DIRECT-TO-CONSUMER GENETIC TESTING: EMPOWERING EU CONSUMERS AND GIVING MEANING TO THE INFORMED CONSENT PROCESS WITHIN THE IVDR AND GDPR FRAMEWORKS

Consumer genomics is an industry that is undergoing exponential growth. Although consumers in the United States (U.S.) currently purchase the bulk of online direct-to-consumer (DTC) genetic tests, the DTC industry’s business model depends on exploiting markets worldwide. DTC genetic testing companies increasingly seek to market and sell their services throughout the European Union (EU), which is one of the world’s largest economies and is home to a digital, educated, and wealthy consumer base. Since May 2018, the EU General Data Protection Regulation (GDPR) provides EU consumers with enhanced data privacy protections and places stricter controls on genetic data. When EU consumers purchase online DTC genetic tests, they exercise two distinct fundamental rights—the right to data privacy and the right to informed medical consent. The article explores the intersection of these rights by examining relevant EU and other legislation, mainly the GDPR, the In Vitro Diagnostic Medical Devices Regulation, and the Council of Europe’s Oviedo Convention on Human Rights and Biomedicine. Additionally, the discussion highlights the challenges associated with protecting consumers’ autonomy and freedom to purchase online DTC genetic tests, while also safeguarding the bioethical standards of informed consent. The analysis explains that the online purchase of a DTC genetic test involves two distinct consent processes—one for data processing and the other for informed consent. These two consent processes are highly dependent upon each other to protect consumers adequately. Yet, the status quo reveals that informed consent is severely lacking in the purchase of online DTC genetic tests. This results in consumers’ loss of control over health and medical decisions, as well as over personal data. Consequently, as the DTC genetic testing industry continues to grow, there is a critical need for more robust online informed consent procedures. The article concludes that current EU regulations fail to sufficiently address the issues specific to online DTC genetic tests. Furthermore, an EU regulation on informed consent, in general, is not feasible. Thus, the article considers opportunities for the EU and its Member States, consumers, and industry to work together to both empower and protect consumers who purchase online DTC genetic tests. Finally, the article discusses methods for industry to improve the online informed consent process

UAV-CLOUD: A PLATFORM FOR UAV RESOURCES AND SERVICES ON THE CLOUD

UAVs - Unmanned Aerial Vehicles – have gained significant attention recently, due to the increasingly growing range of applications. However, developing collaborative UAV applications using traditional technologies in a tightly coupled design requires a great deal of development effort, time, and budget especially for heterogeneous UAVs. Moreover, monitoring and accessing UAV resources using traditional communication media suffer from several restrictions and limitations. This research aims to simplify the efforts, reduce the time, and lower the costs of developing collaborative applications for distributed heterogeneous UAVs. In addition, the research aims to provide ubiquitous UAV resources access. A platform is proposed for developing distributed UAVs. This platform provides services to simplify application development. In this approach, UAVs are integrated with the Cloud Computing paradigm to provide ubiquitous access to their resources and services. Due to the limited capabilities of UAVs, a lightweight architecture is adopted. UAV resources and services are modeled in a Resource Oriented Architecture which is a new flexible web service design pattern with loosely coupled interaction between services. Hence, they are accessed as Representational State Transfer RESTful services using HTTP. Moreover, the research proposes using a broker architecture to increase efficiency by separating responsibilities. Therefore, it separates the requester’s logic and functionalities from the provider’s. It also takes the responsibility for allocating the issued request to the available and suitable UAV(s). To test the proposed platform, I first developed the UAV resources as a payload subsystem then provided them with Internet connectivity. Then, resource identifiers and uniform interfaces were developed using the RESTful Application Programming Interfaces (APIs). I also developed the broker service along with a database containing the information of the registered UAVs and their resources. The platform system components were tested using a requester interface in a browser by issuing a request for a resource to the broker to find and request the service from a suitable UAV. The test was done for retrieving data from UAVs as well as requesting actions from them. The main contributions of this research are proposing the UAV-Cloud platform for simplifying the development of ubiquitous UAV applications and its vii perspectives, as well as a lightweight loosely coupled design for UAV resources. Another contribution is developing the broker architecture for separating responsibilities in this platform

Inter-organ control of gut sexual dimorphism by steroid hormone signaling in Drosophila

Suggestive evidence points that exogenous exposure to steroid hormones has detrimental consequences that are not well explored specifically in the gut, where nutrient uptake occurs. The human gastrointestinal (GI) tract expresses endogenous steroid hormone receptors in the crypts and the enterocytes but their functions are not well understood. Accumulating epidemiological data suggest that GI tumor progression in most cases maybe endocrine dependent. Given the complexity of the mammalian gut yet, the genetic amenability of cell-type specific gene manipulation in Drosophila melanogaster, I studied the effect of exogenously fed or endogenous steroid hormone signaling on the gut and its implications during homeostasis and disease. In this PhD thesis, I discover the gut to be a sexually dimorphic organ that is regulated by steroid sex hormone: 20-hydroxyecdysone (20HE), which binds EcRUsp receptor complex and activates downstream target gene transcription during aging and after mating, but not after stress (the receptors have non-overlapping functions). 20HE stimulates intestinal stem cell (ISC) division in a biphasic manner when fed for 16-20hrs, with males being insensitive to the 1st peak and both sexes competent to divide at the 2nd peak of ISC division. EcR functions in the ISCs cell autonomously and in enteroblasts (EBs) non-autonomously to regulate the ISC division. Females have higher levels of circulating 20HE than the males and I identified the ovaries as an endogenous ecdysone source to control mating-induced ecdysone-dependent ISC mitoses and post-matingdependent gut growth to promote optimal egg-laying. This reproductive advantage given by the highly active female gut comes at the expense of a faster aging epithelium and higher propensity to tumors. Interestingly, exogenous 20HE feeding to males overrides the restricted ability of male ISCs to divide and abolishes the sex differences in ISC division accompanied by transcriptional regulation of metabolic and cell-cycle related genes and subsequent gut growth. All in all, this study identifies sexually dimorphic 20HE levels as a regulator of ISC behavior and intestinal growth at the expense of gut deterioration and aging

Effect of Teaching Sessions Implementation on Performance of Internship Nursing Students Regarding Intra Osseous Access

Context: Intraosseous (IO) access is an emergency vascular access for providing venous administration of drugs and fluids in emergencies. Nurses are responsible for preparing and administering fluids and medications through IO access so that nurses should be aware of IO indications, contraindications, complications, and also practicing Intraosseous (IO) access insertion.Aim: The current study was conducted to assess the effect of teaching sessions implementation on the performance of internship nursing students regarding intraosseous access. Methods: A quasi-experimental (pre/post-test) design was unitized to conduct this study. The study recruited a convenient sample of fifty (50) internship nursing students. The Critical care lab at the Faculty of Nursing Ain Shams University was used to conduct the teaching sessions. The study used two tools to achieve the aim of this study; Intraosseous Access Self-Administered Questionnaire and Internship Nurses' Practice Observational Checklist regarding intraosseous access. Results: After teaching session implementation regarding intraosseous access, there were statistically significant improvements in the level of performance of internship nursing students at P >0.05.Conclusion: Teaching session implementation had a statistically significant positive effect on internship nursing students' performance regarding intraosseous access. Repetitive training regarding IO access is recommended to be integrated as a part of the nursing faculty's clinical skills to ensure the highest standard of care in emergencies and to maximize skill retention

RICING INSURANCE IN ORDER TO MINIMIZING THE EXPECTED LOSS IN WEALTH VIA OPTIMAL CONTROL

Abstract. In this paper we are interested in Pricing insurance in order to minimizing the expected loss inwealth via optimal control. The objective is to find the policy which maximizes the total wealth in company insurances. For this purpose, First, a dynamic model is introduced to describe the process of receiving premium and paying claims. Then, we introduce the premium variable as the problem control variable. Next, we define an appropriate objective function for the control variable and state variables in order to reduce expected losses and increase the wealth. In the end, one of the main variables is estimated by statistical methods and we solve the optimal control problem by PMP method and finally, numerical example are presented.Keywords: Optimal control, Premium, Dynamical systems, expected loss, Optimization