Science and Technology Law Commons^™

Book Review, Aamir S. Abdullah

Publications

No abstract provided.

The Law Of Ai, Margot Kaminski

Publications

No abstract provided.

Beyond Transparency And Accountability: Three Additional Features Algorithm Designers Should Build Into Intelligent Platforms, Peter K. Yu

Faculty Scholarship

In the age of artificial intelligence, innovative businesses are eager to deploy intelligent platforms to detect and recognize patterns, predict customer choices and shape user preferences. Yet such deployment has brought along the widely documented problems of automated systems, including coding errors, corrupt data, algorithmic biases, accountability deficits and dehumanizing tendencies. In response to these problems, policymakers, commentators and consumer advocates have increasingly called on businesses seeking to ride the artificial intelligence wave to build transparency and accountability into algorithmic designs.

While acknowledging these calls for action and appreciating the benefits and urgency of building transparency and accountability into algorithmic …

The Easterbrook Theorem: An Application To Digital Markets, Joshua D. Wright, Murat C. Mungan

Faculty Scholarship

The rise of large firms in the digital economy, including Amazon, Apple, Facebook, and Google, has rekindled the debate about monopolization law. There are proposals to make finding liability easier against alleged digital monopolists by relaxing substantive standards; to flip burdens of proof; and to overturn broad swaths of existing Supreme Court precedent, and even to condemn a law review article. Frank Easterbrook’s seminal 1984 article, The Limits of Antitrust, theorizes that Type I error costs are greater than Type II error costs in the antitrust context, a proposition that has been woven deeply into antitrust law by the Supreme …

Isscr Guidelines For The Transfer Of Human Pluripotent Stem Cells, Ellen W. Clayton, I Hyun, Et. Al.

Vanderbilt Law School Faculty Publications

The newly revised 2021 ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models. In this white paper, the ISSCR subcommittee that drafted these guidelines for research involving the use of nonhuman embryos and postnatal animals explains and summarizes their recommendations.

The newly revised ISSCR Guidelines for Stem Cell Research and Clinical Translation includes scientific and ethical guidance for the transfer of human pluripotent stem cells and their direct derivatives into animal models (ISSCR, 2021). We are the members of the …

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 …

Artificial Intelligence As Evidence, Paul W. Grimm, Maura R. Grossman, Gordon V. Cormack

Faculty Scholarship

This article explores issues that govern the admissibility of Artificial Intelligence (“AI”) applications in civil and criminal cases, from the perspective of a federal trial judge and two computer scientists, one of whom also is an experienced attorney. It provides a detailed yet intelligible discussion of what AI is and how it works, a history of its development, and a description of the wide variety of functions that it is designed to accomplish, stressing that AI applications are ubiquitous, both in the private and public sectors. Applications today include: health care, education, employment-related decision-making, finance, law enforcement, and the legal …

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.

Constructing Countervailing Power: Law And Organizing In An Era Of Political Inequality, Kate Andrias

Faculty Scholarship

This Article proposes an innovative approach to remedying the crisis of political inequality: using law to facilitate organizing by the poor and working class, not only as workers, but also as tenants, debtors, welfare beneficiaries, and others. The piece draws on the social-movements literature, and the successes and failures of labor law, to show how law can supplement the deficient regimes of campaign finance and lobbying reform and enable lower-income groups to build organizations capable of countervailing the political power of the wealthy. As such, the Article offers a new direction forward for the public-law literature on political power and …

Fedaccounts: Digital Dollars, John Crawford, Lev Menand, Morgan Ricks

Faculty Scholarship

We are entering a new monetary era. Central banks around the world – spurred by the development of privately controlled digital currencies as well as competition from other central banks – have been studying, building, and, in some cases, issuing central bank digital currency (“CBDC”).

Although digital fiat currency is one of the hottest topics in macroeconomics and central banking today, the discussion has largely overlooked the most straightforward and appealing strategy for implementing a U.S. dollar-based CBDC: expanding access to bank accounts that the Federal Reserve already offers to a small, favored set of clients. These accounts consist of …

How The Administrative State Got To This Challenging Place, Peter L. Strauss

Faculty Scholarship

Written for a dispersed agrarian population using hand tools in a local economy, our Constitution now controls an American government orders of magnitude larger that has had to respond to profound changes in transportation, communication, technology, economy, and scientific understanding. How did our government get to this place? The agencies Congress has created to meet these changes now face profound new challenges: transition from the paper to the digital age; the increasing centralization in an opaque, political presidency of decisions that Congress has assigned to diverse, relatively expert and transparent bodies; the thickening, as well, of the political layer within …

Race Cartels: How Constructor Collaboration Is Curbing Innovation In Formula 1, Chandler C. Gerard-Reimer

Vanderbilt Journal of Entertainment & Technology Law

Formula 1 is in the midst of a copycat scandal: technology has made it possible for teams to reverse engineer clones of competitors’ race cars. This is a less than ideal state of affairs for the championship series, which prides itself on being the pinnacle of motorsport and automotive innovation, thanks in large part to the cars’ rapid rate of technological advancement. In order to address this problem, the Fédération Internationale de l’Automobile (FIA), Formula 1’s governing body, must increase independent innovation efforts by amending the technical regulations to restrict the extent of presently allowed inter-team collaboration. Worried that the …

The Communitarian Deficit In The Usa: Three Telling Cases, Amitai Etzioni

SMU Science and Technology Law Review

Liberal communitarianism suggests that the balance between individual rights and the common good must be adjusted as historical conditions change. Much attention has been paid to violations of rights, e.g., by the police, for good reasons. This Article examines three new technologies that undermine public safety, a key common good, and asks whether they should be banned. The 2020 pandemic revealed that scores of millions of Americans objected, not merely to government mandates to take measures that are likely to spare fellow Americans a severe disease or death, but even to respond to moral calls, especially wearing a mask. This …

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, …

Regulating Wave, Tidal And Ocean Thermal Energy, Meinhard Doelle, Theodore Nsoe Adimazoya

Articles, Book Chapters, & Popular Press

Ocean renewable energy sources hold the potential to contribute to the options of low-carbon energy sources and enhance the efforts by the global community to slow down climate change. In this Chapter, we provide a brief background on the current state of technology and development of wave, tidal and ocean thermal energy and consider their potential as forms of renewable energy as well as the potential negative environmental footprints of ocean renewable energy installation and development. Secondly, we examine the relevant international legal and policy framework governing ocean energy, highlighting in particular, the absence of a global legal instrument that …

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.

From Sandbox To Pandemic: Agile Reform Of Canadian Drug Regulation, Ipek Eren Vural, Matthew Herder, Janice E. Graham

Articles, Book Chapters, & Popular Press

Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Om- nibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, how- ever, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. …

Exploring The Food And Drug Administration’S Review And Approval Of Entresto (Sacubitril/Valsartan), Ashley Eadie, Keith Brunt, Matthew Herder

Articles, Book Chapters, & Popular Press

Federal regulatory agencies such as the United States Food and Drug Administration review pharmacological evidence to ensure the safety and efficacy of new and repurposed pharmaceuticals prior to market approval. The discussions, disagreements and procedural decisions contained within such reviews offer unique insight into a pharmaceutical's strengths, weaknesses and opportunities, yet are often overlooked as a significant source of pharmacological information for research and development. To highlight the value of such resources, we present a case study on Entresto, a first-in-class angiotensin receptor-neprilysin inhibitor for the treatment of heart failure with reduced ejection fraction, and explore the regulatory rationale underlying …

Consultation On How To Implement Canada's Cusma Commitment To Extend The General Term Of Copyright Protection, Carys Craig, Ariel Katz, Lucie Guibault, Graham Reynolds, Bita Amani, Sara Bannerman, Pascale Chapdelaine, Myra Tawfik, Samuel Trosow

Articles, Book Chapters, & Popular Press

As a group of Canadian Intellectual Property Law scholars, we write regarding the Ministers’ recently launched consultation on extending the term of copyright protection in order to meet Canada’s CUSMA commitments. With this letter, which we jointly submit in response to the call for comments, we wish to express our shared concerns about both the proposed term extension and, more immediately, the inappropriately curtailed nature of this consultation process.

Reasonable Expectations Of Privacy In An Era Of Drones And Deepfakes: Expanding The Supreme Court Of Canada’S Decision In R V Jarvis, Suzie Dunn, Kristen Mj Thomasen

Articles, Book Chapters, & Popular Press

Perpetrators of Technology-Facilitated gender-based violence are taking advantage of increasingly automated and sophisticated privacy-invasive tools to carry out their abuse. Whether this be monitoring movements through stalker-ware, using drones to non-consensually film or harass, or manipulating and distributing intimate images online such as deep-fakes and creepshots, invasions of privacy have become a significant form of gender-based violence. Accordingly, our normative and legal concepts of privacy must evolve to counter the harms arising from this misuse of new technology. Canada’s Supreme Court recently addressed Technology-Facilitated violations of privacy in the context of voyeurism in R v Jarvis (2019). The discussion of …

Is It Actually Violence? Framing Technology-Facilitated Abuse As Violence, Suzie Dunn

Articles, Book Chapters, & Popular Press

When discussing the term “Technology-Facilitated violence” (TFV) it is often asked: “Is it actually violence?” While international human rights standards, such as the United Nations’ Convention on the Elimination of All Forms of Discrimination against Women, have long recognized emotional and psychological abuse as forms of violence, including many forms of technology-facilitated abuse, law makers and the general public continue to grapple with the question of whether certain harmful technology-facilitated behaviors are actually forms of violence. This chapter explores this question in two parts. First, it reviews three theoretical concepts of violence and examines how these concepts apply to technology-facilitated …

How Supreme Court Precedent Sheds Light On Corporate Bill Of Attainder Claims, Alina Veneziano

Seattle Journal for Social Justice

No abstract provided.

Tragedy Of The Energy Commons: How Government Regulation Can Help Mitigate The Environmental And Public Health Consequences Of Cryptocurrency Mining, Jeff Thomson

Seattle Journal of Technology, Environmental, & Innovation Law

The use of cryptocurrencies in daily life has continued to rise over the last decade and shows no signs of slowing down. Although cryptocurrencies, such as Bitcoin, provide numerous tangible benefits to society, the process of mining these cryptocurrencies is extremely energy intensive. Accordingly, a tragedy of the energy commons has resulted whereby the monetary incentive to mine cryptocurrencies has distorted our collective ability to care for our shared energy resources. The current system allows for industrious individuals to set up cryptocurrency mines in regions that have access to plentiful and cheap energy sources, utilize this energy to power their …

The “Green Patent Paradox” And Fair Use: The Intellectual Property Solution To Fight Climate Change, Samuel Cayton

Seattle Journal of Technology, Environmental, & Innovation Law

As the climate crisis consistently worsens, the United States’ response to the crisis has proven inconsistent. Even with the United States likely to recommit to the Paris Climate Agreement, political tensions will likely further delay a climate response. The polarized characterization of the Green New Deal, the inaction of scientifically misguided conservatives, and the incessant proposal for middle ground approaches lacking the urgency needed to change course all contribute to this delay. While swift action from the federal government is needed, looking to the private sector to transition to sustainability is equally important. Specifically, patent protection is a strong intellectual …