Regulatory Compliance Issues Research Articles

Customer Due Diligence in the FinTech Era: A Bibliometric Analysis

This study examined the current developments in customer due diligence (CDD) in the financial technology (FinTech) era. The study of anti-money laundering (AML) and combating financing of terrorism (CFT) gained prominence after the 2007–2009 global financial crisis (GFC), in which administrative penalties were issued to financial institutions. Faced with AML regulatory compliance issues, technological solutions were or are still being developed. Thus, several technological innovation developments have shaped the future direction of the CDD aspects in the AML/CFT sphere. A bibliometric review and meta-analysis was employed for the study. The Scopus database was utilised to generate the dataset for the study, while SciVal was applied for research metric analysis. The major findings revealed that the key research themes in this area include anti-money laundering, banks and crime, and cryptocurrency, as well as blockchain and corruption. It was also established that most of the research done in this area is focused on the United Kingdom, the United States, and China. The integration of CDD with FinTech is still an emerging area that requires interdisciplinary collaborations.

Walking the Last Mile: Barriers and Solutions to Suburban Transit Access

Pedestrian infrastructure plays a critical role in facilitating first-/last-mile access to transit. Efforts to connect pedestrians to transit through infrastructure improvements, however, often face considerable implementation barriers. These barriers can be particularly pronounced for suburban transit providers, which serve low-density, automobile-oriented development and often must coordinate across many jurisdictions. In this analysis, we examine strategies that transit agencies, metropolitan planning organizations, and municipalities use to build pedestrian infrastructure near suburban transit services in the United States, and the barriers they face in this process. We use Pace Suburban Bus, a transit provider in the Chicago, Illinois region, as an illustrative case study, conducting surveys with planners and interviews with diverse stakeholder groups in the agency’s service area. To complement these findings, we conduct an online survey of similar agency types in ten peer regions across the United States. The results suggest that agencies support pedestrian access to transit through a variety of plans, policies, programs, and partnerships. However, agencies face significant implementation barriers, including limited funding, competing investment priorities, jurisdictional/coordination issues, automobile-oriented planning and development, regulatory compliance issues, and limited staff capacity. Based on these findings, we propose recommendations related to planning (e.g., better inclusion/documentation of pedestrian needs in plans), policy (e.g., regional support for Complete Streets and Americans with Disability Act related policy efforts), funding (e.g., regional platforms for sharing funding opportunities), and education (e.g., staff training and community awareness campaigns). These recommendations provide specific actions that agencies at multiple levels of government can take to better support pedestrian access to transit in suburban communities.

Reshaping Bank Leadership and Governance in the Context of New Normal

The global banking industry is taking a changed shape. Innovation, technologyled disruption, convergence, and data analytics are reshaping the banking industry. Considering the market development and concerns associated with the Covid-19 crisis, banks should focus on capital, liquidity, operational capacity, customers’ preferences, financial infrastructure, business restructuring, regulatory compliance issues, financial crime, and cybersecurity concerns. A transformed and integrated strategy by the banking institutions to handle these issues is connected with effective business continuity measures and long-term business development. The transformation is necessary to sustain and avail the opportunity to leverage banks’ role in economic support programs to improve their reputation and speed up digitisation and digitalisation. In such a stage of transformation, demands from banks’ leadership have become exponentially more significant, which is not easy to meet. From the risk management standpoint, this is the time for adopting an enterprise approach to cope with the changing environment. Improved and reshaped corporate governance in banks might help handle the situation better in this complex situation. The paper’s objective is to sketch the reshaped leadership and governance practices for the banking industry in the wake of the Covid-19 scenario. The paper identified an indicative leadership-governance framework for the long-term sustainability of banks.

Quantifying the Information Flow between Ghana Stock Market Index and Its Constituents Using Transfer Entropy

We quantify the strength and the directionality of information transfer between the Ghana stock market index and its component stocks as well as observe the same among the individual stocks on the market using transfer entropy. The information flow between the market index and its components and among individual stocks is measured by the effective transfer entropy of the daily logarithm returns generated from the daily market index and stock prices of 32 stocks ranging from 2nd January 2009 to 16th February 2018. We find a bidirectional and unidirectional flow of information between the GSE index and its component stocks, and the stocks dominate the information exchange. Among the individual stocks, SCB is the most active stock in the information exchange as it is the stock that receives the highest amount of information, but the most informative source is EGL (an insurance company) that has the highest net information outflow while the most information sink is PBC that has the highest net information inflow. We further categorize the stocks into 9 stock market sectors and find the insurance sector to be the largest source of information which confirms our earlier findings. Surprisingly, the oil and gas sector is the information sink. Our results confirm the fact that other sectors including oil and gas mitigate their risk exposures through insurance companies and are always expectant of information originating from the insurance sector in relation to regulatory compliance issues. It is our firm conviction that this study would allow stakeholders of the market to make informed buy, sell, or hold decisions.

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007-2018.

Warning Letters issued by the Food and Drug Administration's Bioresearch Monitoring (BIMO) Program provide insight into data integrity issues and other research misconduct in the premarket side of the pharmaceutical industry. The objectives of this study were to understand the common compliance issues for clinical investigators, institutional review boards, sponsors of clinical studies, good laboratory practice laboratories, and bioequivalence studies and to see how compliance has changed over time. Warning letters and closeout letters issued by the BIMO program between US fiscal years 2007-2018 were analyzed by categorizing regulatory violations into violation themes. Inspections during the same time period were analyzed based on the assigned inspection classification. A combined total of 300 warning letters were analyzed as a part of this study. The most common violations found in all warning letter categories included failing to follow and maintain procedures and poor documentation practices. Inspection results show that overall the percentage of Official Action Indicated results has decreased over time, while the percentage of No Action Indicated results has increased. Although the number of warning letters has decreased over the past decade and inspection results have been improving, there are still significant data integrity and other regulatory compliance issues found in the premarket side of the pharmaceutical industry. It is unclear if the reduction of warning letters is due to improved compliance in the industry or other factors unrelated to compliance.

Adaptive co-management model for the East Kolkata wetlands: A sustainable solution to manage the rapid ecological transformation of a peri-urban landscape

Human-induced land use changes like agriculture and urban development occur commonly at the cost of natural wetlands, which require immediate attention and sustained efforts from urban planners and concerned governments. In view of the East Kolkata Wetlands (EKW), India, this paper has examined the trend, causes, extent and impacts of landscape transformation during the last few decades. Hence we aim to present a review of several studies in and around EKW and suggests a sustainable model for EKW. This ‘Ramsar site of International Importance’ is one of the world's largest wastewater-fed aquaculture systems where the city sewage is recycled for pisciculture and agriculture, and acts as flood resistance for the city of Kolkata. Rapid encroachment in the EKW due to unplanned development has caused various environmental, social and economic impacts. The key ecological impacts found in the study included loss of faunal and floral diversity, eco-toxicological impacts, etc. In terms of biodiversity loss, while the number of bird species in the EKW decreased from 248 in 1960s to 72 in 2005, about 59% fish species are near threats, vulnerable and endangered. Reported persistent organic pollutants (POPs) around the EKW region were found to pose deleterious impact on environment and ambient biota. Several studies have evidenced that the open burning of solid waste in the dumping ground of Dhapa is a potential source of polychlorinated biphenyls (PCBs) and polychlorinated dibenzo dioxin/furans (PCDD/Fs). Further the ecological transformation of the EKW focussing on policy development and regulatory compliance issues has been studied in this paper. The aspects of encroachment and wetland shrinkage triggered by economic drivers like urban sprawl have been analyzed. The paper presents adaptive co-management as the future roadmap for action to curb further degradation of the wetlands, and adopt an integrated approach of environmental, political, physical, economic and institutional aspects. It is envisaged that the adaptive co-management model will contribute to long-term sustainable sustenance of this precious ecosystem.

Leadership Challenges: Handling Sexual Assault on Campus and Promoting Socioemotional Learning

Joaquin, a 15-year-old Latino high school student, was arrested and removed from the Upward Bound (UB) program following a student-on-student sexual assault allegation. UB adopted a student-centered discipline approach that promoted socioemotional learning opportunities. However, the staff was regulated by complex state and federal policies and had not experienced severe student misconduct claims prior to 2018. This case illustrates how educational leaders grappled with disciplinary issues in a compensatory program with a strong pro-socioemotional learning policy. The case examines the legal, regulatory compliance, and policy issues that arise for leaders in upholding their commitment to socioemotional learning, while holding students accountable.

Deriving social benefits from mining through regulation: Lessons learned in South Africa

Shortly after the transition to the post-apartheid state, South Africa began a process of requiring mining companies to invest in community and workforce development in areas surrounding operations. This development shifted the concept of corporate social responsibility from mainly a discretionary activity to an issue of regulatory compliance. Drawing on field-based interviews and regulatory and company documents, this article analyzes the process of compliance with South Africa’s mining regulation and the stakeholders formally involved or marginalized in this process. Findings demonstrate the challenges that remain in ensuring that regulation leads to mining company activities that actually yield effective and impactful local social benefits. While regulation has increased entry points for government involvement and has increased corporate social spending, it has undermined the idea of corporate citizenship by focusing on mandatory compliance, while failing to put in place effective process transparency and monitoring mechanisms that would allow for local government and community participation and sanctioning. The lessons learned in the case of South Africa have implications as more African countries attempt to regulate the promotion of social benefits derived from mining.

Role of Government in Ensuring Safety Consciousness During Mineral Mining Activities in Nigeria

There are a lot safety issues bordering on events that are taking place in various mineral mining sites including destruction of lives, properties and environmental degradation which have been reported across Nigeria. These issues are further exacerbated because being aware of safety regulations and procedures does not necessarily imply that they will be adequately enforced or complied with. The study looked at the role of government in ensuring safety consciousness during mining activities in Nigeria, by identifying regulatory frameworks, enforcement and compliance issues as well as government mechanisms on safety during mining activities. Reviewed literature showed that there is no holistic regulatory framework on safety management; enforcement and compliance of safety regulations is plagued by corruption and ineptness. Safety issues were usually at the discretion of mining companies and implementing existing safety regulations was challenging and ineffective. The study concluded that the success or failure of government actions is vital in ensuring safety consciousness during mining activities in Nigeria. The study recommends a more comprehensive evaluation of environmental and safety consciousness during mining activities among others.

SMCQL

People and machines are collecting data at an unprecedented rate. Despite this newfound abundance of data, progress has been slow in sharing it for open science, business, and other data-intensive endeavors. Many such efforts are stymied by privacy concerns and regulatory compliance issues. For example, many hospitals are interested in pooling their medical records for research, but none may disclose arbitrary patient records to researchers or other healthcare providers. In this context we propose the Private Data Network (PDN), a federated database for querying over the collective data of mutually distrustful parties. In a PDN, each member database does not reveal its tuples to its peers nor to the query writer. Instead, the user submits a query to an honest broker that plans and coordinates its execution over multiple private databases using secure multiparty computation (SMC). Here, each database's query execution is oblivious , and its program counters and memory traces are agnostic to the inputs of others. We introduce a framework for executing PDN queries named smcql . This system translates SQL statements into SMC primitives to compute query results over the union of its source databases without revealing sensitive information about individual tuples to peer data providers or the honest broker. Only the honest broker and the querier receive the results of a PDN query. For fast, secure query evaluation, we explore a heuristics-driven optimizer that minimizes the PDN's use of secure computation and partitions its query evaluation into scalable slices.

Classifying Pharmaceutical Capsules Through X-Ray Image Analysis Based on the Agglomeration of Their Contents

Purpose Pharmaceutical gelatin shell capsules are commonly used to deliver powdered solid dosage forms. The dissolution behavior of these products depends on a number of factors, including, notably, powder distribution within capsules. Powder agglomeration occurring during the filling and sealing stages may lead to regulatory compliance issues. Although not a typical procedure, X-ray images of the final capsules may be inspected manually to determine the presence of such agglomerates.

Evaluation of enterprise-level benefits of manufacturing flexibility

An enterprise-level #exible manufacturing approach for a multi-product manufacturer like an automotive company requires a cost-e4ective mix of many key enablers, including #exible assembly plants, part commonality between products, and supply base #exibility. This paper develops a strategic planning model that determines the overall business value of #exible manufacturing systems. The model is designed to be capable of dealing with problems of realistic size and scope. Interpretation of results of the model gives important strategic insights on factors in#uencing manufacturing #exibility and capacity requirements in the presence of these factors. The model is applied to study a #exibility evaluation problem faced by a major automotive company. The experimental results show that #exibility enablers such as #exible product to manufacturing facility assignments and part commonality can lead to improved protability. Increases in protability of up to 17% (? $300 M=year) are seen in the modeled system. Increased commonality and/or #exibility also result in a reduction of the optimal capacity for the assembly system while simultaneously slightly improving sales. These results are robust with respect to introduction of the regulatory compliance issue of fuel economy standards, although the incremental prots from improved #exibility and commonality are reduced by approximately 25% when fuel economy standards are included. ? 2004 Elsevier Ltd. All rights reserved.

EasyPaisa: Seizing the white space and business model innovation

EasyPaisa is a diversification case study written about two very different organizations, a Telco and Microfinance Bank, and how they merged to create a new business. This new business was providing Mobile Financial Services. Both Telenor (a Telco) and Tameer Bank (Microfinance bank) saw a business opportunity in branchless banking (business white space). They were committed to make this acquisition successful, where Telenor bought over 51%sharesof Tameer Bank. However, as per regulations, the branchless banking model is to be governed under a bank-led model. Therefore, the face of EasyPaisa has always been Tameer Bank which is expected to manage all the regulatory issues and compliance issues and back end processes while Telenor uses its vast distribution network and marketing skills to create a winning business model. The case provides opportunities for students to explore EasyPaisa business model generation and how they capture the white space beyond existing market and business model. Case also looks future challenges from Telenor and for Tameer Bank point of views. The success of EasyPaisa brings new opportunities and complexities for Telenor and for Tameer Bank top management.

Package leaflets of the most consumed medicines in Portugal: safety and regulatory compliance issues. A descriptive study.

Package leaflets are necessary for safe use of medicines. The aims of the present study were: 1) to assess the compliance between the content of the package leaflets and the specifications of the pharmaceutical regulations; and 2) to identify potential safety issues for patients. Qualitative descriptive study, involving all the package leaflets of branded medicines from the three most consumed therapeutic groups in Portugal, analyzed in the Department of Pharmacoepidemiology, School of Pharmacy, University of Lisbon. A checklist validated through an expert consensus process was used to gather the data. The content of each package leaflet in the sample was classified as compliant or non-compliant with compulsory regulatory issues (i.e. stated dosage and descriptions of adverse reactions) and optional regulatory issues (i.e. adverse reaction frequency, symptoms and procedures in cases of overdose). A total of 651 package leaflets were identified. Overall, the package leaflets were found to be compliant with the compulsory regulatory issues. However, the optional regulatory issues were only addressed in around half of the sample of package leaflets, which made it possible to identify some situations of potentially compromised drug safety. Ideally, the methodologies for package leaflet approval should be reviewed and optimized as a way of ensuring the inclusion of the minimum essential information for safe use of medicines.

Common questions and suggestions of evaluation for NDA of TCM

According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.

The Influence of Government Regulations on Content Management Systems: An Exploratory Study

The primary focus of this study was to determine why and how small businesses implement content management and to clarify the relationship of content management to regulatory compliance issues presented by the Health Insurance Portability and Accountability and Sarbanes-Oxley Act.

CAN OIL SPILL RESPONSE PLANS BE FUNCTIONAL AND REGULATORY COMPLIANT?

ABSTRACT In the event of an oil spill, rapid and effective response actions are the key to minimizing impacts to the environment and local communities. Consequently, oil spill response plans (OSRPs) should be prepared in a user friendly format that maximizes access to crucial information and focuses on the critical first few hours or days of a response. While existing OSRPs are generally adequate, they typically are not organized logically and contain fairly general information that focuses on the overall response rather than the initial stages. For many plan holders the primary, or in some cases the only, objective when preparing OSRPs is obtaining regulatory approval and believe there is little latitude in deviating from the format or content of previously approved plans to make them more functional. Following the 2010 Macondo incident in the Gulf of Mexico, the American Petroleum Institute (API) sponsored Joint Industry Task Force (JITF) identified the need to enhance the usefulness of OSRPs. A workgroup was convened consisting of representatives from integrated and independent oil companies and spill response planning consultants to develop a guidance document for preparing OSRPs that are highly functional and regulatory compliant. The JITF guidance document includes a detailed OSRP outline that provides the intended purpose and recommended content and format for each section. The primary features include:Information presented in the general order required when responding to an oil spillFocus is on the first 24 hours when guidance is needed the mostKey information is provided in tabular or graphical formats at the front of each sectionInitial responder health and safety issues are addressed that are often missing in OSRPsSimilar information is located in the same section to avoid searching multiple sectionsMore expansive and detailed information, response guidance and specific cleanup strategies are referenced, as appropriate, in other documents The guidelines were designed to be Gulf of Mexico centric with the concepts being applicable to all industry sectors and regions of the world. Similar to the Integrated Contingency Plan concept developed in 1996, they can be adapted to comply with multiple oil spill planning regulations. They were, however, designed specifically to comply with the Bureau of Safety and Environmental Enforcement (BSEE) 30 Code of Federal Regulations (CFR) Part 254 and Notice to Lessees NTL 2012-N06. The draft guidelines were reviewed and well received by BSEE and the few regulatory compliance issues they identified were addressed in the final document. Therefore, it is possible to prepare OSRPs that are both functional and regulatory compliant.

A Financial and Environmental Analysis of Constructed Wetlands for Industrial Wastewater Treatment

SummaryThe Dow Chemical Co. (Dow) is actively working to develop an approach to value ecosystem services and incorporate them in business decisions. This study investigates the use of replacement cost methodology (RCM) for financial analysis and life cycle assessment (LCA) for environmental assessment. The case study analyzes a business decision made in 1995, where a constructed wetland was built instead of a sequencing batch reactor to solve a regulatory compliance issue in meeting suspended solids requirements for a wastewater treatment system at the Union Carbide Corp. (a subsidiary of The Dow Chemical Co.) plant in Seadrift, Texas. The financial results indicate that the total net present value savings calculated for implementing the constructed wetland instead of the sequencing batch reactor is $282 million over the project's lifetime. The LCA demonstrates that the lower energy and material inputs to the constructed wetland resulted in lower potential impacts for fossil fuel use, acidification, smog formation, and ozone depletion and likely lead to lower potential impacts for global warming and marine eutrophication. The result from the inventory of land use shows that both the upstream land burdens (for the sequencing batch reactor) and the on‐site acreage of the constructed wetland are similar in magnitude and importance, contrary to the assumption that green infrastructure always requires greater land area. This case study illustrates how Dow can consider financial and environmental analyses in comparing gray and green infrastructure solutions and further understand the benefits of implementing green infrastructure in an appropriate industrial application.

Cloud Computing, Regulatory Policy and Student Privacy

Rapid change in the technology landscape has resulted in the introduction of a range of new technologies into the classroom. But unlike the past use of technology in schools, many of these new products and services introduce two new dynamics that school counsel (and the teachers and administrators they support) need to understand fully. First, many of these new products and services are run “in the cloud” by a third party service provider as opposed to on servers operated by the school’s IT staff. This third party operation and control can raise important new regulatory compliance issues, including data protection and data privacy issues, as your school and student data will be handled by a third party. Second, increasingly these products and services are available without monetary payment for teachers to deploy directly in their classrooms. This means that the products or services often won’t go through a more formal procurement process where regulatory compliance and other similar issues would be evaluated. These new cloud products and services are being widely adopted by schools across the country because they lower school costs, increase productivity, and maximize innovation and efficiency. With a renewed partnership between the school’s counsel, teachers, school administrators and school IT staff, those benefits can be reaped without sidestepping important regulatory obligations, such as student privacy.

REAL Data Collection Essential for Care of Vulnerable Populations

With minorities projected to constitute a majority of the U.S. population by 2043 (Census Bureau, 2012)-and considering that the disparities in healthcare access and quality they face are well documented (CDC, 2011)-it's clear that improving care for this population will depend on understanding who they are and where gaps exist. The need to reduce disparities in care has become particularly pressing with the Affordable Care Act's (ACA) focus on value-based care and quality improvement and a growing recognition that a reformed, high-performing healthcare system must make eliminating disparities a fundamental goal. We can achieve this goal by providing the best care possible to society's most vulnerable.Low-income and other disadvantaged patients are a population that members of America's Essential Hospitals (formerly the National Association of Public Hospitals and Health Systems) know well and a key reason we have joined forces with our allies in the Equity of Care initiative. Essential hospitals-those that serve a safety net role in their communities-are uniquely positioned to help reduce healthcare disparities, as more than half our patients are racial and ethnic minorities and a majority are uninsured or qualify for Medicaid. Although our members represent just 2% of U.S. hospitals, they deliver nearly 20% of all uncompensated care (NAPH, 2012).So, collecting reliable race, ethnicity, and language (REAL) data-and viewing it as an essential component of quality improvement-has become a priority for us and our hospitals, as it should be for all healthcare providers.WHY REAL DATA IS IMPORTANTIt seems self-evident, but this tenet is often overlooked: To provide the best quality of care to your patient population, you need to know who your patients are. REAL data helps you understand your patients' varying needs and view treatments and outcomes through the lens of their rich ethnic and racial diversity. It drives better care and a better patient experience. It enhances prevention-risk of disease varies by ethnicity and race, making this information as important to the future as it is to the present. It supports culturally competent care that respects each patient's social and cultural background and aids communication to improve patient compliance and outcomes.While improving patient care and the patient experience is the primary reason for collecting REAL data, regulatory and other compliance issues also come into play- meeting federal requirements for meaningful use of health information technology, for example, and achieving patient-centered medical home certification. Collecting REAL data is always the right thing to do and often the required thing to do.WORK TO DATE, AND MOVING FORWARDIn 2011, the Equity of Care National Call to Action made collecting and using REAL data a key component of a three-pronged approach to reducing disparities that also seeks increased cultural competency training and leadership diversity (Equity of Care, 2011).Other national stakeholders over the past decade have joined the fight to improve equity, including through better collection of data. In 2001, the Institute of Medicine (lOM) report Crossing the Quality Chasm: A New Health System for the 21st Century named equity as one of six domains of quality that all healthcare organizations must address. Other important milestones along the way, particularly with respect to REAL data, include the 2009 American Recovery and Reinvestment Act and its meaningful use requirements; the 2010 ACA, with its requirement that federally funded programs collect data on race, ethnicity, primary language, disability status, and gender; the 2011 federal Action Plan to Reduce Health Disparities, which outlines ways to increase health equity, including upgrading collection and analysis of REAL data and other demographics consistent with the ACA; and The Joint Commission's 2012 patient-centered communication standards, which require hospitals to collect a patient's preferred language for both verbal and written communications regarding their care. …