Health Law and Policy Commons^™

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 …

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 …

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 …

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Telehealth And Telework Accessibility In A Pandemic-Induced Virtual World, Blake Reid, Christian Vogler, Zainab Alkebsi

University of Colorado Law Review Forum

This short essay explores one dimension of disability law’s COVID-related “frailty”: how the pandemic has undermined equal access to employment and healthcare for Americans who are deaf or hard of hearing as healthcare and employment migrate toward telehealth and telework activities. This essay’s authors—a clinical law professor; a computer scientist whose research focuses on accessible technology; and a deaf policy attorney for the nation’s premier civil rights organization of, by, and for deaf and hard of hearing individuals in the United States—have collaborated over the past months on detailed advocacy documents aimed at helping deaf and hard of hearing patients …

Untag Me: Why Federal Judges Are Broadly Construing Illinois’S Biometric Privacy Law, Lisa P. Angeles

Cardozo Law Review

No abstract provided.

How Congress Can Help Raise Vaccine Rates, Dorit Rubinstein Reiss, Y. Tony Yang

Notre Dame Law Review Reflection

2019 saw an unusually high number of measles cases, and other preventable disease outbreaks, at least in part linked to vaccines refusal. States are considering legislative responses. This Essay examines what role the federal government can fill in increasing vaccines rates. The Essay suggests that the federal government has an important role to fill in funding research, coordination, and local efforts. It also suggests that a federal school vaccine mandate is likely not the solution: first, such mandates can run into plausible constitutional challenges, and second, there are policy arguments against it. The policy contentions include the unfairness of imposing …

Good Health And Good Privacy Go Hand-In-Hand (Originally Published By Jnslp), Jennifer Daskal

Joint PIJIP/TLS Research Paper Series

No abstract provided.

Biosimilars: The Quest For A Rational Regulatory And Intellectual Property Approach In Canada, Elizabeth S. Dipchand

LLM Theses

Biologics and biosimilars represent the promise for more effective treatments of many diseases. International treaty obligations influenced heavily by the biopharmaceutical industry and advanced through the international trade agenda may lead to an imbalance between incentivizing innovation and the public interest. Canada’s implementation of its obligations into national patent and regulatory laws encourages aggressive biologic patent protection strategies that, coupled with linked regulatory assessments, may establish compounding layers of exclusion that disproportionately disincentivizes both the biologics innovation and biosimilar development. This comparative analysis addresses the progression of international obligations and the way in which they have been implemented into Canada’s …

Japanese Government Actions Against Covid-19 Under The Directives Of Constitutional And Administrative Law, Yuichiro Tsuji

Cardozo International & Comparative Law Review

This paper presents law on the State ofEmergency held jointly on June 16, 2020, by the Asian Law Center of Melbourne University and School of Law, and Vietnam National University, Hanoi.

This paper further elucidates the actions of the Japanese government against COVID-19 during the first five months of 2020. On May 25, 2020, the government fied the emergency declaration passed under the amended Art. 49(2) of the amended Influenza Special Measures Act (ISMA).

This paper argues that the effects of the Japanese government action is not unique, but is instead similar to those of other countries. In 2012, the …

Genetic Duties, Jessica L. Roberts, Alexandra L. Foulkes

William & Mary Law Review

Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians …

How The Covid-19 Pandemic Has And Should Reshape The American Safety Net, Gabriel Scheffler, Andrew Hammond, Ariel Jurow Kleiman

Articles

No abstract provided.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Shifting Public Perception: Climate Change Means Living With Fire And Smoke, Robert Froembling

Seattle Journal of Technology, Environmental, & Innovation Law

The urgency to prepare for the climate crisis has never been greater. We are currently living in the sixth mass extinction and the effects are only going to accelerate. We will inherit more wildfires, larger wildfires, and more frequent wildfires.

This piece is not meant to stoke fear in its readers or be depressing, but to shift public perception on what our future holds by evaluating the laws and science presented to us. This piece will look at regional and federal regulations and assess the increased rate of forest fires and the grave public health concerns from stagnant smoke specifically …

Why We (Probably) Must Deliberately Infect, Adam J. Kolber

Faculty Scholarship

No abstract provided.

Regulating Care Robots, Valarie K. Blake

Law Faculty Scholarship

Care robots already assist the elderly in some nursing homes around the globe and could be in widespread use in hospitals and private homes sooner than we think. These robots promise great hope for patients: robots can provide increased independence, assistance with daily living, comfort and distraction during procedures, education, and companionship during vulnerable and lonely times in patients' lives. Despite these promising features, there are a number of concerns; care robots, designed with the aim of winning patient trust and affection, have unprecedented access to personal lives as well as recording and sensory capabilities beyond any human. They pose …

Keeping Ai Under Observation: Anticipated Impacts On Physicians' Standard Of Care, Iria Giuffrida, Taylor Treece

Faculty Publications

As Artificial Intelligence (AI) tools become increasingly present across industries, concerns have started to emerge as to their impact on professional liability. Specifically, for the medical industry--in many ways an inherently "risky" business--hospitals and physicians have begun evaluating the impact of Al tools on their professional malpractice risk. This Essay seeks to address that question, zooming in on how AI may affect physicians' standard of care for medical malpractice claims.

Next Verse, Same As The First: Inadequacies In The Government's Legal Approach Toward Biotechnology, Kimberly Righter

Sustainable Development Law & Policy

No abstract provided.

Medical And Mental Health Implications Of Gestational Surrogacy And Trends In State Regulations On Compensated Gestational Surrogacy: A Report Submitted To The New York State Legislature, Steven Spandorfer, Allison Petrini, Sital Kalantry

Cornell Law Faculty Publications

As the New York State legislature considers legalizing compensated gestational surrogacy this legislative session, this report provides insight into (1) the impact of surrogacy on the medical and mental health of women who become surrogates and the children born through gestational surrogacy, and (2) how other state legislatures have addressed compensated gestational surrogacy in recent years.

Medical research demonstrates that there is significant growth in gestational surrogacy in the United States. The number of families working with gestational surrogates has quadrupled in the new millennium. Weill Cornell Medicine physicians and medical students reviewed the published literature on the medical and …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

The Problems With Decision-Making, Joanna K. Sax

Faculty Scholarship

Our society faces major challenges in numerous areas, including climate change and healthcare. Addressing these problems with technological advances are of great importance. Increasingly, however, consumers are resisting or rejecting such technological interventions based on inappropriate assignment of risk. In other words, the consumer assessment of risk is not in line with evidence-based assessment of risk. This article focuses on two controversial areas, vaccines and genetically engineered food, as examples in which consumers assign a high risk despite an evidence-based assessment of low risk. This article describes how empirically tested decision-making theories explain why consumers inappropriately assign risk. While these …

Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015, Andrea Macgregor, Audrey D. Zhang, Joshua D. Wallach, Joseph S. Ross, Matthew Herder

Articles, Book Chapters, & Popular Press

Thirty days after a novel therapeutic agent, a new molecular entity, or original biologic is approved, the US Food and Drug Administration (FDA) must publicly disclose its approval package, including scientific reviews completed by FDA disciplines (eg, pharmacology, statistical, and medical reviewers) and any available assessments by agency leadership.1 Although reports of internal disagreement have surfaced,2 it is unclear how often such disagreements occur. Disagreements document differing points of view or engaged discussion and may, thus, capture important scientific debates or signal challenging decisions within the agency. We sought to determine the frequency of disagreements within the FDA regarding approval …

Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19, Joel Lexchin, Janice Graham, Matthew Herder, Tom Jefferson, Trudo Lemmens

Articles, Book Chapters, & Popular Press

Medicine regulators rely on pivotal clinical trials to make decisions about approving a new drug, but little is known about how they judge whether pivotal trials justify the approval of new drugs. We explore this issue by looking at the positions of 3 major regulators: the European Medicines Agency, Food and Drug Administration, and Health Canada. Here we report their views and the implications of those views for the approval process. On various points, the 3 regulators are ambiguous, consistent, and demonstrate flexibility. The range of views may well reflect different regulatory cultures. Although clinical trial information from pivotal trials …

Transparency Too Little, Too Late? Why And How Health Canada Should Make Clinical Data And Regulatory Decision-Making Open To Scrutiny In The Face Of Covid-19, Sterling Edmonds, Andrea Macgregor, Agnieszka Doll, Ipek Eren Vural, Janice Graham, Katherine Fierlbeck, Joel Lexchin, Peter Doshi, Matthew Herder

Articles, Book Chapters, & Popular Press

Hard-won gains in the transparency of therapeutic product data in recent years1 have occurred alongside growing reliance by regulators upon expedited review processes.2 The concurrence of these two trends raises fundamental questions for the future of pharmaceutical regulation about whether the institutionalization of transparency will foster improved oversight of drugs, biologics, vaccines, and other interventions, or else, provide cover for a relaxing of regulatory standards of safety, effectiveness, and quality.3 The urgency of the COVID-19 pandemic, however, has brought this tension into immediate and sharp relief. During the course of the global health crisis, regulatory bodies have markedly expanded the …

Editorial, Lucie Guibault

Articles, Book Chapters, & Popular Press

1 This issue marks the tenth month into the COVID-19 pandemic. Since March 2020, we have learned to live with the more or less strict public health measures put in place to ‘flatten the curve’ of infection from the virus. Words like ‘social distancing’, ‘mask wearing’, and ‘lockdowns’ have taken an entirely new meaning. In spite of these measures, the human toll is huge, most clearly among frontline workers and vulnerable people. While the curve is far from flat in most countries, the pandemic has brought to light the long time unacknowledged persistence of systemic inequalities: figures show that poorer, …

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 …

The Survival Of Critical Infrastructure: How Do We Stop Ransomware Attacks On Hospitals?, Helena Roland

Catholic University Journal of Law and Technology

Our nation’s infrastructure is under an emerging new threat: ransomware attacks. These attacks can cause anything from individual laptops, to entire cities to shut down for a period of time until the victim pays a ransom to the attacker. Unfortunately, these attacks are on the rise and the attackers have a new target: hospitals. Ransomware attacks on hospitals can temporarily shut down operating room technology and limit physician access to patient files, ultimately threatening the safety of hospital patients and the surrounding community. This paper examines how the threat of ransomware attacks on hospitals is on the rise and what …

Consumer Protections In The Context Of Holistic Healthcare, Rachel Pauerstein

SMU Science and Technology Law Review

No abstract provided.

In Re Zhu: Implied Consent To Posthumous Sperm Retrieval, Mary Kathryn Sapp

SMU Science and Technology Law Review

No abstract provided.

Crispr And The Future Of Fertility Innovation, June R. Carbone

SMU Science and Technology Law Review

No abstract provided.