Regulatory Compliance Programs Research Articles

Patulin removal in fruit-based products using probiotics and potential probiotics

<p>Patulin (PAT) is a prevalent mycotoxin frequently found in fruit and its derivatives, such as apple, pear, and juices. Despite worldwide attempts to diminish the levels of PAT at every stage of the fruit production process, its contamination rate remains high. This mycotoxin is worrisome due to its potential adverse impacts on human health. Eating PAT-contaminated fruit can lead to acute and chronic health issues. It is established, by the Joint FAO/WHO, a maximum tolerable daily intake for PAT at 0.4 µg/kg/day. Therefore, monitoring for PAT contamination is essential for the safe consumption of fruits and fruit-related products such as juices, purees, ciders, jams, marmalades, vinegar, and dried fruits. PAT has physiochemical properties that enable its survival in cold, hypoxic, acidic, or high-temperature conditions. Ideally, detoxification procedures should aim to reduce the level of toxins to safe levels whilst preserving the nutritional and palatable values of the treated commodity. There are several physical, chemical, and biological techniques available for PAT detoxification. However, while physical and chemical methods can remove PAT, they may also lower the nutrient quality and organoleptic properties of the food. Biological detoxification is an effective, environmentally friendly, easy, and cost-effective method, as established by existing research. It has proven efficacy in food safety research and regulatory compliance programs. Probiotics have been studied for their potential to reduce PAT in foods via different mechanisms (such as adsorption, degradation, and transformation), as well as all their health-beneficial effects. In this review, the reduction of PAT in fruit-based products using probiotics or potential probiotics is widely discussed.<strong></strong></p>

Achievements and Challenges of the Regulatory Compliance Program in a Large Philanthropical Hospital Institution


 
 
 
 Objective: The objective of this work was to do a self-assessment of the Regulatory Compliance (RC) program of Santa Casa de Belo Horizonte Group (SCBH) using the methodology validated nationally by the Comptroller General of the Union (CGU) for detailing the achievements and challenges in six primary areas of RC.
 
 Theoretical framework: The RC program was established at the end of 2018 in the SCBH to ensure the compliance and ethics of the processes performed by all people who participate or perform their professional activities in any of the units that make up the institution. Different methodologies for evaluating RC programs are available in the non-academic literature; to our knowledge, they have not been applied in a structured empirical way in philanthropical hospitals.
 
 Design/methodology/approach: The present work used a methodology validated nationally by the CGU within an exploratory and documentary approach. SCBH's profile was evaluated by verifying the company's degree of exposure to compliance and integrity risks (acts of corruption or misconduct). Evidence documents demonstrating SCBH's performance in six significant themes were also evaluated. Finally, the achievements and challenges of the RC were discussed based on the SCBH performance in all estimated items.
 
 Findings: The RC program was created in 2018 and is in a consolidated stage of maturity in the primary criteria evaluated by the CGU: a score greater than 70 points and at least 40% of the score in each area assessed.
 
 Research, Practical & Social implications: This research brings practical and managerial contributions. From a practical perspective, this work shows the consolidation of the RC area as a strategic part of the business environment, seeking coherence between thought, speech, and action. From a managerial perspective, this work confirms the importance of shared responsibility among the entire institution in building a culture of ethical and legal compliance.
 
 Originality/value: This is the first RC self-assessment work carried out by a philanthropic institution. The healthcare market has driven the establishment of an RC area in Brazilian institutions. Regardless of regulation and external audit processes, healthcare institutions have sought to improve business relations and create a critical organizational mass.
 
 
 

Assessing Legal Protection of Biometric Data in China: Gaps, Principles, and Policy Recommendations

The legal protection of biometric data is becoming an increasingly important issue in the information society. China attaches importance to the legal protection of biometric data. Over the past decades, the rapid development of digital technology has profoundly influenced Chinese information society. However, digital technology may also trigger substantial risks. In this article, we provide an in-depth examination of existing Chinese laws protecting biometric data. We explore general laws and facial recognition laws, administrative regulations, sector-based rules, judicial interpretations, regulatory documents, policy documents, and (draft) national standards. We find gaps in laws in China. Building on this analysis, we elaborate on five principles for the legal protection of biometric data: (1) legality, propriety, and necessity; (2) integrity; (3) purpose; (4) minimization; and (5) controllability. We provide three policy recommendations for the legal protection of biometric data: (1) sufficiently considering the purpose of the collection of biometric data, (2) creating controllable mechanisms, and (3) implementing regulatory compliance programs.

Well‐crafted compliance program prevents, detects and corrects malfeasance

Crafting an effective regulatory compliance program is an important duty for nonprofit board members looking to ensure that adequate policies and processes are in place to protect the organization from malfeasance and legal troubles that follow.

Reinforce the purpose, goals and necessity of a good compliance program

For new board members—and even some seasoned ones—understanding the importance of a regulatory compliance program is critical in ensuring that such matters are taken seriously, and adequate measures are in place to protect the organization from malfeasance and legal troubles that follow.

Autorregulación y programas de cumplimiento empresarial en materia de publicidad comercial y protección al consumidor

El propósito de este trabajo es brindar una aproximación a la autorregulación en materia mercantil y, en específico, a los sistemas de autorregulación referidos a publicidad comercial y protección al consumidor en el Perú. En particular, el artículo analiza la reciente aprobación del Decreto Supremo N° 185-2019-PCM, Reglamento que promueve y regula la implementación voluntaria de programas de cumplimiento normativo en materia de protección al consumidor y publicidad comercial. En ese sentido, se subrayan los objetivos que se busca alcanzar con los programas de cumplimiento y se abordan los lineamientos a seguir para que la implementación de estos sea realmente efectiva dentro de una organización empresarial, en particular en materia de protección al consumidor y publicidad comercial. Finalmente, se desarrollan las ventajas y desventajas de los sistemas de autorregulación y se concluye que la adopción de programas de cumplimiento es positiva para consumidores, empresas y autoridades administrativas.

A Retrospective Evaluation of the Impact of the Planetree Patient-Centered Model of Care on Inpatient Quality Outcomes

This retrospective quasi-experimental study evaluated the Planetree patient-centered model of care on inpatient quality outcomes. The research questions to be addressed were: What is the impact of the Planetree patient-centered model of care (1) on patient satisfaction, (2) on clinical outcomes (length of stay and readmission), and (3) on the cost of providing care (cost per case and productive nursing hours per patient day)? Patients and their families have described a more patient-centered approach as key to meeting their needs. The Planetree model of care provides a framework and operational guidance on how to implement programs targeting these key areas. The link between patient-centered care and quality outcomes such as patient satisfaction, length of stay, readmission, cost per case, and productive nursing hours per patient day has been postulated; however, to date little to no research has been conducted examining this issue. This was a retrospective, nonexperimental comparison study evaluating units with the same types of patients and the same skill mix, and with standardized organizational pay rates, supply costs, policies, procedures, contracts, and a regulatory compliance program. This provided a unique opportunity to evaluate the impact on inpatient quality outcomes of the Planetree patient-centered model of care as practiced in the Planetree unit. Data were analyzed using a 2 × 5 analysis of variance (ANOVA) and logistic regression (readmission only). This was a study of five separate cohorts grouped by calendar year rather than a study of repeated measures. No differences in demographic profiles were noted between the two groups. The patient satisfaction composite mean score evaluation, length-of-stay evaluation, and the cost-per-case evaluation demonstrated that the Planetree group was different from the comparison group (p = <.05 with Eta squared = >.01). This evidence validates that the Planetree patient-centered model of care had a positive impact on patient satisfaction, length of stay, and cost per case. This evaluation of 869 hospitalized adults undergoing elective total-knee or total-hip joint replacement surgery indicated that the Planetree patient-centered model of care positively affected patient satisfaction, length of stay, and cost per case. Nursing and hospital administrators seeking to improve the inpatient hospital experience should consider implementation of the Planetree patient-centered model of care. Hospitals and healthcare organizations seeking an evidence-based approach to the implementation of patient-centered care will benefit from the information in this study.

Encouraging industry to assess and implement cleaner production measures

Cleaner production stakeholders have a strong desire for industry to consider cleaner production opportunities in their facilities and once they are assessed, to follow through on their implementation. This paper examines local and international initiatives within the Canadian stakeholder community (including government, NGOs, consultants, industry) that contribute to the initiation and implementation of cleaner production in industry. Specifically, stakeholders have consciously drafted regulatory compliance, education, co-funding incentives, and development-based cleaner production programs. As illustrated by case studies from six industries, the programs work together to create a climate favorable for implementation of cleaner production concepts and approaches. Based on the cleaner production drivers and barriers identified by research, the programs are well designed. However, as with cleaner production itself, there is always room for further improvement. Specifically: (i) regulatory compliance programs and timetables should leave room for cleaner production (versus end-of-pipe) approaches; (ii) cleaner production co-funding programs should target small and medium-sized enterprises (SME) and require them to use a multimedia approach (air, water, waste); (iii) education programs should incorporate demonstration assessments, feasibility assessments of common recommendations, and follow-up communication to foster implementation and continuous improvement; and (iv) mandated cleaner production should include absolute (i.e. waste/tonne production) rather than relative standards (i.e. X% reduction from status quo) in order to avoid penalizing historically proactive corporations.

Complying with Executive Order 13148 Using the Enterprise Environmental Safety and Occupational Health Management Information System

All U.S. Department of Defense (DoD) facilities are required under Executive Order (EO) 13148, “Greening the Government through Leadership in Environmental Management,” to establish quality-based environmental management systems (EMSs) that support environmental decision-making and verification of continuous environmental improvement by December 31, 2005. Compliance with EO 13148 as well as other federal, state, and local environmental regulations places a significant information management burden on DoD facilities. Cost-effective management of environmental data compels DoD facilities to establish robust database systems that not only address the complex and multi-faceted environmental monitoring, record-keeping, and reporting requirements demanded by these rules but enable environmental management decision-makers to gauge improvements in environmental performance. The Enterprise Environmental Safety and Occupational Health Management Information System (EESOHMIS) is a new electronic database developed by the U.S. Air Force to manage both the data needs associated with regulatory compliance programs across its facilities as well as the non-regulatory environmental information that supports installation business practices. The U.S. Air Force, which has adopted the Plan-Do-Check-Act methodology as the EMS standard that it will employ to address EO 13148 requirements.

The Ethics of Advising on Regulatory Compliance: Autonomy or Interdependence?

Many companies are now implementing ethics and regulatory compliance programs. The growth of employment of both lawyers and specialist "compliance professionals" to advise on and facilitate implementation of these programs has expanded concomitantly. This paper examines the ethical role that should be played by these advisors. Traditional ways of conceptualising corporate lawyers' ethics are shown to be inadequate because they see the legal advisor as an autonomous adversarial advocate or an independent and aloof counsellor. Instead interviews with compliance practitioners are used to show that a superior conceptualisation of the compliance advisor's role is emerging. Compliance practitioners identify explicitly with business and, at the same time, identify with a broader ethical community of other compliance professionals, regulators and stakeholders in order to play a transformative role within the organisation. This conception recognises the interdependence between compliance advisor and corporate client.

Regulatory compliance and product stewardship: Tools for managing tort liability risks

Tort liability contributes significantly to the cost of doing business in the United States. For companies that manufacture and distribute products that pose certain inherent hazards arising from the nature or purpose of their products, it is essential to keep such costs under control. These industries are typically subject to extensive government regulation. If a business violates statutes and regulations controlling the manufacture, labeling, sale, and distribution of regulated products or in providing regulated services, it increases its risk of tort claims and weakens its legal position for defending against those claims. Companies that employ effective programs for regulatory compliance reap substantial indirect benefits from those programs in the form of reduced tort liability. To achieve that, the regulatory compliance program should be integrated fully into the life‐cycle for highly regulated products—such as pesticides and consumer chemical products—from the design stage through post‐sale consumer or customer response.

Phoenix Companies and Corporate Regulatory Challenges

This paper reviews findings from one of the first empirical studies of the phoenix company problem in Australia. The phoenix company phenomenon is a disturbing one, especially as it seems to reflect the emergence of a business culture in which a substantial number of businesses see the payment of debt as being optional, as some insolvency practitioners have begun to suggest. Whilst changing corporate and business cultures is as important as changing or simplifying corporate laws and vigorous law enforcement, any regulatory compliance program needs to pay particular attention to changing attitudes to debt and debt enforcement in Australia. This research suggests that unless grass roots activity such as the use of phoenix companies is adequately attended to, the broader corporate culture may be affected and lead to the further spread of phoenix type attitudes into other areas.

Implementing Standard Operating Procedures: Prescription for a Successful Pharmaceutical Compliance Program

Standard Operating Procedures (SOP's) support the basis of a regulatory compliance program for GMP's, GCP's, and GLP's. the process of developing procedures is described.