Search results for: overarching regulatory agencies

Authors: Fady Tawakol

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BitCoin is a decentralized cryptocurrency that can be used without the need of traditional central banks to accomplish any e-commerce trade. The use of such currency could facilitate new economic interactions and linkages. However, without effective and efficient regulations, cryptocurrency transactions are mostly used by criminals to commit crimes such as money laundering, theft, and blackmailing. And because law is one step behind technological developments, this paper discusses the importance of regulations and supervision for the BitCoin-system, to provide unified regulatory solutions for our digital future in the Middle East. It will provide a detailed analysis of the legal nature of BitCoin along with, its regulation with respect to criminal and civil law.

Keywords: BitCoin, financial protection, crypto currency, money laundering

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Authors: David P. Horton, Gary Lynch-Wood

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Western populations are aging, prone to various lifestyle health problems, and increasing their demand for health and social care services. This demand has created enormous fiscal and regulatory challenges. In response, government institutions have deployed strategies of behavior modification to encourage people to exercise greater personal responsibility over their health and care needs (i.e., welfare responsibilisation). Policy strategies are underpinned by the assumption that people if properly supported, will make better health and lifestyle selections. Not only does this absolve governments of the responsibility for meeting all health and care needs, but it also enables government institutions to assert fiscal control over welfare spending. Looking at the regulation of health and social care in the UK, the authors identify and outline a suite of regulatory tools that are designed to extract and manage the resources of health and social care services users and to encourage them to make (‘better’) use of these resources. This is important for our understanding of how health and social care regulation is responding to ongoing social and economic challenges. It is also important because there has been a failure to systematically examine the relevance of resources for regulation, which is surprising given that resources are crucial to how and whether regulation succeeds or fails. In particular, drawing from the regulatory welfare state concept, the authors analyse the key legal and regulatory changes and mechanisms that have been introduced since the 2008 financial crisis, focusing on critical measures such as the Health and Social Care Act and regulations introduced under the National Health Service Act. The authors show how three types of user resources (i.e., tangible, labor, and data) are being used to assert fiscal control and increase welfare responsibilisation. Amongst other things, the paper concludes that service users have become more than rule followers and targets of behavioral modification; rather, they are producers of resources that regulatory systems have come to rely on.

Keywords: health care, regulation, resources, social care

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Authors: Andrew Thayer, Courtney Rondeau, Paraskevi Papadopoulou

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The Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene-editing technologies have generated considerable discussion about the applications and ethics of their use. However, no consistent guidelines for using CRISPR technologies have been developed -nor common legislation passed related to gene editing, especially as it is connected to genetically modified organisms (GMOs) in the European Union. The recent announcement that the first babies with CRISPR-edited genes were born, along with new studies exploring CRISPR’s applications in treating thalassemia, sickle-cell anemia, cancer, and certain forms of blindness, have demonstrated that the technology is developing faster than the policies needed to control it. Therefore, it can be seen that a reasonable and coherent regulatory framework for the use of CRISPR in human somatic and germline cells is necessary to ensure the ethical use of the technology in future years. The European Union serves as a unique region of interconnected countries without a standard set of regulations or legislation for CRISPR gene-editing. We posit that the EU would serve as a suitable model in comparing the legislations of its affiliated countries in order to understand the practicality and effectiveness of adopting majority-approved practices. Additionally, we present a proposed set of guidelines which could serve as a basis in developing a consistent regulatory framework for the EU countries to implement but also act as a good example for other countries to adhere to. Finally, an additional, multidimensional framework of smart solutions is proposed with which all stakeholders are engaged to become better-informed citizens.

Keywords: CRISPR, ethics, regulatory framework, European legislation

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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Authors: Jessica Peart, Sarim Al Zubaidy

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This paper examines the main dialogic and reformative aspects that have constituted the developing implementation of an English language module in a common pre-sessional program in Oman, the General Foundation Program (GFP), at the new Military Technological College (MTC), in Oman’s capital, muscat. The MTC is the first of its kind in the country to merge military with academic training and has been running programs since September 2013 over five trimesters to date, receiving external validation and accreditation from the University of Portsmouth (UoP), UK. From this starting point, We will provide context on the parameters that necessitated delivery of this common but specially tailored pre-sessional program at the MTC and outline in detail how the English module with integrated key study skills and personal tutoring support was initially conceived before operations commenced and cooperation between all stakeholders took practical shape. This enquiry traces how stakeholders from students to faculty, college boards and collaborative university partners have considered and redefined the in part static and dynamic boundaries of their larger and smaller scale stakes. With regard to the widely held recognition that pre-sessional students require training in transferable study skills in order to succeed at university, we will chart the subsequent and ongoing adjustments made to the generic, pastoral and integrated elements of that program. Driving this concerted effort has been at base the need for a GFP concerned with three criteria for incoming MTC students cadets, namely to develop candidate’s rounded capacity for intellectual, technical and physical skill as both students and cadets, to generate linguistic proficiency and discerning use of appropriate language registers and to allow personal and collective time for adjustment to a multilayered, brand new environment, while also working within a regulated timeline for academic progression to the MTC diploma or degree levels. The English Department teaching staff’s facilitation of the initial program’s methodologies and timeframe for the GFP English module has garnered a keen and diverse sense of the holistic student cadet experience, which a range of alterations to the program demonstrate. These include alterations to the class types and overall program duration as well as greater multiplicity of exposure within learning environments. In surveying the impact of these composite maneuvers and challenges within a proactive and evolving context of teaching and learning, it is finally demonstrated how student cadet levels of productivity and self-reliance on the one hand and retention issues on the other are being gainfully steered towards progression within a framework for inclusive reciprocal dialogue, gathering thereby civilian and military backgrounds toward uniquely united ends.

Keywords: English module transferable skills, faculty dialogue, governance structure, overarching regulatory agencies

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Authors: M. Miljkovic, A. Urakpo, M. Simic-Koumoutsaris

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Benefit-risk assessment (BRA) is a valuable tool that takes place in multiple stages during a medicine's lifecycle, and this assessment can be conducted in a variety of ways. The aim was to summarize current BRA methods used during approval decisions and in post-approval settings and to see possible future directions. Relevant reviews, recommendations, and guidelines published in medical literature and through regulatory agencies over the past five years have been examined. BRA implies the review of two dimensions: the dimension of benefits (determined mainly by the therapeutic efficacy) and the dimension of risks (comprises the safety profile of a drug). Regulators, industry, and academia have developed various approaches, ranging from descriptive textual (qualitative) to decision-analytic (quantitative) models, to facilitate the BRA of medicines during the product lifecycle (from Phase I trials, to authorization procedure, post-marketing surveillance and health technology assessment for inclusion in public formularies). These approaches can be classified into the following categories: stepwise structured approaches (frameworks); measures for benefits and risks that are usually endpoint specific (metrics), simulation techniques and meta-analysis (estimation techniques), and utility survey techniques to elicit stakeholders’ preferences (utilities). All these approaches share the following two common goals: to assist this analysis and to improve the communication of decisions, but each is subject to its own specific strengths and limitations. Before using any method, its utility, complexity, the extent to which it is established, and the ease of results interpretation should be considered. Despite widespread and long-time use, BRA is subject to debate, suffers from a number of limitations, and currently is still under development. The use of formal, systematic structured approaches to BRA for regulatory decision-making and quantitative methods to support BRA during the product lifecycle is a standard practice in medicine that is subject to continuous improvement and modernization, not only in methodology but also in cooperation between organizations.

Keywords: benefit-risk assessment, benefit-risk profile, product lifecycle, quantitative methods, structured approaches

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Authors: Razieh Zarei, Hassan zm, Abolghasem Ajami, Darush Moslemi, Narges Afsary, Amrollah Mostafa-zade

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Introduction: IL-23 is responsible for the differentiation and expansion of Th17/ThIL-17 cells from naive CD4+ T cells. Therefore, may be IL-23/IL17 axis involve in a variety of allergic and autoimmune diseases, such as RA, MS, inflammatory bowel disease (IBD), and asthma. TGF-β is also share for the differentiation Th17 producing IL-17 and CD4+CD25+Foxp3hiT regulatory cells from naïve CD4+ T cells which are involved in the regulation of immune response, maintaining immunological self-tolerance and immune homeostasis ,and the control of autoimmunity and cancer surveillance. Therefore, T regulatory cells play a key role in autoimmunity, allergy, cancer, infectious disease, and the induction of transplantation tolerance. Vitamin A and it's derivatives (retinoids) inhibit or reverse the carcinogenic process in some types of cancers in oral cavity,head and neck, breast, skin, liver, and blood cells. Shark is a murine organism and its cartilage has antitumor peptides to prevent angiogenesis, in vitro. Our purpose is whether simultaneous oral treatment vitamin A and shark cartilage can modulate IL-23/IL-17 and CD4CD25Foxp3 T regulatory cell/TGF-β pathways and Th1/Th2 immunity in patients with gastric cancer. Materials and Methods: First investigated an imbalanced supernatant of cytokines exist in patients with gastric cancer by ELISA. Associated with cytokines measuring such as IL-23,IL-17,TGF-β,IL-4 and γ-IFN, then flow cytometry was employed to determine whether the peripheral blood mononuclear cells such as CD4+CD25+Foxp3highT regulatory cells in patients with gastric cancer were changed correspondingly. Results: An imbalance between IL-17 secretion and TGF-β/Foxp3 t regulatory cell pathway and so, Th1 immunity (γ-IFN production) and TH2 immunity (IL-4 secretion) was not seen in patients with gastric cancer treated by vitamin A and shark cartilage. But, the simultaneously presented down-regulation of IL-23 indicated, at least cytokine level. Conclusion: Il-23, as a pro-angiogenesis cytokine, probably, help to tumor growth. Hence, suggested that down-regulation of IL-23, at least cytokine level, is useful for anti-tumor immune responses in patients with gastric cancer.

Keywords: IL-23/IL17 axis, TGF-β/CD4CD25Foxp3 T regulatory pathway, γ-IFN, IL-4, shark cartilage and gastric cancer

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Authors: Trina Isabel Santiago, Daniel Chua, Jumee Tayaban, Joseph Daniel Timbol, Joshua Yanes

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Numerous instances of human rights violations on healthcare workers have been reported during the COVID-19 pandemic in the Philippines. This brief aims to explore these civil and political rights violations and propose recommendations to address these. Our review shows that a wide range of civic and political human rights violations have been committed by individual citizens and government agencies on individual healthcare workers and health worker groups. These violations include discrimination, red-tagging, evictions, illegal arrests, and acts of violence ranging from chemical attacks to homicide. If left unchecked, these issues, compounded by the pandemic, may lead to the exacerbations of the pre-existing problems of the Philippine healthcare system. Despite all pre-existing reports by human rights groups and public media articles, there still seems to be a lack of government action to condemn and prevent these violations. The existence of government agencies which directly contribute to these violations with the lack of condemnation from other agencies further propagate the problem. Given these issues, this policy brief recommends the establishment of an interagency task force for the protection of human rights of healthcare workers as well as the expedited passing of current legislative bills towards the same goal. For more immediate action, we call for the establishment of a dedicated hotline for these incidents with adequate appointment and training of point persons, construction of clear guidelines, and closer collaboration between government agencies in being united against these issues.

Keywords: human rights violations, healthcare workers, COVID-19 pandemic, Philippines

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Authors: Nicola Urbino

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The definition of corporate social responsibility policies is a central topic in contemporary museology, as the role of museums in developing social, cultural, and environmental impact strategies has become increasingly prominent. An overarching perspective in this domain can be provided by the publication of the primary tool for impact verification and reporting in the CSR field: the Social Report. The presentation, based on an international and national theoretical and regulatory assessment, focuses on the operational significance of structured social reporting for Italian museums. The study involves analyzing over 25 Social Reports from leading Italian museums over the past 5 years to assess their CSR practices, examining both the strengths and weaknesses, in order to offer a comprehensive overview of the phenomenon of social responsibility in the national context. Moreover, a benchmark will be done between the legislative framework and guidelines and the effective implementation of CSR policies and practices. That said, the contribution aims at analyzing the strategies of the main Italian museums regarding their environmental impact on the territory. Through the analysis of the Social Balance Sheets published by a group of museums from the north to the south of Italy, it will highlight the relations that museums have established over the years with the territory and the environment, their sensitivity to climate change, and the strategies proposed to mitigate their environmental impact. Starting from a general analysis, the paper will help to highlight best practices and management models to be followed for sustainable growth, analyzing best practice, case studies and strategies applied to the museological field.

Keywords: museums, social report, sustainable development, footprint

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Authors: A. F. Huseynov, N. T. Mardanov, J. Y. Nakhchivanski

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This practical research is aimed to improve the management quality and efficiency of public administration agencies providing e-services. The monitoring system developed will provide continuous review of the websites compliance with the selected indicators, their evaluation based on the selected indicators and ranking of services according to the quality criteria. The responsible departments in the government agencies were surveyed; the questionnaire includes issues of management and feedback, e-services provided, and the application of information systems. By analyzing the main affecting factors and barriers, the recommendations will be given that lead to the relevant decisions to strengthen the state agencies competencies for the management and the provision of their services. Component 1. E-services monitoring system. Three separate monitoring activities are proposed to be executed in parallel: Continuous tracing of e-government sites using built-in web-monitoring program; this program generates several quantitative values which are basically related to the technical characteristics and the performance of websites. The expert assessment of e-government sites in accordance with the two general criteria. Criterion 1. Technical quality of the site. Criterion 2. Usability/accessibility (load, see, use). Each high-level criterion is in turn subdivided into several sub-criteria, such as: the fonts and the color of the background (Is it readable?), W3C coding standards, availability of the Robots.txt and the site map, the search engine, the feedback/contact and the security mechanisms. The on-line survey of the users/citizens – a small group of questions embedded in the e-service websites. The questionnaires comprise of the information concerning navigation, users’ experience with the website (whether it was positive or negative), etc. Automated monitoring of web-sites by its own could not capture the whole evaluation process, and should therefore be seen as a complement to expert’s manual web evaluations. All of the separate results were integrated to provide the complete evaluation picture. Component 2. Assessment of the agencies/departments efficiency in providing e-government services. - the relevant indicators to evaluate the efficiency and the effectiveness of e-services were identified; - the survey was conducted in all the governmental organizations (ministries, committees and agencies) that provide electronic services for the citizens or the businesses; - the quantitative and qualitative measures are covering the following sections of activities: e-governance, e-services, the feedback from the users, the information systems at the agencies’ disposal. Main results: 1. The software program and the set of indicators for internet sites evaluation has been developed and the results of pilot monitoring have been presented. 2. The evaluation of the (internal) efficiency of the e-government agencies based on the survey results with the practical recommendations related to the human potential, the information systems used and e-services provided.

Keywords: e-government, web-sites monitoring, survey, internal efficiency

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Authors: Sajed Sarabandi, Mostafa Rostampour Vajari

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Breast cancer is the most frequent form of cancer among women and the fifth-leading cause of cancer-related deaths. A common feature of cancer cells is their ability to survive and evade apoptosis. Understanding the mechanisms of these pathways and their regulatory factors can lead to the development of effective treatment strategies. In this study, we aim to model the effect of key miRNAs, which are significant regulatory factors in breast cancer. We designed a Petri net focusing on two crucial pathways, proliferation, and apoptosis, and identified the role of miRNAs in these pathways. Our analysis indicates that the upregulation of miRNAs 99a and 372 can effectively increase apoptosis and decrease proliferation. Moreover, we demonstrate that miRNA-600, previously reported as a potential candidate for treatment, may not be a suitable target due to its dual activity in proliferation. Therefore, further research is required to investigate the potential of this miRNA in cancer treatment. Our model shows that a combination of miRNA upregulation and knockdown can efficiently influence key genes such as MDM2 and PTEN, leading to the activation of apoptosis in cancer cells. Ultimately, our model successfully simulates the connection between regulatory miRNAs and key genes in breast cancer.

Keywords: breast cancer, microRNAs, bio-modeling, Petri net

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Authors: Andhika Danesjvara, Nur Widyastanti

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The constitution regulates the forms, types, and powers of sState organs in a government. The powers of the organs are then regulated in more detail in the legislation. One of these organs is a government organ, headed by a president or by another name that serves as the main organizer of government. The laws and regulations will govern how the organs of government shall exercise their authority and functions. In a modern state, the function of enacting laws or called executive power does not exercise the functions of government alone, but there are other organs that help the government run the country. These organs are often called government agencies, government accelerating bodies, independent regulatory bodies, commissions, councils or other similar names. The legislation also limits the power of officials within the organs to keep from abusing its authority. The main question in this paper is whether organs are the implementation of a democratic country, or as a form of compromise with the power of stakeholders. It becomes important to see how the administrative organs perform their functions. The administrative organs that are bound by government procedures work in the public service; therefore the next question is how far the function of public service is appropriate and not contradictory to the constitution.

Keywords: administrative organs, constitution, democracy, government

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Authors: Shreyas Kumar, Mili Shangari

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Integrating artificial intelligence (AI) in the cyber insurance sector represents a significant advancement, offering the potential to revolutionize risk assessment, fraud detection, and claims processing. However, this integration introduces a range of regulatory and economic challenges that must be addressed to ensure responsible and effective deployment of AI technologies. This paper examines the multifaceted regulatory landscape governing AI in cyber insurance and explores the economic implications of compliance, innovation, and market dynamics. AI's capabilities in processing vast amounts of data and identifying patterns make it an invaluable tool for insurers in managing cyber risks. Yet, the application of AI in this domain is subject to stringent regulatory scrutiny aimed at safeguarding data privacy, ensuring algorithmic transparency, and preventing biases. Regulatory bodies, such as the European Union with its General Data Protection Regulation (GDPR), mandate strict compliance requirements that can significantly impact the deployment of AI systems. These regulations necessitate robust data protection measures, ethical AI practices, and clear accountability frameworks, all of which entail substantial compliance costs for insurers. The economic implications of these regulatory requirements are profound. Insurers must invest heavily in upgrading their IT infrastructure, implementing robust data governance frameworks, and training personnel to handle AI systems ethically and effectively. These investments, while essential for regulatory compliance, can strain financial resources, particularly for smaller insurers, potentially leading to market consolidation. Furthermore, the cost of regulatory compliance can translate into higher premiums for policyholders, affecting the overall affordability and accessibility of cyber insurance. Despite these challenges, the potential economic benefits of AI integration in cyber insurance are significant. AI-enhanced risk assessment models can provide more accurate pricing, reduce the incidence of fraudulent claims, and expedite claims processing, leading to overall cost savings and increased efficiency. These efficiencies can improve the competitiveness of insurers and drive innovation in product offerings. However, balancing these benefits with regulatory compliance is crucial to avoid legal penalties and reputational damage. The paper also explores the potential risks associated with AI integration, such as algorithmic biases that could lead to unfair discrimination in policy underwriting and claims adjudication. Regulatory frameworks need to evolve to address these issues, promoting fairness and transparency in AI applications. Policymakers play a critical role in creating a balanced regulatory environment that fosters innovation while protecting consumer rights and ensuring market stability. In conclusion, the integration of AI in cyber insurance presents both regulatory and economic challenges that require a coordinated approach involving regulators, insurers, and other stakeholders. By navigating these challenges effectively, the industry can harness the transformative potential of AI, driving advancements in risk management and enhancing the resilience of the cyber insurance market. This paper provides insights and recommendations for policymakers and industry leaders to achieve a balanced and sustainable integration of AI technologies in cyber insurance.

Keywords: artificial intelligence (AI), cyber insurance, regulatory compliance, economic impact, risk assessment, fraud detection, cyber liability insurance, risk management, ransomware

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Authors: Olga C. Rodrigue

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Long-term care and skilled nursing facilities experience ebbs and flows of nursing staffing, a problem compounded by the perception of the facilities as undesirable workplaces and competition for staff from other healthcare entities. Travel nurses are contracted to fill staffing needs due to increased admissions, increased and unexpected attrition of nurses, or facility expansion of services. Prior to beginning the contracted assignment, the travel nurse must meet industry, company, and regulatory requirements (The Joint Commission and CMS) for skills and knowledge. Travel nurses, however, inconsistently receive the pre-assignment orientation needed to work at the contracted facility, if any information is given at all. When performance expectations are not met, travel nurses may subsequently choose to leave the position without completing the terms of the contract, and some facilities may choose to terminate the contract prior to the expected end date. The overarching goal of the Doctor of Nursing Practice evidence-based practice improvement project is to provide travel nurses with the basic and necessary information to prepare them to begin a long-term and skilled nursing assignment. The project involves the identification of travel nurse learning needs through a survey and the development and provision of web-based learning modules to address those needs prior to arrival for a long-term and skilled nursing assignment.

Keywords: nurse staffing, travel nurse, travel staff, contract staff, contracted assignment, long-term care, skilled nursing, onboarding, orientation, staff development, supplemental staff

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Authors: Meysam Saidi

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While the specific externalities and required regulatory measures in relation to Islamic banking are fairly uncertain, the business is growing across the world. Unofficial data indicate that the Islamic Finance market is growing with annual rate of 15% and it has reached 1.3 $ trillion size. This trend is associated with inherent systematic connection of Islamic financial institutions to other entities and different sectors of economies. Islamic banking has been subject of market development policies in major economies, most notably the UK. This trend highlights the need for identification of distinct risk features of Islamic banking and crafting customized regulatory measures. So far there has not been a significant systemic crisis in this market which can be attributed to its distinct nature. However, the significant growth and spread of its products worldwide necessitate an in depth study of its nature for customized congruent regulatory measures. In the post financial crisis era some market analysis and reports suggested that the Islamic banks fairly weathered the crisis. As far as heavily blamed conventional financial products such as subprime mortgage backed securities and speculative credit default swaps were concerned the immunity claim can be considered true, as Islamic financial institutions were not directly exposed to such products. Nevertheless, similar to the experience of the conventional banking industry, it can be only a matter of time for Islamic banks to face failures that can be specific to the nature of their business. Using the experience of conventional banking regulations and identifying those peculiarities of Islamic banking that need customized regulatory approach can aid to prevent major failures. Frank Knight has stated that “We perceive the world before we react to it, and we react not to what we perceive, but always to what we infer”. The debate over congruent Islamic banking regulations might not be an exception to Frank Knight’s statement but I will try to base my discussion on concrete evidences. This paper first analyzes both theoretical and actual features of Islamic banking in order to ascertain to its peculiarities in terms of market stability and other externalities. Next, the paper discusses distinct features of Islamic financial transactions and banking which might require customized regulatory measures. Finally, the paper explores how a more transparent path for the Islamic banking regulations can be drawn.

Keywords: Islamic banking, regulation, risks, capital requirements, customer protection, financial stability

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Authors: Sempiga Olivier, Dominika Latusek-Jurczak

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The conflict in Ukraine has had far-reaching economic consequences, not only for the countries directly involved in it but also for their trading partners and allies, and on the global economy in general. Different European Union (EU) countries, being some of Ukraine and Russia's major trading partners, have also felt the impact of the conflict on their economy. In a special way, the energy sector has suffered the most due to the fact that Russia is a huge exporter of gas and other energy sources on which rely European countries. Energy is a locomotive of the economy and once energy prices skyrocket there is a spill over effects in other areas causing different commodities’ prices to rise thereby affecting people’s social economic lifestyles. To minimise the impact energy crisis’ socio-political and economic consequences, the EU and countries have tightened their regulatory mechanisms to stop some energy firms exploit the crisis at the expense of the vulnerable mass. The key question is to what extent these regulatory instruments put in place during the energy crisis times have an affect on citizen trust in the governing institutions. The question is of paramount importance after years of declining trust in the EU and in most countries in Europe. Earlier research have analysed how wars or global political risks relate to citizen trust in government and organizations but very few empirical research have examined the relationship between regulatory instruments during the time of crisis on citizen trust in government and institutions. Using data from INSEE (the French National Institute of Statistics and Economic Studies) and European Social Survey (ESS), it carry out a multilinear regression analysis and investigate the impact of regulation both from the EU and different countries on energy prices on citizen trust. To understand the dynamics between regulatory actions during crises and citizen trust, this study draws on the theoretical framework of institutional trust and regulatory legitimacy. Institutional trust theory posits that citizens’ trust in government and institutions is influenced by perceptions of fairness, transparency, and efficacy in governance. Regulatory legitimacy, a related concept, suggests that regulatory measures, especially in response to crises, are more effective when perceived as just, necessary, and in the public interest. Results of this cross sectional study show that regulatory frameworks strongly affect the levels of trust, the association varying from strong to moderate depending on countries and period. This study contributes to the understanding of the vital relationship between regulatory measures implemented during crises and citizen trust in government institutions. By identifying the conditions under which trust is fostered or eroded, the findings provide policymakers with valuable insights into effective strategies for enhancing public confidence, ultimately guiding interventions that can mitigate the socio-political impacts of future energy crises.

Keywords: energy crisis, price, regulation, russia-Ukraine conflict, trust

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Authors: A. Bhatt, C. Bassi, H. Farragher, J. Musk

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Background: All medicines placed on the EU market are legally required to be accompanied by labeling and package leaflet, which provide comprehensive information, enabling its safe and appropriate use. Mock-ups with results of assessments using a target patient group must be submitted for a marketing authorisation application. Consumers need confidence in non-prescription, OTC medicines in order to manage their minor ailments and umbrella brands assist purchasing decisions by assisting easy identification within a particular therapeutic area. A number of regulatory agencies have risk management tools and guidelines to assist in developing umbrella brands for OTC medicines, however assessment and decision making is subjective and inconsistent. This study presents an evaluation in the UK following the US FDA warning concerning methaemoglobinaemia following 21 reported cases (11 children under 2 years) caused by OTC oral analgesics containing benzocaine. METHODS: A standard face to face, 25 structured task based user interview testing methodology using a standard questionnaire and rating scale in consumers aged 15-91 years, was conducted independently between June and October 2015 in their homes. Whether individuals could discriminate between the labelling, safety information and warnings on cartons and PILs between 3 different OTC medicines packs with the same umbrella name was evaluated. Each pack was presented with differing information hierarchy using, different coloured cartons, containing the 3 different active ingredients, benzocaine (oromucosal spray) and two lozenges containing 2, 4, dichlorobenzyl alcohol, amylmetacresol and hexylresorcinol respectively (for the symptomatic relief of sore throat pain). The test was designed to determine whether warnings on the carton and leaflet were prominent, accessible to alert users that one product contained benzocaine, risk of methaemoglobinaemia, and refer to the leaflet for the signs of the condition and what to do should this occur. Results: Two consumers did not locate the warnings on the side of the pack, eventually found them on the back and two suggestions to further improve accessibility of the methaemoglobinaemia warning. Using a gold pack design for the oromucosal spray, all consumers could differentiate between the 3 drugs, minimum age particulars, pharmaceutical form and the risk factor methaemoglobinaemia. The warnings for benzocaine were deemed to be clear or very clear; appearance of the 3 packs were either very well differentiated or quite well differentiated. The PIL test passed on all criteria. All consumers could use the product correctly, identify risk factors ensuring the critical information necessary for the safe use was legible and easily accessible so that confusion and errors were minimised. Conclusion: Patients with known methaemoglobinaemia are likely to be vigilant in checking for benzocaine containing products, despite similar umbrella brand names across a range of active ingredients. Despite these findings, the package design and spray format were not deemed to be sufficient to mitigate potential safety risks associated with differences in target populations and contraindications when submitted to the Regulatory Agency. Although risk management tools are increasingly being used by agencies to assist in providing objective assurance of package safety, further transparency, reduction in subjectivity and proportionate risk should be demonstrated.

Keywords: labelling, OTC, risk, user testing

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Authors: Olia Kanevskaia

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Standardization has been in the limelight of numerous academic studies. Typically described as ‘any set of technical specifications that either provides or is intended to provide a common design for a product or process’, standards do not only set quality benchmarks for products and services, but also spur competition and innovation, resulting in advantages for manufacturers and consumers. Their contribution to globalization and technology advancement is especially crucial in the Information and Communication Technology (ICT) and telecommunications sector, which is also characterized by a weaker state-regulation and expert-based rule-making. Most of the standards developed in that area are interoperability standards, which allow technological devices to establish ‘invisible communications’ and to ensure their compatibility and proper functioning. This type of standard supports a large share of our daily activities, ranging from traffic coordination by traffic lights to the connection to Wi-Fi networks, transmission of data via Bluetooth or USB and building the network architecture for the Internet of Things (IoT). A large share of ICT standards is developed in the specialized voluntary platforms, commonly referred to as Standards Development Organizations (SDOs), which gather experts from various industry sectors, private enterprises, governmental agencies and academia. The institutional architecture of these bodies can vary from semi-public bodies, such as European Telecommunications Standards Institute (ETSI), to industry-driven consortia, such as the Internet Engineering Task Force (IETF). The past decades witnessed a significant shift of standard setting to those institutions: while operating independently from the states regulation, they offer a rather informal setting, which enables fast-paced standardization and places technical supremacy and flexibility of standards above other considerations. Although technical norms and specifications developed by such nongovernmental platforms are not binding, they appear to create significant regulatory impact. In the United States (US), private voluntary standards can be used by regulators to achieve their policy objectives; in the European Union (EU), compliance with harmonized standards developed by voluntary European Standards Organizations (ESOs) can grant a product a free-movement pass. Moreover, standards can de facto manage the functioning of the market when other regulative alternatives are not available. Hence, by establishing (potentially) mandatory norms, SDOs assume regulatory functions commonly exercised by States and shape their own legal order. The purpose of this paper is threefold: First, it attempts to shed some light on SDOs’ institutional architecture, focusing on private, industry-driven platforms and comparing their regulatory frameworks with those of formal organizations. Drawing upon the relevant scholarship, the paper then discusses the extent to which the formulation of technological standards within SDOs constitutes a private legal order, operating in the shadow of governmental regulation. Ultimately, this contribution seeks to advise whether a state-intervention in industry-driven standard setting is desirable, and whether the increasing regulatory importance of SDOs should be addressed in legislation on standardization.

Keywords: private order, standardization, standard-setting organizations, transnational law

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Authors: Umamaheswari Shanmugam, Silvia Ronchi, Radu Vornicu

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that are able to use the large amount and variety of data generated during healthcare services every day. As we read the news, over 500 machine learning or other artificial intelligence medical devices have now received FDA clearance or approval, the first ones even preceding the year 2000. One of the big advantages of these new technologies is the ability to get experience and knowledge from real-world use and to continuously improve their performance. Healthcare systems and institutions can have a great benefit because the use of advanced technologies improves the same time efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and also to protect patients’ safety. The evolution and the continuous improvement of software used in healthcare must take into consideration the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device approval, but they are necessary to ensure performance, quality, and safety, and at the same time, they can be a business opportunity if the manufacturer is able to define in advance the appropriate regulatory strategy. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems.

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Authors: M. Macchiaroli, L. Dolores, V. Pellecchia

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With the recent Resolution n. 580/2019/R/idr, the Italian Regulatory Authority for Energy, Networks, and Environment (ARERA) for the Urban Water Management has introduced, for water managements characterized by persistent critical issues regarding the planning and organization of the service and the implementation of the necessary interventions for the improvement of infrastructures and management quality, a new mechanism for determining tariffs: the regulatory scheme of Convergence. The aim of this regulatory scheme is the overcoming of the Water Service Divided in order to improve the stability of the local institutional structures, technical quality, contractual quality, as well as in order to guarantee transparency elements for Users of the Service. Convergence scheme presupposes the identification of the cost items to be considered in the tariff in parametric terms, distinguishing three possible cases according to the type of historical data available to the Manager. The study, in particular, focuses on operations that have neither data on tariff revenues nor data on operating costs. In this case, the Manager's Constraint on Revenues (VRG) is estimated on the basis of a reference benchmark and becomes the starting point for defining the structure of the tariff classes, in compliance with the TICSI provisions (Integrated Text for tariff classes, ARERA's Resolution n. 665/2017/R/idr). The proposed model implements the recent studies on optimization models for the definition of tariff classes in compliance with the constraints dictated by TICSI in the application of the Convergence mechanism, proposing itself as a support tool for the Managers and the local water regulatory Authority in the decision-making process.

Keywords: decision-making process, economic evaluation of projects, optimizing tools, urban water management, water tariff

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Authors: S. Masud, J. Merson, D. F. Robinson

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The management of environmental resources requires engagement of a range of stakeholders including public/private agencies and different community groups to implement sustainable conservation practices. The challenge which is often ignored is the analysis of agencies involved and their power relations. One of the barriers identified is the difference in risk perceptions among the agencies involved that leads to disjointed efforts of assessing and managing risks. Wood et al 2012, explains that it is important to have an integrated approach to risk management where decision makers address stakeholder perspectives. This is critical for an effective risk management policy. This abstract is part of a PhD research that looks into barriers to flood management under a changing climate and intends to identify bottlenecks that create maladaptation. Experiences are drawn from international practices in the UK and examined in the context of Australia through exploring the flood governance in a highly flood-prone region in Australia: the Hawkesbury Ne-pean catchment as a case study. In this research study several aspects of governance and management are explored: (i) the complexities created by the way different agencies are involved in assessing flood risks (ii) different perceptions on acceptable flood risk level; (iii) perceptions on community engagement in defining acceptable flood risk level; (iv) Views on a holistic flood risk management approach; and, (v) challenges of centralised information system. The study concludes that the complexity of managing a large catchment is exacerbated by the difference in the way professionals perceive the problem. This has led to: (a) different standards for acceptable risks; (b) inconsistent attempt to set-up a regional scale flood management plan beyond the jurisdictional boundaries: (c) absence of a regional scale agency with license to share and update information (d) Lack of forums for dialogue with insurance companies to ensure an integrated approach to flood management. The research takes the Hawkesbury-Nepean catchment as case example and draws from literary evidence from around the world. In addition, conclusions were extrapolated from eighteen semi-structured interviews from agencies involved in flood risk management in the Hawkesbury-Nepean catchment of NSW, Australia. The outcome of this research is to provide a better understanding of complexity in assessing risks against a rapidly changing climate and contribute towards developing effective risk communication strategies thus enabling better management of floods and achieving increased level of support from insurance companies, real-estate agencies, state and regional risk managers and the affected communities.

Keywords: adaptive governance, flood management, flood risk communication, stakeholder risk perceptions

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Authors: Ali Alshamrani

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This article aims to give a comprehensive and critical review of sukuk issuance in Saudi Arabia, and the extent to which the issuance of sukuk in Saudi Arabia is consistent with Shariah requirements. The article is divided into two sections. Accordingly, the first section of this article begins with an examination of sukuk in general, and includes the concept of sukuk, the basic principles of sukuk, common types of sukuk, and a critical analysis of the most important differences between sukuk and conventional bonds. The second section gives a critical analysis of how sukuk work in Saudi Arabia, offering the regulatory framework of the issuance of sukuk in the KSA, and the legal challenges from Shariah point of view, and provide recommendations to overcome these challenges.

Keywords: sukuk issuance, Shariah, Saudi Arabia, capital market authority

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Authors: Hannah K. M. Tang, Muhammad Ateeq, Mark J. Lake, Badr Abdullah, Frederic A. Bezombes

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Based on a theoretical assessment of current literature, virtual reality (VR) could help to treat sporting injuries in a number of ways. However, it is important to obtain rehabilitation specialists’ perspectives in order to design, develop and validate suitable content for a VR application focused on treatment. Subsequently, a one-day observation and interview study focused on the use of VR for the treatment of lower limb musculoskeletal conditions in athletes was conducted at St George’s Park England National Football Centre with rehabilitation specialists. The current paper established the methods suitable for obtaining practitioner’s viewpoints through observation and interview in this context. Particular detail was provided regarding the method of qualitatively processing interview results using the qualitative data analysis software tool NVivo, in order to produce a narrative of overarching themes. The observations and overarching themes identified could be used as a framework and success criteria of a VR application developed in future research. In conclusion, this work explained the methods deemed suitable for obtaining practitioner’s viewpoints through observation and interview. This was required in order to highlight characteristics and features of a VR application designed to treat lower limb musculoskeletal injury of athletes and could be built upon to direct future work.

Keywords: athletes, lower-limb musculoskeletal injury, rehabilitation, return-to-sport, virtual reality

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Authors: Djehich Mohamed Yousri

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In recent years, the world has witnessed a phenomenon of displacement that is unprecedented in history. The number of refugees has reached record levels, due to wars, persecution, many conflicts and repression in a number of countries. The interest of United Nations bodies and international and regional organizations in the issue of refugees has increased, as they have defined a refugee and thus Determining who is entitled to this legal protection, and the 1951 Convention for the Protection of Refugees defines rights for refugee protection and sets obligations that they must perform. The institutional mechanisms for refugee protection are represented in the various agencies that take care of refugee affairs. At the forefront of these agencies is the United Nations High Commissioner for Refugees, as well as the various efforts provided by the International Committee of the Red Cross and the United Nations Relief and Works Agency for Palestine Refugees in the Middle East (UNRWA).

Keywords: protection, refugees, international, persecution, legal

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Authors: Mauricio Filho, Carina Castro

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The object of this project is to analyze long-time public agents that passed through several governments and see themselves in the position of having to deliberate with new agents, recently settled in the public administration. For theoretical ends, internal deliberation is understood as the one practiced on the public administration agencies, without any direct participation from the general public in the process. The assumption is: agents with longer periods of public service tend to step away from momentary political discussions that guide the current administration and seek to concentrate on institutionalized routines and procedures, making the most politically aligned individuals with the current government deliberate with less "passion" and more exchanging of knowledge and information. The theoretical framework of this research is institutionalism, which is guided by a more pragmatic view, facing the fluidity of reality in ways showing the multiple relations between agents and their respective institutions. The critical aspirations of this project rest on the works of professors Cass Sunstein, Adrian Vermeule, Philipp Pettit and in literature from both institutional theory and economic analysis of law, greatly influenced by the Chicago Law School. Methodologically, the paper is a theoretical review and pretends to be unfolded, in a future moment, in empirical tests for verification. This work has as its main analytical tool the appeal to theoretical and doctrinaire areas from the Juridical Sciences, by adopting the deductive and analytical method.

Keywords: institutions, state, law, agencies

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Authors: Khaled Alkadamani

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Using the simultaneous equations model, this paper examines the impact of capital requirements on bank risk-taking during the recent financial crisis. It also explores the relationship between capital and risk decisions and the impact of economic instability on this relationship. By analyzing the data of 20 Islamic commercial banks between 2004 and 2014 from four Middle East countries, the study concludes a positive effect of regulatory pressure on bank capital in Saudi Arabia and UAE and a negative effect in Jordan and Kuwait. Moreover, the results show a negative impact of regulatory pressure on bank risk taking in Saudi Arabia, Jordan and UAE. The findings reveal also that banks close to the minimum regulatory capital requirements improve their capital adequacy by increasing their capital and decreasing their risk taking. Furthermore, the results show that economic crisis negatively affects bank risk changes, suggesting that banks react to the impact of uncertainty by reducing their risk taking. Finally, the estimations show a negative correlation between banks profitability and capital adequacy ratio (CAR), implying that as more capital is set aside as a buffer for banks safety; it affects the performance of Islamic banks.

Keywords: bank capital, bank regulation, crisis, Islamic banks, risk taking

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Authors: Justin Bin

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Artificial intelligence (AI) has been rapidly rising in usage recently, already active in the daily lives of millions, from distinguished AIs like the popular ChatGPT or Siri to more obscure, inconspicuous AIs like those used in social media or internet search engines. As upcoming generations grow immersed in emerging technology, AI will play a vital role in their development. Namely, the education sector, an influential portion of a person’s early life as a student, faces a vast ocean of possibilities concerning the implementation of AI. The main purpose of this study is to analyze the effect that AI will have on the future of the educational field. More particularly, this study delves deeper into the following three categories: school admissions, the productivity of students, and ethical concerns (role of human teachers, purpose of schooling itself, and significance of diplomas). This study synthesizes research and data on the current effects of AI on education from various published literature sources and journals, as well as estimates on further AI potential, in order to determine the main, overarching effects it will have on the future of education. For this study, a systematic organization of data in terms of type (quantitative vs. qualitative), the magnitude of effect implicated, and other similar factors were implemented within each area of significance. The results of the study suggest that AI stands to change all the beforementioned subgroups. However, its specific effects vary in magnitude and favorability (beneficial or harmful) and will be further discussed. The results discussed will reveal to those affiliated with the education field, such as teachers, counselors, or even parents of students, valuable information on not just the projected possibilities of AI in education but the effects of those changes moving forward.

Keywords: artificial intelligence, education, schools, teachers

Procedia PDF Downloads 522

Authors: Cai Qianyi

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In the midst of global digital revolution, the flow of data poses security threats that call China's existing legislative framework for protecting personal information into question. As a preliminary procedure for risk analysis and prevention, the risk assessment of personal data transmission lacks detailed guidelines for support. Existing provisions reveal unclear responsibilities for network operators and weakened rights for data subjects. Furthermore, the regulatory system's weak operability and a lack of industry self-regulation heighten data transmission hazards. This paper aims to compare the regulatory pathways for data information transmission risks between China and Europe from a legal framework and content perspective. It draws on the “Data Protection Impact Assessment Guidelines” to empower multiple stakeholders, including data processors, controllers, and subjects, while also defining obligations. In conclusion, this paper intends to solve China's digital security shortcomings by developing a more mature regulatory framework and industry self-regulation mechanisms, resulting in a win-win situation for personal data protection and the development of the digital economy.

Keywords: personal information data transmission, risk assessment, DPIA, internet service provider, personal information data transimission, risk assessment

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Authors: Walter E. Allen, Robert D. Murray

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Many large transit agencies have adopted RFID technology and electronic automatic fare collection (AFC) or smart card systems, but small and rural agencies remain tied to obsolete manual, cash-based fare collection. Small countries or transit agencies can benefit from the implementation of smart card AFC technology with the promise of increased passenger convenience, added passenger satisfaction and improved agency efficiency. For transit agencies, it reduces revenue loss, improves passenger flow and bus stop data. For countries, further implementation into security, distribution of social services or currency transactions can provide greater benefits. However, small countries or transit agencies cannot afford expensive proprietary smart card solutions typically offered by the major system suppliers. Deployment of Contactless Fare Media System (CFMS) Standard eliminates the proprietary solution, ultimately lowering the cost of implementation. Acumen Building Enterprise, Inc. chose the Yuma County Intergovernmental Public Transportation Authority (YCIPTA) existing proprietary YCAT smart card system to implement CFMS. The revised system enables the purchase of fare product online with prepaid debit or credit cards using the Payment Gateway Processor. Open and interoperable smart card standards for transit have been developed. During the 90-day Pilot Operation conducted, the transit agency gathered the data from the bus AcuFare 200 Card Reader, loads (copies) the data to a USB Thumb Drive and uploads the data to the Acumen Host Processing Center for consolidation of the data into the transit agency master data file. The transition from the existing proprietary smart card data format to the new CFMS smart card data format was transparent to the transit agency cardholders. It was proven that open standards and interoperability design can work and reduce both implementation and operational costs for small transit agencies or countries looking to expand smart card technology. Acumen was able to avoid the implementation of the Payment Card Industry (PCI) Data Security Standards (DSS) which is expensive to develop and costly to operate on a continuing basis. Due to the substantial additional complexities of implementation and the variety of options presented to the transit agency cardholder, Acumen chose to implement only the Directed Autoload. To improve the implementation efficiency and the results for a similar undertaking, it should be considered that some passengers lack credit cards and are averse to technology. There are more than 1,300 small and rural agencies in the United States. This grows by 10 fold when considering small countries or rural locations throughout Latin American and the world. Acumen is evaluating additional countries, sites or transit agency that can benefit from the smart card systems. Frequently, payment card systems require extensive security procedures for implementation. The Project demonstrated the ability to purchase fare value, rides and passes with credit cards on the internet at a reasonable cost without highly complex security requirements.

Keywords: automatic fare collection, near field communication, small transit agencies, smart cards

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Authors: Daniel C. Bonzo

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Practical considerations lead to the use of unit of analysis within subjects, e.g., bleeding episodes or treatment-related adverse events, in rare disease settings. This is coupled with data augmentation techniques such as extrapolation to enlarge the subject base. In general, one can think about extrapolation of data as extending information and conclusions from one estimand to another estimand. This approach induces hierarchichal clustered data with varying cluster sizes. Extrapolation of clinical trial data is being accepted increasingly by regulatory agencies as a means of generating data in diverse situations during drug development process. Under certain circumstances, data can be extrapolated to a different population, a different but related indication, and different but similar product. We consider here the problem of estimation (point and interval) using a mixed-models approach under an extrapolation. It is proposed that estimators (point and interval) be constructed using weighting schemes for the clusters, e.g., equally weighted and with weights proportional to cluster size. Simulated data generated under varying scenarios are then used to evaluate the performance of this approach. In conclusion, the evaluation result showed that the approach is a useful means for improving statistical inference in rare disease settings and thus aids not only signal detection but risk-benefit evaluation as well.

Keywords: clustered data, estimand, extrapolation, mixed model

Procedia PDF Downloads 136