Health Law and Policy Commons^™

A Qualitative Analysis Of Section 1983 Filings By Incarcerated Plaintiffs, Hollie Macdonald

Theses and Dissertations

The onset of the COVID-19 pandemic was a “watershed moment" in human history, transcending its role as a mere health crisis to reveal deeper fissures within societies. The present retrospective longitudinal study examined COVID-19 as an “era” of complexity utilizing it as an intermediate construct that delineates “pre-COVID” and “post-COVID.” In order to understand the impact of the COVID-19 era, the design of the study and hypotheses stem from an assumption of the interconnectedness of issues related to health, social justice, racial justice, politics, and information dissemination.

This study utilized both manifest and latent content analysis to explore the most …

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

Biased But Reasonable: Bias Under The Cover Of Standard Of Care, Maytal Gilboa

Georgia Law Review

Inequities in the distribution of healthcare are widely acknowledged to plague the United States healthcare system. Controversies as to whether anti-discrimination law allows individuals to bring lawsuits with respect to implicit rather than intentional bias render negligence law an important avenue for redressing harms caused by implicit bias in medical care. Yet, as this Article argues, the focus of negligence law on medical standards of care to define the boundaries of healthcare providers’ legal duty of care prevents the law from adequately deterring implicit bias and leaves patients harmed by biased treatment decisions without redress for their losses, so long …

The Future Of Ivf Post Dobbs, Rebecca Feinberg

Scholarly Works

No abstract provided.

Un-Erasing Race In A Medical-Legal Partnership: Antiracist Health Justice Advocacy By Design, Danielle Pelfrey Duryea, Peggy Maisel, Kelley Saia

Faculty Scholarship

This Article covers a potential response to a Massachusetts state law which has been interpreted to require health care providers and birthing hospitals to report to state authorities any infant born to a person taking medication of opioid use disorder. While the statute mandates reports where a professional has "reasonable cause to believe that a child is suffering physical or emotional injury" as a result of substance dependence at birth, the Article highlights that many institutions report all infants born to persons with substance abuse disorders, regardless of risk of harm, for fear of penalty for failure to report. As …

From Patients To Patents: The Disappearing I Of Innovation, Maggi Robert

St. Mary's Law Journal

The creation of the Mayo/Alice two-step test for patent eligible subject matter flipped the patent world upside down. Following its establishment, invalidation rates soared—particularly in the healthcare sector—impacting patients everywhere. The importance of patents in healthcare innovation and innovation generally has been emphasized as the consequences of this framework are realized.

The United States is no longer seen as a clear leader in innovation, and as a result, the economy is at risk. Start-ups and investors have turned to foreign nations where return on their investments in innovation are protected. This level of uncertainty regarding patents has never been seen …

Transcript: Presentation On Artificial Intelligence And Discrimination In Healthcare, Sharona Hoffman

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

Transcript: Presentation On Individual Autonomy In Ai Healthcare, Charlotte Tschider

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

What The Harm Principle Says About Vaccination And Healthcare Rationing, Christopher Robertson

Faculty Scholarship

Clinical ethicists hold near consensus on the view that healthcare should be provided regardless of patients’ past behaviors. In classic cases, the consensus can be explained by two key rationales—a lack of acute scarcity and the intractability of the facts around those behaviors, which make discrimination on past behavior gratuitous and infeasible to do fairly. Healthcare providers have a duty to help those who can be helped. In contrast, the COVID-19 pandemic suggests the possible recurrence of a very different situation, where a foreseeable acute shortage of healthcare resources means that some cannot be helped. And that shortage is exacerbated …

From Healthcare To Hiring: Impacts Of Social And Public Policy On Disabled Veterans In The United States, Benjamin Michael Stoflet

Student Scholarship

The United States Government is struggling to fulfill commitments it has made to service members suffering from disabilities incurred during honorable service to the country. The Department of Veterans Affairs (VA) disability compensation structure, job training programs, and methods of alternative dispute resolution is a patchwork resulting from decades of legislation creating a system where veterans often become locked in a complicated and often combative process to obtain benefits they have earned. Employers, advocacy groups, academics, and federal officials agree that there are systematic issues within the VA negatively impacting disabled veterans. These include a lack of patient-centered care, divergent …

International Rights Affecting The Covid–19 Vaccine Race, Samantha Johnson

University of Miami Inter-American Law Review

The impact of the COVID–19 pandemic has been felt world-wide, and despite having several vaccines in the market at this point, there are still issues of accessibility for certain countries. International intellectual property law has been a breeding ground for the exploration of intellectual curiosity and creation as it provides strong protections to creators. These strong protections have allowed for the monopolization of certain goods, such as vaccines, under the concept of patents. While patents are important to incentivize pharmaceutical companies to create life–saving medicines, these protections have also become a barrier for access to medicines, especially in less–developed countries. …

The Fate Of The Advancing American Kidney Health Initiative In A Biden Administration, Seth Shepherd

Journal of the National Association of Administrative Law Judiciary

This article analyzes the Biden Administration’s healthcare priorities, contrasts them with those of the Trump Administration, discusses how Presidential administrations determine whether to continue policies, and examines the proper procedures for continuing previous administration policies. This article will then examine whether the Initiative will have a place in the Biden Administration’s healthcare policy. Part II considers Biden’s overall approach to healthcare. Part III discusses what the Trump Administration’s healthcare policy accomplished. Part IV dissects the Initiative and begins a discussion regarding its effectiveness. Part V explores an administration’s decision-making process regarding retention or rejection of a previous administration’s policies and …

Rationing Healthcare During A Pandemic: Shielding Healthcare Providers From Tort Liability In Uncharted Legal Territory, Frederick V. Perry, Miriam Weismann

University of Miami Business Law Review

As the coronavirus pandemic intensified, many communities in the U.S. experienced shortages of ventilators, ICU beds, and other medical supplies and treatment. There was no single national response providing guidance on the allocation of scarce healthcare resources. There has been no consistent state response either. Instead, various governmental and nongovernmental state actors in several but not all states formulated “triage protocols,” known as Crisis Standards of Care, to prioritize patient access to care where population demand exceeded supply. One intended purpose of the protocols was to immunize or shield healthcare providers from tort liability based on injuries resulting from a …

Clinical Interactions In Electronic Medical Records Towards The Development Of A Token-Economy Model, Nicole Allison S. Co, Jason Limcaco, Hans Calvin L. Tan, Ma. Regina Justina E. Estuar, Christian E. Pulmano, Dennis Andrew Villamor, Quirino Sugon Jr, Maria Cristina G. Bautista, Paulyn Jean Acacio-Claro

Graduate School of Business Publications

The use of electronic medical records (EMRs) plays a crucial role in the successful implementation of the Universal Healthcare Law which promises quality and affordable healthcare to all Filipinos. Consequently, the current adoption of EMRs should be studied from the perspective of the healthcare provider. As most studies look into use of EMRs by doctors or patients, there are very few that extend studies to look at possible interaction of doctor and patient in the same EMR environment. Understanding this interaction paves the way for possible incentives that will increase the use and adoption of the EMR. This study uses …

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.

Reconnecting The Patient: Why Telehealth Policy Solutions Must Consider The Deepening Digital Divide, Laura C. Hoffman

Law Faculty Articles and Essays

This Article will attempt to untangle the complicated web of providing telehealth to those populations it is potentially capable of further alienating from access to healthcare including: 1) race/minority populations, 2) aging adults, 3) individuals with disabilities, 4) non-English speakers, 5) individuals living in rural areas, 6) socioeconomic class, and 7) children, in order to advance the argument that telehealth can be successful in providing healthcare access to these populations. Rather than suggesting that telehealth simply "cannot work" for these populations, instead consideration can and must meet these individuals through technology, access, and policy developments.

First, this Article will explain …

Reparations For Black Health, Alexandre Rotondo-Medina

Journal of Race, Gender, and Ethnicity

No abstract provided.

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.

An Immigration Solution For Improving Rural Healthcare, Kit Johnson

Faculty Articles

If you are one of the more than 249 million people who live in urban areas of the United States, more than 80% of the U.S. population, you’ve likely never thought much about your physical proximity to a doctor. Primary care physicians and medical specialists abound in urban America. But if you are among the more than 59 million people who live in rural areas of the country, you may well know the struggle of finding primary care, a specialist, or a dentist. That is because there is a worrying shortage of medical professionals in rural America. There is a …

American Motherhood - A Taking, Nicole Knight

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

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 …

A Modest Proposal: Leveraging Private Enforcement Mechanisms And The Bayh-Dole Act To Reduce Drug Prices In The U.S. Healthcare Industry, Brittany Day

Duke Journal of Constitutional Law & Public Policy Sidebar

The United States healthcare system is one of the most expensive in the world. Unlike other products, when drug prices skyrocket, people may die. While advocating for various solutions, both the Biden and Trump administrations have recognized the importance of halting the rise of prescription drug prices. Most of the solutions advanced are focused on government-side initiatives, such as allowing Medicare to directly negotiate with pharmaceutical companies. Yet, the "march-in rights" built into the Bayh-Dole Act create an opportunity to set up a mechanism that would invite private actors to sue pharmaceutical companies for unconscionable drug pricing. The Bayh-Dole Act …

How To Compromise On Saving The Most Lives: A Commentary On Hellman And Nicholson, “Rationing And Disability”, David Wasserman

Washington and Lee Law Review Online

Deborah Hellman and Kate Nicholson’s “Rationing Disability” is a skillfully integrated analysis of the legal and ethical challenges of avoiding disability discrimination in setting priorities for the allocation of scarce lifesaving resources. Their analysis goes beyond the important but narrow question of what it means to wrongfully discriminate against people with disabilities in this context to the broader question of how to find a principled compromise between the consequentialist goals of public health and the potentially conflicting public value of “equal concern and respect” for each person. I will focus on this broader issue.

I agree with much …

Rationing And Disability: The Civil Rights And Wrongs Of State Triage Protocols, Deborah Hellman, Kate M. Nicholson

Washington and Lee Law Review

The COVID-19 pandemic and the unprecedented natural disasters of 2020 remind us of the importance of emergency preparedness. This Article contributes to our legal and ethical readiness by examining state “Crisis Standards of Care,” which are the standards that determine how medical resources are allocated in times of scarcity. The Article identifies a flaw in the policy choice at the heart of the standards: the standards focus on saving as many lives as possible but, in so doing, will predictably disadvantage the ability of people with disabilities and racial minorities to access life-saving care.

To date, scholarly attention has focused …

Freedom Without Opportunity: Using Medicare Policy And Cms Mechanisms To Anticipate The Platform Economy’S Pitfalls And Ensure Healthcare Platform Workers Are Fairly Paid, Kim A. Aquino

Brooklyn Law Review

The rapidly aging population, along with the demand for innovative Medicare delivery models such as bundled payment programs have incentivized the use of technology in healthcare because of its potential to cut costs and improve quality of care. Like many industries embracing technological strides to automate and digitize services, the healthcare industry has welcomed new labor markets like the platform economy to facilitate connections between patients and workers with ease. Along with streamlining connections, the platform economy also promises workers flexibility and autonomy over their own schedule. The platform economy’s promise of freedom, however, is not enough to prevent the …

Re-Imagining Possibilities Of Governance For Global Health, Alicia Ely Yamin

Georgia Journal of International & Comparative Law

No abstract provided.

Health Care Fraud Means Never Having To Say You're Sorry, Jacob T. Elberg

Washington Law Review

For decades, the Department of Justice (DOJ) has issued a steady flood of press releases announcing False Claims Act (FCA) settlements against health care entities and extolling the purportedly sharp message sent to the industry through these settlements about the consequences of engaging in wrongdoing. The FCA is the primary mechanism for government enforcement against health care entities engaged in wrongdoing, and it is expected to be DOJ’s key tool for addressing fraud arising out of government programs in response to the COVID-19 pandemic. DOJ has pointed to three key goals of its enforcement efforts (deterrence, incentivizing cooperation, and building …

Unexpected Inequality: Disparate-Impact From Artificial Intelligence In Healthcare Decisions, Sahar Takshi

Journal of Law and Health

Systemic discrimination in healthcare plagues marginalized groups. Physicians incorrectly view people of color as having high pain tolerance, leading to undertreatment. Women with disabilities are often undiagnosed because their symptoms are dismissed. Low-income patients have less access to appropriate treatment. These patterns, and others, reflect long-standing disparities that have become engrained in U.S. health systems.

As the healthcare industry adopts artificial intelligence and algorithminformed (AI) tools, it is vital that regulators address healthcare discrimination. AI tools are increasingly used to make both clinical and administrative decisions by hospitals, physicians, and insurers—yet there is no framework that specifically places nondiscrimination obligations …

A Unified Theory Of Data, William Magnuson

Faculty Scholarship

How does the proliferation of data in our modern economy affect our legal system? Scholars that have addressed the question have nearly universally agreed that the dramatic increases in the amount of data available to companies, as well as the new uses to which that data is being put, raise fundamental problems for our regulatory structures. But just what those problems might be remains an area of deep disagreement. Some argue that the problem with data is that current uses lead to discriminatory results that harm minority groups. Some argue that the problem with data is that it impinges on …

Privacy In Pandemic: Law, Technology, And Public Health In The Covid-19 Crisis, Tiffany C. Li

Law Faculty Scholarship

The COVID-19 pandemic has caused millions of deaths and disastrous consequences around the world, with lasting repercussions for every field of law, including privacy and technology. The unique characteristics of this pandemic have precipitated an increase in use of new technologies, including remote communications platforms, healthcare robots, and medical Al. Public and private actors alike are using new technologies, like heat sensing, and technologically influenced programs, like contact tracing, leading to a rise in government and corporate surveillance in sectors like healthcare, employment, education, and commerce. Advocates have raised the alarm for privacy and civil liberties violations, but the emergency …