Compliance Failure Research Articles

The evolving role of compliance: How companies need to enforce their three lines of defence to protect the business

Despite the increasing legal and regulatory requirements for financial institutions within the European Union, scandals surrounding compliance and corporate governance failures are continuously being revealed. Apart from significant fines and monetary losses as well as reputational damage for the concerned organisations, such scandals lead to pressure on legislators and international (supervisory) bodies to again further increase regulatory requirements. This paper describes the Three Lines of Defence Model within organisations in connection with the Danske Bank scandal and outlines key principles that can serve as the basis to strengthen the compliance environment and culture within organisations to prevent major scandals.

Analysis of FDA Warning Letters Issued to Indian Pharmaceutical and Medical Device Companies: A Retrospective Study.

FDA issues warning letters to pharmaceutical manufacturers, distributors, or clinical investigators if it observes serious violations of federal regulations. These warning letters contain the details about the nature of the violations observed and the corrective actions recommended by the FDA. A follow-up inspection may be requested by the recipient after taking the corrective actions. Analysis of warning letters issued to Indian pharmaceutical companies from January 1, 2005, to December 31, 2018, was carried out. The warning letters were extracted from FDA's public database. Across the 14-year study period, the number of warning letters issued to Indian pharmaceutical and medical device manufacturers has gradually increased. Of all the violations listed in these warning letters, 85.87% were related to the failure of compliance with the cGMP guidelines. Moreover, 80.72% of these warning letters were not followed by a close-out warning, which indicated that the violations listed in these warning letters could not be resolved. As the inability of the recipients to comply with the cGMP guidelines formed the majority of the violations observed in the warning letters, more resources and manpower have to be assigned to the manufacturing process of the pharmaceutical products.

PIH6 APPROACH TO THE IMPACT OF COVERAGE IN LONG-TERM CONTRACEPTION IN THE ECONOMIC BURDEN OF UNPLANNED PREGNANCY FROM THE PERSPECTIVE OF ISAPRES IN CHILE

Unplanned pregnancy (UP) is a public health problem that impacts women, families and countries, with social, health and economic repercussions, even greater on risk subgroups such as the adolescent population (10 to 19 years). Contraception in Private System is still an out-of-pocket therapy, without coverage by private insurers ISAPRES. Our objective is to calculate the costs of UPs in ISAPRES and generate a coverage proposal for Long-term contraceptives (LARC), which do not have failure due to compliance of users. This research used the last data published by the Chilean Superintendence of Health (2017). It was considered UPs Cesarean and Vaginal deliveries for women between 10 and 19 years of age. The average cost of reimbursement was considered as a cost for ISAPREs, while the difference with the average cost billed was considered out-of-pocket expense for the user. The study included 561 UPs for all private system, with an annual expense of US$ 636,000 calculated only with average direct costs. 68% is financed by ISAPREs and the rest is out-of-pocket expense for the users. It is possible to save this amount generating a level of coverage in LARC. It was calculated the LARC total coverage multiplying the number of UPs with the average market price of Levonorgestrel Intrauterine System, the result is an annual investment of US$ 79,881. This technology was selected considering that these systems don’t have failure of compliance, unlike Short-term contraceptives that according to studies in Chile are responsible for almost 50% of the UP in the country. The study provides for first time an analysis of RWE on teen pregnancy costs to generate access to LARC systems. Also allows make decisions to get savings and redistribute to generate coverages for other health actions that could generate more value for affiliates in this system.

Evaluating the effects of a neonatal hypoglycemia bundle on NICU admission and exclusive breastfeeding.

Early feeding, skin-to-skin contact, and dextrose gel have been independently shown to promote breastfeeding and decrease NICU admission for neonatal hypoglycemia. We combined these interventions to decrease NICU admissions for asymptomatic hypoglycemia and increase exclusive breastfeeding rates. The IHI Model for Improvement was used to design a bundle including feeding within 1 h of birth, 1 h of uninterrupted skin-to-skin within 2 h of birth, and administration of buccal 40% dextrose gel for hypoglycemic infants. Utilization of dextrose gel was 94% following implementation. There were no trends in exclusive breastfeeding at discharge or NICU admissions for asymptomatic hypoglycemia. Post hoc multivariate analysis identified cesarean delivery as an independent risk factor for compliance failure and failure of exclusive breastfeeding but not for NICU admission. Despite high compliance with dextrose gel utilization, there was no change in exclusive breastfeeding at discharge or NICU admission rates for asymptomatic hypoglycemia.

Resetting dense graded airport asphalt production and construction tolerances

All elements of pavement material supply and construction are variable in nature and some specifications recognize this variability via statistically based specification limits and pay rates that are related to the percentage of complying quality assurance test results. It was perceived that the traditional and prescriptive airport asphalt specification in Australia included some tolerances that were unreasonably tight and this was preliminarily addressed in conjunction with the development of a more performance-based specification in 2017. However, the reasonableness of the current tolerances required verification based on data generated by actual airport pavement resurfacing works. The quality testing results from three well-constructed and adequately performing recent runway resurfacing projects were statistically analyzed to review, verify and where necessary reset, the tolerances relating to raw material manufacture, asphalt production and surface layer construction. The majority of the current tolerances were appropriate. However, the tolerances associated with the Marshall Stability and Marshall Flow, as well as some compacted field air void limits were recommended to be tightened. It was also recommended that the tolerances for surface cross fall deviation from design be widened and that new tolerances be added for asphalt maximum density and Marshall bulk density. The recommended tolerances aim to allow an average compliance failure rate of approximately 5%, which is consistent with other statistical approaches to infrastructure material specification in Australia.

Common step-wise interventions improved primary care clinic visits and reduced emergency department discharge failures: a large-scale retrospective observational study

BackgroundIt is critical to understand whether providing health insurance coverage, assigning a dedicated Primary Care Physician (PCP), and arranging timely post-Emergency Department (ED) clinic follow-up can improve compliance with clinic visits and reduce ED discharge failures. We aim to determine the benefits of providing these common step-wise interventions and further investigate the necessity of urgent PCP referrals on behalf of ED discharged patients.MethodsThis is a single-center retrospective observational study. All patients discharged from the ED over the period Jan 1, 2015 through Dec 31, 2017 were included in the study population. Step-wise interventions included providing charity health insurance, assigning a dedicated PCP, and providing ED follow-up clinics. PCP clinic compliance and ED discharge failures were measured and compared among groups receiving different interventions.ResultA total of 227,627 patients were included. Fifty-eight percent of patients receiving charity insurance had PCP visits in comparison to 23% of patients without charity insurance (p < 0.001). Seventy-seven percent of patients with charity insurance and PCP assignments completed post-ED discharge PCP visits in comparison to only 4.5% of those with neither charity insurance nor PCP assignments (p < 0.001).ConclusionsStep-wise interventions increased patient clinic follow-up compliance while simultaneously reducing ED discharge failures. Such interventions might benefit communities with similar patient populations.

Calculating Corporate Compliance &amp; The Foreign Corrupt Practices Act

Technology is rapidly disrupting every industry and institution around the globe. Yet, corporate compliance has remained relatively unaffected by technological change when compared to other industries. If firms continue to lag behind in their compliance efforts, their risk exposure to the potentially lethal sanctions associated with major compliance failures will continue to increase with time. This is particularly true in the context of the Foreign Corrupt Practices Act. Generally, the Foreign Corrupt Practices Act (“FCPA”) is a regulatory statute that forbids bribery and false accounting for domestic firms doing business abroad. And, in the past decade the DOJ and SEC have begun aggressively enforcing the FCPA. Firms should begin using technology to develop more robust and cost-efficient compliance programs to insulate themselves from the FCPA’s harsh penalties. This Article provides an algorithm that allows firms to evaluate and improve their compliance programs in accordance with several published sources of guidance. Compliance scholars have made clear that it is critical for firms to maintain strong corporate compliance programs and have suggested different models and frameworks for internal evaluation and auditing. However, those suggestions fail to consider how technology may be used to improve the cost-efficiency of corporate compliance and ethics programs. This Article takes an informatics-based approach to evaluating and improving firm compliance by focusing on the most important compliance functions according to the Department of Justice (“DOJ”), courts, and other Government actors. Indeed, firms may drastically improve the cost-efficiency of their compliance efforts by adopting the analytical framework proposed in this Article.

Automated Source Selection Scoring &amp;amp; FAR Compliance

Technology is changing the world at an accelerating rate. However, federal agencies’ public procurement and compliance tools have remained relatively unaffected by technology when compared to other industries. If Government agencies continue to lag behind in their compliance efforts, then Government agencies’ risk exposure to a specific type of lawsuit called a bid-protest will remain static. Bid-protests cause time delays for government projects and cost contractors and the Government substantial amounts of money each year. Government agencies should use technology to standardize and automate their source selection scoring procedures in order to improve their regulatory compliance and gain cost-efficient advantages. This paper provides an algorithm that standardizes and automates Government agencies’ source selection scoring systems. Scholars have suggested different approaches to improve the source selection process that focus on regulatory changes to the structure of the acquisition process. However, those suggestions fail to consider how technology may be used to improve source selection and regulatory compliance within the current structure of the acquisition process. This paper takes an informatics based approach to reducing the occurrence of common compliance failures that arise from defective source selection procedures. Government agencies may drastically reduce the occurrence of compliance failures and resulting bid-protests by adopting the analytical framework proposed in this paper.

The predictors for the non-compliance to follow-up among very low birth weight infants in the Korean neonatal network.

The critical need to emphasize preterm infant follow-up after neonatal intensive care unit (NICU) discharge assures early identification of and intervention for neurodevelopmental disability. The aims of this study were to observe the follow-up rates in high-risk follow-up clinics, and analyze factors associated with non-compliance to follow-up among very low birth weight (VLBW) infants. The data was prospectively collected for 3063 VLBW infants between January 2013 and December 2014 from 57 Korean neonatal network (KNN) centers at a corrected age of 18–24 months. Correlations among demographic data, clinical variables, and neonatal intensive care unit (NICU) volume (divided into 4 quartiles) with the occurrence of non-compliance were analyzed. The overall follow-up rate at the corrected age of 18–24 month was 65.4%. The follow-up rates were inversely related to birth weight and gestational age. Apgar score, hospital stay, maternal age, and maternal education were significantly different between the compliance and non-compliance groups. The follow-up rate was higher for mothers with chorioamnionitis, abnormal amniotic fluid, multiple pregnancy, and in vitro fertilization. Infants with respiratory distress syndrome, bronchopulmonary dysplasia, patent ductus arteriosus ligation, periventricular leukomalacia, and retinopathy of prematurity were more common in the compliance group. Follow-up rates showed significant differences according to NICU volume. Using multivariate logistic regression, high birth weight, low NICU volume, siblings, foreign maternal nationality and high 5 min APGAR scores were significant independent factors associated with the non-compliance of VLBW infants for follow-up at 18–24 months of age. This is the first nation-wide analysis of follow-up for VLBW infants in Korea. Understanding factors associated with failure of compliance could help improve the long-term follow-up rates and neurodevelopmental outcomes through early intervention.

Short-Changing Compliance

How can we ensure corporations play by the “rules of the game”—that is, laws encouraging firms to avoid socially harmful conduct? Corporate compliance programs play a central role in society’s current response. Prosecutors give firms incentives—through discounts to penalties—to implement compliance programs that guide and monitor employees’ behavior. However, focusing on the incentives of firms overlooks the perspective of managers, who decide how much firms invest in compliance. We show that stock-based pay, ubiquitous for corporate executives, creates systematic incentives to short-change compliance. Compliance is a long-term investment for firms, whereas managers’ time horizon is truncated to the date they expect to liquidate stock. Moreover, investors find it hard to value compliance programs because firms routinely disclose little or nothing about their compliance activities. We show that stock-compensated managers prefer not to disclose compliance because such disclosure can reveal private information about a firm’s propensity to misconduct. As a result, both managers and markets are likely myopic about compliance. How can this problem be resolved for the benefit of society and shareholders? Boards of directors are supposed to act as monitors to control managerial agency costs. We show that the increasing use of stock-based compensation for directors, justified as a means of encouraging more vigorous oversight of business decisions, also has a corrosive effect on boards’ monitoring incentives for compliance. Directors in theory face liability for compliance oversight failures, but only if so egregious as to amount to bad faith. We argue that this standard of liability, established in an era before ubiquitous stock-based compensation for both managers and directors, has now become too lax. We propose more assertive directors’ liability for compliance failures, limited in quantum to a proportionate clawback of stock-based pay. This would add power to the alignment of directors’ interests with those of shareholders— directors would stand to lose more than just a decrease in the value of their stock in the event of a compliance failure—but limiting liability in this way would avoid pushing boards to overinvest in compliance. We outline ways in which this proposal could be implemented either by shareholder proposals or judicial innovation.

On momentum transfer and external work done to clamped elasto-plastic beams in an air blast

This paper revisits a classical fluid-structure interaction problem on the momentum transfer and external work done to structures by a blast wave propagating in a nonlinear compressible medium (air). A fully-clamped ductile beam system is considered here, in place of the rigid free-standing plate used in the KNR theory (Kambouchev et al., 2006 [2], 2007 [3]), which takes into account limits to material deformation, boundary compliance and boundary failure. The model is used to critically re-evaluate the impulse imparted to the beam, and the subsequent external work done by a blast wave, for different modes of the beam deformation compared to its free-standing counterpart of identical mass per unit area (considered previously by others). It will be shown that the maximum beam deflection, transmitted impulse and external work done by the interface pressure are insensitive to FSI effects if loading is sufficient severe to induce boundary failure. Comparisons are also made between the structural performance of the beam system during fluid structure interaction in a compressible and incompressible fluid medium.

Integrated Hydrological and Geophysical Characterisation of Surface and Subsurface Water Contamination at Abandoned Metal Mines

The mining and processing of metal ores in the UK has left a legacy of environmental degradation, and abandoned metal mines still pose a significant threat to terrestrial and fluvial environments. Flow gauging, water quality and geophysics were combined in an integrated assessment of surface and subsurface hydrological contamination at Esgair Mwyn, an abandoned mine in Ceredigion, Wales. Heavy metals discharged from the site are polluting downstream watercourses, leading to widespread Environmental Quality Standards (EQS) compliance failures. Through salt water dilution gauging and water quality sampling, a daily efflux of 876 g of heavy metals was calculated, with contaminant mobilisation occurring mainly in two primary surface streams draining an exposed tailings heap. Electrical resistivity tomography subsurface imaging found a seepage plane within the tailings lagoon wall, whilst the main tailings heap became increasingly saturated with depth. A large adjacent field also had a high potential to convey pollutants in solution, yet its morphological characteristics have limited transmission, as the area acts as a passive treatment type system. With remediation of already polluted water both difficult and expensive, this approach provides a cost-effective way to identify the origins and pathways of contaminants, informing mitigation strategies focussed on containment. Esgair Mwyn is not an isolated case, as abandoned metal mines release at least 860 t of heavy metals annually into UK water bodies. These techniques could reduce or prevent abandoned metal mine hydrological pollution for decades to come, and enable associated UK water bodies to comply with future water quality standards.

WORPLACE SAFETY IMPROVEMENT IN SME MANUFACTURING: A GOVERNMENT INTERVENTION

Workplace accident in Malaysia shows an increasing trend in recent years with the SMEs sector is found to contribute 80-90% of the total number of accidents. Poor levels of occupational safety and health compliances within the SME manufacturings is determined to be the main cause of accidents. The underlying factors towards the compliance failures are financial constraint, lack of knowledge and expertise, limited human resources and inexistence of knowledgeable safety personnel. Therefore, the Department of Occupational Safety and Health Malaysia conducted an intervention programme with the objective is to improve the compliance of OSH within SME manufacturings. A total number of 59 SME manufacturings within Negeri Sembilan were selected based on their poor grading in OSH Compliance audits and a specific design intervention in the form of trainings then was conducted.The results of OSH compliance post-audit showed an improvement of 38% as compared to the pre-audit. The T-test analysis result also indicated a significant difference in OSH compliance grading among the participating SME manufacturing companies (P-value <0.01). In conclusion, government intervention conducted by DOSH could elevate OSHcompliance performance among the SME manufacturings. Article DOI: https://dx.doi.org/10.20319/mijst.2018.42.2739 This work is licensed under the Creative Commons Attribution-Non-commercial 4.0 International License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc/4.0/ or send a letter to Creative Commons, PO Box 1866, Mountain View, CA 94042, USA.

RETHINKING THE GLOBAL ANTI-MONEY LAUNDERING REGULATIONS TO DETER CORRUPTION

AbstractWhile ‘global anti-money laundering (AML)’ regulations aim to detect and deter corrupt ‘politically exposed persons (PEPs)’, they have caused tremendous collateral damage to many innocent PEPs, particularly foreign PEPs. Due to the significant compliance costs of identifying and managing accounts of foreign PEPs coupled with an increased risk of serious fines against compliance failures, financial institutions have voluntarily terminated the accounts of foreign PEPs. Global AML regulations could avoid the collateral damage while maximising the deterrence of corruption if high degrees of coordination along two dimensions are satisfied, namely, transborder coordination and coordination between public enforcement entities and private actors. This study illustrates a cornerstone change made in 2012 to fulfil the first dimension and offers policy recommendations to build on this cornerstone by pursuing coordination along the second dimension.

Why Governance Matters for Your Startup

Founders, investors, board members, employees and all participants in venture-backed companies should understand the basic principles of corporate governance. Different rules and practices will apply depending on the type of organization, ownership structure, stage of the company, investor base, size, geography or industry. In this article, we only focus on corporate governance for U.S. private venture-backed corporations. Specifically, we focus on the basic corporate governance framework for venture-backed companies and we address three governance issues: 1) the late stage “unicorn” phenomenon and its governance consequences, 2) conflicts of interests and “dual fiduciary conflicts”, and 3) multi-class share structures. As companies are “staying private for longer”, there should be an increased focus on governance of private venture-backed companies, particularly after a string of leading unicorns such as Uber, Theranos, Zenefits and SoFi, engaged in illegal and/or bad behavior that led to serious failures of culture, ethics and compliance. There has also been an uptick in private company lawsuits, particularly in Delaware, targeting poor governance practices in some venture-backed companies. “Growth at all costs” should no longer be the sole driving mantra of Silicon Valley and the technology startup industry. Boards of directors of venture-backed companies should take notice.

A Comprehensive Study of Single and Multiple Truck Crashes Using Violation and Crash Data

Around 4,000 people died in crashes involving trucks in 2016 alone in the U.S., with 21 percent of these fatalities involving only single-unit trucks. Many studies have identified the underlying factors for truck crashes. However, few studies detected the factors unique to single and multiple crashes, and none have examined these underlying factors in conjunction with violation data. The current research assessed all of these factors using two approaches to improve truck safety. An injury/fatal crash was defined as a crash that results in an injury or fatality. The first approach investigated the contributory factors that increased the odds of injury/fatal single truck and multiple vehicle crashes with involvement of at least one truck. The literature has indicated that previous violations can be used to predict future violations and crashes. Therefore, the second approach used violations related to driver actions that could result in truck crashes. The analysis for the first approach indicated that driving on dry-roadway surfaces, driver distraction, and rollover/jackknife types of truck crashes, speed compliance failure, and higher posted speed limits are some of the factors that increased the odds of injury/fatal single and multiple vehicle crashes. With the second approach, the violations related to risky driver actions, which were underlying causes of truck crashes, were identified and analyses were run to identify the groups at increased risk of truck involved crashes. The results of violations indicated that being nonresident, driving off peak hours, and driving on weekends could increase the risk of truck involved crashes.

A Public Health Analysis on Gaps in Disease Monitoring and Opportunities for Improved Care for the Management of Hepatitis B and C.

Hepatitis B and Hepatitis C have been major disease-causing agents among humans since they were discovered in the 1960s. Both cause jaundice-like symptoms initially but their prognosis and treatment are somehow different and depend upon many demographic details, such as the age and susceptibility of the patients and any other comorbid conditions. They clinically present primarily with hepatitis and can have many adverse effects or even be life-threatening at times, if not treated properly. However, their epidemiological background and findings in terms of morbidity, mortality, and case fatality rates are different. The disease burden, impact on the healthcare system, and prevention of the two diseases are quite different. The treatment and management options along with the prevention and control measures share unique strategies for handling the two diseases. The purpose of this review is to highlight the gaps in disease monitoring and to find ways and opportunities that can lead to improved care and better management of Hepatitis B and C locally and globally. Online databases were searched and peer-reviewed articles were selected. Key issues identified were lack of education globally in resource-limited settings, leading to a decreased understanding of the potential hazards associated with needle sharing and lack of access to healthcare because of a lack of insurance. The failure of compliance with vaccination leads to an increase in mother-to-child transmission (MTCT)-related infections. Increased global travel demands a systematic program in most immigrant-receiving countries to screen for hepatitis B virus (HBV)/hepatitis c virus (HCV) infections. Delayed U.S. Food and Drug Administration (FDA) licensing for new drugs hampers the treatment of chronic Hepatitis-B (CHB) among children. With the advancement in science, an effective vaccine against HCV will definitely help in eradicating the infection.

Calculating Corporate Compliance &amp;amp; The Foreign Corrupt Practices Act

Technology is rapidly disrupting every industry and institution around the globe. Yet, corporate compliance has remained relatively unaffected by technological change when compared to other industries. If firms continue to lag behind in their compliance efforts, their risk exposure to the potentially lethal sanctions associated with major compliance failures will continue to increase with time. This is particularly true in the context of the Foreign Corrupt Practices Act (“FCPA”). Generally, the FCPA is a regulatory statute that forbids bribery and false accounting for domestic firms doing business abroad. And, in the past decade the DOJ and SEC have begun aggressively enforcing the FCPA. Firms should begin using technology to develop more robust and cost-efficient compliance programs in order to insulate themselves from the FCPA’s harsh penalties. This paper provides an algorithm that allows firms to evaluate and improve their compliance programs in accordance with several published sources of guidance. Compliance scholars have made clear that it is critical for firms to maintain strong corporate compliance programs and have suggested different models and frameworks for internal evaluation and auditing. However, those suggestions fail to consider how technology may be used to improve the cost-efficiency of corporate compliance & ethics programs. This paper takes an informatics based approach to evaluating and improving firm compliance by focusing on the most important compliance functions according to the DOJ, courts, and other Government actors. Indeed, firms may drastically improve the cost-efficiency of their compliance efforts by adopting the analytical framework proposed in this paper.

Private Transaction Costs of Water Trade in the Murray–Darling Basin

High transaction costs can prevent the efficient allocation of resources towards socially-desirable outcomes. Water is a classic example of a resource with private and public socially-desirable benefits, which depend on its efficient allocation. Public and private institutions thus fulfil an important function by seeking to lower transaction costs in water markets. Where transaction costs are reduced, those same institutions may benefit from positive economic outcomes. However, in spite of their importance for policy performance evaluation, very few studies have investigated the impacts of transaction costs over time on the success or failure of public policy implementation and compliance. This study identifies important transaction costs and their rate of change in the world's leading water market: the southern Murray–Darling Basin in Australia. It was found that some progress towards lowering transaction costs in water markets has been achieved, particularly in respect to water allocation (temporary) transfers. However, some water entitlement (permanent) transaction costs have increased in the time-period, which may be justifiable given the inherent complexities associated with individual entitlement transfer assessments. Overall, the analysis suggests that institutional investment in water markets have improved irrigator private gains from trade.

Association of Preventive Maintenance Therapy Compliance and Peri-Implant Diseases: A Cross-Sectional Study.

This study aims to investigate association between peri-implant maintenance therapy (PIMT) and the frequency of peri-implant diseases and to further identify factors that contribute to failure of PIMT compliance. A cross-sectional study on patients who were healthy and partially edentulous was conducted. They were grouped in the following categories according to PIMT compliance: 1) regular compliers (RC) (≥2 PIMT/year); 2) erratic compliers (EC) (<2 PIMT/year); and 3) non-compliers (NC) (no PIMT). Radiographic and clinical analyses were carried out including probing depth (PD), plaque index (PI), bleeding on probing (BOP), mucosal redness (MR), suppuration (SUP), keratinized mucosa dimension, and marginal bone loss. A multiple logistic regression model was estimated at implant and patient level to obtain adjusted odds ratios (ORs) and to control possible confounding effects among variables. Overall, 206 implants in 115 patients fulfilled inclusion criteria. At patient level, it was shown that association between compliance and peri-implant condition was statistically significant (P = 0.04). Compliance was associated with 86% fewer conditions of peri-implantitis. The probability of PIMT compliance was substantially associated with frequency of peri-implantitis (OR = 0.13, P = 0.01). Patients with a history of periodontal disease multiplied their probability of being EC (versus NC) 4.23 times with respect to not having a history of periodontal disease (P = 0.02). Moreover, light smokers significantly resulted to be NC compared with RC (P = 0.04) and EC (P = 0.02). Nevertheless, mucositis was not found to be statistically associated with level of compliance. In addition, PD, PI, BOP, MR, and SUP varied significantly according to PIMT compliance and peri-implant condition. Peri-implant maintenance compliance ≥2 PIMT/year seems to be crucial to prevent peri-implantitis in healthy patients. Furthermore, history of periodontal disease and disease severity, as well as its extent and a smoking habit, appear to be factors that influence the compliance risk profile (NCT02789306).