating changes in practice or evidentiary standards to better effectuate the law’s animating purpose, and even suggesting updates to legal standards to account for modern understandings of functionalities of concern. This Article uses the science of delusions to assess the law regarding, and practice of establishing, criminal irresponsibility for defendants with psychosis. Over the last two decades, researchers from the cognitive sciences have compiled strong evidence that a host of cognitive and emotional impairments contribute to the origin and maintenance of …

Stealing Organs?, Benjamin Mcmichael

Indiana Law Journal

Every nine minutes, a new person joins a waitlist for an organ transplant, and every day, seventeen people die waiting for an organ that will never come. Because the need for organ transplants far outstrips the number of available organs, the policies and rules governing organ allocation in the United States are critically important and highly contentious. Recently, proponents of a new allocation system—one focused more on sharing organs across the nation instead of allocating organs primarily to local transplant candidates—have gained ground. Bolstered by two separate lawsuits in the past five years, advocates of greater national sharing have succeeded …

Patient Decision Aids Improve Patient Safety And Reduce Medical Liability Risk, Thaddeus Pope

Faculty Scholarship

Tort-based doctrines of informed consent have utterly failed to assure that patients understand the risks, benefits, and alternatives to the healthcare they receive. Fifty years of experience with the doctrine of informed consent have shown it to be an abject catastrophe. Most patients lack an even minimal understanding of their treatment options. But there is hope. Substantial evidence shows that patient decision aids (PDAs) and shared decision making can bridge the gap between the theory and practice of informed consent. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than clinician-patient discussions …

Telemedicine Scams, Katrice B. Copeland

Faculty Scholarship

Telemedicine emerged as a lifeline during the COVID-10 pandemic. Although the technology existed long before the pandemic, its use was limited due to strict government regulations that limited reimbursement for telemedicine visits. In response to the pandemic, the Government waiver many of its restrictions for the duration of the Public Health Emergency. These changes fueled the growth of telemedicine.

The problem, however, is that telemedicine makes it easier to conduct fraud on a larger scale because without in-person visits, medical providers can reach many more beneficiaries in a short period of time. Thus, the size and scale of typical health …

Assistance In Dying: A Comparative Look At Legal Definitions, Jocelyn Downie, Mona Gupta, Stefano Cavalli, Samuel Blouin

Articles, Book Chapters, & Popular Press

Euthanasia, assisted suicide, medical assistance in dying, death with dignity: these and many other different terms are used around the world to capture various types of assistance in dying. This diversity in terminology can create confusion both in academic debates and in policy-making if it is unclear what type of action or inaction is intended to be captured, by whom, and under what circumstances. By defining and contrasting several terms and legal status of assistance in dying in jurisdictions authorizing it, this comparative glossary aims to lay a foundation that prevents linguistic and conceptual confusion.

Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder

Articles, Book Chapters, & Popular Press

Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …

Protecting Expert Advice For The Public: Promoting Safety And Improved Communications, Julia M. Wright, Wendy Hui Kyong Chun, Amanda Clarke, Matthew Herder, Howard Ramos

Articles, Book Chapters, & Popular Press

The drivers of the harassment and intimidation of researchers are complex, widespread, and global in their reach and were being studied across many disciplines even before COVID-19. This policy briefing reviews some of the scholarship on this wide-ranging problem but focuses on what can be done to help ensure that Canadians fully benefit from the work of Canada’s researchers while also preserving the security and safety of those researchers. It identifies policies and actions that can be implemented in the near term to gather information on the problem, better frame public research communications, and ensure that mechanisms are readily available …

Permissive Regulation: A Critical Review Of The Regulatory History Of Buprenorphine Formulations In Canada, Abhimanyu Sud, Meghan Mcgee, Barbara Mintzes, Matthew Herder

Articles, Book Chapters, & Popular Press

Suboxone (buprenorphine-naloxone) is an opioid product approved in the US and Canada for the treatment of opioid use disorder. The drug is considered an important response to the opioid overdose epidemic with consistent calls for wider prescribing and deregulation. The history of Suboxone regulation in Canada has not been critically examined. Part of the rationale for doing so stems from the US regulatory experience, with documented irregularities, or what some have called abuses, that support profit-making by Suboxone's manufacturers. This regulatory analysis allows us to determine how opportunities to address health crises through drug innovation are managed at a federal …

Reducing Barriers To Accessing Administrative Data On Sars-Cov-2 Vaccination For Research, Andrew Mcrae, Patrick Archambault, Patrick Fok, Hana Wiemer, Laurie Morrison, Matthew Herder

Articles, Book Chapters, & Popular Press

Public trust in scientific research, especially research regarding vaccines, has proven fragile during the COVID-19 pandemic. To counter abundant misinformation about SARS-CoV-2 vaccines, rigorous, ongoing evaluations of vaccine safety and effectiveness by independent Canadian researchers are important. However, researchers' efforts to conduct timely, national studies of vaccine effectiveness have been hindered by barriers to data sharing that have made it difficult to integrate patients' vaccination status into SARS-CoV-2 clinical and epidemiological studies. Here, McRae et al discuss how a risk-averse data-sharing culture has led to missed opportunities to conduct robust, timely, pan-Canadian SARS-CoV-2 clinical and vaccine effectiveness studies, and outline …

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

Articles, Book Chapters, & Popular Press

The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …

Abortion Rights Beyond The Medico-Legal Paradigm, Mariana Prandini Assis, Joanna Erdman

Articles, Book Chapters, & Popular Press

Abortion rights in international law have historically been framed within a medico-legal paradigm, the belief that regulated systems of legal and medical control guarantee safe abortion. However, a growing worldwide practice of self-managed abortion (SMA) supported by feminist activism challenges key precepts of this paradigm. SMA activism has shown that more than medical service delivery matters to safe abortion and has called into question the legal regulation of abortion beyond criminal prohibitions. This article explores how abortion rights have begun to depart from the medico-legal paradigm and to support the novel norms and practices of SMA activism in a transformation …

Medicare "Bankruptcy", Matthew B. Lawrence

Faculty Articles

Medicare, the social insurance program for the elderly and disabled, is once again facing insolvency. Spending from the program’s hospital insurance trust fund is predicted to exceed the accumulated payroll taxes and other revenues that support the fund within the next five years, leaving Medicare unable to honor some of its obligations. Yet, what happens if and when Medicare becomes insolvent has not previously been explored in legal scholarship and is not addressed in statute or regulation. This Article confronts for the first time the major legal questions that Medicare insolvency would present. It explains what policymakers could do to …

Towards Racial Justice: The Role Of Medical-Legal Partnerships, Medha D. Makhlouf

Faculty Scholarly Works

Medical-legal partnerships (MLPs) integrate knowledge and practices from law and health care in pursuit of health equity. However, the MLP movement has not reached its full potential to address racial health inequities, in part because its original framing was not explicitly race conscious. This article aims to stimulate discussion of the role of MLPs in racial justice. It calls for MLPs to name racism as a social determinant of health and to examine how racism may operate in the field. This work sets the stage for the next step: operationalizing racial justice in the MLP model, research, and practice.

Debunking The Standardized Nature Of Insurance Policies, Elizabeth Sousa

Fordham Journal of Corporate & Financial Law

This article discredits the conventional view of insurance policies as standardized contracts that do not vary across insurance companies and policyholders. Contrary to this view, there are wide variations in policy language in both the admitted and non-admitted insurance markets. These deviations reduce the perceived benefit of insurance policies as standardized contracts intended to promote predictability and lower transaction costs for policyholders by focusing only on the most salient terms. Nowhere is this deviation more apparent than with Commercial General Liability (CGL) policies defendants are turning to in the current opioid litigation.

The opioid epidemic has been plaguing the United …

Patient Referral Failures, Jessica L. Mantel, Leah R. Fowler

Health Matrix: The Journal of Law-Medicine

No abstract provided.

No-Fault Vaccine Injury Compensation Systems Adopted Pursuant To The Covid-19 Public Health Emergency Response, Sam Halabi, Katherine Ginsbach, Katie Gottschalk, John Monahan, Judith Murungi

Emory International Law Review

No-fault vaccine injury compensation systems have developed over the course of the twentieth century, mostly in the richest countries in the world. Acknowledging that severe reactions to vaccines are rare, but can result in serious and sometimes complex injury, these systems provide financial and social support for those suffering these rare side effects. During the COVID-19 pandemic, and the rapid development and deployment of vaccines using novel technologies, these systems have proliferated not only among wealthy countries, where in their modern form they originated and spread, but also low- and middle-income ones. Adopting varying approaches to funding, eligibility, administration, process, …

Stifling Innovation: How Global Data Protection Regulation Trends Inhibit The Growth Of Healthcare Research And Start-Ups, Ryan Preston

Emory International Law Review

No abstract provided.

Boarding Mental Health Patients In Minnesota Emergency Departments--The Unintended Consequence Of An Inadequate Mental Health System, Jordan Engler

Mitchell Hamline Law Review

No abstract provided.

A Prescription For Crisis: Opioids, Patients, And The Controlled Substances Act, Dennis Davis

Mitchell Hamline Law Review

No abstract provided.

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Stumbling Over Trips: The International Intellectual Property Waiver Petition And The U.S. Executive, Jordan Paradise, Christina Conroy

Faculty Publications & Other Works

This article examines the relationship among intellectual property (IP) law protections; United States (U.S.) and international law and policy; and the actualization of diagnostics, drugs, and vaccines in the time of the COVID-19 coronavirus. Two key international treaties that relate to IP law--The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration) - establish international norms for the protection of IP. Core aspects of each of these treaties are described along with the role of the World Trade Organization (WTO) and concepts of compulsory licensing. As a result …

Biosimilar Bias: A Barrier To Addressing American Drug Costs, Cynthia M. Ho

Faculty Publications & Other Works

Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there …

An Attempt To Bring Modern Workplace Realities To The Social Security Disability Adjudication System, Robert E. Rains

Dickinson Law Review (2017-Present)

No abstract provided.

Comment: On Patents And Appropriations—And Tragedies, David O. Taylor

Washington and Lee Law Review

I write to provide a few remarks concerning Sasha Hoyt’s illuminating work published in the pages of this journal. In it, Hoyt addresses the impact of the Supreme Court’s patent eligibility decisions on private investment in the development of medical diagnostic technologies. As an initial matter, I want to congratulate Hoyt for tackling an important topic. As Hoyt discusses, medical diagnostic technologies enable the diagnosis of diseases and other medical conditions such as genetic disorders, and early and accurate diagnosis may lead to early treatments and, ultimately, at least in some cases, saved lives. But the creation of medical diagnostic …

Points Of No Return: How The Ninth Circuit’S New Voluntary Undertaking Doctrine Changes Return-To-Play In Sports, Sam C. Ehrlich

University of San Francisco Law Review

No abstract provided.

Artificial Intelligence In Canadian Healthcare: Will The Law Protect Us From Algorithmic Bias Resulting In Discrimination?, Bradley Henderson, Colleen M. Flood, Teresa Scassa

Canadian Journal of Law and Technology

In this article, we canvas why AI may perpetuate or exacerbate extant discrimination through a review of the training, development, and implementation of healthcare-related AI applications and set out policy options to militate against such discrimination. The article is divided into eight short parts including this introduction. Part II focuses on explaining AI, some of its basic functions and processes, and its relevance to healthcare. In Part III, we define and explain the difference and relationship between algorithmic bias and data bias, both of which can result in discrimination in healthcare settings, and provide some prominent examples of healthcare-related AI …