John M Conley, Arlene M Davis, Gail E Henderson, Eric T Juengst, Karen M Meagher, Rebecca L Walker, Margaret Waltz, Jean Cadigan
{"title":"A New Governance Approach to Regulating Human Genome Editing.","authors":"John M Conley, Arlene M Davis, Gail E Henderson, Eric T Juengst, Karen M Meagher, Rebecca L Walker, Margaret Waltz, Jean Cadigan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>For years, genomic medicine-medicine based on the growing understanding of the genetic contribution to many diseases and conditions-has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations. In the wake of ethically dubious experiments with human embryos in China, the international governance of human genome editing is emerging as an urgent topic for scientists, regulators, and the public. Efforts to develop a governance model are underway at national and international levels. These efforts are the subject of multiple initiatives by national and international health and science organizations and are topics of discussion at scientific conferences, summits, and meetings. This Article reports on the Authors' multi-year, interdisciplinary project to identify and investigate the practical, ethical, and policy considerations that are emerging as the greatest concerns about human genome editing, and ultimately to develop policy options. The project involves monitoring the discussions of groups, both government-sponsored and private, that are considering how genome editing should be governed; observing conferences where the topic is discussed; analyzing emerging policy reports by national and international bodies; and interviewing a wide range of stakeholders, including scientists, ethicists, and those who make and comment on public policy. The Article identifies several stakeholder concerns that are especially prominent in the research to date and begins to explore the implications of these concerns for alternative models of governance. There are current indications that, for practical purposes, a focus on \"soft,\" hybrid forms of governance based on networks of multiple public and private stakeholders may turn out to be the most promising course to pursue. The \"new governance\" paradigm developed in the corporate and financial sectors offers a useful model for understanding the dynamics of this approach.</p>","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"22 2","pages":"107-141"},"PeriodicalIF":0.0,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8565716/pdf/nihms-1748795.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39592175","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Is Cyberattack the Next Pearl Harbor","authors":"L. Trautman","doi":"10.2139/SSRN.2711059","DOIUrl":"https://doi.org/10.2139/SSRN.2711059","url":null,"abstract":"Central Intelligence Agency Director Leon Panetta states in his Secretary of Defense confirmation testimony before the Senate Armed Services Committee that, “The next Pearl Harbor that we confront could very well be a cyberattack that cripples America’s electrical grid and its security and financial systems.” Cyberattacks have become a daily threat to businesses, consumers, and all nation states resulting in the profound loss of economic assets and intellectual property. Cyberattack represents a real threat to geopolitical stability and world peace. This article depicts a fictional scenario of what a cyberattack on a massive scale might look like. First, a possible scenario of such a cyberattack is presented. Second, for historical perspective, the December 7, 1941 attack on Pearl Harbor is discussed. Third, is a review of contemporary and credible warnings. Fourth, is a discussion about the privacy versus national security debate, and geopolitical developments that determine the stage upon which the cyber drama may be played-out. Fifth, the question of what is to be done is addressed. Next, the 1946 Congressional Joint Committee on the Investigation of the Pearl Harbor Attack’s recommended principles (designed to prevent the repetition of such a future attack) is reviewed with our contemporary environment in mind and in search of lessons to be learned. Thoughtful people everywhere will do well to remember that “Those who cannot remember the past are condemned to repeat it.”","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"18 1","pages":"233"},"PeriodicalIF":0.0,"publicationDate":"2016-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68266685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Costs of Regulatory Redundancy: Consumer Protection Oversight of Online Travel Agents and the Advantages of Sole FTC Jurisdiction","authors":"James C. Cooper","doi":"10.2139/SSRN.2579738","DOIUrl":"https://doi.org/10.2139/SSRN.2579738","url":null,"abstract":"Every administration in recent history has attempted to reduce regulatory redundancies. One area of regulatory redundancy that deserves attention is the FTC’s and Department of Transportation’s (DOT) consumer protection authority over online travel agents (OTAs), which generated $111 billion in revenue last in 2013. This regulatory redundancy guarantees that two agencies will oversee OTAs, prevents harmonization of online consumer protection policy, and is likely to impose unnecessary costs on OTAs to adhere to two separate regulatory regimes. The importance of this conflict will grow as privacy and data security become preeminent consumer protection issues and DOT expands its jurisdiction to online information providers. Efficiency suggests the FTC as the sole consumer protection overseer of OTAs. Only the FTC has the current capacity to regulate all OTA activities, and it enjoys unrivaled expertise with respect to e-commerce consumer protection. Further, in contrast with FTC’s ex post enforcement approach, which focuses on actual or likely consumer harm, DOT’s ex ante regulatory approach is ill-suited for the fast moving world of e-commerce. Finally, the FTC faces more serious internal and external constraints on its enforcement authority, which tends to temper the potential for regulatory overreach. There are several possible ways to effect this regulatory reform, ranging from the complete abolition of DOT’s aviation consumer protection authority and the FTC Act’s common carrier exemption, to a memorandum of understanding between FTC and DOT that harmonizes policy.","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"17 1","pages":"179"},"PeriodicalIF":0.0,"publicationDate":"2015-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68211901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
John M Conley, Robert Cook-Deegan, Gabriel Lázaro-Muñoz
{"title":"MYRIAD AFTER <i>MYRIAD:</i> THE PROPRIETARY DATA DILEMMA.","authors":"John M Conley, Robert Cook-Deegan, Gabriel Lázaro-Muñoz","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Myriad Genetics' long-time monopoly on BRCA gene testing was significantly narrowed by the Supreme Court's decision in <i>AMP v. Myriad Genetics, Inc.</i>, and will be further narrowed in the next few years as many of its still-valid patents expire. But these developments have not caused the company to acquiesce in competition. Instead, it has launched a litigation offensive against a number of actual and potential competitors, suing them for infringement of numerous unexpired patents that survived the Supreme Court case. A parallel strategy may have even greater long-term significance, however. In announcing expanded operations in Europe, Myriad has emphasized that it will rely less on patents and more on its huge proprietary database of genetic mutations and associated health outcomes-a strategy that could be used in the United States as well. Myriad has built that database over its many years as a patent-based monopolist in the BRCA testing field, and has not shared it with the medical community for more than a decade. Consequently, Myriad has a unique ability to interpret the health significance of patients' genetic mutations, particularly in the case of rare \"variants of unknown significance.\" This article reviews the current state of Myriad's patent portfolio, describes its ongoing litigation offensive, and then analyzes its proprietary database strategy. The article argues that Myriad's strategy, while legally feasible, undercuts important values and objectives in medical research and health policy. The article identifies several ways in which the research and health care communities might fight back, but acknowledges that it will be a difficult uphill fight.</p>","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"15 4","pages":"597-637"},"PeriodicalIF":0.0,"publicationDate":"2014-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4275833/pdf/nihms626011.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32938311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Google Search Results: Buried If Not Forgotten","authors":"Allyson Haynes Stuart","doi":"10.2139/SSRN.2343398","DOIUrl":"https://doi.org/10.2139/SSRN.2343398","url":null,"abstract":"The right to be forgotten or to require that online information be deleted squarely confronts the First Amendment right to free speech. But the underlying problem giving rise to this right is only increasing: harmful information posted online has the real potential to destroy a person’s reputation or livelihood. In addition, the way Internet users get their information – search engines, primarily Google – emphasizes harmful information if it is “popular” under Google’s algorithm. Google’s response to requests for removal is that it cannot control the underlying websites, so removing information from its results is pointless. But in fact, the search results themselves are of crucial importance. And those results are already being altered. If Internet users’ primary access to the vast amount of online information is filtered – and hand-edited – by a search engine, why shouldn’t that editing take into consideration the harmful nature of some information? This Article proposes that Google consider “demoting” references to information in its search results that falls within one of several sensitive categories, and the party requesting removal has unsuccessfully exhausted her remedies with respect to the website publisher of the information. This amounts not to censorship, but to factoring in the nature of the information itself in determining its relevance in response to search requests.","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"15 1","pages":"463"},"PeriodicalIF":0.0,"publicationDate":"2013-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68124593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Criminal Copyright Enforcement Against Filesharing Services","authors":"B. Martin, J. Newhall","doi":"10.2139/SSRN.2229376","DOIUrl":"https://doi.org/10.2139/SSRN.2229376","url":null,"abstract":"The high-profile prosecution of the popular online storage website Megaupload for criminal copyright infringement is the latest in a series of recent criminal prosecutions of online filesharing services. This Article addresses what pushes a legitimate online file-storing business over the edge to criminal enterprise, and how criminal copyright enforcement differs from civil enforcement. The Article first explains the history of criminal copyright enforcement in the United States. It then addresses why “secondary” theories of infringement apply in the criminal, as well as civil, context and why the DMCA “safe harbor” defense is a red herring in criminal copyright actions. It concludes by suggesting guidelines for prosecutorial discretion in enforcing criminal copyright law against filesharing services, proposing that prosecutions be limited to theories of liability already established in civil case law, and that prosecutors target only prominent filesharing-service operators that openly defy civil enforcement actions.","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"15 1","pages":"101"},"PeriodicalIF":0.0,"publicationDate":"2013-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68008513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Neutral Litigants in Patent Cases","authors":"Jeremy W. Bock","doi":"10.2139/SSRN.2126353","DOIUrl":"https://doi.org/10.2139/SSRN.2126353","url":null,"abstract":"Patent cases at the district court level are one of the most complex, time-consuming, and contentious forms of civil litigation. As an alternative to the conventional, two-sided adversarial process, this Article proposes a structural change to the manner of conducting patent litigation in the district courts: the addition of a neutral litigant who, as the “third” side, represents the public interest and participates alongside the parties in all aspects of the case. Based on a novel game theoretic model, along with lessons from the International Trade Commission and the Solicitor General’s amicus practice before the Supreme Court, the presence of the neutral litigant is expected to decrease the overall level of contentiousness so as to improve the district court’s ability to adjudicate complex issues in a manner that both advances the development of the law, and serves the public interest in the fair, accurate, timely, and efficient resolution of patent disputes.","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"15 1","pages":"233"},"PeriodicalIF":0.0,"publicationDate":"2013-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67929049","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"After United States v. Jones, After the Fourth Amendment Third Party Doctrine","authors":"S. Henderson","doi":"10.2139/SSRN.2195274","DOIUrl":"https://doi.org/10.2139/SSRN.2195274","url":null,"abstract":"In United States v. Jones, the Supreme Court unanimously rejected the proposition that the Government can surreptitiously electronically track vehicle location for an entire month without Fourth Amendment restraint. While the Court's three opinions leave much uncertain, in one perspective they fit nicely within a long string of cases in which the Court is cautiously developing new standards of Fourth Amendment protection, including a rejection of a strong third party doctrine. This Article develops that perspective and provides a cautiously optimistic view of where search and seizure protections may be headed.More detail:United States v. Jones, in which the Court unanimously held that month-long Global Positioning System (GPS) tracking of a vehicle constitutes a Fourth Amendment search, did not in itself tell us much. The Government took an egregious position, and therefore lost nine to zero. The Court now applies a resurrected trespass-based conception of search, but we know extremely little about its application and what results it will alter. Five Justices believe long-term location tracking is typically a search because it invades a reasonable, seemingly empirical, expectation of privacy. And one Justice, Justice Sotomayor, is willing to reconsider the entire third party doctrine, which holds that one typically retains no Fourth Amendment expectation of privacy in information conveyed to another.But in the broader view, it is not merely one Justice who will not apply the third party doctrine in a strong form, and thus I have previously written the doctrine’s obituary. Jones fits nicely within a string of cases in which the Court is cautiously developing new standards of Fourth Amendment protections, rather than declaring generally applicable categorical rules. Given that it was a grand pronouncement of an allegedly categorical rule in United States v. Miller that has caused much of the trouble, this strikes me as a sensible way to proceed. One can expect the road will not be smooth, but we are used to zigs and zags in Fourth Amendment jurisprudence. It is hard to imagine anything less when the High Court is attempting to ferret out what is reasonable, which requires balancing private and law enforcement interests, and when technology, policing, crime, and social norms are constantly in flux.Much of the ground has been plowed before, including in articles dating back many years, which calls for brevity here. Indeed, Jones will surely spark a new crop of Fourth Amendment papers, the authors of some of which will read what has gone before and some of whom will not. But Jones provides a nice hinge around which to discuss where the Fourth Amendment has been and where it might be going — and more generally where citizens’ protections against unreasonable searches and seizures, which do not depend solely upon the Fourth Amendment, might be going. This Article will analyze that relatively high level, and, like many others, the author will begin in ot","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"14 1","pages":"431"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2139/SSRN.2195274","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67978921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Front Matter and Contents","authors":"N. Carolina.","doi":"10.2307/j.ctt20mvcf9.5","DOIUrl":"https://doi.org/10.2307/j.ctt20mvcf9.5","url":null,"abstract":"","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"10 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2008-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"68741135","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The 2006 Trademark Dilution Revision Act Rolls Out a Luxury Claim and a Parody Exemption","authors":"D. Gerhardt","doi":"10.2139/SSRN.1932337","DOIUrl":"https://doi.org/10.2139/SSRN.1932337","url":null,"abstract":"In 2006, Congress changed federal trademark dilution law when it enacted the Trademark Dilution Revision Act (“TDRA”). This Article first outlines the history of the dilution doctrine in the United States so that the changes enacted through the TDRA may be understood contextually. The TDRA’s new provisions are then delineated and explained. The author argues that the TDRA narrows the scope of federal dilution protection. Although the TDRA lowered the burden of proof to a “likelihood of dilution” standard, the Act’s new definition of fame creates a high bar that will exclude many marks from qualifying for federal dilution protection. Finally, through a case study, the Article illustrates how the TDRA’s parody exemption will work as a defense against dilution by blurring and dilution by tarnishment claims.","PeriodicalId":90661,"journal":{"name":"North Carolina journal of law & technology","volume":"8 1","pages":"205"},"PeriodicalIF":0.0,"publicationDate":"2007-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"67799630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}