Regulating Data as Property: A New Construct for Moving Forward

The global community urgently needs precise, clear rules that define ownership of data and express the attendant rights to license, transfer, use, modify, and destroy digital information assets. In response, this article proposes a new approach for regulating data as an entirely new class of property. Recently, European and Asian public officials and industries have called for data ownership principles to be developed, above and beyond current privacy and data protection laws. In addition, official policy guidances and legal proposals have been published that offer to accelerate realization of a property rights structure for digital information. But how can ownership of digital information be achieved? How can those rights be transferred and enforced? Those calls for data ownership emphasize the impact of ownership on the automotive industry and the vast quantities of operational data which smart automobiles and self-driving vehicles will produce. We looked at how, if at all, the issue was being considered in consumer-facing statements addressing the data being collected by their vehicles. To formulate our proposal, we also considered continued advances in scientific research, quantum mechanics, and quantum computing which confirm that information in any digital or electronic medium is, and always has been, physical, tangible matter. Yet, to date, data regulation has sought to adapt legal constructs for “intangible” intellectual property or to express a series of permissions and constraints tied to specific classifications of data (such as personally identifiable information). We examined legal reforms that were recently approved by the United Nations Commission on International Trade Law to enable transactions involving electronic transferable records, as well as prior reforms adopted in the United States Uniform Commercial Code and Federal law to enable similar transactions involving digital records that were, historically, physical assets (such as promissory notes or chattel paper). Finally, we surveyed prior academic scholarship in the U.S. and Europe to determine if the physical attributes of digital data had been previously considered in the vigorous debates on how to regulate personal information or the extent, if at all, that the solutions developed for transferable records had been considered for larger classes of digital assets. Based on the preceding, we propose that regulation of digital information assets, and clear concepts of ownership, can be built on existing legal constructs that have enabled electronic commercial practices. We propose a property rules construct that clearly defines a right to own digital information arises upon creation (whether by keystroke or machine), and suggest when and how that right attaches to specific data though the exercise of technological controls. This construct will enable faster, better adaptations of new rules for the ever-evolving portfolio of data assets being created around the world. This approach will also create more predictable, scalable, and extensible mechanisms for regulating data and is consistent with, and may improve the exercise and enforcement of, rights regarding personal information. We conclude by highlighting existing technologies and their potential to support this construct and begin an inventory of the steps necessary to further proceed with this process

Defining International Electronic Commerce

Electronic commerce has become a practical reality for thousands of businesses throughout the world. By combining the functional capabilities of computers and telecommunication systems, companies can now exchange information electronically rather than sending and receiving paper documents. In so doing, businesses are achieving remarkable and unparalleled improvements in the accuracy, speed and efficiency with which commercial transactions may be negotiated, confirmed and performed. By eliminating reliance upon paper as the medium through which commerce occurs, new and radically different approaches are emerging regarding how commercial relationships are defined and maintained. Used for international business transactions, the technologies of electronic commerce are confronting and overcoming traditional barriers to international trade presented by geographic, lingual and cultural disparities between possible trading partners. As a result, facilitating international electronic commerce throughout the global trading community is now fairly considered a project of the highest priority on the international agenda

Alzheimer\u27s Disease Drug Development Pipeline: 2019

Introduction Alzheimer\u27s disease (AD) has few available treatments, and there is a high rate of failure in AD drug development programs. Study of the AD drug development pipeline can provide insight into the evolution of drug development and how best to optimize development practices. Methods We reviewed clinicaltrials.gov and identified all pharmacologic AD trials of all agents currently being developed for treatment of AD. Results There are 132 agents in clinical trials for the treatment of AD. Twenty-eight agents are in 42 phase 3 trials; 74 agents are in 83 phase 2 trials; and 30 agents are in 31 phase 1 trials. There is an increase in the number of agents in each phase compared with that in the 2018 pipeline. Nineteen agents in trials target cognitive enhancement, and 14 are intended to treat neuropsychiatric and behavioral symptoms. There are 96 agents in disease modification trials; of these, 38 (40%) have amyloid as the primary target or as one of several effects. Eighteen of the antiamyloid agents are small molecules, and 20 are monoclonal antibodies or biological therapies. Seven small molecules and ten biologics have tau as a primary or combination target (18%). Amyloid is the most common specific target in phase 3 and phase 2 disease modification trials. Novel biomarkers (e.g., neurofilament light), new outcomes (e.g., AD Composite Score [ADCOMS]), enrollment of earlier populations, and innovative trial designs (e.g., Bayesian adaptive designs) are new features in recent clinical trials. Discussion Drug development continues robustly at all phases despite setbacks in several programs in the recent past. Continuing unmet needs require a commitment to growing and accelerating the pipeline

Metastatic disease to the breast: the Washington University experience

<p>Abstract</p> <p>Background</p> <p>Metastases to the breast occur rarely, but may be increasing in incidence as patients live longer with malignant diseases. The aim of this study is to characterize metastatic disease to the breast and to describe the management and prognosis of patients who present with this diagnosis.</p> <p>Methods</p> <p>A retrospective review of our institution's pathology and breast cancer databases was performed in order to identify patients with breast malignancies that were not of primary breast origin. Chart review provided additional information about the patients' primary malignancies and course of illness.</p> <p>Results</p> <p>Between 1991 and 2006, eighteen patients with metastatic disease to the breast of non-hematologic origin were identified and all had charts available for review. Among the 18 patients with disease metastatic to the breast, tissues of origin included 3 ovarian, 6 melanoma, 3 medullary thyroid, 3 pulmonary neuroendocrine, 1 pulmonary small cell, 1 oral squamous cell, and 1 renal cell. Overall mean survival after diagnosis of metastatic disease to the breast was 22.4 months. Treatment of metastases varied and included combinations of observation, surgery, radiation, and chemotherapy. Five patients (27.8%) required a change in management of their breast disease for local control.</p> <p>Conclusion</p> <p>Due to the variable course of patients with metastatic disease, a multi-disciplinary approach is necessary for each patient with disease metastatic to the breast to determine optimal treatment. Based on our review, many patients survive for long periods of time and local treatment of metastases to the breast may be beneficial in these patients to prevent local complications.</p

Gender Socialization during Adolescence in Low- and Middle-Income Countries : Conceptualization, influences and outcomes

Adolescence is a critical period in the development of gender attitudes and behaviours, which have potentially life-long effects.The rapid changes that take place during adolescence provide opportunities for the development and implementation of policies and programmes, which can influence the gender socialization process, in order to maximize positive outcomes.This paper set out to provide a conceptual understanding of the gender socialization process during adolescence, its influences and outcomes, and practical suggestions on how to use this knowledge in the design of policies and programmes to improve gender equality. First, theoretical contributions from psychology, sociology and biology were reviewed to situate the gender socialization process during adolescence in a broader context of multi-level influences. Second, a socio-ecological framework was introduced to bring together the main factors that influence the gender socialization process and its outcomes.Third, knowledge on how to influence the gender socialization process and its outcomes was summarized in order to provide practical recommendations for policies and programmes.This included: a) reviewing changes in demographics, the global media and gendered economic opportunities, to understand how the gender socialization process, gender norms and identities have been transformed at the macro level; and b) conducting a literature review of smallscale programmes designed to impact the gender socialization process.The literature review identified 31 programmes grouped around three broad strategies: 1) empowering young people (mainly girls) with information, skills, and social support to challenge norms; 2) fostering an enabling environment in which to challenge gender norms; and 3) working with men and boys, including directly with young individuals and with influential males to change attitudes and beliefs The paper concludes with recommendations for more holistic policy and programming efforts around gender socialization in adolescence

Rasagiline Effects on Glucose Metabolism, Cognition, and Tau in Alzheimer’s Dementia

Background: A Phase II proof of concept (POC) randomized clinical trial was conducted to evaluate the effects of rasagiline, a monoamine oxidase B (MAO-B) inhibitor approved for Parkinson disease, in mild to moderate Alzheimer\u27s disease (AD). The primary objective was to determine if 1 mg of rasagiline daily for 24 weeks is associated with improved regional brain metabolism (fluorodeoxyglucose–positron emission tomography [FDG-PET]) compared to placebo. Secondary objectives included measurement of effects on tau PET and evaluation of directional consistency of clinical end points. Methods: This was a double-blind, parallel group, placebo-controlled, community-based, three-site trial of 50 participants randomized 1:1 to receive oral rasagiline or placebo (NCT02359552). FDG-PET was analyzed for the presence of an AD-like pattern as an inclusion criterion and as a longitudinal outcome using prespecified regions of interest and voxel-based analyses. Tau PET was evaluated at baseline and longitudinally. Clinical outcomes were analyzed using an intention-to-treat (ITT) model. Results: Fifty patients were randomized and 43 completed treatment. The study met its primary end point, demonstrating favorable change in FDG-PET differences in rasagiline versus placebo in middle frontal (P \u3c 0.025), anterior cingulate (P \u3c 0.041), and striatal (P \u3c 0.023) regions. Clinical measures showed benefit in quality of life (P \u3c 0.04). Digit Span, verbal fluency, and Neuropsychiatric Inventory (NPI) showed non-significant directional favoring of rasagiline; no effects were observed in Alzheimer\u27s Disease Assessment Scale-Cognitive Subscale (ADAS-cog) or activities of daily living. Rasagiline was generally well tolerated with low rates of adverse events and notably fewer neuropsychiatric symptoms in the active treatment group. Discussion: These outcomes illustrate the potential benefits of rasagiline on clinical and neuroimaging measures in patients with mild to moderate AD. Rasagiline appears to affect neuronal activity in frontostriatal pathways, with associated clinical benefit potential warranting a more fully powered trial. This study illustrated the potential benefit of therapeutic repurposing and an experimental medicine proof-of-concept design with biomarkers to characterize patient and detect treatment response

Structure in the 3D Galaxy Distribution: I. Methods and Example Results

Three methods for detecting and characterizing structure in point data, such as that generated by redshift surveys, are described: classification using self-organizing maps, segmentation using Bayesian blocks, and density estimation using adaptive kernels. The first two methods are new, and allow detection and characterization of structures of arbitrary shape and at a wide range of spatial scales. These methods should elucidate not only clusters, but also the more distributed, wide-ranging filaments and sheets, and further allow the possibility of detecting and characterizing an even broader class of shapes. The methods are demonstrated and compared in application to three data sets: a carefully selected volume-limited sample from the Sloan Digital Sky Survey redshift data, a similarly selected sample from the Millennium Simulation, and a set of points independently drawn from a uniform probability distribution -- a so-called Poisson distribution. We demonstrate a few of the many ways in which these methods elucidate large scale structure in the distribution of galaxies in the nearby Universe.Comment: Re-posted after referee corrections along with partially re-written introduction. 80 pages, 31 figures, ApJ in Press. For full sized figures please download from: http://astrophysics.arc.nasa.gov/~mway/lss1.pd