Healthcare Compliance Research Articles

Telemedicine in Italy: Healthcare authorization profiles in the modern medico-legal reading

Background The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine. Objective This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services. Methods Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place. Results Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users’ safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed. Conclusion The questioning of States’ health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified.

The Role of Visualization in Estimating Cardiovascular Disease Risk: Scoping Review.

Supporting and understanding the health of patients with chronic diseases and cardiovascular disease (CVD) risk is often a major challenge. Health data are often used in providing feedback to patients, and visualization plays an important role in facilitating the interpretation and understanding of data and, thus, influencing patients' behavior. Visual analytics enable efficient analysis and understanding of large datasets in real time. Digital health technologies can promote healthy lifestyle choices and assist in estimating CVD risk. This review aims to present the most-used visualization techniques to estimate CVD risk. In this scoping review, we followed the Joanna Briggs Institute PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews) guidelines. The search strategy involved searching databases, including PubMed, CINAHL Ultimate, MEDLINE, and Web of Science, and gray literature from Google Scholar. This review included English-language articles on digital health, mobile health, mobile apps, images, charts, and decision support systems for estimating CVD risk, as well as empirical studies, excluding irrelevant studies and commentaries, editorials, and systematic reviews. We found 774 articles and screened them against the inclusion and exclusion criteria. The final scoping review included 17 studies that used different methodologies, including descriptive, quantitative, and population-based studies. Some prognostic models, such as the Framingham Risk Profile, World Health Organization and International Society of Hypertension risk prediction charts, Cardiovascular Risk Score, and a simplified Persian atherosclerotic CVD risk stratification, were simpler and did not require laboratory tests, whereas others, including the Joint British Societies recommendations on the prevention of CVD, Systematic Coronary Risk Evaluation, and Framingham-Registre Gironí del COR, were more complex and required laboratory testing-related results. The most frequently used prognostic risk factors were age, sex, and blood pressure (16/17, 94% of the studies); smoking status (14/17, 82%); diabetes status (11/17, 65%); family history (10/17, 59%); high-density lipoprotein and total cholesterol (9/17, 53%); and triglycerides and low-density lipoprotein cholesterol (6/17, 35%). The most frequently used visualization techniques in the studies were visual cues (10/17, 59%), followed by bar charts (5/17, 29%) and graphs (4/17, 24%). On the basis of the scoping review, we found that visualization is very rarely included in the prognostic models themselves even though technology-based interventions improve health care worker performance, knowledge, motivation, and compliance by integrating machine learning and visual analytics into applications to identify and respond to estimation of CVD risk. Visualization aids in understanding risk factors and disease outcomes, improving bioinformatics and biomedicine. However, evidence on mobile health's effectiveness in improving CVD outcomes is limited.

Role of online health communities in patient compliance: a social support perspective

PurposeOnline health communities (OHC) can transform the healthcare industry, particularly in developing economies. Technology advancement and increased health literacy pave the way for these communities to become powerful tools for empowering patients. The purpose of this study was to empirically validate the linkages between social support and how it overarchingly influences patient compliance. Following social support theory, this study delineates how support from the community affects the patient–physician relationship (PERP) and consequently patient compliance regarding the treatment plan. This study also invents the role of patient trust in an OHC in moderating the relationship between PERP and engagement.Design/methodology/approachThis paper is based on social support and empowerment theories to investigate the importance of social support in improving patients’ health behaviours and health outcomes via patient empowerment, patient engagement and patient compliance. The authors surveyed users from three Facebook cancer communities in India to collect data. The authors used partial least squares structured equation modelling and necessary condition analysis (NCA) with 265 participants to support the proposed model.FindingsThe result demonstrates that PERP is a crucial factor for patient engagement in OHC, and patient engagement has a significant effect on patient compliance. The results also showed that trust was a significant moderator between PERP and engagement. The NCA analysis shows all the relationships are significant; however, emotional support is not a necessary condition for PERP.Research limitations/implicationsBy empowering cancer patients and enabling them to meet their emotional and informational needs through OHCs, the study model can aid in the development of solutions that will improve compliance with their treatment in an emerging economic context. The findings indicate the potential chain reaction of social support and PERP in online cancer health communities. This study also contributes to quantifying the social impacts of online healthcare services and how to enhance the healthcare compliance framework.Originality/valueThis study combines social support and empowerment theory with patient, physician, and technology to provide a fine-grained picture of PERP in OHC. It explains how social support in OHC promotes self-care behaviour. This linkage validation enables readers and the community at large to gain a more nuanced understanding of how social support – through PERP, engagement and trust – enables patient compliance using primary data.

Cybersecurity and Compliance in Healthcare: A Study on Key Management and Other Regulatory Requirements

Typically, WSNs are implemented in several applications with various topologies. Nodes use wireless mode of communication, and unattended areas are typically selected for WSN deployment. Attack risk is higher in WSNs. Furthermore, the WSN nodes have severe resource constraints. It is quite difficult to provide security in such a setting. Numerous protocols for key management chores and encryption strategies for maintaining security in the WSN environment have been documented in literature. The criticality of the data being transferred over the network determines how complex the assault will be. Applications that monitor agriculture, for example, are safe from attacks. However, applications related to the military and healthcare could attract attackers who are far more skilled. Applications that involve process control and habitat monitoring attract attackers with medium to low skill levels. There isn't a single protocol available right now that could be flexible enough to meet the different requirements of the apps, which typically have variable security requirements. For these different applications, there are differences in the key management task, which is strongly related to the security requirements. As a result, the precise kind and complexity of the key management technique must be chosen and built in accordance with the necessary level of security, the capabilities of the hardware devices available, and the network topology that is used.

Telemedicine in Italy: Healthcare authorization profiles in the modern medico-legal reading.

The ruling n. 38485, 20 June 2019, of the Italian Supreme Court, III criminal section, addressed by the perspective of the law the very sensitive and new issue of telemedicine. This commentary deals with the issue of authorization of telemedicine activities by the health authority, starting from the Italian Court of Criminal Cassation, III section, decision n. 38485/2019. The case law explored the authorization of a health point, which carries out telemedicine services. Starting from the perspective discussed by Italian health regulations, the paper examines how the health act could be defined, with the possibilities offered by telecommunications, and how it now relates legally to the physical place where it takes place. Even if telemedicine opens the way to virtual spaces of health practice, the Ministry of Health Italian Guidelines pose functional and logistical issues to guarantee users' safety and health care system accountability. Then, functional requirements for health legitimate practice, and their continuous monitoring, together with the responsibilities of the service centers, health professionals and health facilities, are discussed. The questioning of States' health law, in a broad health system such as that of the Europe, characterized by autonomous health regulations, is extremely important for cross-border health policy with telemedicine, as overall regulatory compliance in health care is the ground criterion for risk prevention and patient safety, to be properly verified.

IDF23-0302 Person-Centred Caring Towards Improvement of Diabetic Foot Care Compliance in Rural Primary Health Care, KwaZulu-Natal

IDF23-0302 Person-Centred Caring Towards Improvement of Diabetic Foot Care Compliance in Rural Primary Health Care, KwaZulu-Natal

The association between air pollutions and emergency hospitalizations due to COPD and asthma across 16 Polish cities: population-based study.

In recent years numerous initiatives aimed at reducing air pollution have been undertaken in Poland. The general objective was to examine the correlation between air pollution measured by the level of particulate matter ≤10 μm in diameter (PM10) and emergency hospitalizations due to chronic obstructive pulmonary disease (COPD) and asthma in 16 Polish cities (capitals of the regions). The authors aimed to diagnose the situation across 16 cities over a 5‑year period (2014-2019). Data on the number of hospitalizations was retrieved from the national public insurance system, the National Health Fund. A total number of 22 600 emergency hospitalizations was analyzed (12 000 and 10 600 in 2014 and 2019, respectively). The data on air pollution was accessed via the public register of the Chief Inspectorate for Environmental Protection air quality database. The authors of this article have used the data on PM10 daily exposure in each of the 16 cities in 2014 and 2019. Statistical methods included: non-parametric tests, a 2-stage modelling approach for time-series data, and multivariate meta-analysis of the results. The results indicated that there was a statistically significant decrease in PM10 concentration in 2019 in comparison to 2014 in all cities, mainly in the autumn and winter season. However, the correlation between the improvement in the air quality and a decrease in emergency hospitalizations due to asthma and COPD turned out to not be as strong as expected. The authors observed a strong correlation between PM10 concentrations and hospitalizations due to asthma and COPD, but only when air quality norms were significantly above acceptable levels. Air pollution measured by PM10 concentration might be used as one of the predictors of the asthma and COPD emergency hospitalization risk, yet other factors like respiratory tract infection, health care organizational aspect, patient self-control, compliance and comorbidities should also be taken into consideration. Int J Occup Med Environ Health. 2024;37(1):110-27.

Occupations and balance during the transition to motherhood with a lifetime chronic illness: A scoping review examining cystic fibrosis, asthma, and Type-1 diabetes.

Throughout the transition to motherhood, changes are experienced across a woman's physical, mental, social, and occupational self. Maternal chronic illness adds the complexity of increased healthcare needs and navigating a high-risk, medicalised pregnancy, birth, and post-natal period. Literature concerning motherhood transitions in chronic illness generally focusses on the mother's medical health and pregnancy outcomes; little is known about the impacts on women's occupations, balance, and quality of life. Understanding these issues may help support women in a more tailored and holistic way. This scoping review aims to gather, analyse, and synthesise existing empirical research on occupational engagement and occupational balance as they impact on wellbeing and quality of life in women with a lifetime chronic illness before and during pregnancy and in early motherhood. The review follows the nine-stage framework described in the Joanna Briggs Institute Manual for Evidence Synthesis (2020). Five databases were searched: Embase, Medline, PsycINFO, CINAHL, Scopus, and OT Seeker. Data were extracted and examined via content analysis, described in narrative synthesis, summarised into a conceptual framework, and tabulated. A total of 8,655 papers were discovered on initial search. Following title and abstract screening, 220 full-text studies were assessed for eligibility, and 46 papers were finally included. Analysis generated four major themes: The Disrupted Transition Journey; Adaptation, Compromise and Choice; Outcomes; and Drawing on What's Available. The themes were conceptualised into a framework to explain how women sought to balance motherhood and illness-related occupations. Adequate access to information, social support, expert care, and financial resources improved both quality of life and healthcare compliance. Findings of this scoping review deepen the understanding of occupational balance during the transition to motherhood in the context of lifetime chronic illness. Healthcare providers and supportive family and friends can use this knowledge to adapt their approach to assisting women with chronic illness on the motherhood journey. These findings may also inform further inquiry into the scope of occupational therapy practice with this population.

HUBUNGAN PAPARAN INFODEMIC COVID-19 TERHADAP KEPATUHAN PENERAPAN PROTOKOL KESEHATAN PADA MAHASISWA FAKULTAS KEDOKTERAN UNIVERSITAS UDAYANA

The outbreak of the coronavirus has had an impact on people's lives. COVID-19 not only has an impact on health but also on the economy, education, social and security. A lot of COVID-19 hoax information circulating on social media can confuse the public (infodemic). Infodemic leads to excessive information related to COVID-19 that can interfere with finding solutions and not necessarily valid information content. This study aims to determine the relationship between exposure to COVID-19 infodemic and compliance with the application of health protocols in Udayana University Medical Faculty students. This research is a quantitative analytic study with a cross sectional study approach which obtained 236 respondents. Based on the results of the study, most of the women (70.34%), reside in Denpasar (33.90%), the PSSKPD study program (38.56%) and the 2019 batch (53.81%). In addition, respondents also access information well through social media (94.07%), have a positive attitude in receiving COVID-19 information (69.92%), have a positive perception of COVID-19 information (67.37%) so that respondents were not exposed to COVID-19 hoaxes (58.47%) and respondents were obedient in implementing health procedures (75%). In this study, gender characteristics had a relationship with health care adherence (p=0.002). Likewise, access to information (p=0.026) and perception of COVID-19 information (p=0.045) had a relationship with health care compliance. Therefore, it is expected to use FK's social media to provide positive information, especially regarding COVID-19 and urge students to follow all FK's social media.
 Keyword : Coronavirus, Infodemic, Health Protocol

Association between health care facility level and compliance with informative elements of informed consent forms, 2019-2021

Objective: To identify the relationship between public health care facility level and compliance with the essential and desired informative elements of informed consent (IC) forms, Lima Metropolitan Area, 2019-2021.Materials and methods: A descriptive and cross-sectional study. A total of 455 IC forms used in public tertiary health care facilities—hospitals (III-1, III-E) and specialized health care institutions (III-2)—were analyzed to assess the compliance of 22 essential and nine desired elements set forth in the current Peruvian laws and regulations and provided by the Inter-American Court of Human Rights (IACHR). This matrix was submitted to the opinion of a group of experts made up of 11 lawyers and health professionals, registering a Kappa coefficient of 1, which implies a “perfect agreement.” In addition, expert competence coefficient (K) was assessed, registering among the specialists an average of 0.92, which represents a “high influence.” Statistical tests such as Spearman's correlation coefficient, chi-square test, Fisher's exact test and Cramér’s phi were performed. Results: IC forms were mostly developed by the specialized health care institutions (66.00 %) and the medical activity (96.90 %) prevailed in said forms. Compliance with the essential (Rho = 0.69) and desired (Rho = 0.64) informative elements showed a significant relationship (p < 0.05) with the health care facility level. The elements "Benefits," "Drug adverse effects,” “Prognosis” and “Recommendations” showed a significant positive relationship (p < 0.05; Φ > 0.00). The elements "Procedure duration," "Contraindications" and "Solution to questions" showed a significant negative relationship (p < 0.05; Φ < 0.00). Conclusions: There is an association between health care facility level and compliance with the essential and desired informative elements of IC forms in public health care facilities in Lima Metropolitan Area between 2019 and 2021.

From Policy to Practice: Ensuring Regulatory Compliance in Healthcare and Lifesciences: Discussing strategies to integrate legal, compliance, and operational objectives seamlessly

From Policy to Practice: Ensuring Regulatory Compliance in Healthcare and Lifesciences: Discussing strategies to integrate legal, compliance, and operational objectives seamlessly

Geiger, Healthcare Compliance

Geiger, Healthcare Compliance

Long-term follow-up on HIV infected and non-infected women with cervical cancer from Tanzania: staging, access to cancer-directed therapies and associated survival in a real-life remote setting

BackgroundWorldwide 85% of cervical cancer (CC) related deaths occur in low- and middle-income countries. Sub-Saharan Africa is burdend by an overlapping high incidence of CC as well as HIV infection, a risk factor for HPV associated disease progression. Recent upscaling of CC screening activities increased the number of CC diagnoses in a previous unscreened population. The aim of the 2H study was to follow up on women with CC in the context of available health care services in Tanzania in relation to their HIV infection status.MethodsThis longitudinal observational cohort study included women with histological confirmed CC from Mbeya, Tanzania, between 2013–2019. All women were referred for CC staging and cancer-directed therapies (CDT), including surgery and/or radio-chemotherapy, or palliative care. Annual follow-up focused on successful linkage to CDT, interventions and survival. We assessed factors on compliance, used Kaplan–Meier-Survivor functions to evaluate survival time and poisson regression models to calculate incidence rate ratios on mortality (IRR) two years after diagnosis.ResultsOverall, 270 women with CC (123 HIV infected) were included. Staging information, available in 185 cases, showed 84.9% presented with advanced stage disease (FIGO ≥ IIB), no difference was seen in respect to HIV status. HIV-infected women were 12 years younger at the time of cancer diagnosis (median age 44.8 versus 56.4 years, p < 0.001). Median follow up period was 11.9 months (range 0.2–67.2). Survival information, available in 231 cases, demonstrated for women diagnosed in early-stage disease a median survival time of 38.3 months, in advanced-stage 16.0 months and late-stage disease 6.5 months after diagnosis. Of all women, 42% received CDT or palliative support. HIV co-infection and education were associated with higher health care compliance. CDT was significantly associated with lower 2-year mortality rates (IRR 0.62, p = 0.004). HIV coinfection did not impact mortality rates after diagnosis.ConclusionHigh numbers of advanced and late staged CC were diagnosed, compliance to CDT was low. A beneficial impact of CDT on CC mortality could be demonstrated for local health care services. This study indicates challenges for successful linkage and supports an effective scale up of cancer care and treatment facilities.

A blockchain-based framework to support pharmacogenetic data sharing

The successful implementation of pharmacogenetics (PGx) into clinical practice requires patient genomic data to be shared between stakeholders in multiple settings. This creates a number of barriers to widespread adoption of PGx, including privacy concerns related to the storage and movement of identifiable genomic data. Informatic solutions that support secure and equitable data access for genomic data are therefore important to PGx. Here we propose a methodology that uses smart contracts implemented on a blockchain-based framework, PGxChain, to address this issue. The design requirements for PGxChain were identified through a systematic literature review, identifying technical challenges and barriers impeding the clinical implementation of pharmacogenomics. These requirements included security and privacy, accessibility, interoperability, traceability and legal compliance. A proof-of-concept implementation based on Ethereum was then developed that met the design requirements. PGxChain’s performance was examined using Hyperledger Caliper for latency, throughput, and transaction success rate. The findings clearly indicate that blockchain technology offers considerable potential to advance pharmacogenetic data sharing, particularly with regard to PGx data security and privacy, large-scale accessibility of PGx data, PGx data interoperability between multiple health care providers and compliance with data-sharing laws and regulations.

Patient Adherence to Tuberculosis Treatment: A Relation between Family Support and Patient Behavior

Introduction: Knowledge, family support, and behavior have a significant impact on an individual's and community's health. They play a critical part in deciding disease control programs and transmission prevention of tuberculosis. The purpose of the study was to determine the association between family support, patient behavior, and tuberculosis treatment compliance in the Baing Primary Health Care of Wulla-Waijilu DistrictMethods:The study design was cross-sectional using the Spearman Rho test. The sample was 123 respondents with purposive sampling technique. The data collection was using sociodemographic questionnaires, family support, behavior, TB treatment adherence and MMAS-8. The dependent variable in this study was family support. The independent variables in this study were patient behavior and TB treatment adherence.Result:There was a relationship between family support and patient behavior (p=0.025), a relationship between family support and compliance with TB treatment (p=0.042)Conclusion:It can be concluded that there was a relationship between family support and TB patient behavior and there was a strong and significant relationship between family support and the level of TB treatment adherence.

Neither Carrots nor Sticks: DOJ's Unfulfilled Commitment to Corporate Health Care Compliance

The Department of Justice (“DOJ”) has for decades sought to encourage four compliant behaviors in corporate actors: maintenance of an effective pre-existing compliance program, post-enforcement adoption of an effective compliance program, cooperation with a government investigation, and self-disclosure of misconduct. While DOJ’s public statements reflect a claimed commitment to all four, analysis of DOJ policy and resolved cases makes clear that as DOJ has increasingly prioritized and incentivized the latter three behaviors, the first—maintenance of an effective pre-existing compliance program, the only one aimed towards stopping fraud before it occurs—has been cast aside in one of DOJ’s highest-profile enforcement areas.In criminal prosecutions, both DOJ policy and the United States Sentencing Guidelines (“USSG”) consider pre-existing compliance programs in determining whether a business entity should be prosecuted and the amount of a fine if a prosecution does occur. DOJ’s Criminal Division has hired compliance experts and enthusiastically publicized internal training aimed at improving prosecutors’ ability to evaluate corporate compliance programs. For the health care industry, however, the civil False Claims Act (“FCA”) is DOJ’s primary enforcement tool, and neither that DOJ policy nor the USSG apply. Instead, in civil cases DOJ guidance has been opaque or non-existent, offering little clarity as to how, if at all, DOJ will consider pre-existing compliance programs when resolving FCA cases. This is particularly surprising given that health care compliance has evolved over decades into a major industry not only with sophisticated and expensive corporate programs, but the subject of increasingly frequent and hands-on DOJ public statements and guidance.This article is the third in a series analyzing civil FCA resolutions, looking not only at DOJ’s stated policies but at actual outcomes through review of a data set of resolved cases against health care entities. Until now, those analyzing the extent of benefits for corporate compliance programs have focused on criminal cases, particularly those under the Foreign Corrupt Practices Act and primarily focused on the potential for a compliance defense to criminal liability. Surprisingly, the literature has to-date failed to analyze the question in the context of the FCA and thus the health care industry despite its supremacy as a DOJ enforcement target and although the FCA’s mens rea standard is more likely to sweep in cases where applying a compliance benefit would further DOJ’s enforcement goals.With health care enforcement gaining increased attention in the wake of government spending relating to COVID-19, and additional visibility into DOJ settlement policy now possible due to a change in the tax code, DOJ’s current failure to reward pre-existing compliance programs in FCA resolutions puts DOJ’s enforcement goals at risk, potentially demotivating corporate actors and adding to skepticism about DOJ’s motivations and the legitimacy of the enforcement regime, as it prevents DOJ from separating the most culpable corporate actors from those less worthy of condemnation. It is also a missed opportunity, as the large quantity of health care resolutions provides the potential for industry to learn from others’ compliance successes and failures, and for DOJ to encourage advancements as it claims to desire to do.

Coronavirus Disease (Covid-19) Compliance Level Of Hospital Health Personnel

Coronavirus disease 2019 or COVID 19 is a virus that is spreading in China with a very rapid rate of infection. According to WHO life report, the death toll from COVID 19 in Indonesia reached 12,000 people. Health care as a front end in hospital management should also optimize the performance of its duties according to established operational procedures. The purpose of this research is to explain the level of healthcare professional commitment to the prevention and transmission of coronavirus disease 2019 or COVID 19. The literature review search uses three electronic databases, namely PubMed, Scient direct and google scholar. The average number of respondents is 500 Responders. Articles selected by paying attention to the PEOS Framework then the articles analyzed one by one. Of the 10 articles analyzed, the results were articles that discussed handwashing obedience with n equal 7 and masking obedience with n equal 3. Ten articles were found that met the criteria of inclusiveness and exclusivity. Seven articles on health care compliance in hand washing and three articles on the use of masks with the highest level of compliance. In the COVID 19 pandemic, the level of health care compliance in the effort to wash hands and use face masks increases with the hand washing guidelines 7 moment in accordance with the WHO recommendation and using masks in accordance with the CDC guidelines&#x0D;

DIGITAL PATH OF THE HYPERTENSIVE PATIENT BEFORE A FIRST VISIT IN A TERTIARY CARE HYPERTENSION UNIT: A REAL-LIFE PILOT STUDY

Objective: There is growing evidence that the information and communication technologies (ICT) can improve health care access, patient education, compliance or outcomes, particularly in chronic diseases such as hypertension. In this e-Health context, our group validated, several years ago, a standardized patient self-questionnaire (Hy-Quest) and a software system to help patients manage Home Blood Pressure Measurement (Hy-Result software). But to what degree can patients use ICT before any face to face contact with a health care professional? Design and method: Between October 2017 and October 2018, 304 patients booked an appointment through the website of an ESH Excellence Centre, (www.centre-hypertension.org). Among them, 81% were first-visiting patients and 75% declared owning a sphygmomanometer. A simple, short E-mail was sent to a sample of 63 of them asking them to complete two tasks before attending their first appointment: ie. complete the Hy-Quest questionnaire (Hy-Q)and self-measure their blood pressure (BP), communicating their readings using the Hy-Result software (Hy-R). Results: Patients who responded were 56 (19-86) years old, had a mean office BP of 143/90 mmHg, a mean home BP of 137/84 mmHg under 1.8 antihypertensive drug/person. The mean duration of hypertension was 9 years (0–46). Attending their first visit, 54% of patients were able to successfully get through the digital path (27% completing Hy-Q+Hy-R; 25.4% Hy-Q only; 1.6% Hy-R only). Different problems (unattended or delayed visit, neither Hy-Q nor Hy-R completed, refusal to participate, computer problems) led the remaining 46% of patients to an unsuccessful digital path [Fig.]. Conclusions: This pilot study shows that approximately half of the patients can contribute to preparing their first visit by going through a digital path starting from the online reservation, to filling in Hy-Quest and communicating their self-measured BP readings using the Hy-Result software. This study confirms the interest for continuing with a larger study to confirm these percentages, to gain a better understanding of the reasons that prevent the patient from preparing online for his first visit and subsequently, optimize the steps of the hypertensive patient's digital path.

Assessing Health Care Utilization and Compliance in Kawasaki Disease

To characterize health care utilization and costs associated with care after diagnosis of Kawasaki disease including adherence to guidelines for echocardiograms. We analyzed children hospitalized for Kawasaki disease using 2015-2017 national TruvenMarketScan commercial claims data. The mean 90-day prehospitalization utilization and costs were quantified and compared with the 90days posthospitalization via Wilcoxon 2-sample test. Adherence to echocardiogram guidelines was examined using multivariable logistic regression to identify factors associated with adherence. The mean total payments 90days prior to hospitalization ($2090; n=360) were significantly lower than those after discharge ($3778), though out of pocket costs were higher ($400 vs $270) (P<.0001). There was an increase in office visits, medical procedures, and echocardiograms after discharge. A majority of health care utilization before hospitalization occurred in the 7days immediately prior to the date of admission; 51% obtained an echocardiogram within the first 2weeks, and 14% were completely adherent with recommendations. Children with greater utilization prior to admission were more likely to adhere to American Heart Association guidelines for follow-up echocardiograms (OR 1.03, 95% CI 1.01-1.06). Outpatient health care expenditure nearly doubles after Kawasaki disease hospital discharge when compared with prehospitalization, suggesting the financial ramifications of this diagnosis persist beyond costs incurred during hospitalization. A significant portion of patients do not receive guideline recommended follow-up echocardiograms. This issue should be explored in more detail given the morbidity and mortality associated with this diagnosis.

A Path to Data-Driven Health Care Enforcement

The Department of Justice (“DOJ”) has a long-stated goal of encouraging companies to engage in what the author refers to as “compliant behaviors”—maintenance of an effective pre-existing compliance program, post-enforcement adoption of an effective compliance program, cooperation with a government investigation, and self-disclosure of misconduct. Substantial DOJ guidance over the past two decades, along with the concrete incentive structure of the United States Sentencing Guidelines, have increasingly made clear to organizations when and how such behaviors will be rewarded in criminal matters. Recently, DOJ has made transparency and clarity regarding the benefit of compliant behaviors a priority in calculating and announcing criminal resolutions. With respect to civil False Claims Act (“FCA”) settlements, however, meaningful formal DOJ guidance on the effect of compliant behavior only arrived in 2019. More significantly, DOJ’s treatment of compliant behavior in civil cases, in contrast to that in the case of criminal resolutions, has appeared inconsistent and certainly opaque. This lack of clear implementation philosophy is particularly problematic in the area of health care, an industry for which the FCA is the primary tool for government action in response to misconduct. While much has been written on the systemic efficiencies—or lack thereof—that DOJ’s enforcement practices bring to the activities of regulated industries, this is the first article to use data to ask whether DOJ has a governing practice concerning civil settlements, or whether instead, its settlement practices fail to match its stated principles. For decades, even as resources devoted to health care compliance by market participants have skyrocketed and DOJ has pressed corporate entities to engage in compliant behaviors, the health care industry and the defense bar have expressed skepticism regarding the actual payoff they might realize by engaging in those behaviors. DOJ’s response has been a series of public statements amounting to, “trust us, they matter.” Until now, the health care industry has been without any mechanism to test those assurances. In response to changes in the tax code, however, DOJ made adjustments in 2018 to its practice of disclosing information regarding FCA settlements—changes that have shaken loose data that provides an opportunity to test DOJ’s claims of rewarding compliant behaviors in civil cases. The author is the first and thus far the only person to have identified and analyzed this newly available data. Examination of this data demonstrates that wide-ranging, structural changes are necessary. The data raises substantial questions about: the quantum of credit given for cooperation; conduct DOJ values in resolving FCA cases; and the degree of consistency in cases settled by U.S. Attorney’s Offices across the country. For example, analysis of the data reveals inconsistent benefits for cooperation. Cases where defendants self-disclosed misconduct or cooperated were often not treated more leniently than cases where defendants did not self-disclose or cooperate, and a review of more than 100 settlements did not find a single instance in which DOJ purported to give an entity a reduction based on its pre-existing compliance program. At the same time, DOJ appears to be greatly rewarding defendants for agreeing to settle—highlighting concerns both with regard to whether DOJ is achieving adequate deterrence and with regard to whether the FCA’s potential penalties are coercing settlements. And the data appears to show significant variation in settlement positions depending on the identity of enforcing DOJ component, with cases handled by DOJ’s Civil Division in Washington, D.C. treated more leniently than cases handled solely by U.S. Attorney’s Offices across the country. With the data now public—and at a moment in time when DOJ is emphasizing transparency and clarity in rewarding compliant behaviors in the resolution of criminal cases—DOJ’s corporate health care enforcement regime is at a crossroads. Without change in this area, DOJ risks undercutting its efforts at encouraging compliant behaviors in one of DOJ’s primary enforcement areas. No longer left in the dark about the impact of compliant behaviors in calculating FCA resolutions, the health care industry may be less likely to continue investing in compliance programs at the same rate, to cooperate with government investigations, and especially to self-disclose misconduct to the government. The analysis reveals that a detailed structure of DOJ’s calculations in FCA settlements, with calculations transparent in each FCA resolution, is needed to accomplish DOJ’s goal of encouraging cooperation and investment in compliance programs, as well as to provide an assurance that like cases are treated alike.