Safe Harbor Provisions Research Articles

Twenty Years of the Health Insurance Portability and Accountability Act Safe Harbor Provision: Unsolved Challenges and Ways Forward.

The Health Insurance Portability and Accountability Act (HIPAA) was an important milestone in protecting the privacy of patient data; however, the HIPAA provisions specific to geographic data remain vague and hinder the ways in which epidemiologists and geographers use and share spatial health data. The literature on spatial health and select legal and official guidance documents present scholars with ambiguous guidelines that have led to the use and propagation of multiple interpretations of a single HIPAA safe harbor provision specific to geographic data. Misinterpretation of this standard has resulted in many entities sharing data at overly conservative levels, whereas others offer definitions of safe harbors that potentially put patient data at risk. To promote understanding of, and adherence to, the safe harbor rule, this paper reviews the HIPAA law from its creation to the present day, elucidating common misconceptions and presenting straightforward guidance to scholars. We focus on the 20,000-person population threshold and the 3-digit zip code stipulation of safe harbors, which are central to the confusion surrounding how patient location data can be shared. A comprehensive examination of these 2 stipulations, which integrates various expert perspectives and relevant studies, reveals how alternative methods for safe harbors can offer researchers better data and better data protection. Much has changed in the 20 years since the introduction of the safe harbor provision; however, it continues to be the primary source of guidance (and frustration) for researchers trying to share maps, leaving many waiting for these rules to be revised in accordance with the times.

Automatic Multi-Label ECG Diagnosis of Impulse or Conduction Abnormalities in Patients with Deep Learning Algorithm: A Cohort Study

Background: Electrocardiography (ECG) is a fundamental diagnostic tool, frequently used in clinical practice, for testing heart conditions. Recently, computer-aided ECG interpretation has become more widely investigated. However, researches on concurrent ECG diagnosis for multiple heart abnormalities are limited and therefore a market-applicable multi-label automatic diagnosis framework that covers a wide range of arrhythmias, with better-than-human accuracy in diagnosing ECGs with multi-labels, has not yet been developed. We therefore aimed to engineer a deep learning approach for the automated multi-label diagnosis of impulse or conduction abnormalities by realtime ECG analysis. Methods: We utilized a dataset with 70,692 patients, consisting of adults with age ≥18 years. 180112 ECGs (standard 10-second and 12-lead format) with 21 distinct rhythm classes, including various impulse or conduction abnormalities, were used for the diagnosis of arrhythmias in multi-label and single-label level. Base rhythm labels were assessed by trained personnel under the supervision of cardiologists. We ensured that each abnormality had a sample size of at least 4,000 ECGs, except idioventricular rhythm (1,780 ECGs due to the rarity of said disease), for compiling a balanced dataset. We allocated ECGs to a training or a validation dataset for the multi-label diagnostic model training, and evaluated model performance on a test dataset by calculating the area under the curve (AUC) of the receiver operating characteristic (ROC) curve, as well as quantifying accuracy, sensitivity, specificity, and the F1 score. The test dataset was annotated by the consensus of a committee of board-certified actively-practicing cardiologists. Validation of results for the test dataset were compared to diagnoses made by 53 ECG cardiologists who have a wide range of ECG interpretation experience (range=0-12+ years). Findings: We demonstrated that in multi-label level, our convolutional neural network (CNN) approach toward diagnosing heart abnormalities resulted in AUC scores above 0.913 for most of the diseases, with an average score of 0.985 (95% confidence interval (CI) 0.988-0.994). The model obtained an average F1 score of 0.890 (95% CI0.877- 0.903), sensitivity of 0.869 (95% CI 0.851-0.887), specificity of 0.995 (95% CI 0.994- 0.996). The average F1 score computed from our deep learning model exceeded the score from human cardiologists regardless of ECG interpretation experience (0 12 years: 0.829). The CNN outputs also showed identical or increased performance with respect to average sensitivity and accuracy as compared to the cardiologists. In single-label level, the CNN achieved an average F1 of 0.918, higher than the average level of the cardiologists 0.798. Interpretation: Our automatic ECG diagnosis system is better than human cardiologists to classify particular waveforms into clinically defined categories accurately, to distinguish a wide range of distinct arrhythmias, and to apply both single label and multiple label ECGs. Our study is therefore a promising foundation for the deployment of computational decision-support systems in practical clinical applications. Funding Statement: Project supported by the Major International (Regional) Joint Research Project, the Ministry of Management Science, the National Natural Science Foundation of China (Grant No. 71520107003). Declaration of Interests: Dr. Yuan reports grants from National Natural Science Foundation of China, during the conduct of the study; In addition, Dr. Yuan has a patent An automatic ECG classification method, system and equipment based on deep learning algorithm pending to Ye Yuan, Xiaoyun Yang, Hongling Zhu, Yiran Wang, Cheng Cheng, Xingyi Li, Hang Yin, Jingyi Wang. There are no other conflicts of interest. Ethics Approval Statement: To protect patients’ privacy, we used anonymized data as to prevent breaches. Accordingly, a written informed consent was not required for this study, since the ECG samples were appropriately anonymized and de-identified, as according to the Health Insurance Portability and Accountability Act Safe Harbor provision. The study design was evaluated and exempted from full review by the Huazhong University of Science and Technology Institutional Review Board.

3D Printing and Section 512(c): Safe Harbor Provision of the Digital Millennium Copyright Act

This paper addresses the topic of whether, and to what extent, copyrights should govern the distribution of 3D printing plans which are used in creating 3D printed, tangible objects. The essay discusses the various 3D printing technologies, describes how 3D printing is accomplished, defines copyright, and then briefly outlines the Digital Millennium Copyright Act (“DMCA”) of 1998. In particular, the paper lists the conditions that a firm publishing 3D printing plans must satisfy to invoke Section 512(c) safe harbor provision of the DMCA. Finally, the essay discusses when a distributor of 3D printing plans would be protected under the safe harbor provisions, arguing that when a 3D printing plan is released not-for-profit, the organization is protected under Section 512(c).

Fixing Section 512 - Legislative Reforms for the DMCA Safe Harbor Provisions

Since the implementation of the Digital Millennium Copyright Act (“DMCA”) in 1998, both the creative landscape and the way internet users interact with this landscape has changed as well. Over the last eighteen years, everyone from remix artists to independent creators to Hollywood has experimented and exploited various online media platforms in ways that were only distant imagination in 1998. With this experimentation have come unexpected consequences, affecting both the creative decisions and protection measures of large-scale copyright holders and individual artists alike. In this ever-changing landscape, there is a constant power struggle between those who have the ability to protect their content, and those who do not. The DMCA has provided a shield for innovation in intermediary technologies by protecting these technologies against legal claims for third party user infringement. However, there are deficiencies within section 512 of the DMCA and the flawed, out-of-court resolution process it creates.This article is based on work directly with clients who rely on section 512 and lawful content reuse, particularly internet users, smaller intermediaries, and independent creators. First, we address key problems with 17 U.S.C. § 512 and offer a proposal for legislative solutions to these problems. Specifically, we discuss the fact that section 512(f) is ineffectual at preventing copyright overreach and bullying. Second, we address the section 512 notice and takedown procedures, and the particular problem of large-scale automated takedowns. Specifically, we analyze the vagueness of the law as it pertains to a fair use consideration before sending a takedown notice. We also propose three legislative solutions that would clarify fair use in section 512(c)(3)(A)(v), impose a gross negligence standard for section 512(f), and clarify section 512(f) damages. Third, we focus on the significant power imbalance between large- and small-scale copyright holders, and the settling culture that results from the financial disparity between rightsholders and defendants. Fourth, we focus on the problem of the inaccuracies of mass automated takedowns, and reject “notice and staydown” style changes that would place extraordinary further burdens on internet users and service providers.

Review of Korea and U.S. Courts' Decisions for File Hosting Service Providers' Safe Harbor Provisions of DMCA 512(c) and Copyright Act 102.

Review of Korea and U.S. Courts' Decisions for File Hosting Service Providers' Safe Harbor Provisions of DMCA 512(c) and Copyright Act 102.

ADA safe‐harbor provision doesn't save recovering addict

Case name: Quinones v. University of Puerto Rico, et al., No. 14‐1331 (D. P.R. 02/13/15).

Keeping the Internet Free: Why the DMCAAs Safe Harbor Provision Should Be Expanded to Help Curb Overregulation of Content by Removing the Financial Benefit with Right and Ability to Control Exclusion

The Digital Millennium Copyright Act (DMCA) was passed in 1999 as an attempt to update copyright law to the age of the internet. The law was intended to serve as a compromise for both sides, giving copyright holders an easy means of taking action against infringements while giving websites reduced liability. To that end, the DMCA included the Online Copyright Infringement Liability Limitation Act (OCILLA), which created Safe Harbors for service providers.While creating a Safe Harbor was a good idea, it has not been encouraging sites to be less fearful of lawsuits. With the rise of video hosting sites like YouTube, the internet is a far larger and more critical part of society than it was in 1999. Unfortunately, there has been a recent trend of sites like YouTube regulating their content more strictly than the Safe Harbor provision requires in order to avoid any chance of liability. This has resulted in the unnecessary take down and removal of countless videos, and if things are left alone, content removal across the internet will only become more frequent.The issue of over regulation stems from an ambiguous section of the Safe Harbor provision which removes protection from content hosting sites that gain a financial benefit from the infringing content and have a right and ability to control it. This has been interpreted several ways by courts. Some have said that a site must do more than just have the content on their site, while others have used the common law vicarious liability test, which raises its own problems and ambiguities when applied to a content hosting site. An uncertainty on what to do has lead to sites over regulating to avoid liability. Because of this, the financial gain with right and ability to control language should be struck from the Safe Harbor provision to resolve this ambiguity and over regulation. While the concept that the OCILLA is ambiguous has been discussed in academic literature before, the outright removal of the financial benefit with right and ability to control language is a new solution.

Game On: Building an Analytic Framework for Addressing Copyright and Trademark Issues in Mobile Gaming

The mobile gaming industry is a multi-billion dollar international industry. This paper addresses a variety of copyright and trademark issues that could arise for mobile game developers and publishers. The problem of copycat apps and cyber-plagiarism is viewed through an analysis of traditional copyright infringement; fair use; the transformative work doctrine; secondary liability; and the Safe Harbor Provision of the Digital Millennium Copyright Act. A similar analysis is undertaken in the second half of this work under trademark law looking at general infringement and theories such as dilution and false advertisement law.

Massachusetts Court Looked at Safe Harbor Provision Too Narrowly

Massachusetts Court Looked at Safe Harbor Provision Too Narrowly

Cursing the Cloud (or) Controlling the Cloud?

Inspired by the cloud computing hypes, this paper responds to some of the hypes, but not to all. The hype in this paper refers to the level of the adequacy of data protection and privacy in a cloud computing (the Cloud) environment. Paradoxically, this paper proffers observational insights that surround the Cloud from the perspectives of data protection and privacy. It examines briefly the efforts of January 2010 led by Microsoft and anticipating “liability” scenarios. The liability rhetorically refers to the illegal access in the Cloud. This paper does not focus entirely on the technology sophistication; however, it analyses two scenarios of illegal access. To mitigate the liability, it suggests a “Cloud Compliant Strategy (CCS)” being a proposed model to control the Cloud. The observational insights of this paper have also intertwined with the adequacy of data protection from the lenses of the European Union (EU) Data Protection Directive 95/46/EC (DPD) and Safe Harbor provisions (SH).

Drug Discovery and the Impact of the Safe Harbor Provision of the Hatch-Waxman Act

Many facets of drug discovery involve the use of patented materials and methods, subjecting the researcher to potential liability from infringement of the underlying patents. Enacted in 1984, the Hatch-Waxman Act established a “safe harbor” for activities that would otherwise constitute infringement of a patented invention, if those activities were “solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products”. This article examines the major court decisions interpreting the scope of the safe harbor and their application to various activities in drug development.

Amgen v. International Trade Commission: The 271(e)(1) Safe Harbor Provision and ITC Jurisdiction in Section 337 Proceedings

<i>Amgen</i> v. <i>International Trade Commission</i>: The 271(e)(1) Safe Harbor Provision and ITC Jurisdiction in Section 337 Proceedings

Merck KgaA v. Integra Life Sciences: US Supreme Court Clarifies Scope of the Safe Harbor Provision

<i>Merck KgaA</i> v. <i>Integra Life Sciences</i>: US Supreme Court Clarifies Scope of the Safe Harbor Provision

The Right to Destroy

Do you have the right to destroy that which is yours? This paper addresses that fundamental question. In contested cases, courts are becoming increasingly hostile to owners' efforts to destroy their own valuable property. This sentiment has been echoed in the legal academy, with recent scholarship calling for further restrictions on an owner's right to destroy cultural property. Yet this property right has received little systematic attention. The paper therefore examines owners' rights to destroy various forms of property, including buildings, jewelry, transplantable organs, frozen human embryos, patents, personal papers, and works of art. A systematic treatment of the subject helps support a qualified defense of the right to destroy one's own property. For example, an examination of American laws and customs regarding the disposition of cadaveric organs helps one understand and weigh the expressive interests that prompt people to try to destroy jewelry via will. Similarly, an examination of patent suppression case law points toward a form of ex ante analysis that has been de-emphasized in opinions involving the destruction of buildings and other structures. An analysis of cases involving the destruction of frozen human embryos may shed light on creators' rights to burn unpublished manuscripts or works of art. And collectivist theories of free speech may help explain why the Visual Artists Rights Act sensibly prohibits the destruction of paintings by living artists, but not Old Masters. In advocating a more unified treatment of destruction rights, the paper argues that greater deference to owners' destructive wishes often serves important welfare and expressive interests. The paper also critiques existing case law that calls for particular hostility toward will provisions that direct the destruction of a testator's valuable property. Courts and commentators have not given particularly persuasive justifications for restricting testamentary destruction, and the paper proposes a safe-harbor provision whereby sincere testators who jump through certain hoops during their lifetimes can have their destructive wishes enforced.

From Rhetoric to Reality: The Case for High-Quality Compensatory Prekindergarten Programs

The No Child Left Behind Act requires all children to reach proficiency reading and mathematics by 2013-14. But this goal is based on the erroneous assumption that all children start school ready to learn. If we are to succeed closing the achievement gap, Ms. Neuman argues, we must put our efforts into creating high-quality prekindergarten programs for the nation's at-risk children. THESE ARE difficult times for public education. Faced with their worst financial crisis decades, states are eliminating all but essential programs, schools are shortening their sessions, textbook purchases are being put on hold, and teachers are feeling more vulnerable than ever before. These conditions are bad enough for small suburban school districts. They are all that much worse for districts the inner cities, where years of funding inequities have already curtailed all but the most vital services. Unfortunately, at a time when the public is being asked to challenge the soft bigotry of low expectations, schools are struggling to hold on to hot breakfasts, decent bathrooms, and writing paper for their students. Because of the lack of the resources and support to sustain the gains that many urban schools have seen recent years,1 the current budget gap now threatens to trump the achievement gap. Paradoxically, just as programs and personnel are being slashed, standards and academic expectations are rising -- along with the sanctions for schools that fail to meet them. In the landmark reauthorization of the Elementary and Secondary Education Act, known as the No Child Left Behind (NCLB) Act of 2001, state accountability systems must now require schools to meet absolute targets for growth scores on mandatory state tests measuring achievement reading and math, so that all children will reach proficiency by 2013-14. And all means all. The results must be broken down by demographic categories, including economic disadvantage, ethnicity/minority status, limited proficiency English, and special education. If any of these subgroups fails to show adequate progress for two consecutive years, sanctions will be put place that involve an option allowing students to transfer to another public school and the provision of supplemental services, followed by corrective actions and school restructuring if necessary. The rhetoric of higher standards and achievement may be appealing, but the reality is not. Even with safe-harbor provisions, projections a number of states indicate that some subgroups, starting from behind, might have to make gains of 20% or more order to reach the absolute targets reading and math achievement two years.2 This could mean that 20,000 or more schools could be identified as in need of improvement -- a tripling of the number of schools this category previous years. There are a couple of ways for states to deal with this problem. They can find loopholes the law or devise strategies to continue to do business as usual and maintain the status quo, with large numbers of children being left behind. Or they can face reality, get serious, and address the enormous disparities children's skill levels before they even come to school and help schools and their beleaguered teachers, reeling from bad budget news, to accelerate and improve student learning. The Reality Several assumptions underlie the logic of NCLB. The law makes a bold and important statement that all children are able to learn the schools have to teach. It acknowledges the importance of highly qualified teachers significantly improving children's achievement and of research-based methods -- using what works to more efficiently and effectively teach reading and math skills. But the law also makes another and more troubling assumption: that of a level playing field. In expecting universal proficiency reading and math by 2013-14, NCLB seems to assume that all children are equally prepared for formal instruction kindergarten and first grade -- that all children start school ready to learn. …

Arbitrage, Options and Endangered Species

I model the impact of mitigation banking accompanied by Safe Harbor provisions on a land-owner’s choices about supporting a population of an endangered species. The Safe Harbor provision is equivalent to a free call option on a population with market value, and mitigation banking can allow a landowner with an endangered species to arbitrage between land without and with permission to develop. A land-owner whose land is not zoned for development may therefore stand to beneÞt from the discovery of an endangered species on

Understanding the 2000 election: a guide to the legal battles that decided the presidency

Introduction Background1 Winning the Presidency: The Electoral Vote Part I. Counting by Hand2 Manual Recounts: In Florida, and Across the Nation 3 Protesting the Election: What Sort of Deadline WasNovember 14? 434 Contesting the Election: What Does the Law Mean by Rejection of Legal Votes? 5 Challenging Hand Counts in Federal CourtPart II. The Bush Attack on the Florida Supreme Court6 The Safe-Harbor Provision and Article II of the Constitution7 Article II of the U.S. Constitution8 The U.S. Supreme Court Asks for Clari?cationPart III. The End of the Road9 The U.S. Supreme Court Ends the ElectionPart IV. The Wild-Card Lawsuits10 The Butter?y Ballot11 Absentee BallotsPart V. The Legislative Role12 The Florida Legislature13 The U.S. CongressAfterword Notes Acknowledgments Index About the Author

Recent Developments in the Safe Harbor Provisions of 271(e)1

Recent Developments in the Safe Harbor Provisions of 271(e)1

Do the SEC's Safe Harbor Provisions Encourage Forward-Looking Disclosures?

Recent surveys indicate that CEOs are reluctant to make disclosures of forward-looking information because they believe these disclosures expose them and their firms to stockholder litigation. Partly as a result of these claims, the SEC has recently called for testimony on whether the current safe harbor provisions are effective in encouraging corporate managers to disclose voluntarily forward-looking information. Evidence from the voluntary disclosure literature suggests that legal liability concerns have important effects on managers' voluntary disclosure choices and that these concerns often prevent managers from issuing earnings forecasts. By strengthening the safe harbor provisions to reduce the expected legal costs of disclosure, the SEC can increase the extent to which managers voluntarily disclose forward-looking information.