Health Law and Policy Commons^™

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 …