Search results for: regulatory compliance

Authors: Khan Shahid, Shahid Zakia

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The article demonstrates how Theology and Islamic Philosophy can be illuminated and enhanced through the application of the SOUL framework (Sincere act, Optimization effort, Ultimate goal, Law compliance). The study explores historical development using a phenomenological approach and integrates the SOUL framework to enrich Theology and Islamic Philosophy. The proposed framework highlights the significance of these elements, ultimately leading to a deeper understanding of Theology and Islamic Philosophy.

Keywords: SOUL framework, illuminating human identity, theology, Islamic Philosophy, sincerity act, optimization effort, ultimate goals, law compliance

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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: Beatrice Arthur

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The rapid development of artificial intelligence (AI) has transformed various industries, enabling faster and more accurate decision-making processes. However, with these advancements come increased risks, including data privacy issues, systemic biases, and challenges related to transparency and accountability. As AI technologies become more integrated into business processes, there is a growing need for comprehensive auditing and assurance frameworks to manage these risks and ensure ethical use. This paper provides a literature review on AI auditing and assurance programs, highlighting the importance of adapting traditional audit methodologies to the complexities of AI-driven systems. Objective: The objective of this review is to explore current AI audit practices and their role in mitigating risks, ensuring accountability, and fostering trust in AI systems. The study aims to provide a structured framework for developing audit programs tailored to AI technologies while also investigating how AI impacts governance, risk management, and regulatory compliance in various sectors. Methodology: This research synthesizes findings from academic publications and industry reports from 2014 to 2024, focusing on the intersection of AI technologies and IT assurance practices. The study employs a qualitative review of existing audit methodologies and frameworks, particularly the COBIT 2019 framework, to understand how audit processes can be aligned with AI governance and compliance standards. The review also considers real-time auditing as an emerging necessity for influencing AI system design during early development stages. Outcomes: Preliminary findings indicate that while AI auditing is still in its infancy, it is rapidly gaining traction as both a risk management strategy and a potential driver of business innovation. Auditors are increasingly being called upon to develop controls that address the ethical and operational risks posed by AI systems. The study highlights the need for continuous monitoring and adaptable audit techniques to handle the dynamic nature of AI technologies. Future Directions: Future research will explore the development of AI-specific audit tools and real-time auditing capabilities that can keep pace with evolving technologies. There is also a need for cross-industry collaboration to establish universal standards for AI auditing, particularly in high-risk sectors like healthcare and finance. Further work will involve engaging with industry practitioners and policymakers to refine the proposed governance and audit frameworks. Funding/Support Acknowledgements: This research is supported by the Information Systems Assurance Management Program at Concordia University of Edmonton.

Keywords: AI auditing, assurance, risk management, governance, COBIT 2019, transparency, accountability, machine learning, compliance

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Authors: Fatemah Al-Baroud, Sudharani Shreenivas Kshatriya

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Kuwait Oil Company (KOC) is one of the companies for gas & oil production in Kuwait. The oil and gas industry is truly global; with operations conducted in every corner of the globe, the global community will rely heavily on oil and gas supplies. KOC has made many commitments to protect all due to KOC’s operations and operational releases. As per KOC’s strategy, the substantial increase in production activities will bring many challenges in managing various environmental hazards and stresses in the company. In order to handle those environmental challenges, the need of implementing effectively the health, safety, and environmental management system (HSEMS) is significant. And by implementing the HSEMS system properly, the environmental aspects of the activities, products, and services were identified, evaluated, and controlled in order to (i) Comply with local regulatory and other obligatory requirements; (ii) Comply with company policy and business requirements; and (iii) Reduce adverse environmental impact, including adverse impact to company reputation. Assessments for the Jurassic Production Facilities are being carried out as a part of the KOC HSEMS procedural requirement and monitoring the implementation of the relevant HSEMS procedures in the facilities. The assessments have been done by conducting series of theme audits using KOC’s audit protocol at JPFs. The objectives of the audits are to evaluate the compliance of the facilities towards the implementation of environmental procedures and the status of the KEPA requirement at all JPFs. The list of the facilities that were covered during the theme audit program are the following: (1) Jurassic Production Facility (JPF) – Sabriya (2) Jurassic Production Facility (JPF) – East Raudhatian (3) Jurassic Production Facility (JPF) – West Raudhatian (4)Early Production Facility (EPF 50). The auditing process comprehensively focuses on the application of KOC HSE MS procedures at JPFs and their ability to reduce the resultant negative impacts on the environment from the operations. Number of findings and observations were noted and highlighted in the audit reports and sent to all concerned controlling teams. The results of these audits indicated that the facilities, in general view, were in line with KOC HSE Procedures, and there were commitments in documenting all the HSE issues in the right records and plans. Further, implemented several control measures at JPFs that minimized/reduced the environmental impact, such as SRU were installed for sulphur recovery. Future scope and monitoring audit after a sufficient period of time will be carried out in conjunction with the controlling teams in order to verify the current status of the recommendations and evaluate the contractors' performance towards the required actions in preserving the environment.

Keywords: assessment of the environmental compliance, environmental and social impact assessment, kuwait environment public authority regulations, health, safety and environment management procedures, jurassic production facilities

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Authors: Aishat Abdul-Qadir Zubair

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Background: The absence of Shari’ah screening methodology for companies in Nigeria has further engineered the uncertainty surrounding the acceptability of investing in certain companies by people professing the religion of Islam due to the nature of the activities carried out by these companies. There are some existing shariah screening indices in other jurisdictions whose criteria can be used to check if a company or business is shariah-compliant or not. Examples such as FTSE, DJIM, Standard and Poor to mention just a few. What these indices have tried to do is to ensure that there are benchmarks to check with before investing in companies that carry out mixed activities in their business, wherein some are halal and others may be haram. Purpose: There have been numerous studies on the need to adopt certain screening methodologies as well as call for new methods in screening companies for shariah compliance in order to suit the investments needs of Muslims in other jurisdictions. It is, however, unclear how suitable these methodologies will be to Nigeria. This paper, therefore, seeks to address this gap to consider an appropriate screening methodology to be employed in Nigeria, drawing from the experience of other jurisdictions. Methods: This study employs a triangulation of both quantitative and qualitative methods to analyze the need for Shari’ah screening of companies in Nigeria. The qualitative method is used by way of ijtihad, and this study tries to apply some Islamic Principles of Maqasid al-shari’ah as well as Qawaid al-Fiqiyyah to analyze activities of companies in order to ensure that they are indeed Shari’ah compliant. In addition, using the quantitative data gathered from the interview survey, the perspective of the investors with regards to the need for Shari’ah screening of companies in Nigeria is further analyzed. Results: The result of the study shows that there is a lack of awareness from the teeming Muslim population in Nigeria on the need for Shari’ah screening of companies in Nigeria. The result further shows that there is the need to take into cognizance the peculiar nature of company activities in Nigeria before any particular Shari’ah screening methodology is adopted and setting the necessary benchmarks. Conclusion and Implications: The study concludes that there is the need to ensure that the conscious Muslims in Nigeria screen companies for Shari’ah compliance so that they can easily identify the companies to invest in. The paper, therefore, recommends that the Nigerian government need to come up with a screening methodology that will suit the peculiar nature of companies in Nigeria. The study thus has a direct implication on the Investment regulatory bodies in Nigeria such as the Securities and Exchange Commission (SEC), Central Bank of Nigeria (CBN) as well as the investor Muslims.

Keywords: Shari'ah screening, Muslims, investors, companies

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Authors: Shakiera Sallie, Angela James

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Global concern about healthcare-associated infections through the transmission of microorganisms, resulting in outbreaks in overcrowded intensive care units (ICU), is current. Medical equipment and surfaces in the immediate patient zone, the high-touch objects, may become contaminated. A study was conducted across six intensive care units in a healthcare facility to determine the understanding and practice of the cleaning of high-touch objects (HTO), and an intervention program was undertaken. A mixed-method approach with the selection of ICUs, HTOs, and healthcare personnel was undertaken. Data collection included Ultra-Violet instruments, a questionnaire, and an intervention. In the pre-intervention, 41 (52.5%) of the healthcare personnel (n=78) rated their understanding of HTOs as “sufficient”; post-intervention, it was 67 (75%), (n=89), p=0.0015, indicates an improvement. The UV stamp percentage compliance to indicate whether cleaning of the HTOs had taken place across the six intensive care units before the intervention ranged from 0% compliance to 88% compliance, and after, it ranged from 67% to 91%. An intervention program on the cleaning of HTOs and the transmission cycle of microorganisms in the ICUs enhanced the healthcare personnel’s understanding and practices on the importance of environmental cleaning.

Keywords: high touch objects, infections, intensive care units, intervention program, microorganisms

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Authors: Hitalo Silva

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The most famous corruption scandals in the past four years were taken in Latin America, especially in Brazil, but besides the stain that these countries suffered in an international field, there was a huge effort to create or modernize its national anti-corruption laws. Also, the countries are implementing new standards for investigations and corporate compliance programs, in order to combat corruption and prevent the money laundering. But here is the following question: is here an invisible uniformization/transnationalization of the anti-corruption systems in Latin America? This new scenario reflects the impacts of the corruption investigations conducted in Latin America countries, such as Car Wash Operation in Brazil, Pretelt Case in Colombia, Gasoducto Sur Peruano case and the Mr. Alex Kouri’s case both in Peru. Legal and institutional pro-transparency reforms were made recently, the companies are trying to implement new standards of conduct and investing in their compliance department. In this sense, there is a huge homogeneity in Latin America concerning the structuring of corporate compliance programs, a truly transnationalization not only of laws but also corporate standards among these countries. Although legislative initiatives vary among the countries, there is a tendency to impose rigid liability standards for the companies being investigated for corruption, not only the personal punishments of their executives, which demonstrate the power of authorities to strength the investigative tools. Also, instruments such as leniency agreements and plea bargain are essential to put a central role in enforcement activities in Latin America. In other words, in a region where six former Presidents were convicted for acts of corruption, and, companies such as Odebrecht that is accused of offering bribes to politicians from Argentina to México, passing through Ecuador, Colombia, Guatemala and Panama, this demonstrates the necessity to increase strength of their legal framework in a sense that unify transnational goals. All things considered, this paper will show how anti-corruption regulators are cooperating in Latin America jurisdictions in order to unify their laws and how the private sector is dealing with this new scenario of corporate culture change.

Keywords: compliance, corruption, investigations, Latin America, transnational

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Authors: Rodrigo Zepeda

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Transaction cost analysis (TCA) is a way of analyzing the relative performance of different intermediaries and different trading strategies for trades undertaken in financial instruments. It is a way for an investor to determine the overall quality of execution of a particular trade, and there are many different approaches to undertaking TCA. Under the updated Markets in Financial Instruments Directive (2014/65/EU) (MiFID II), investment firms are required when executing orders, to take all sufficient steps to obtain the best possible result for their clients. This requirement for 'Best Execution' must take into account price, costs, speed, likelihood of execution and settlement, size, nature or any other consideration relevant to the execution of the order. The new regulatory compliance framework under MiFID II will now also apply across a very broad range of financial instruments. This article will provide a comprehensive technical analysis of how TCA and Best Execution will significantly change under MiFID II. It will also explain why harmonization of post-trade reporting requirements under MiFID II could potentially support the development of peer group analysis, which in turn could provide a new and highly advanced framework for TCA that could more effectively support Best Execution requirements under MiFID II. The study is significant because there are no studies that have dealt with TCA and Best Execution under MiFID II in the literature.

Keywords: transaction cost analysis, execution quality, best execution, MiFID II, financial instruments

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Authors: Qingxin Chen, Liben Jiang, Andrew Smith, Karim Hadjri

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Since 2007, the Chinese food industry has undergone serious food contamination in the baby dairy industry, especially milk powder contamination. One of the milk powder products was found to contain melamine and a significant number (294,000) of babies were affected by kidney stones. Due to growing concerns among consumers about food safety and protection, and high pressure from central government, companies must take radical action to ensure food quality protection through the use of an appropriate quality management system. Previously, though researchers have investigated the health and safety aspects of food industries and products, quality issues concerning food products in China have been largely over-looked. Issues associated with baby dairy products and their quality issues have not been discussed in depth. This paper investigates the impact of quality management systems on the Chinese baby dairy product industry. A literature review was carried out to analyse the use of quality management systems within the Chinese milk power market. Moreover, quality concepts, relevant standards, laws, regulations and special issues (such as Melamine, Flavacin M1 contamination) have been analysed in detail. A qualitative research approach is employed, whereby preliminary analysis was conducted by interview, and data analysis based on interview responses from four selected Chinese baby dairy product companies was carried out. Through the analysis of literature review and data findings, it has been revealed that for quality management system that has been designed by many practitioners, many theories, models, conceptualisation, and systems are present. These standards and procedures should be followed in order to provide quality products to consumers, but the implementation is lacking in the Chinese baby dairy industry. Quality management systems have been applied by the selected companies but the implementation still needs improvement. For instance, the companies have to take measures to improve their processes and procedures with relevant standards. The government need to make more interventions and take a greater supervisory role in the production process. In general, this research presents implications for the regulatory bodies, Chinese Government and dairy food companies. There are food safety laws prevalent in China but they have not been widely practiced by companies. Regulatory bodies must take a greater role in ensuring compliance with laws and regulations. The Chinese government must also play a special role in urging companies to implement relevant quality control processes. The baby dairy companies not only have to accept the interventions from the regulatory bodies and government, they also need to ensure that production, storage, distribution and other processes will follow the relevant rules and standards.

Keywords: baby dairy product, food quality, milk powder contamination, quality management system

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Authors: Mahshid TalebianKiakalayeh

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As AI technologies can be used by both civilians and soldiers, it is vital to consider the consequences emanating from AI military as well as civilian use. Indeed, many of the same technologies can have a dual-use. This paper will explore the military uses of AI and assess its compliance with international legal norms. AI developments not only have changed the capacity of the military to conduct complex operations but have also increased legal concerns. The existence of a potential legal vacuum in legal principles on the military use of AI indicates the necessity of more study on compliance with International Humanitarian Law (IHL), the branch of international law which governs the conduct of hostilities. While capabilities of new means of military AI continue to advance at incredible rates, this body of law is seeking to limit the methods of warfare protecting civilian persons who are not participating in an armed conflict. Implementing AI in the military realm would result in potential issues, including ethical and legal challenges. For instance, when intelligence can perform any warfare task without any human involvement, a range of humanitarian debates will be raised as to whether this technology might distinguish between military and civilian targets or not. This is mainly because AI in fully military systems would not seem to carry legal and ethical judgment, which can interfere with IHL principles. The paper will take, as a case study, Canada’s compliance with IHL in the area of AI and the related legal issues that are likely to arise as this country continues to develop military uses of AI.

Keywords: artificial intelligence, military use, international humanitarian law, the Canadian perspective

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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: Nahid Tavakoli, Asghar Ehteshami, Akbar Hassanzadeh, Fatemeh Amini

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Introduction: The Information security incident management guidelines was been developed to help hospitals to meet their information security event and incident management requirements. The purpose of this Study was to investigate on Information Security Incident Management in Isfahan’s educational hospitals in accordance to ISO/IEC 27002 standards. Methods: This was a cross-sectional study to investigate on Information Security Incident Management of educational hospitals in 2014. Based on ISO/IEC 27002 standards, two checklists were applied to check the compliance with standards on Reporting Information Security Events and Weakness and Management of Information Security Incidents and Improvements. One inspector was trained to carry out the assessments in the hospitals. The data was analyzed by SPSS. Findings: In general the score of compliance Information Security Incident Management requirements in two steps; Reporting Information Security Events and Weakness and Management of Information Security Incidents and Improvements was %60. There was the significant difference in various compliance levels among the hospitals (p-valueKeywords: information security incident management, information security management, standards, hospitals

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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: Alvaro Armenta-Ramade, Arturo Serrano-Santoyo, Veronica Rojas-Mendizabal, Roberto Conte-Galvan

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The availability and affordability of commercial off-the-shell products have brought a major impetus in the development of university projects related to the design, construction and launching of small satellites on a global scale. Universities in emerging economies as well as in least developed countries have been able to develop prototypes of small satellites (cubesats and cansats) with limited budgets. The experience gained in the development of small satellites gives rise to capacity building for designing more complex aerospace systems. This trend has significantly increased the pace and number of aerospace university projects around the world. In the case of Mexico, projects funded by different agencies have been very effective in accelerating the capacity building and technology transfer initiatives in the aerospace ecosystem. However, many of this initiatives have centered their efforts in technology development matters with minimum or no considerations of key regulatory issues related to frequency assignment, management and licensing, as well as launching requirements and measures of mitigation of space debris. These regulatory concerns are fundamental to accomplish successful missions that take into account the complete value chain of an aerospace project. The purpose of this paper is to develop a regulatory framework to support the efforts of educational institutions working on the development of small satellites in Mexico. We base our framework on recommendations from the International Telecommunications Union (ITU), the United Nations Office for Outer Space Affairs (UNOOSA) and other major actors of the Mexican regulatory ecosystem. In order to develop an integrated and cohesive framework, we draw on complexity science to identify the agents, their role and interactions. Our goal is to create a guiding instrument available both in print and online that can also be used in other regions of the world

Keywords: capacity building, complexity science, cubesats, space regulations, small satellites

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Authors: Jessica Ho

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AI has helped government, businesses and industries transform the way they do things. AI is used in automating tasks to improve decision-making and efficiency. AI is embedded in sensors and used in automation to help save time and eliminate human errors in repetitive tasks. Today, we saw the growth in AI using the collection of vast amounts of data to forecast with greater accuracy, inform decision-making, adapt to changing market conditions and offer more personalised service based on consumer habits and preferences. Government around the world share the opportunity to leverage these disruptive technologies to improve productivity while reducing costs. In addition, these intelligent solutions can also help streamline government processes to deliver more seamless and intuitive user experiences for employees and citizens. This is a critical challenge for NSW Government as we are unable to determine the risk that is brought by the unprecedented pace of adoption of AI solutions in government. Government agencies must ensure that their use of AI complies with relevant laws and regulatory requirements, including those related to data privacy and security. Furthermore, there will always be ethical concerns surrounding the use of AI, such as the potential for bias, intellectual property rights and its impact on job security. Within NSW’s public sector, agencies are already testing AI for crowd control, infrastructure management, fraud compliance, public safety, transport, and police surveillance. Citizens are also attracted to the ease of use and accessibility of AI solutions without requiring specialised technical skills. This increased accessibility also comes with balancing a higher risk and exposure to the health and safety of citizens. On the other side, public agencies struggle with keeping up with this pace while minimising risks, but the low entry cost and open-source nature of generative AI led to a rapid increase in the development of AI powered apps organically – “There is an AI for That” in Government. Other challenges include the fact that there appeared to be no legislative provisions that expressly authorise the NSW Government to use an AI to make decision. On the global stage, there were too many actors in the regulatory space, and a sovereign response is needed to minimise multiplicity and regulatory burden. Therefore, traditional corporate risk and governance framework and regulation and legislation frameworks will need to be evaluated for AI unique challenges due to their rapidly evolving nature, ethical considerations, and heightened regulatory scrutiny impacting the safety of consumers and increased risks for Government. Creating an effective, efficient NSW Government’s governance regime, adapted to the range of different approaches to the applications of AI, is not a mere matter of overcoming technical challenges. Technologies have a wide range of social effects on our surroundings and behaviours. There is compelling evidence to show that Australia's sustained social and economic advancement depends on AI's ability to spur economic growth, boost productivity, and address a wide range of societal and political issues. AI may also inflict significant damage. If such harm is not addressed, the public's confidence in this kind of innovation will be weakened. This paper suggests several AI regulatory approaches for consideration that is forward-looking and agile while simultaneously fostering innovation and human rights. The anticipated outcome is to ensure that NSW Government matches the rising levels of innovation in AI technologies with the appropriate and balanced innovation in AI governance.

Keywords: artificial inteligence, machine learning, rules, governance, government

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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: 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: R. Manjula, Kaustav Bagchi, Sushant Ramesh, Anush Baskaran

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In the past century, the emergence of information technology has had a significant positive impact on human life. While companies tend to be more involved in the completion of projects, the turn of the century has seen importance being given to investment in information security policies. These policies are essential to protect important data from adversaries, and thus following these policies has become one of the most important attributes revolving around information security models. In this research, we have focussed on the factors affecting information security policy compliance in two models : The theory of planned behaviour and the integration of the social bond theory and the involvement theory into a single model. Finally, we have given a proposal of where these theories would be successful.

Keywords: information technology, information security, involvement theory, policies, social bond theory

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Authors: Wiji Wijaya

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The aim of this research is to examine the effect of internal control weaknesses and audit opinion on the state’s loss findings of audit compliance to the regulation in public sector. The samples of this research consisted of 175 local government financial statements in the area of Central Java Province at 2009 until 2013. Area sampling design was used to select the financial statements. This study using quantitative descriptive statistical analysis and regression was run for data analysis and hypothesis examination. Result of this study indicated that internal control weaknesses and audit opinion contributes a positive influence which is significant to the state’s loss findings of audit compliance to the regulation. The internal control weaknesses that affect the state's loss finding are weakness control system of accounting and reporting with the value of the critical ratio 0.010 p 2.613 ; weakness budget execution control system with critical ratio value of 3.421 p 0.001 and weaknesses internal control structure with critical ratio value of 2.246 p 0.026 . While the audit opinion with a critical ratio value of 4.401 p 0.000. The implications of this research so that policy makers at the local government should give more attention to the implementation and improvement of internal control system.

Keywords: audit compliance findings, state’s loss, audit opinion, internal control, local government

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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: Abderrahim El Maslouhi

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The paper aims to analyze an often-overlooked dimension of global constitutionalism, which is the rise of the regulatory state and its impact on parliamentary dynamics in transition regimes. In contrast to Majone’s technocratic vision of convergence towards a single regulatory system based on competence and efficiency, national transpositions of regulatory governance and, in general, the relationship to global standards primarily depend upon a number of distinctive parameters. These include policy formation process, speed of change, depth of parliamentary tradition and greater or lesser vulnerability to the normative conditionality of donors, interstate groupings and transnational regulatory bodies. Based on a comparison between three post-Arab Spring countries -Morocco, Tunisia, and Egypt, whose constitutions have undergone substantive review in the period 2011-2014- and some European Union state members, the paper intends, first, to assess the degree of permeability to global constitutionalism in different contexts. A noteworthy divide emerges from this comparison. Whereas European constitutions still seem impervious to the lexicon of global constitutionalism, the influence of the latter is obvious in the recently drafted constitutions in Morocco, Tunisia, and Egypt. This is evidenced by their reference to notions such as ‘governance’, ‘regulators’, ‘accountability’, ‘transparency’, ‘civil society’, and ‘participatory democracy’. Second, the study will provide a contextual account of internal and external rationales underlying the constitutionalization of regulatory governance in the cases examined. Unlike European constitutionalism, where parliamentarism and the tradition of representative government function as a structural mechanism that moderates the de-parliamentarization effect induced by global constitutionalism, Arab constitutional transitions have led to a paradoxical situation; contrary to the public demands for further parliamentarization, the 2011 constitution-makers have opted for a de-parliamentarization pattern. This is particularly reflected in the procedures established by constitutions and regular legislation, to handle the interaction between lawmakers and regulatory bodies. Once the ‘constitutional’ and ‘independent’ nature of these agencies is formally endorsed, the birth of these ‘fourth power’ entities, which are neither elected nor directly responsible to elected officials, will raise the question of their accountability. Third, the paper shows that, even in the three selected countries, the de-parliamentarization intensity is significantly variable. By contrast to the radical stance of the Moroccan and Egyptian constituents who have shown greater concern to shield regulatory bodies from legislatures’ scrutiny, the Tunisian case indicates a certain tendency to provide lawmakers with some essential control instruments (e. g. exclusive appointment power, adversarial discussion of regulators’ annual reports, dismissal power, later held unconstitutional). In sum, the comparison reveals that the transposition of the regulatory state model and, more generally, sensitivity to the legal implications of global conditionality essentially relies on the evolution of real-world power relations at both national and international levels.

Keywords: Arab legislatures, de-parliamentarization, global constitutionalism, normative conditionality, regulatory state

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Authors: Yu-Min Chang, Kuo-Sheng Tsai, Hung-Te Tsai, Chia-Hsin Li

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This paper presents the early-warning lights classification management system for industrial parks promoted by the Taiwan Environmental Protection Administration (EPA) since 2011, including the definition of each early-warning light, objectives, action program and accomplishments. All of the 151 industrial parks in Taiwan were classified into four early-warning lights, including red, orange, yellow and green, for carrying out respective pollution management according to the monitoring data of soil and groundwater quality, regulatory compliance, and regulatory listing of control site or remediation site. The Taiwan EPA set up a priority list for high potential polluted industrial parks and investigated their soil and groundwater qualities based on the results of the light classification and pollution potential assessment. In 2011-2013, there were 44 industrial parks selected and carried out different investigation, such as the early warning groundwater well networks establishment and pollution investigation/verification for the red and orange-light industrial parks and the environmental background survey for the yellow-light industrial parks. Among them, 22 industrial parks were newly or continuously confirmed that the concentrations of pollutants exceeded those in soil or groundwater pollution control standards. Thus, the further investigation, groundwater use restriction, listing of pollution control site or remediation site, and pollutant isolation measures were implemented by the local environmental protection and industry competent authorities; the early warning lights of those industrial parks were proposed to adjust up to orange or red-light. Up to the present, the preliminary positive effect of the soil and groundwater quality management system for industrial parks has been noticed in several aspects, such as environmental background information collection, early warning of pollution risk, pollution investigation and control, information integration and application, and inter-agency collaboration. Finally, the work and goal of self-initiated quality management of industrial parks will be carried out on the basis of the inter-agency collaboration by the classified lights system of early warning and management as well as the regular announcement of the status of each industrial park.

Keywords: industrial park, soil and groundwater quality management, early-warning lights classification, SOP for reporting and treatment of monitored abnormal events

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Authors: Michelle J. Miller

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In recent year, there has been a rise of two emerging issues that impact the global employment and business market that the legal community must review closer: offshore outsourcing and data privacy. These two issues intersect because employment opportunities are shifting due to offshore outsourcing and some States, like the United States, anti-outsourcing legislation has been passed or presented to retain jobs within the country. In addition, the legal requirements to retain the privacy of data as a global employer extends to employees and third party service provides, including services outsourced to offshore locations. For this reason, this paper will review the intersection of these two issues with a specific focus on data privacy.

Keywords: outsourcing, data privacy, international compliance, multinational corporations

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Authors: Nouara Boulfoul, Fatima Brabez

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This article presents the status of ISO 9001: 2000 certification in some agro-food companies in Algeria. The article discusses challenges and contributions of certification as perceived by quality managers as well as the difficulties encountered during certification. It also provides the recommendations of these managers for companies that have a certification project. The results show that the top three reasons for adopting ISO 9001: 2000 certification are building a better organization, reducing the costs of non-compliance and meeting customer expectations. The contributions are of an external nature (recognition, brand image, extension of markets, etc.) but also of an internal nature (improvement of the organization, etc.). The recommendations mainly concern management motivation, staff awareness and involvement and compliance with the requirements of the standard.

Keywords: quality management, certification, ISO 9001: 2000, food companies

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Authors: Eloise Thomson

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The COVID-19 global pandemic challenged our normative conceptualization of teaching across all age levels, requiring the transition to remote instruction, in some instances, literally overnight. Included in the rapidly changing education environment was the delivery of early childhood education. In Victoria, Australia, the capital city, Melbourne, became known as the most locked down city in the world. This presentation examines the ways educators used social media to collaborate with families before the COVID-19 pandemic and during the lockdown phase through the use of a Third Space conceptual framework and case study methodology. As a first step, the paper examines how social media may offer new opportunities for collaborative practice between educators and families. Second, the data is outlined and discussed with respect to collaborative practice and quality. Finally, a postscript then allows for insight into how educators’ practice of using social media to collaborate with families has been impacted by the COVID-19 global pandemic. Finally, the implications of the ways in which educators are using social media to collaborate with families are discussed. The use of social media in early-childhood education has the potential to provide a valuable platform for educators to connect with families and students. However, the use of social media by educators uncovered a dialogue of ‘quality’ and appeared to be dominated by evidence around compliance and attaining quality in a very specific, and perhaps narrow, way. The findings suggest a culture of compliance that is dominated by outcomes, standards and assessments and that this has changed the dynamics by which educators engage with families. Furthermore, findings highlighted the disparity between educators' and families' understanding of the intent of the collaborations themselves. This research was significant as it exposed the ways in which educators are engaging with social media, resulting in a discussion on the intent of collaborations, the questioning of imposed quality, and the notion that quality is measurable and exists in only one form.

Keywords: collaboration, compliance, early childhood, third space, pedagogy of caring, social media

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Authors: Suman Podder

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As Australian ‘Open Banking’ allows customers to share their financial data with accredited Third-Party Providers (‘TPPs’), it is necessary to evaluate whether the regulators have achieved the balance between protecting customer data privacy and promoting data-related innovation. Recognising the need to increase customers’ influence on their own data, and the benefits of data-related innovation, the Australian Government introduced ‘Consumer Data Right’ (‘CDR’) to the banking sector through Open Banking regulation. Under Open Banking, TPPs can access customers’ banking data that allows the TPPs to tailor their products and services to meet customer needs at a more competitive price. This facilitated access and use of customer data will promote innovation by providing opportunities for new products and business models to emerge and grow. However, the success of Open Banking depends on the willingness of the customers to share their data, so the regulators have augmented the protection of data by introducing new privacy safeguards to instill confidence and trust in the system. The dilemma in policymaking is that, on the one hand, lenient data privacy laws will help the flow of information, but at the risk of individuals’ loss of privacy, on the other hand, stringent laws that adequately protect privacy may dissuade innovation. Using theoretical and doctrinal methods, this paper examines whether the privacy safeguards under Open Banking will add to the compliance burden of the participating financial institutions, resulting in the undesirable effect of stifling other policy objectives such as innovation. The contribution of this research is three-fold. In the emerging field of customer data sharing, this research is one of the few academic studies on the objectives and impact of Open Banking in the Australian context. Additionally, Open Banking is still in the early stages of implementation, so this research traces the evolution of Open Banking through policy debates regarding the desirability of customer data-sharing. Finally, the research focuses not only on the customers’ data privacy and juxtaposes it with another important objective of promoting innovation, but it also highlights the critical issues facing the data-sharing regime. This paper argues that while it is challenging to develop a regulatory framework for protecting data privacy without impeding innovation and jeopardising yet unknown opportunities, data privacy and innovation promote different aspects of customer welfare. This paper concludes that if a regulation is appropriately designed and implemented, the benefits of data-sharing will outweigh the cost of compliance with the CDR.

Keywords: consumer data right, innovation, open banking, privacy safeguards

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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: Noor Suhaida Kasri

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In the last three decades, Malaysia has developed fundamental legal and regulatory structures that aim to accommodate and facilitate the growth of Islamic banking and finance industry. Important building blocks have been put in place, to cite a few, the elevation of the position of the Malaysian Central Bank Shariah Advisory Council (SAC) as the apex advisory body and the empowerment of their Shariah resolutions through the Central Bank Act 1958; the promulgation of the Islamic Financial Services Act 2013 that regulate and govern Islamic finance market with a robust statutory requirement of Shariah governance and Shariah compliance. Notwithstanding these achievements, enforceability of Shariah-compliant contract remains a contentious subject. The validity of Al Bai Bithaman Ajil concept that was commonly used by the Islamic financial institutions in their financing facilities structures and documentation has been unabatedly challenged by the customers in courts. The challenge was due to the manner in which the Al Bai Bithaman Ajil transactions were carried out. Due to this legal challenge, Al Bai Bithaman Ajil financing structure seems to no longer be the practitioners’ favourite in Malaysia, though its substitute tawarruq and commodity murabahah financing structure may potentially face similar legal challenges. This paper examines the legal challenges affecting the enforceability of these underlying Shariah contracts. The examination of these cases highlights the manner in which these contracts were being implemented and applied by the Malaysian Islamic financial institutions that triggered Shariah and legal concern. The analysis also highlights the approach adopted by the Malaysian courts in determining the Shariah issues as well as the SAC in ascertaining the rulings on the Shariah issues referred to it by the courts. The paper adopts a qualitative research methodology by using textual and documentary analysis approach. The outcome of this study underlines factors that require consideration by industry stakeholder in order to ameliorate the efficacy of the existing building blocks that would eventually strengthens the validity and enforceability of Shariah-compliant contracts. This, in the long run, will further reinforce financial stability and trust into the Islamic banking and finance industry in Malaysia.

Keywords: enforceability of Shariah compliant contract, legal challenge, legal and regulatory framework, Shariah Advisory Council

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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: Chrysthia Papacleovoulou

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The era of de-regulation, off-shore and tax haven jurisdictions, and shelf companies has come to an end. The usage of complex corporate structures involving trust instruments, special purpose vehicles, holding-subsidiaries in offshore haven jurisdictions, and taking advantage of tax treaties is soaring. States which raced to introduce corporate friendly legislation, tax incentives, and creative international trust law in order to attract greater FDI are now faced with regulatory challenges and are forced to revisit the corporate form and its tax treatment. The fiduciary services industry, which dominated over the last 3 decades, is now striving to keep up with the new regulatory framework as a result of a number of European and international legislative measures. This article considers the challenges to the company and the corporate form as a result of the legislative measures on tax planning and tax avoidance, CRS reporting, FATCA, CFC rules, OECD’s BEPS, the EU Commission's new transparency rules for intermediaries that extends to tax advisors, accountants, banks & lawyers who design and promote tax planning schemes for their clients, new EU rules to block artificial tax arrangements and new transparency requirements for financial accounts, tax rulings and multinationals activities (DAC 6), G20's decision for a global 15% minimum corporate tax and banking regulation. As a result, states are found in a race of over-regulation and compliance. These legislative measures constitute a global up-side down tax-harmonisation. Through the adoption of the OECD’s BEPS, states agreed to an international collaboration to end tax avoidance and reform international taxation rules. Whilst the idea was to ensure that multinationals would pay their fair share of tax everywhere they operate, an indirect result of the aforementioned regulatory measures was to attack private clients-individuals who -over the past 3 decades- used the international tax system and jurisdictions such as Marshal Islands, Cayman Islands, British Virgin Islands, Bermuda, Seychelles, St. Vincent, Jersey, Guernsey, Liechtenstein, Monaco, Cyprus, and Malta, to name but a few, to engage in legitimate tax planning and tax avoidance. Companies can no longer maintain bank accounts without satisfying the real substance test. States override the incorporation doctrine theory and apply a real seat or real substance test in taxing companies and their activities, targeting even the beneficial owners personally with tax liability. Tax authorities in civil law jurisdictions lift the corporate veil through the public registries of UBO Registries and Trust Registries. As a result, the corporate form and the doctrine of limited liability are challenged in their core. Lastly, this article identifies the development of new instruments, such as funds and private placement insurance policies, and the trend of digital nomad workers. The baffling question is whether industry and states can meet somewhere in the middle and exit this over-regulation frenzy.

Keywords: company, regulation, TAX, corporate structure, trust vehicles, real seat

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