Health Law and Policy Commons^™

Session 2: Access To Health And Health Services Panel - The Covid-19 Experience, Annette Clark, Wendy Chalres, Dan Laster, Anna Santos Rutschman, Madhavi Sunder, Margret Chon

SITIE Symposiums

COVID-19 has had a massive impact on the U.S. and the world regarding health care and health care access. Improving access has been the topic of scholarship for many years. It took the COVID- 19 pandemic to bring these issues to the forefront of public discussion. Inequities in public health access, not only domestically but globally, have become apparent in the light of COVID-19. This expert panel addresses the inequities of vaccines worldwide and the concept of vaccine sharing programs. It also explores the role that intellectual property plays in these equity issues and some of the risks inherent in …

Opening Session, Annette Clark, Steven Bender

SITIE Symposiums

This year's conference focuses on the social good, highlighting three access barriers fundamental in law and society - access to legal services (and more generally, justice), access to health and health care during the COVID-19 pandemic, and access to financial services for the unbanked or underbanked.

Catch And Contain Novel Pathogens Early!—Assessing U.S. Medical Isolation Laws As Applied To A Future Pandemic Detection And Prevention Model, April Xiaoyi Xu

University of Michigan Journal of Law Reform Caveat

As of July 2, 2021, there have been 196,553,009 confirmed cases of the Coronavirus Disease (COVID-19), including 4,200,412 deaths, globally. Unfortunately, infectious diseases have been an “unavoidable fact of life” throughout history. While the global community looks forward to a gradual return to normalcy from COVID-19 with an increasing number of individuals getting vaccinated on a daily basis, the COVID-19 public health crisis has exposed significant inadequacies in many countries’ pandemic responses—the United States included. Governing authorities must actively consider more effective solutions to quickly detect and prevent the spread of future pandemics.

One proposed model that offers promising potential, …

Medical Volunteers During Pandemics, Disasters, And Other Emergencies: Management Best Practices, John I. Winn, Seth Chatfield, Kevin H. Govern

Seattle Journal of Technology, Environmental, & Innovation Law

How best to utilize volunteers^[1] during medical emergencies is an essential part of hospital compliance planning. Onboarding recruited and spontaneous volunteers during crisis situations require careful consideration of multiple legal issues. Volunteer planning becomes more complex if volunteers move across state lines because applicable tort immunity statutes,^[2] compensation limits,^[3]and workers compensation regimes vary significantly from one jurisdiction to another. Effective planning for volunteers requires these and other issues to be addressed well in advance of actual emergencies. Although predicting the scope or severity of any future crisis is impossible, the provided checklist of management best practices …

Don't You Know That You're Toxic? Cercla Section 113(H) Challenges, Sovereign Immunity, And Perfluoroalkyl Substances In Pennsylvania Drinking Water In Giovanni V. Navy, Stephanie J. Oppenheim

Villanova Environmental Law Journal (1991 - )

No abstract provided.

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 …

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

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 …

How To Build More Equitable Vaccine Distribution Technology, Laura M. Moy, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic and the distribution of vaccines that promise to bring it to an end have spotlighted inequities in our nation’s healthcare system. But the vaccine distribution problem illustrates a peculiar fact of our digital era: just how hard it is to ensure equitable delivery of services via the internet. This is especially the case when distributing a scarce critical resource as quickly as possible on a massive scale.

In this Brookings Institution article, Professors Laura Moy and Yael Cannon argue that digital infrastructure is a critical determinant of health, and call for the restructuring of online vaccine appointment …

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 …

Put More Women In Charge And Other Leadership Lessons From Covid-19, Peter H. Huang

FIU Law Review

No abstract provided.

Big Pharma, Big Problems: Covid-19 Heightens Patent-Antitrust Tension Caused By Reverse Payments, Hannah M. Lasting

Seattle University Law Review

In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard …

Just Plain Dumb?: How Digital Contact Tracing Apps Could’Ve Worked Better (And Why They Never Got The Chance), Brian E. Ray

Law Faculty Articles and Essays

This essay describes how the privacy debate that emerged over digital contact tracing and Google’s and Apple’s decisions to strictly limit apps permitted to use their platforms resulted in undercutting their potential usefulness as a tool to combat the pandemic while still failing to engender trust in these tools as intended.

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, …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Tracing The Invisible: Information Fiduciaries And The Pandemic, Anne L. Washington, Lauren Rhue

American University Law Review

Predictive data technology designed to contain the COVID-19 pandemic was not as successful as promised. Data-centric solutions to providing testing and tracing did little to limit the virus’s spread in part because they served only the most visible parts of society. This Article argues for more robust solutions to protect individuals’ privacy—whether those individuals are currently visible or invisible to pandemic technology—if pandemic technology is to provide the universal coverage necessary for a public health emergency, such as the COVID- 19 pandemic. First, we contend that current pandemic data technology operates under rigid technical and social assumptions that thwart participation …

Does Mitochondrial Replacement Therapy Violate Laws Against Human Cloning?, Kerry Lynn Macintosh

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

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 …

Inherent Powers And The Limits Of Public Health Fake News, Michael Goodyear

Articles & Chapters

The world has changed dramatically over the past year. The COVID-19 pandemic has presented unprecedented challenges and has caused a catastrophic loss of over 300,000 U.S. lives. This crisis has been compounded by an infodemic, an effusion of misinformation and fake news about COVID-19. This incorrect information has flooded social media and online platforms, confusing and misleading the American public. Yet U.S. constitutional law largely upholds fake news as protected free speech under the First Amendment. This legal reality has significantly compounded the COVID-19 crisis.

But U.S. law is not limited to only constitutional enumerated powers. An underexamined approach to …

Covid-19 And Digital Contact Tracing: Regulating The Future Of Public Health Surveillance, Divya Ramjee, Pollyanna Sanderson, Imran Malek

Cardozo Law Review de•novo

Digital surveillance tools are at the forefront of potential public health response strategies for the COVID-19 pandemic. The United States is in desperate need of a national-level contact tracing and exposure notification strategy to supplement traditional public health response efforts. This article addresses data privacy and security concerns, as well as epidemiological considerations, when developing digital contact tracing and exposure notification tools. It is both feasible and prudent that the United States establish a federal network for public health surveillance aided by digital tools, especially considering that waves of COVID-19 are expected to continue well into 2021 and while the …

Foreward, Cesare P.R. Romano, Jessica Almqvist, Andrea Boggio, Timo Faltus, Kerry Lynn Macintosh, Scott J. Schweikart

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

A Human Rights Approach To Risk: The Case Of Human Germline Editing, Jessica Almqvist

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

The Regulation Of Human Germline Genome Modification (Hggm) At The National Level: A Call For Comprehensive Legal Reform, Andrea Boggio, Cesare P.R. Romano, Jessica Almqvist

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Medicinal Genome Editing In Germany – Tensions Between Safeguarding And Circumventing Ethical And Legal Standards, Timo Faltus

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Global Regulation Of Germline Genome Editing: Ethical Considerations And Application Of International Human Rights Law, Scott J. Schweikart

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

A Code Of Ethics For Gene Drive Research, George J. Annas, Chase L. Beisel, Kendell Clement, Andrea Crisanti, Stacy Francis, Marco Galardini, Roberto Galizi, Julian Grunewald, Greta Immobile, Ahmad S. Khalil, Ruth Muller, Vikram Pattanayak, Karl Petri, Ligi Paul, Luca Pinello, Alekos Simoni, Chrysanthi Taxiarchi, J. Keith Joung

Faculty Scholarship

Gene drives hold promise for use in controlling insect vectors of diseases, agricultural pests, and for conservation of ecosystems against invasive species. At the same time, this technology comes with potential risks that include unknown downstream effects on entire ecosystems as well as the accidental or nefarious spread of organisms that carry the gene drive machinery. A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration in the interest …

Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …

Legislative Options To Address Institutional Objections To Voluntary Assisted Dying In Australia, Ben P. White, Lindy Willmott, Eliana Close, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Voluntary assisted dying is being considered by parliaments and law reform bodies across Australia. Although individual conscientious objection is routinely considered in these deliberations, an institution’s desire to object to providing voluntary assisted dying has received very little attention. After briefly considering the concept of institutional objection in voluntary assisted dying, this article examines the available (albeit limited) Australian evidence on this practice. Institutional objection is happening in Victoria (where voluntary assisted dying is lawful) and is likely to occur in other Australian states. The article proposes that regulation is needed and presents three models for parliaments and law reformers …

Factors Affecting Access To Administrative Health Data For Research In Canada: A Study Protocol, Cynthia Kendell, Adrian Levy, Geoff Porter, Elaine Gibson, Robin Urquhart

Articles, Book Chapters, & Popular Press

In Canada, most provinces have established administrative health data repositories to facilitate access to these data for research. Anecdotally, researchers have described delays and substantial inter-provincial variations in the timeliness of data access approvals and receipt of data. Currently, the reasons for these delays and variations in timeliness are not well understood. This paper provides a study protocol for (1) identifying the factors affecting access to administrative health data for research within select Canadian provinces, and (2) comparing factors across provinces to assess whether and how they contribute to inter-provincial variations in access to administrative health data for research.

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Articles, Book Chapters, & Popular Press

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.