Science and Technology Law Commons^™

How Bodily Autonomy Can Fail Against Vaccination Mandates; The Few Vs. The Many, Jason Yadhram

Journal of Law and Health

Humans have been a communal species since inception and continue to be so to this day. Because of this, if even a small scale of a measured population becomes severely ill, the entire remaining population and surrounding area is thrown into absolute chaos. In fact, we have seen these circumstances throughout history and in the recent COVID-19 pandemic yet, some of us have forgotten that the only way this chaos can be curbed, is by enacting a mandatory vaccination policy. Since COVID-19 however, vaccination mandates have become an uneasy topic of conversation in the United States for essentially one main …

Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci

Seattle Journal of Technology, Environmental & Innovation Law

The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …

Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath

Michigan Journal of International Law

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …

A Proportionality-Based Framework For Government Regulation Of Digital Tracing Apps In Times Of Emergency, Sharon Bassan

Dickinson Law Review (2017-Present)

Times of emergency present an inherent conflict between the public interest and the preservation of individual rights. Such times require granting emergency powers to the government on behalf of the public interest and relaxing safeguards against government actions that infringe rights. The lack of theoretical framework to assess governmental decisions in times of emergency leads to a polarized and politicized discourse about potential policies, and often, to public distrust and lack of compliance.

Such a discourse was evident regarding Digital Tracing Apps (“DTAs”), which are apps installed on cellular phones to alert users that they were exposed to people who …

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 …

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. …

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 …

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.

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

FIU Law Review

No abstract provided.

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 …

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 …

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 …