Proposal for Health Insurance Policy When Telehealth Is Legalized: Focused on Telemedicine Platform, Remote Monitoring Device, Digital Therapeutics, and Homecare Medical Device

Background/Introduction Over the past decade, various studies have demonstrated an association between remote device monitoring (RM) in implantable cardioverter-defibrillator (ICD) patients and all-cause mortality. However, it is unclear which clinical phenotypes account for this survival benefit. Purpose We aimed to identify clinical phenotypes within an ICD population on RM and conventional follow-up (NRM), and evaluate differences in long-term survival per clinical phenotype. Methods This is a single-center, retrospective, observational study of de novo ICD implantations (single- and dual chamber, biventricular and subcutaneous) between 2010 and 2021 in patients ≥18 years old. Data was extracted from electronic health records. Unsupervised two-step cluster analysis (TSC) was performed to identify distinct clinical phenotypes in the RM and NRM cohorts. Multinomial logistic regression analysis was performed to identify cluster characteristics, differences among the different clusters were analysed by Chi-squared test. Variable importance was evaluated for each of the 18 included clinical variables. Survival analysis was performed using the Kaplan-Meier method, log-rank was used to compare survival between groups. Results A total of 1872 ICD patients were analysed using TCS, comprising 1265 RM and 607 NRM patients, respectively. TCS for a mean follow-up duration of 5.4±3.1 years partitioned the RM and NRM groups into six clusters (Table 1). Clusters RM1 (n=444) and NRM3 (n=220) represented a predominantly primary prevention and DCM phenotype. Clusters RM2 (n=300) and NRM2 (n=173) indicated young and secondary prevention phenotypes. Clusters RM3 (n=220) and NRM1 (n=214) comprised an older, male and ischaemic cardiomyopathy (ICM) phenotype. In survival analysis 5-year cumulative incidence of mortality for the subsequent clusters was 7.4%, 4.5%, 11.6%, 41.4%, 29.8%, and 25.1%, respectively (log rank p-value <0.001, Figure 1). Thus, younger and DCM phenotypes (often with genetic aetiologies) experienced superior survival and high rates on RM, whereas older, male and ICM phenotypes with low rates on RM were associated with worse survival. In addition, between-group cluster-comparison of patients on RM only demonstrated important differences in long-term survival, where RM3 (comprising older, male with predominantly ICM) had poorer survival compared to young patients with a high prevalence of DCM, primary arrhythmia syndrome and low proportions of comorbidities (i.e. atrial arrhythmias, cerebral vascular accidents, diabetes mellitus). Conclusion We identify novel clinical phenotypes (clusters) of ICD patients on RM and having conventional follow-up with large differences in long-term survival. Future studies should further explore if these differences reflect benefit from RM, or the underlying natural history of each phenotype. These results may accordingly guide monitoring strategies tailored to specific ICD patient profiles. Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Public funding

Introduction Asthma is a common chronic respiratory disease affecting 262 million people globally, causing half a million deaths each year. Poor asthma outcomes are frequently due to non-adherence to medication, poor engagement with asthma services, and a lack of objective diagnostic tests. In recent years, technologies have been developed to improve diagnosis, monitoring, and care. Areas Covered Technology has impacted asthma care with the potential to improve patient outcomes, reduce healthcare costs, and provide personalized management. We focus on current evidence on home diagnostics and monitoring, remote asthma reviews, and digital smart inhalers. PubMed, Ovid/Embase, Cochrane Library, Scopus and Google Scholar were searched in November 2023 with no limit by year of publication. Expert Opinion Advanced diagnostic technologies have enabled early asthma detection and personalized treatment plans. Mobile applications and digital therapeutics empower patients to manage their condition and improve adherence to treatments. Telemedicine platforms and remote monitoring devices have the potential to streamline asthma care. AI algorithms can analyze patient data and predict exacerbations in proof-of-concept studies. Technology can potentially provide precision medicine to a wider patient group in the future, but further development is essential for implementation into routine care which in itself will be a major challenge.

HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices.

Relevance: Remote cardiac monitoring is currently increasingly important, which is due to the development of technology, the growing interest on the part of patients and the healthcare system as a whole, and the creation of a functioning remote cardiac monitoring system integrated into the public healthcare system. With regard to Russia, it is crucial to investigate the features of the development of cardiac monitoring devices and the current state of the latter. At the same time, it is worth noting the lack of studies that examine the availability of mobile devices and their integration into the healthcare system in the early 2020s. Objective: To investigate the development of remote cardiac monitoring devices in Russia in the context of socially important problems of providing medical care and preventing diseases, and the possibility of their use in the public healthcare system, taking into account the current state of technology, the characteristics of the market for wearable cardiac monitoring devices and their availability to patients in Russia. Material and methods: The main method employed by us was a comprehensive analysis of the technical characteristics, availability for purchase, and reliability of the measurements performed by mobile remote cardiac monitoring devices available on the Russian market at the beginning of 2022. In addition, the article presents a comparison of the prevalence of remote cardiac monitoring devices in Russia, the Asia-Pacific region, the USA and Europe. Results: In the second half of the 20th century, remote medical monitoring was used mainly in extreme circumstances when the direct participation of doctors was impossible or very problematic. However, at the turn of the 21st century, the development of technology and healthcare system, as well as the attitude of the population to their health, triggered a change in the approach to remote monitoring and diagnosing diseases, thereby putting the task of increasing the effectiveness of prevention, diagnosis and treatment of various ailments, including cardiovascular diseases, in the foreground of routine clinical practice. New generations of remote monitoring devices are becoming more effective, and their measurements are as accurate as possible. However, a study of the devices presented on the Russian market shows that each developer creates an individual closed ‘ecosystem’ that is not connected to the healthcare system. In this regard, the task of contemporary healthcare is the full integration of existing ‘ecosystems’ with available electronic medical records, along with spreading this practice to all regions of Russia. The solution to this problem is largely determined by the involvement of the state; it should be part of social policy in the healthcare sector. Conclusion: The development of remote cardiac monitoring in Russia corresponds to the general global trends in the growth of the prevalence of wearable devices among patients with cardiovascular diseases. At the same time, one of the pressing issues remains the technical and legal feasibility of integrating the services of different manufacturers of cardiac monitoring devices into the state healthcare system.

Heart failure (HF) is a significant clinical and financial burden worldwide. Remote monitoring (RM) devices capable of identifying early physiologic changes in decompensation have the potential to reduce the HF burden. However, few trials have discussed at length the practical aspects of implementing RM in real-world clinical practice. The present paper reviews current RM devices and clinical trials, focusing on patient populations, outcomes, data collection, storage, and management, and describes the implementation of an RM device in clinical practice, providing a pragmatic and adaptable framework.

Background: Southlake@home aims to improve accessibility, cost-effectiveness, and outcomes by leveraging new tools, such as remote monitoring devices, telemedicine platforms, and electronic health records. By embracing innovation, home care services enhances efficient care delivery, improves communication and collaboration between patients and healthcare providers, empowering patient active participation self-care management. Approach: Failing to achieve hospital-wide patient flow - the right care, in the right place, at the right time - puts patients at risk for suboptimal care. Many understand the problem, but lack the comprehensive strategies to address it. Our service delivery and funding model was designed to promote greater integration in health care delivery and improve patient outcomes. Public involvement and buy-in was essential to program development and success. A population-based approach at the outset facilitated understanding of the public perspective, and ensured the care planning and provision is tailed to the actual needs of the public.Personal public involvement is a key aspect of our approach as we actively seek input from individuals directly affected by healthcare policies and services. Engaging multiple stakeholders ensures the perspectives and experiences are considered in decision making processes. We adapted a co-design approach that allowed prioritization of complex patients who were at risk of becoming ALC and bridged their knowledge about the community to support transition back. Our bundled care model encourages innovation and collaboration between all healthcare providers and the community. Results: Since its inception, Southlake@home has served over 2800 patients in the Northern York South Simcoe area, and saved over 5000 ALC days per year. 45% of emergency patients were discharged to self-care, with reduction in ED visits and hospital readmissions, demonstrating an annual system savings of $.8M or $8,000 per patient. We have seen improved patient satisfaction (96%) by addressing social determinants of health and the root causes of disparities. Likewise, staff also express satisfaction with the reduced readmission rates indicating successful care delivery. Implications: Fundamentally, Southlake@home is about transitions of care. We have shown that better outcomes, improved patient and staff experience, and reduced costs to the system are possible by redesigning the pathway home for those with complex medical and social care needs. Southlake@home offers a model for other transitional care programs across Ontario aimed at integrating home and community care for high-need populations. Like many initiatives, Southlake@home has been about developing new relationships and trialing new ways of working together.There is much to learn for organizations who are considering integrated community care or homecare partnerships aimed at reducing hallway healthcare pressures. We welcome fellow organizations to replicate these learnings and take our experiences into consideration for future initiatives to enhance ALC across Canada.

Introduction of digital therapeutics

Using Digital Health Technology to Prevent and Treat Diabetes.

Technological progress in digital therapeutics—and, in particular prescription digital therapeutics (PDTs)—has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.

This article is devoted to the issue of the necessity of implementation of a remote radiation monitoring device. The main purpose of the article is to present a model of a remote monitoring device. During the research, the author considers the application areas of the device and presents technical requirements and design descriptions of the monitoring. Moreover, the researcher conducts the spectrometric equipment analysis of the device for accurate measurement of the level of radiation pollution. The device model proposed in the article is capable for secure monitoring for personnel and the public in the event of a radiation accident. The author states the importance of such monitoring device, which is primarily designed for automated radiation monitoring of environmental pollution during the operation of ships with nuclear power plants, ships of nuclear-technological services and ships transporting nuclear materials and radioactive substances.

Tele-Allergy: Here Today and Rapidly Advancing

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Health-related quality of life (HRQoL) improves shortly after pacemaker (PM) implantation. No studies have investigated the HRQoL trend for elderly patients with a remote device monitoring follow-up system. Using EuroQol-5D Questionnaire and the PM-specific Assessment of Quality of Life and Related Events Questionnaire, HRQoL was measured at baseline and then repeatedly during the 6months following PM implantation in a cohort of 42 consecutive patients. Twenty-five patients were followed-up with standard outpatient visits, while 17 used a remote monitoring system. Aquarel scores were significantly higher in patients with remote device monitoring system regarding chest discomfort and arrhythmia subscales the first month after PM implant and remained stable until 6months. Remote monitoring affected the rate of HRQoL improvement in the first 3months after pacemaker implantation more than ambulatory follow-up. Remote device monitoring has a significant impact on HRQoL in pacemaker patients, increasing its levels up to 6months after implant.

Introduction: There is increasing use of digital health solutions in heart failure (HF), but few studies have demonstrated its impact on public healthcare systems in North America. The Continuum project developed a mobile app for remote patient monitoring (RPM) and a digital therapeutics (DTx) solution aimed at assisting clinicians in medication optimization and preventing hospitalizations among HF outpatients. Research Question: Are RPM and DTx cost-effective for care of outpatients with HF? Methods: A 3-month randomized controlled trial for HF outpatients at risk of hospitalisation evaluated the Continuum program versus standard of care alone. This 12-week program included: 1. A self-care app via smartphone or tablet where patients entered vital signs, weight, and HF symptoms; 2. Remote monitoring of these data by clinical nurses; 3. DTx automated medication suggestions sent to the treating medical team; and 4. HF educational modules for patients. Results: A total of 171 patients were included. Preliminary results are available for the first 63 patients that completed the study, 32 intervention (INT) and 31 control (CTRL). Patients were similar in age (70±12 vs 69±13y), NYHA class (II 81 vs 87%), patients with ejection fraction <40% (56 vs 48%) and comorbidities such as diabetes (38 vs 45%; INT vs CTRL). The number of emergency room (ER) visits and/or hospitalisations (all cause) per patient was 0.19±0.47 for the INT group and 0.55±0.89 for the CTRL one (P=0.05). Survival analysis (Figure) showed a trend in favor of the INT group (95 days (CI95% 87-104) vs 78 days (CI95% 68-89); P=0.08). The total cost of healthcare consumption (hospitalizations + ER visits) in the INT group was 134,088 Canadian dollars vs 174,924 in the CTRL group (+30%). Conclusions: Our preliminary results show potential benefits of a mobile app incorporating self-care, remote monitoring, and digital therapeutics in preventing major events in HF outpatients at a reduced cost for the healthcare system.

Digital health technologies for people with epilepsy (PWE) include internet-based resources and mobile apps for seizure management. Since non-pharmacological interventions, such as listening to specific Mozart's compositions, cognitive therapy, psychosocial and educational interventions were shown to reduce epileptic seizures, these modalities can be integrated into mobile software and delivered by mobile medical apps as digital therapeutics. Herein, we describe: (1) a survey study among PWE about preferences to use mobile software for seizure control, (2) a rationale for developing digital therapies for epilepsy, (3) creation of proof-of-concept mobile software intended for use as an adjunct digital therapeutic to reduce seizures, and (4) broader applications of digital therapeutics for the treatment of epilepsy and other chronic disorders. A questionnaire was used to survey PWE with respect to preferred features in a mobile app for seizure control. Results from the survey suggested that over 90% of responders would be interested in using a mobile app to manage their seizures, while 75% were interested in listening to specific music that can reduce seizures. To define digital therapeutic for the treatment of epilepsy, we designed and created a proof-of-concept mobile software providing digital content intended to reduce seizures. The rationale for all components of such digital therapeutic is described. The resulting web-based app delivered a combination of epilepsy self-care, behavioral interventions, medication reminders and the antiseizure music, such as the Mozart's sonata K.448. To improve long-term patient engagement, integration of mobile medical app with music and multimedia streaming via smartphones, tablets and computers is also discussed. This work aims toward development and regulatory clearance of software as medical device (SaMD) for seizure control, yielding the adjunct digital therapeutic for epilepsy, and subsequently a drug-device combination product together with specific antiseizure medications. Mobile medical apps, music, therapeutic video games and their combinations with prescription medications present new opportunities to integrate pharmacological and non-pharmacological interventions for PWE, as well as those living with other chronic disorders, including depression and pain.