Insurance Accounting Research Articles

Assess and Forecast Social Insurance trends to 2025 to serve the State Management of Social Insurance in Vietnam

After more than 28 years of dedication and growth, overcoming many difficulties and challenges, Vietnam Social Insurance is increasingly recognized and positively evaluated by the regional and international social security community for its successes and developments. compared with social security systems in countries with similar GDP and development levels. With social insurance and unemployment insurance; database system on households and centralized health insurance payment assessment system connected to nearly 14,000 medical examination and treatment establishments; transaction in the form of online public service level 4; the percentage of people who are satisfied with the services provided by Vietnam Social Security on new and traditional platforms is relatively high; the social insurance fund becomes the largest social security fund, which is uniformly and safely managed and has made certain contributions to the development of the country's economy; The national unified model of social insurance management and implementation is receiving increasing attention from the regional and international community. With a specific goal of striving by 2030 to reach about 60% of the workforce of the age group participating in social insurance, of which farmers and informal sector workers participating in voluntary social insurance account for about 5% of the labor force. in the age; about 45% of the workforce in the age group participating in unemployment insurance; about 60% of people after retirement age are entitled to pensions, monthly social insurance and social pension benefits; The index assessing the satisfaction level of social insurance participants reached 90%. Therefore, forecasting social insurance trends is a very important job in the process of state management of social insurance in the coming time.

Due process as a legitimating mechanism: Participation and responsiveness in the development of IFRS 17: Insurance contracts

This paper investigates the role of due process in legitimizing the International Accounting Standards Board (IASB) and uses the development of IFRS 17-Insurance Contracts (IASB, 2017a) as a case study. It examines stakeholders’ participation and assesses the IASB’s responsiveness to the views expressed in the comment letters. It focuses on changes in recognition, valuation, and disclosure during the 10-year process, in which the Financial Accounting Standards Board (FASB) played a relevant role. For input and through-put legitimacy analysis, we conduct content analysis of comment letters and consult additional sources to understand key concerns in insurance accounting. The IASB received substantial feedback from diverse stakeholders and geographical regions, primarily preparers and European constituents. Our findings indicate that decisions throughout the standard-setting process align with stakeholders’ interests, without preferential treatment for any groups, affirming the institution’s legitimacy was preserved. This confirms that the IASB’s due process can be seen as a shield against political and constituent pressures. Nevertheless, this study cannot definitively attribute identified changes solely to comment letters, as other channels may have been equally influential.

The evaluation of Acehnese people's health insurance from the welfare perspectives

Link of Video Abstract: https://youtu.be/UEJWESqCEvo Introduction: Indonesia has tried to implement the UHC system by implementing the National Health Insurance (JKN) program since 2014. To extend the coverage of JKN, the government of Aceh, one of the poorest provinces in Indonesia carries out Acehnese People's Health Insurance (JKA), which aims to improve the health and welfare of the people of Aceh. However, there has never been an evaluation of the usefulness of JKA related to the welfare of the Acehnese people. Therefore, this study aims to evaluate the impact of JKA on the level of welfare of the people of Aceh. Methods: This was an ecological study with a cross-sectional approach to evaluate the correlation between welfare indicators (education, health, and housing) and Community Coverage Levels and Capitation Costs on Acehnese People's Health Insurance. All study data were taken from the Acehnese public health insurance accountability report and the people's welfare statistics report from the Central Statistics Agency. All data collected were analyzed using SPSS ver. 25. Results: JKA has an average community coverage of about 2 million people with an average capitation payment of around 139 billion rupiahs from 2015 to 2021. Immunization coverage was significantly correlated with community coverage, non-capitation fee, and drug cost. In addition, drug costs are also significantly related to formal school coverage. Meanwhile, medical equipment cost was correlated with sanitation and internet coverage. However, other welfare indicators did not find a correlation between community coverage and capitation costs. Conclusion: Some indicators of JKA were significantly correlated with several indicators of welfare in Aceh.

Design and implementation of geographic information system with mobile terminal and 5G network

AbstractRemote insurance mainly completes quotation, insurance application and payment through the PC terminal and mobile terminal, and the premium directly enters the insurance account. This article takes remote insurance as an example. First, it analyses the requirements of the remote insurance and insurance system, and then collects data from the mobile terminal. The system geographic information system (GIS) server subsystem and GIS information management subsystem are designed in three aspects. GPS data and video image data are collected and processed in the data acquisition subsystem, forwarded by the GIS server, and sent to the GIS information management subsystem. Geographic information system information management realises online loss determination through basic information query, geographic location identification, scheduling, path planning, real‐time tracking, image information etc. on the mobile terminal, combined with insurance and insurance business. In terms of implementation, the GIS information management platform and Google Maps are used to realise the monitoring, scheduling and path planning of the mobile terminal GIS online platform. And conduct experimental research on the content‐centric 5G structure. The results show that the transmission interference time of the content‐centric network‐based 5G structure is 390 ms, which is much lower than the 800 ms demanded for GSM‐R system. It proves that the content‐centric network‐based 5G structure has good mobile performance; the test of the content‐centric network verifies that the content‐centric network has the advantages of balancing network load and preventing network congestion; meanwhile, the test of the proposed The functions and performance of the GIS system proposed in this paper are tested. The results meet the user requirements.

Insurance: in or out of the ‘too difficult’ box?

IFRS 17 requires a significant change to insurer accounting, and we look at some of the frictions resulting from its implementation. We make three points. First, since IFRS 17 is a principles-based standard, it will be costly to implement. Audit committees must become sophisticated users of the underlying models generating the reports. Second, we examine the effect of the Sarbanes-Oxley Act on U.S. public insurers and a similar law for private insurers to assess the costs of complying with new rules. We find evidence that these costs vary in their incidence across the industry. Third, we conduct an event study of specific announcements regarding IFRS 17 promulgation and implementation. We find a negative sentiment for announcements concerning the implementation. However, we cannot identify a single specific rationale for the negative sentiment as it could be related to several factors. In sum, we find that there are many reasons to keep insurance accounting as part of IFRS and some reasons that may lead to delays in implementation, but any concern this accounting standard is ‘too difficult’ is likely not due to the standard itself but to other things that may reflect the ultimate net benefits of the standard to investors.

Caring about Other People

Caring about Other People

An Introduction to Speech Privacy for Early Career Clinicians: General Considerations and the Specific Example of Electrolarynx Users

Purpose: This article introduces early career clinicians to speech privacy (SP): its definition, a brief history in the context of the Health Insurance Portability and Accountability Act, and applications in health care settings. General considerations for speech-language pathologists (SLPs) are outlined, along with basic principles for considering what might threaten SP. The example of speakers who use an electrolarynx (EL) is used to call attention to some specific issues that clinicians may encounter in trying to maintain SP. Conclusions: This article provided an overview of SP considerations for early career clinicians. In the case of EL users, these include the unique quality of EL speech and the settings in which SLPs may work with these patients. More research is needed to investigate SP concerns for specific clinical populations that seek SLP services and the physical conditions in which clinician–client discussions occur. Recommendations for clinical practice are provided.

“We document everything”: Interpretations of HIPAA and their impact on ASO staff charting practices in the context of HIV criminalization in the state of Georgia

Abstract
 Introduction: The growing professionalization of AIDS Service Organizations (ASO) and the criminalization of HIV nondisclosure have reshaped both ASO staff interactions with people living with HIV/AIDS (PLWHA) as well as ASO staff charting practices.
 
 Methods: Building on a recent national research project in Canada, we conducted semi-structured interviews in February-April 2017 with N=12 ASO staff in Atlanta, Georgia to investigate their charting practices in the context of HIV criminalization.
 
 Results: Our data showed no variation between professionalized and peer ASO staff in terms of charting practices, although the American participants reported being less protective about the content of their notes and less concerned about the risk their notes may pose in cases involving the criminal prosecution of an alleged HIV nondisclosure incident than was previously reported by their Canadian counterparts. In fact, we identified a false sense of security among American ASO staff stemming from their belief that the Health Insurance Portability and Accountability Act (HIPAA) would protect them from having to disclose their charting notes.
 Conclusions: We suggest that training and educational opportunities for both professionalized and peer ASO staff are needed to sensitize them to the implications of record-keeping on the prosecution of HIV nondisclosure.

Effect of the COVID-19 Pandemic on Stimulant Use and Antiretroviral Therapy Adherence Among Men Who Have Sex With Men Living With HIV: Qualitative Focus Group Study.

BackgroundEvidence suggests that economic, social, and psychological circumstances brought about by the COVID-19 pandemic may have a serious impact on behavioral health. Men who have sex with men (MSM) are disproportionally impacted by HIV and stimulant use, the co-occurrence of which heightens HIV transmission risk and undermines nationwide treatment strategies as prevention efforts for ending the HIV epidemic. There is a paucity of information regarding the potential impact of the COVID-19 pandemic on the substance use and HIV medication adherence in this key vulnerable population—MSM who use stimulants and are living with HIV.ObjectiveThe aim of this qualitative study was to identify ways in which the COVID-19 pandemic has affected stimulant use and antiretroviral therapy (ART) adherence among a sample of MSM living with HIV.MethodsTwo focus groups were conducted in August 2020 via videoconferencing technology compliant with the Health Insurance Portability and Accountability Act. Potential participants from an established research participant registry at State University of New York Downstate Health Sciences University were invited and screened for study participation on the basis of inclusion criteria. A semistructured interview guide was followed. A general inductive approach was used to analyze the data. Findings in two general areas of interest, the impact of the COVID-19 pandemic on stimulant use and ART adherence, emerged directly from the raw data.ResultsA total of 12 ethnically diverse participants over the age of 25 years took part in the study. Results were heterogeneous in terms of the effects of the pandemic on both stimulant use and ART adherence among MSM living with HIV. Some men indicated increased or sustained stimulant use and ART adherence, and others reported decreased stimulant use and ART adherence. Reasons for these behavioral changes ranged from concerns about their own health and that of their loved ones to challenges brought about by the lack of daily structure during the lockdown phase of the pandemic and emotion regulation difficulties.ConclusionsThe COVID-19 pandemic has had a differential impact on stimulant use and ART medication adherence among MSM living with HIV. The reasons for behavioral change identified in this study may be salient intervention targets to support ART medication adherence and lower stimulant use among MSM in the aftermath of the of the COVID-19 pandemic, as well as beyond.

Telemedicine and Plastic Surgery: Principles from the American Society of Plastic Surgeons Health Policy Committee.

In the wake of the recent coronavirus disease of 2019 public health emergency, care delivery by means of telemedicine using audiovisual virtual platforms has become an important tool for patient communication. There are many logistic, medicolegal, and practical aspects of telemedicine that should be considered by the practicing plastic surgeon. Successful virtual patient interactions require an understanding of medical licensure requirements to perform telemedicine visits in a certain region. In addition, it is imperative to be familiar with specific liability and malpractice concerns, in addition to Health Insurance Portability and Accountability Act regulations before conducting electronic visits. During consultations, providers should be aware of proper physician conduct and the potential role of chaperones. Furthermore, appropriate visit documentation, in addition to telemedicine billing and coding, has to be ensured. Lastly, plastic surgeons should adhere to the rules of controlled substance prescription by means of telemedicine platforms. This article describes these salient topics surrounding telemedicine visits that are faced by plastic surgeons and discusses strategies to optimize and ensure safe use of virtual platforms.

Notes From the Field: A Voice-Activated Video Communication System for Nurses to Communicate With Inpatients With COVID-19.

With the relaxing of telehealth regulations through the Health Insurance Portability and Accountability Act (HIPAA) waiver notification for Telehealth Remote Communications during the COVID-19 Nationwide Public Health Emergency, our organization had the opportunity to pilot an innovative virtual care solution using a modified consumer-grade voice-activated video communication system (Amazon Echo Show 8) within one inpatient COVID-19 unit. In this brief report, we describe our experiences with implementing the system and general feedback from clinicians, and discuss areas for future development required to enable future scaling of this solution. Our pilot demonstrates the feasibility of deploying a consumer-grade voice assistant device in COVID-19 patient rooms. We found the devices engaging due to the voice technologies and Alexa functionalities for both clinician and patient entertainment. To enable future deployment at scale, enhancements to the Echo Show and data analytics will need to be further explored.

INTERNATIONAL FINANCIAL ACTIVITIES: ACCOUNTING, TAXATION AND INSURANCE

The need for the study of international financial relations is justified by the lack of modern scientific discourses on the methods of regulation of financial tensions in the new epidemiological conditions of business environment and appropriate methodology to manage the level of rejection of players in the international financial market. The purpose of this study is to find points of contact between accounting, tax and insurance accounting in the development of joint measures to overcome global financial risks in the process of international cooperation. The focus of the study: the development of modified accounting tools for a comprehensive and systemic solution to the internalization of international relations; unification of the national tax system, based on the requirements of the modern development of the global financial system; development of insurance measures to overcome global risks in the process of international financial cooperation. The research was conducted on the basis of expert reviews and assessments of the state of international financial relations, modern theoretical and methodological, normative-legal and legislative aspects of international financial activity; methods of dialectics, methods and principles of scientific knowledge, statistical and economic tools were used. The growth of cross-border cooperation, the emergence of new financial flows and the transformation of financial relations online have created a number of new financial linkages that not only change the traditional financial systems worldwide and the global financial system, but also require the universalization, modification, internalization of certain accounting, taxation and insurance instruments. In order to universalize the measurement of failure trends of business players in international financial markets, one of the possible models for managing a dynamic object – a system-situation model of behavior of international investors, based on combining the systemic and situational views of business players on the interpretation of financially sensitive information – is proposed; a schematic representation of the vulnerability of financial and innovation activities of business players in the context of unpredictable reactions to the proposed positions of the global financial market. It is determined that the development of international financial activity should move in the direction of: the coordination and development of countries in various financial spheres on the adoption of appropriate regulations supranational character; meaningful universalization in international financial relations; restructuring of the national financial system of Ukraine; the viability of the national financial system in the direction of centralized imperative regulation of international financial relations.

REDCap Delivery of a Web-Based Intervention for Patients With Voice Disorders: Usability Study.

BackgroundWeb-based health interventions are increasingly common and are promising for patients with voice disorders because web-based participation does not require voice use. To address needs such as Health Insurance Portability and Accountability Act compliance, unique user access, the ability to send automated reminders, and a limited development budget, we used the Research Electronic Data Capture (REDCap) data management platform to deliver a patient-facing psychological intervention designed for patients with voice disorders. This was a novel use of REDCap.ObjectiveWe aimed to evaluate the usability of the intervention, with this intervention serving as a use case for REDCap-based patient-facing interventions.MethodsWe used REDCap survey instruments to develop the web-based voice intervention modules, then conducted usability evaluations using (1) heuristic evaluations by 2 evaluators, and (2) formal usability testing with 7 participants, consisting of predetermined tasks, a think-aloud protocol, ease-of-use measurements, a product reaction card, and a debriefing interview.ResultsHeuristic evaluations found strengths in visibility of system status and real-world match, and weaknesses in user control and help documentation. Based on this feedback, changes to the intervention were made before usability testing. Overall, usability testing participants found the intervention useful and easy to use, although testing revealed some concerns with design, content, and terminology. Some concerns were readily addressed, and others required adaptations within REDCap.ConclusionsThe REDCap version of a complex web-based patient-facing intervention performed well in heuristic evaluation and formal usability testing. REDCap can effectively be used for patient-facing intervention delivery, particularly if the limitations of the platform are anticipated and mitigated.

User Engagement and Assessment of Treatment Effectiveness in Patients Using a Novel Digital mHealth App During Spinal Cord Stimulation Screening Trials.

BackgroundPatient outcomes and experience during a Spinal Cord Stimulation (SCS) screening trial can have a significant effect on whether to proceed with long-term, permanent implantation of an SCS device for the treatment of chronic pain. Enhancing the ability to track and assess patients during this initial trial evaluation offers the potential for improved understanding regarding the suitability of permanent device implantation as well as identification of the SCS-based neurostimulative modalities and parameters that may provide substantial analgesia in a patient-specific manner.ObjectiveIn this report, we aimed to describe a preliminary, real-world assessment of a new, real time tracking, smart, device-based digital app used by patients with chronic pain undergoing trial screening for SCS therapy.MethodsThis is a real-world, retrospective evaluation of 13,331 patients diagnosed with chronic pain who used the new “mySCS” mobile app during an SCS screening trial. The app design is health insurance portability and accountability act (HIPAA)-compliant and compatible with most commercially available smartphones (eg, Apple, iPhone, and Android). The app enables tracking of user-inputted health-related responses (ie, pain relief, activity level, and sleep quality) in addition to personal trial goals and a summary of overall experience during the SCS trial. A deidentified, aggregate analysis of user engagement, user-submitted responses, and overall trial success was conducted.ResultsWhen provided the opportunity, the percentage of users who engaged with the tracking app for ≥50% of the time during their trial was found to be 64.43% (n=8589). Among the 13,331 patients who used the app, 58.24% (n=7764) entered a trial goal. Most patients underwent SCS screening with a trial duration of at least 7 days (n=7739, 58.05%). Of those patients who undertook a 7-day SCS trial, 62.30% (n=3456) engaged the app for 4 days or more. In addition, among all who submitted descriptive responses using the app, health-related improvements were reported by 77.84% (n=10,377) of patients who reached day 3 of the screening phase assessment and by 83.04% (n=11,070) of those who reached trial completion. A trial success rate of 91% was determined for those who used the app (versus 85% success rate for nonusers).ConclusionsData from this initial, real-world examination of a mobile, digital-health–based tracking app (“mySCS”), as used during the SCS screening phase, demonstrate that substantial patient engagement can be achieved while also providing for the acquisition of more real time patient-outcome measures that may help facilitate improved SCS trial success.

Occurrence Patterns of Traumatic Brain Injury Within the Emergency Department and Internal Screening Process Efficacy During the COVID-19 Pandemic: Retrospective Analysis.

BackgroundTraumatic brain injury (TBI) is one of the leading causes of death in pediatric patients. Continued recruitment of pediatric TBI participants into a biobank amidst the COVID-19 pandemic not only necessitates adaptive changes to traditional recruitment methods but also requires an evaluation of emergency department (ED) utilization by TBI-presenting patients.ObjectiveThe primary objective of this exploratory retrospective study was to evaluate pediatric TBI-related ED utilization during the pandemic. The secondary objective was to appraise the efficacy of the research team’s internal screening processes.MethodsPotential participants (ie, individuals who met all inclusion criteria and would be approached by a consenter) were screened from an ED’s electronic health record system. Data regarding their visit were recorded in a Health Insurance Portability and Accountability Act–compliant manner, which were cleaned through Google Sheets. Cleaned data were then coded as either a screening variable or a hospital utilization variable to examine the effects of the pandemic on internal operations and hospital utilization patterns. The variables were compared between select months during the pandemic in 2020 to analogous months in 2019 in the R programming language via the two-sample Student t test and the Mann-Whitney-Wilcoxon rank-sum test.ResultsThe sample (N=2321) consisted of 1245 entries from 2019 and 1076 entries from 2020. A significantly greater proportion of potential participants (P<.001) were identified in 2020 (222/633, 35.1%) than in 2019 (195/908, 21.4%). A significantly greater proportion of potential participants (P<.001) had a visit reason indicative of a TBI in 2020 (181/222, 81.5%) than in 2019 (103/195, 52.8%). A significantly greater proportion of these injuries (P=.02) occurred inside (39/181, 21.5%) in 2020 than in 2019 (11/103, 10.7%). No significant difference was found across the mechanism of injury categories reported for potential participants between 2019 and 2020. Potential participants were significantly older (P=.006) in 2019 (mean 8.93 years) than in 2020 (mean 7.31 years). Screeners spent significantly longer (P=.03) to identify potential participants in March 2020 (55 minutes) than in March 2019 (32 minutes), but spent significantly less time (P=.01) to do so in July 2020 (22 minutes) than in July 2019 (42 minutes). Screening coverage was significantly lower (P<.001) in March 2020 (241.8 hours) than in March 2019 (346.5 hours). Screening coverage was significantly greater (P<.001) in April 2020 (611.5 hours) and July 2020 (513.5 hours) than in April 2019 (470.5 hours) and July 2019 (404.3 hours), respectively.ConclusionsThere was a significant increase in the rate of incoming TBI cases to the ED during the COVID-19 pandemic, warranting continued enrollment with added safety measures. Additionally, refinement of internal processes improved the accuracy of data collection. As demonstrated in this study, researchers can leverage ongoing data collection to facilitate process improvements and evaluate the impact of unexpected global events on their research.

Privacy as the Price of Drug Access

In response to the recent increase in FDA-approved specialty drugs and escalating specialty drug prices, drug companies now offer patient support programs (“PSPs”) for eligible patients prescribed a particular pharmaceutical drug. Such programs encompass both financial assistance for the purchase of a specialty drug and behavioral services, including nursing support and injection training, intended to improve drug adherence. Although ostensibly gratuitous, these programs have a steep and underappreciated cost: disclosure of protected health information. In effect, patient support programs compel patients to trade protected health information for drug access. This Article provides the first in- depth examination of the legal and ethical concerns associated with patient support programs. Enrollment in a drug company’s patient support program furnishes the company with linked patient- and prescriber- identifying information for each enrollee, data which may enable drug companies to target marketing to patients and healthcare providers with an otherwise unattainable degree of precision. Moreover, once a drug company acquires an enrollee’s protected health information pursuant to a valid Health Insurance Portability and Accountability Act (HIPAA) authorization, a drug company faces few limits on downstream uses of those data. This Article illuminates a possible role for patient support program-mediated data collection in two unlawful drug company practices: (1) kickback schemes in coordination with foundations that cover pharmaceutical drug copays, and (2) “product hopping” to a new brand-name drug formulation after patent expiration of an older formulation. The current regime for health data privacy in the United States lacks adequate safeguards to prevent drug companies from exploiting patient support program-derived data to the detriment of patients. The Article ends by proposing practical modifications to the HIPAA Privacy Rule to modernize HIPAA’s protections vis-à-vis health data transferred from covered entities to noncovered entities such as drug companies.

Confocal Microscopy and its Role in Teledermatology: Diagnosis of Basal Cell Carcinoma in a Clinical Setting

Background Reflectance confocal microscopy (RCM) is a noninvasive tool that is used to diagnose skin cancers. However, RCM requires an expert consultation, which is often performed via store-and-forward (SAF) teledermatology. Unfortunately, SAF does not mimic bedside diagnosis, nor permits interaction between the remote expert reader, physician, and patient. Recently, a live interactive method (LIM)–tele-RCM approach was shown to diagnose basal cell carcinoma (BCC) from a remote location, demonstrating advantages over SAF by providing a bedside diagnosis during consultation. Objective The aim of this study is to validate the LIM-tele-RCM approach to diagnose BCC in a real-world setting. Methods In this pilot study, 4 patients with 6 clinically suspicious BCC lesions were enrolled and imaged with RCM at a Los Angeles dermatology clinic. A Health Insurance Portability and Accountability Act–compliant teleconferencing application was used to livestream RCM images to an expert RCM reader in New York. The expert reader had remote control of the software, direct audio communication with the clinic, and the patient’s clinical history with dermoscopy. During imaging, RCM features were noted, and a diagnosis was made at the bedside. After imaging, patients completed a short questionnaire (on a 5-point scale, with 5 being the highest score) about satisfaction, comfort, and communication during the session. Results RCM diagnosed 4/6 (67%) lesions correctly as BCC and 2/6 (33%) were false-positive diagnoses. The true-positive lesions had “tumor islands with palisading and clefting” and were directly managed with Mohs surgery. The false-positive lesions had “dark silhouettes” (a common false-positive feature for BCC) and underwent a shave biopsy for confirmation. The entire session ranged from 15 to 20 minutes (an average of 17.7 minutes), comparable to the reported RCM procedure time. On the questionnaire, all patients responded with the highest rating (5/5) for each question. Conclusions LIM-tele-RCM demonstrates potential advantages over the SAF method, enabling bedside diagnosis with similar diagnostic accuracy as reported in the literature and proper management. Additionally, the remote reader had access to patients’ clinical backgrounds and could engage with patients. It may also be useful for training novice RCM users and beneficial in settings where remote diagnostics are desired, such as during the COVID-19 pandemic. However, technical challenges such as image quality degradation during video streaming, poor internet bandwidth, and end user latency may impact diagnosis. Larger, multicenter studies are needed to assess the accuracy of LIM-tele-RCM for the diagnosis of BCC and other neoplastic and inflammatory lesions, and to quantify technical limitations. Acknowledgments This work was funded by the National Cancer Institute Cancer Center (Grant P30 CA008748). Conflicts of Interest None declared.

Empowering Families Through Technology: A Mobile-Health Project to Reduce the TAND Identification and Treatment Gap (TANDem).

IntroductionTuberous Sclerosis Complex (TSC) is a multi-system genetic disorder with various TSC-Associated Neuropsychiatric Disorders (TAND) that significantly impact the mental health and wellbeing of individuals with TSC and their caregivers. TAND represents the number one concern to families worldwide, yet is highly under-identified and under-treated. The clinician-administered TAND-Checklist (Lifetime version, TAND-L) has improved identification of TAND in clinical settings. However, many individuals with TSC and their caregivers still have difficulty accessing suitable support for diagnosis and evidence-informed interventions. The TANDem study is a community-based participatory research project with a broad range of TSC stakeholders aimed at reducing the TAND identification and treatment gap.ObjectivesParticipatory research identified three priority next steps: 1) development and validation of a self-report, quantified version of the TAND Checklist (TAND-SQ) and building the TAND-SQ into a smartphone application, 2) generation of consensus clinical recommendations for the identification and treatment of TAND, to be incorporated as a TAND toolkit on the app, and 3) establishment of a global TAND consortium through networking, capacity-building and public engagement activities.MethodsTANDem is a four-year project, and includes 24 consortium members from 10 countries representing all World Health Organization regions. Collaborators represent five stakeholder groups (family representatives, technology experts, clinical experts, non-profit organisations and researchers). Here we outline the project study protocol in detail, describing the scientific rationale, the project aims and objectives, the methods involved in participant recruitment, multi-site and multi-phase data collection, data analysis, ethical considerations including informed consent, data protection, privacy and confidentiality considerations related to the European Union General Data Protection Regulation and the USA Health Insurance Portability and Accountability Act. The expected outcomes and potential impact on the TSC community, implementation and dissemination of results, as well as future scale-up and scale-out plans are also discussed.ConclusionsThe TANDem project has the potential to transform the global TSC community by empowering families living with TSC through an easily accessible digital solution to allow them to document their own TAND needs linked to an evidence-informed toolkit to enhance personalised healthcare, and by providing healthcare professionals with consensus clinical recommendations to prevent, identify and manage TAND manifestations.

Training undergraduate students in HIPAA compliance

ABSTRACT The Health Insurance Portability and Accountability Act (HIPAA) has radically changed the way healthcare is conducted, and its relevance continues to expand as healthcare technology evolves. This article describes a method for training inexperienced undergraduate students to become HIPAA-compliant clinical research volunteers in a pediatric traumatic brain injury (TBI) study. Volunteers are trained to use the hospital’s electronic health records (EHR) system to identify potential study candidates for approach, and they develop this skill set through google classroom modules/quizzes along with routine zoom calls to solidify their consenting approach. Since the inception of this study in 2018, there have been over one hundred different undergraduate research volunteers involved, and there has not been a single HIPAA violation to date. This compliance success rate is indicative of the efficacy of this training protocol. This paper serves as a guide to implementing HIPAA compliance training and ensuring accountability in new and existing clinical research studies.

An Open-Source Privacy-Preserving Large-Scale Mobile Framework for Cardiovascular Health Monitoring and Intervention Planning With an Urban African American Population of Young Adults: User-Centered Design Approach.

BackgroundCardiovascular diseases (CVDs) are the leading cause of death worldwide and are increasingly affecting younger populations, particularly African Americans in the southern United States. Access to preventive and therapeutic services, biological factors, and social determinants of health (ie, structural racism, resource limitation, residential segregation, and discriminatory practices) all combine to exacerbate health inequities and their resultant disparities in morbidity and mortality. These factors manifest early in life and have been shown to impact health trajectories into adulthood. Early detection of and intervention in emerging risk offers the best hope for preventing race-based differences in adult diseases. However, young-adult populations are notoriously difficult to recruit and retain, often because of a lack of knowledge of personal risk and a low level of concern for long-term health outcomes.ObjectiveThis study aims to develop a system design for the MOYO mobile platform. Further, we seek to addresses the challenge of primordial prevention in a young, at-risk population (ie, Southern-urban African Americans).MethodsUrban African Americans, aged 18 to 29 years (n=505), participated in a series of co-design sessions to develop MOYO prototypes (ie, HealthTech Events). During the sessions, participants were orientated to the issues of CVD risk health disparities and then tasked with wireframing prototype screens depicting app features that they considered desirable. All 297 prototype screens were subsequently analyzed using NVivo 12 (QSR International), a qualitative analysis software. Using the grounded theory approach, an open-coding method was applied to a subset of data, approximately 20% (5/25), or 5 complete prototypes, to identify the dominant themes among the prototypes. To ensure intercoder reliability, 2 research team members analyzed the same subset of data.ResultsOverall, 9 dominant design requirements emerged from the qualitative analysis: customization, incentive motivation, social engagement, awareness, education, or recommendations, behavior tracking, location services, access to health professionals, data user agreements, and health assessment. This led to the development of a cross-platform app through an agile design process to collect standardized health surveys, narratives, geolocated pollution, weather, food desert exposure data, physical activity, social networks, and physiology through point-of-care devices. A Health Insurance Portability and Accountability Act–compliant cloud infrastructure was developed to collect, process, and review data, as well as generate alerts to allow automated signal processing and machine learning on the data to produce critical alerts. Integration with wearables and electronic health records via fast health care interoperability resources was implemented.ConclusionsThe MOYO mobile platform provides a comprehensive health and exposure monitoring system that allows for a broad range of compliance, from passive background monitoring to active self-reporting. These study findings support the notion that African Americans should be meaningfully involved in designing technologies that are developed to improve CVD outcomes in African American communities.