Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning,
2020
Harvard Law School
Ethical Testing In The Real World: Evaluating Physical Testing Of Adversarial Machine Learning, Kendra Albert, Maggie Delano, Jonathon Penney, Afsaneh Ragot, Ram Shankar Siva Kumar
Articles, Book Chapters, & Popular Press
This paper critically assesses the adequacy and representativeness of physical domain testing for various adversarial machine learning (ML) attacks against computer vision systems involving human subjects. Many papers that deploy such attacks characterize themselves as “real world.” Despite this framing, however, we found the physical or real-world testing conducted was minimal, provided few details about testing subjects and was often conducted as an afterthought or demonstration. Adversarial ML research without representative trials or testing is an ethical, scientific, and health/safety issue that can cause real harms. We introduce the problem and our methodology, and then critique the physical domain testing …
Introduction,
2020
Marine & Environmental Law Institute, Schulich School of Law, Dalhousie University, Halifax, NS, Canada
Introduction, Aldo Chircop, Floris Goerlandt, Claudio Aporta, Ronald Pelot
Articles, Book Chapters, & Popular Press
This chapter introduces a multidisciplinary collection of chapters addressing various aspects of governance of Arctic shipping written by leading international scholars. It investigates how ocean changes and anthropogenic impacts affect our understanding of risk, policy, management and regulation for safe navigation, environment protection, conflict management between ocean uses, and protection of Indigenous peoples’ interests in Canadian Arctic waters. The book is divided in three parts, together providing a multi-faceted and interdisciplinary view on governance of Arctic shipping. The first part addresses conceptual and empirical aspects of risk governance, management, and assessment in the Canadian Arctic. The second part focuses on …
Regulators, Pivotal Clinical Trials, And Drug Regulation In The Age Of Covid-19,
2020
School of Health Policy and Management, York University
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 …
Disagreements Within The Us Food And Drug Administration Regarding Approval Of Novel Therapeutic Agents, 2011-2015,
2020
Schulich School of Law, Dalhousie University
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 …
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,
2020
Schulich School of Law, Dalhousie University
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,
2020
Dalhousie University, Schulich School of Law
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, …
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress,
2020
Schulich School of Law and Marine & Environmental Law Institute, Dalhousie University
Sustaining Canadian Marine Biodiversity: Policy And Statutory Progress, Jeffrey A. Hutchings, Julia K. Baum, Susanna D. Fuller, Josh Laughren, David Vanderzwaag
Articles, Book Chapters, & Popular Press
A 2012 Expert Panel Report on marine biodiversity by the Royal Society of Canada (RSC) concluded that Canada faced significant challenges in achieving sustainable fisheries, regulating aquacul- ture, and accounting for climate change. Relative to many countries, progress by Canada in fulfilling international obligations to sustain biodiversity was deemed poor. To track progress by Canada since 2012, the RSC struck a committee to track policy and statutory developments on matters pertaining to marine biodiversity and to identify policy challenges, and leading options for implementation that lie ahead. The report by the Policy Briefing Committee is presented here. It concluded that …
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu,
2020
Dalhousie University Schulich School of Law
Unscrewing The Future: The Right To Repair And The Circumvention Of Software Tpms In The Eu, Anthony D. Rosborough
Articles, Book Chapters, & Popular Press
This analysis examines the impact of software technological protection measures (“TPMs”) in the European Union which inhibit the repair and maintenance of products. Using John Deere tractors as a case study, this analysis addresses the growing number of products which incorporate computerisation and TPMprotected software into their design and function. In utilising software integration and TPMs, many product designs now allow manufacturers to retain considerable control over the manner of repair and choice of technician. In response, consumers and lawmakers are calling for legal reforms to make self-repair and servicing easier. Both the competition law and moral implications of this …
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action,
2020
American University - Washington College of Law; Program on Information Justice and Intellectual Property
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action, Sean Flynn, Christophe Geiger, Joao Pedro Quintais, Thomas Margoni, Matthew Sag, Lucie Guibault, Michael W. Carroll
Articles, Book Chapters, & Popular Press
Last year, before the onset of a global pandemic highlighted the critical and urgent need for technology-enabled scientific research, the World Intellectual Property Organization (WIPO) launched an inquiry into issues at the intersection of intellectual property (IP) and artificial intelligence (AI). We contributed comments to that inquiry, with a focus on the application of copyright to the use of text and data mining (TDM) technology. This article describes some of the most salient points of our submission and concludes by stressing the need for international leadership on this important topic. WIPO could help fill the current gap on international leadership, …
Technology-Facilitated Gender-Based Violence: An Overview,
2020
Dalhousie University Schulich School of Law
Technology-Facilitated Gender-Based Violence: An Overview, Suzie Dunn
Articles, Book Chapters, & Popular Press
Technology facilitated gender-based violence (TFGBV) is a complex worldwide phenomenon with devastating results. Research to date shows that victim-survivors of intimate partner violence are tracked by their abusive partners who use technology to monitor their movements and communication. Many women journalists, human rights defenders and politicians face daily death threats and rape threats for speaking out about equality issues or for simply being a woman in a leadership role. Those with intersecting marginalized identities are at specific risk, with Black, Indigenous, and people of colour, LGBTQ+ people, and people with disabilities facing higher rates of attacks and concerted attacks that …
Tinkering With Circuit Conflicts Beyond The Schoolhouse Gate,
2020
American University Washington College of Law
Tinkering With Circuit Conflicts Beyond The Schoolhouse Gate, Stephen Wermiel
Scholarly Articles in Law Reviews & Journals
No abstract provided.
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action,
2020
American University Washington College of Law
Implementing User Rights For Research In The Field Of Artificial Intelligence: A Call For International Action, Sean Flynn, Michael W. Carroll
Scholarly Articles in Law Reviews & Journals
Last year, before the onset of a global pandemic highlighted the critical and urgent need for technology-enabled scientific research, the World Intellectual Property Organization (WIPO) launched an inquiry into issues at the intersection of intellectual property (IP) and artificial intelligence (AI). We contributed comments to that inquiry, with a focus on the application of copyright to the use of text and data mining (TDM) technology. This article describes some of the most salient points of our submission and concludes by stressing the need for international leadership on this important topic. WIPO could help fill the current gap on international leadership, …
Big Data Prosecution And Brady,
2020
American University Washington College of Law
Big Data Prosecution And Brady, Andrew Ferguson
Scholarly Articles in Law Reviews & Journals
Prosecutors are joining the big data revolution, adopting “intelligence-driven” strategies to target crime patterns. Centralized big data systems now track offenders, places, and groups allowing prosecutors to link crimes by time, place, associations, or other connections. Adding to these types of formalized, structured databases are growing sources of raw, unstructured big data from digital surveillance technologies like video cameras, police body cameras, and automated license plate readers. The prosecutors of the future will sit on a wealth of valuable investigative insights – all searchable and potentially relevant for a more aggressive and proactive investigation strategy.But as helpful as these new …
Robo-Bureaucrat And The Administrative Separation Of Powers,
2020
California Public Employment Relations Board
Robo-Bureaucrat And The Administrative Separation Of Powers, Matthew Seipel
Cardozo Law Review de•novo
This Essay argues that the administrative state's use of artificial intelligence (AI) creates concentrated, unchecked power at the agency leadership level. The Essay draws from Professor Jon Michaels' theory of the administrative separation of powers, and it describes how AI in government disrupts this separation. To alleviate this concern, the Essay puts forward one modest proposal: Congress should amend federal public sector labor law to require collective bargaining over an agency’s decision to use AI.
Artificial Intelligence Inventions & Patent Disclosure,
2020
California Western School of Law
Artificial Intelligence Inventions & Patent Disclosure, Tabrez Y. Ebrahim
Faculty Scholarship
Artificial intelligence (“AI”) has attracted significant attention and has imposed challenges for society. Yet surprisingly, scholars have paid little attention to the impediments AI imposes on patent law’s disclosure function from the lenses of theory and policy. Patents are conditioned on inventors describing their inventions, but the inner workings and the use of AI in the inventive process are not properly understood or are largely unknown. The lack of transparency of the parameters of the AI inventive process or the use of AI makes it difficult to enable a future use of AI to achieve the same end state. While …
Patents, Information, And Innovation,
2020
California Western School of Law
Patents, Information, And Innovation, Brenda M. Simon
Faculty Scholarship
Inventors and commercialization partners often rely on patents to facilitate the exchange of sensitive information. Most scholarship in this area has focused on the areas of software and biotechnology. To provide a richer description of the role of patents in the innovative process, this project evaluates the existing literature and sets forth examples drawn from a series of interviews with professionals from the largely-overlooked medical device industry. The limited analysis of the medical device industry has focused on the largest few dozen firms—as publicly-traded entities, a great deal of data about them is readily available. Small medical device companies are …
Transnational Government Hacking,
2020
American University Washington College of Law
Transnational Government Hacking, Jennifer Daskal
Scholarly Articles in Law Reviews & Journals
No abstract provided.
Nonexcludable Surgical Method Patents,
2020
American University Washington College of Law
Nonexcludable Surgical Method Patents, Jonas Anderson
Scholarly Articles in Law Reviews & Journals
A patent consists of only one right: the right to exclude others from practicing the patented invention. However, one class of patents statutorily lacks the right to exclude direct infringers: surgical method patents are not enforceable against medical practitioners or health care facilities, which are the only realistic potential direct infringers of such patents. Despite this, inventors regularly file for (and receive) surgical method patents. Why would anyone incur the expense (more than $20,000 on average) of acquiring a patent on a surgical method if that patent cannot be used to keep people from using the patent?
The traditional answer …
Governing Cascade Failures In Complex Social-Ecological-Technological Systems: Framing Context, Strategies, And Challenges,
2020
Vanderbilt University Law School
Governing Cascade Failures In Complex Social-Ecological-Technological Systems: Framing Context, Strategies, And Challenges, J.B. Ruhl
Vanderbilt Law School Faculty Publications
Cascade failures are events in networked systems with interconnected components in which failure of one or a few parts triggers the failure of other parts, which triggers the failure of more parts, and so on. Cascade failures occur in a wide variety of familiar systems, such as electric power distribution grids, transportation systems, financial systems, and ecosystems. Cascade failures have plagued society for centuries. However, modern social-ecological-technological systems (SETS) have become vast, fast moving, and highly interconnected, exposing these systems to cascade failures of potentially global proportions, spreading at breathtaking speed, and imposing catastrophic harms. The increasing potential for cascade …
Welcome To Cordell Perspectives,
2020
Washington University in St. Louis School of Law
Welcome To Cordell Perspectives, Neil M. Richards, Jonathan W. Heusel
Scholarship@WashULaw
The world around us is changing. Let’s talk about it together. Introducing a series of articles and opinions by the world’s leading experts concerning COVID-19 as it relates to precision medicine and data privacy: Welcome to Cordell Perspectives.
