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Articles 2731 - 2760 of 8627
Full-Text Articles in Science and Technology Law
Introduction To The Research Handbook On Intellectual Property And Technology Transfer, Jacob H. Rooksby
Introduction To The Research Handbook On Intellectual Property And Technology Transfer, Jacob H. Rooksby
Law Faculty Publications
University researchers help improve lives by solving problems that impact health, happiness, and societal wellbeing. Universities harness the power of faculty innovations and disseminate them to the public, using intellectual property to create protections and provide rewards. This process of technology transfer has been vibrant in US universities since at least the Second World War and has grown in importance everywhere since then. The Bayh-Dole Act of 1980 helped spark formalized attention to technology transfer in the US and has inspired similar legislation in countries across the globe. ...
Beyond Formal University Technology Transfer: Innovative Pathways For Knowledge Exchange, Jacob H. Rooksby
Beyond Formal University Technology Transfer: Innovative Pathways For Knowledge Exchange, Jacob H. Rooksby
Law Faculty Publications
University technology transfer is often associated with formal transmission of science-based inventions, for instance through the licensing of patented technology to a firm. Formal conceptions of technology transfer limit our ability to understand fully how scientific knowledge evolves into industrial and social application. In this introductory article, we discuss how knowledge is shared and accessed across boundaries, and argue for a broader conceptualization including the transfer, translation, and transformation of knowledge. This view underlies a necessary conceptual shift from formal technology transfer to a more encompassing conception of pathways for knowledge exchange. We discuss promising avenues for extending research on …
Key Expert Stakeholder Perceptions Of The Law Of Genomics: Identified Problems And Potential Solutions, Lauren E. Clatch
Key Expert Stakeholder Perceptions Of The Law Of Genomics: Identified Problems And Potential Solutions, Lauren E. Clatch
Law Faculty Publications
The law on human genomics in the United States is currently in transition and under debate. The rapid evolution of the science, burgeoning clinical research, and growing clinical application pose serious challenges for federal and state law. Newer genomic assays, such as gene panels, whole exome and whole genome sequencing that can assess many or all of a patient’s genetic variants are different from former genetic assays that consist of assessing for variants in specific genes that indicate risk for medical conditions and for single-gene Mendelian disorders. Overall, single-gene genetic testing has primarily been used for risk prediction, disease diagnosis, …
The Automated Administrative State: A Crisis Of Legitimacy, Danielle K. Citron, Ryan Calo
The Automated Administrative State: A Crisis Of Legitimacy, Danielle K. Citron, Ryan Calo
Faculty Scholarship
The legitimacy of the administrative state is premised on our faith in agency expertise. Despite their extra-constitutional structure, administrative agencies have been on firm footing for a long time in reverence to their critical role in governing a complex, evolving society. They are delegated enormous power because they respond expertly and nimbly to evolving conditions.
In recent decades, state and federal agencies have embraced a novel mode of operation: automation. Agencies rely more and more on software and algorithms in carrying out their delegated responsibilities. The automated administrative state, however, is demonstrably riddled with concerns. Legal challenges regarding the denial …
Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox
Accountability, Secrecy, And Innovation In Ai-Enabled Clinical Decision Software, Arti K. Rai, Isha Sharma, Christina Silcox
Faculty Scholarship
This article employs analytical and empirical tools to dissect the complex relationship between secrecy, accountability, and innovation incentives in clinical decision software enabled by machine learning (ML-CD). Although secrecy can provide incentives for innovation, it can also diminish the ability of third parties to adjudicate risk and benefit responsibly. Our first aim is descriptive. We address how the interrelated regimes of intellectual property law, Food and Drug Administration (FDA) regulation, and tort liability are currently shaping information flow and innovation incentives. We find that developers regard secrecy over training data and details of the trained model as central to competitive …
Automation: A Guide For Policymakers, James Bessen, Maarten Goos, Anna Salomons, Wiljan Van Den Berge
Automation: A Guide For Policymakers, James Bessen, Maarten Goos, Anna Salomons, Wiljan Van Den Berge
Faculty Scholarship
Advancing technologies are increasingly able to fully or partially automate job tasks. These technologies range from robotics to machine learning and other forms of artificial intelligence, and are being adopted across many sectors of the economy. Applications range from selecting job applicants for interviewing, picking orders in a warehouse, interpreting X-rays to diagnose disease, and automated customer service. These developments have raised concern that workers are being displaced by advancing automation technology. Indeed, over 18 recent studies predict job losses from new automation technologies, including some predictions of massive job losses (Winick 2018). A large literature on worker displacement [1] …
Digging Into Algorithms: Legal Ethics And Legal Access, Carla L. Reyes, Jeff Ward
Digging Into Algorithms: Legal Ethics And Legal Access, Carla L. Reyes, Jeff Ward
Faculty Scholarship
The current discussions around algorithms, legal ethics, and expanding legal access through technological tools gravitate around two themes: (1) protection of the integrity of the legal profession and (2) a desire to ensure greater access to legal services. The hype cycle often pits the desire to protect the integrity of the legal profession against the ability to use algorithms to provide greater access to legal services, as though they are mutually exclusive. In reality, the arguments around protecting the profession from the threats posed by algorithms represent an over-fit in relation to what algorithms can actually achieve, while the visions …
Disability And Design, Christopher Buccafusco
Disability And Design, Christopher Buccafusco
Faculty Scholarship
When scholars contemplate the legal tools available to policymakers for encouraging innovation, they primarily think about patents. If they are keeping up with the most recent literature, they may also consider grants, prizes, and taxes as means to increase the supply of innovation. But the innovation policy toolkit is substantially deeper than that. To demonstrate its depth, this Article explores the evolution of designs that help people with disabilities access the world around them. From artificial limbs to the modern wheelchair and the reshaping of the built environment, a variety of legal doctrines have influenced, for better and for worse, …
Tinkering With Circuit Conflicts Beyond The Schoolhouse Gate, Stephen Wermiel
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, Sean Flynn, Michael W. Carroll
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, Andrew Ferguson
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, Matthew Seipel
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, Tabrez Y. Ebrahim
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, Brenda M. Simon
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, Jennifer Daskal
Transnational Government Hacking, Jennifer Daskal
Scholarly Articles in Law Reviews & Journals
No abstract provided.
Nonexcludable Surgical Method Patents, Jonas Anderson
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 …
Inflection Points In Technology Law: An Introduction To Volume 16, Issue 1, Bryan H. Choi, Guy Rub
Inflection Points In Technology Law: An Introduction To Volume 16, Issue 1, Bryan H. Choi, Guy Rub
Publications
No abstract provided.
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 …
People Not Machines: Authorship And What It Means In International Copyright Law, Jane C. Ginsburg
People Not Machines: Authorship And What It Means In International Copyright Law, Jane C. Ginsburg
Faculty Scholarship
This chapter recapitulates Professor Ricketson’s analysis in his 1992 Manges Lecture at Columbia Law School, presciently titled 'People or Machines: The Berne Convention and the Changing Concept of Authorship'. As Ricketson systematically developed the inquiry, it became clear that ‘People or Machines’ in fact meant ‘People Not Machines’. This chapter considers whether, more than twenty-five years later, subsequent technological developments warrant reconsideration of the human authorship premise underlying the Berne Convention. If that premise holds firm, the next question is whether non-human-generated outputs require some form of intellectual property protection. Any such regime, it should be noted, would fall outside …
Fixing America's Founding, Maeve Glass
Fixing America's Founding, Maeve Glass
Faculty Scholarship
The forty-fifth presidency of the United States has sent lawyers reaching once more for the Founders’ dictionaries and legal treatises. In courtrooms, law schools, and media outlets across the country, the original meanings of the words etched into the U.S. Constitution in 1787 have become the staging ground for debates ranging from the power of a president to trademark his name in China to the rights of a legal permanent resident facing deportation. And yet, in this age when big data promises to solve potential challenges of interpretation and judges have for the most part agreed that original meaning should …
Nascent Competitors, C. Scott Hemphill, Tim Wu
Nascent Competitors, C. Scott Hemphill, Tim Wu
Faculty Scholarship
A nascent competitor is a firm whose prospective innovation represents a serious threat to an incumbent. Protecting such competition is a critical mission for antitrust law, given the outsized role of unproven outsiders as innovators and the uniquely potent threat they often pose to powerful entrenched firms. In this Article, we identify nascent competition as a distinct analytical category and outline a program of antitrust enforcement to protect it. We make the case for enforcement even where the ultimate competitive significance of the target is uncertain, and explain why a contrary view is mistaken as a matter of policy and …
Sandbox Boundaries, Hilary J. Allen
Sandbox Boundaries, Hilary J. Allen
Vanderbilt Journal of Entertainment & Technology Law
Around the world, subnational and national regulatory sandboxes are being adopted in an effort to promote fintech innovation. These regulatory sandboxes seek to do so by rolling back some of the consumer protection and prudential regulations that would otherwise apply to firms trialing their financial products and services in the sandbox. While sacrificing such protections in order to promote innovation is problematic, such sacrifice may nonetheless be justifiable if, by working with innovators in the sandbox, regulators are educated about new technologies in a way that enhances their ability to effectively promote consumer protection and financial stability in other contexts. …
Beneficial Precaution: A Proposed Approach To Uncertain Technological Dangers, Edward L. Rubin
Beneficial Precaution: A Proposed Approach To Uncertain Technological Dangers, Edward L. Rubin
Vanderbilt Journal of Entertainment & Technology Law
As a result of the specialization and cumulation of knowledge in the era of High Modernity, research and development in most technical fields is largely incomprehensible to anyone outside that field. What should policy makers do when technical specialists disagree, and particularly when some predict an oncoming catastrophe and others dismiss the concern? This is the situation with the so-called Singularity, the point at which machines design, build, and operate other machines. Some experts in cybernetics and artificial intelligence argue that this is imminent, while others consign the possibility to science fiction. If the skeptics are right, nothing need be …
The Future Of The Confrontation Clause: Semiautonomous And Autonomous Machine Witnesses, Brian Sites
The Future Of The Confrontation Clause: Semiautonomous And Autonomous Machine Witnesses, Brian Sites
Vanderbilt Journal of Entertainment & Technology Law
How should the Confrontation Clause of the Sixth Amendment be interpreted as to machine witnesses? Courts across the country have resisted efforts to cross-examine the human agents who assist machines that generate data used in criminal trials. Such challenges under the Confrontation Clause have been rejected directly and in great number, and the rules of evidence are largely being read to not require the testimony of those who have the best information about the machine's use for the case at hand. This problem arises in an era of machine exceptionalism and widespread use. From increasingly sophisticated forensic lab tools to …
Smart Contracts And The Limits Of Computerized Commerce, Eric D. Chason
Smart Contracts And The Limits Of Computerized Commerce, Eric D. Chason
Faculty Publications
Smart contracts and cryptocurrencies have sparked considerable interest among legal scholars in recent years, and a growing body of scholarship focuses on whether smart contracts and cryptocurrencies can sidestep law and regulation altogether. Bitcoin is famously decentralized, without any central actor controlling the system. Its users remain largely anonymous, using alphanumeric addresses instead of legal names. Ethereum shares these traits and also supports smart contracts that can automate the transfer of the Ethereum cryptocurrency (known as ether). Ethereum also supports specialized "tokens" that can be tied to the ownership of assets, goods, and services that exist completely outside of the …
Provisional Injunctive Relief Under The Utsa And The Dtsa In Federal Court New Product Cases, Richard F. Dole Jr.
Provisional Injunctive Relief Under The Utsa And The Dtsa In Federal Court New Product Cases, Richard F. Dole Jr.
SMU Science and Technology Law Review
No abstract provided.
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
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, …
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
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
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
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 …