Science and Technology Law Commons^™

Paging Doctor Robot: Medical Artificial Intelligence, Tort Liability, And Why Personhood May Be The Answer, Benedict See

Brooklyn Law Review

Artificial intelligence (AI) is a part of everyday life. From our phones, to social media accounts, to online shopping, AI is present and enhances our daily experiences. One area where AI has a heavy (and an increasing) presence is the medical industry. Just as humans make mistakes, so does AI. However, when a human doctor makes a mistake, they can be sued for malpractice, but when AI makes a mistake, who is to be held responsible? Because tort law was designed with humans in mind, it may be hard to apply to medical AI, who’s “black box” algorithms make their …

Contract Remedies Need Not Undercompensate Aspiring Parents When Cryopreserved Reproductive Material Is Lost Or Destroyed: Recovery Of Consequential Damages For Emotional Disturbance When Breach Of Contract Results In The Lost Opportunity To Become Pregnant With One's Own Biological Child, Joseph M. Hnylka

Journal of Law and Health

The Center for Disease Control and Prevention (CDC) has reported that the use of assisted reproductive technology (ART) has doubled over the past decade. In vitro fertilization (IVF) is the most prevalent form of ART. During IVF, a woman’s eggs are extracted, fertilized in a laboratory setting, and then implanted in the uterus. Many IVF procedures use eggs or sperm that were stored using a process called cryopreservation. A recent survey reported that cryopreservation consultations increased exponentially during the coronavirus pandemic, rising as much as 60 percent. It is estimated that more than one million embryos are stored in cryopreservation …

A Trip Through Employment Law: Protecting Therapeutic Psilocybin Users In The Workplace, Benjamin Sheppard

Journal of Law and Health

In 2020, Oregon voters legalized therapeutic psilocybin in response to a plethora of scientific studies showing symptom reduction for depression, anxiety, substance use disorders, opioid addictions, migraines, other mental illnesses, HIV/AIDS, and cancer. The legal rethinking regarding therapeutic psilocybin continues in both state legislatures and city councils. Yet, despite state and local legalization or decriminalization of therapeutic psilocybin it remains illegal under the federal Controlled Substances Act. This tension between local and federal law places therapeutic psilocybin users and their employers in a difficult position. Because all types of psilocybin use remain illegal under federal law, a zero-tolerance drug use …

Copying Copyright: Adopting A Fair Use Defense In Patent Law In Times Of Public Health Crisis, Kellie C. Van Beck

Brooklyn Law Review

Epidemics have devastated humankind for centuries. Given the simultaneous rise of advanced disease prevention and treatment and the great potential for mass public uptake, it is unsurprising that the U.S. pharmaceutical industry has grown to $775 billion in annual sales revenue. It is clear that the commercialization of important public health measures is not without controversy. Of particular debate is that vaccine and other drug manufacturers monopolize their products and control them through patent laws. Yet there is a strong dichotomy between the importance of patents and the need for public access to innovations. This is not to say that …

An Analysis Of The Patent Linkage System And Development Of The Biosimilar Industry In Taiwan, Jerry I-H Hsiao

Brooklyn Journal of International Law

In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By …

Regulating New Tech: Problems, Pathways, And People, Cary Coglianese

All Faculty Scholarship

New technologies bring with them many promises, but also a series of new problems. Even though these problems are new, they are not unlike the types of problems that regulators have long addressed in other contexts. The lessons from regulation in the past can thus guide regulatory efforts today. Regulators must focus on understanding the problems they seek to address and the causal pathways that lead to these problems. Then they must undertake efforts to shape the behavior of those in industry so that private sector managers focus on their technologies’ problems and take actions to interrupt the causal pathways. …

The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier

St. Mary's Law Journal

Emerging technologies of the Fourth Industrial Revolution show fundamental promise for improving productivity and quality of life, though their misuse may also cause significant social disruption. For example, while artificial intelligence will be used to accelerate society’s processes, it may also displace millions of workers and arm cybercriminals with increasingly powerful hacking capabilities. Similarly, human gene editing shows promise for curing numerous diseases, but also raises significant concerns about adverse health consequences related to the corruption of human and pathogenic genomes.

In most instances, only specialists understand the growing intricacies of these novel technologies. As the complexity and speed of …

Held V. State, Alec D. Skuntz

Public Land & Resources Law Review

On March 13, 2020, a group of 16 Montana children and teenagers filed a complaint in the First Judicial District, Lewis and Clark County against the State of Montana and several state agencies. These young Plaintiffs sought injunctive and declaratory relief against Defendants for their complicity in continuing to extract and release harmful amounts of greenhouse gases which contribute to climate change. Plaintiffs premised their argument on the Montana Constitution’s robust environmental rights and protections. The Defendants filed a motion to dismiss which the District Court granted in-part and denied in-part. Held provides a roadmap for future litigation by elucidating …

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

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 …

The Rise Of Ada Title Iii: How Congress And The Department Of Justice Can Solve Predatory Litigation, Sarah E. Zehentner

Brooklyn Law Review

The Americans with Disabilities Act (ADA) was enacted in 1990 to afford equal opportunities for individuals with disabilities. Title III of the ADA, specifically, was enacted to afford disabled individuals equal access to places of public accommodation. When the ADA was enacted, the internet was still in its infancy and Congress did not contemplate the need for governing accessibility to websites of public accommodations. Today, the internet has become embedded in virtually every aspect of our lives, yet there are still millions of disabled individuals who are unable to equally access the websites of American businesses. With the ADA being …

Shifting Antitrust Laws And Regulations In The Wake Of Hospital Mergers: Taking The Focus Off Of Elective Markets And Centering Health Care, Maya Inka Ureño-Dembar

Brooklyn Law Review

Access to health care requires access to a care center and access to comprehensive health care services. Rampant hospital mergers are uniquely poised to reduce both the number of hospitals, requiring patients to travel further, and the services provided within a newly merged hospital, namely reproductive health services. This phenomenon is clearly seen through the merging of secular and nonsecular hospitals, which often result in patients being forced to travel much further for reproductive health care. In the United States’ current model, health care is not a right, but is treated as a commodity. As such, it is governed by …

Covid-19 And Business Interruption Insurance: The Constitutionality Of Legislatively Mandated Coverage, William G. Arnold

South Carolina Law Review

No abstract provided.

Sharing Technology And Vaccine Doses To Address Global Vaccine Inequity And End The Covid-19 Pandemic, Matthew M. Kavanagh, Lawrence O. Gostin, Madhavi Sunder

Georgetown Law Faculty Publications and Other Works

Although COVID-19 cases are declining rapidly in the US, they have reached record highs in low- and middle-income countries (LMICs). The nucleus of the pandemic has shifted decidedly to the global south. The South-East Asia region and Latin America now represent 75% of global weekly deaths. On June 22, the Latin America region reported more than 1 million weekly new cases and 30 000 new deaths. Latin America has the highest deaths per capita, where deaths in countries such as Brazil, Argentina, Mexico, and Peru have reached 177 to 564 per hundred thousand. The Africa region has had increasing numbers …

The Future Of The Americans With Disabilities Act: Website Accessibility Litigation After Covid-19, Randy Pavlicko

Cleveland State Law Review

The Americans with Disabilities Act (ADA) was enacted in 1990 to eliminate discrimination against individuals with disabilities. Over time, as society has become more reliant on the internet, the issue of whether the ADA’s scope extends beyond physical places to online technology has emerged. A circuit split developed on this issue, and courts have discussed three interpretations of the ADA’s scope: (1) the ADA applies to physical places only; (2) the ADA applies to a website or mobile app that has a sufficient nexus to a physical place; or (3) the ADA broadly applies beyond physical places to online technology. …

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

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 …

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, …

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.

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

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 …

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.