Acknowledgments. More recently, the European Commission has made considerable efforts to introduce and implement the MDR as a new regulatory framework, which will provide clarity on what is (and what is not) a medical device software (42). Diabetes Care 1 January 2020; 43 (1): 250260. Increased technological growth has increased efficiency, increased access to healthcare, and increased efficiency leading to a happier and healthier population. Need for a national evaluation system for health technology, ISPAD clinical practice consensus guidelines 2018: diabetes technologies, Guidance document medical devices - scope, field of application, definition - qualification and classification of stand alone software - MEDDEV 2.1/6, Transformation of health and care in the digital single market, Regulation of medical devices in the United States and European Union, The Blue Guide on the implementation of EU products rules, Drugs and devices: comparison of European and U.S. approval processes, Medical Information Systems guidance for qualification and classification of standalone software with a medical purpose, Uppsala, Sweden, Lkemedelsverket Medical Products Agency, European Network of Research Ethics Committee, The Act on Medical Devices (Medical Devices Act) (Medizinproduktegesetz MPG) (especially 19-24), Food and Drug Administration. 31. Telehealth also includes the training and continuing education of medical professionals. With a view to prioritizing its resources in the face of an explosive growth of digital health apps, the FDA has attempted to draw a line between those that do and do not require regulation. Bethesda, MD 20894, Web Policies lack of attention. These evidence suggest that the delivery of telemedicine, as currently constructed, is not suited for individuals with a chronic disease, and as such the delivery of telemedicine and digital health must be refined and customized to serve these individuals. Instead, these responsibilities are retained by individual member states, which delegate to accredited notified bodies responsibilities for implementing these regulations. This approach can also be used to encourage health outcomes (76); examples exist within mySugr and Medtronic Inner Circle (77,78). To help prevent the spread of COVID-19, flu and other infectious diseases, doctors can use telehealth appointments to prescreen patients for possible infectious disease. Hasselfeld is assistant medical director for digital health innovations at Johns Hopkins Medicine. Pros Wearable technology provides us with the ability to monitor our fitness levels, track our location with GPS, and view text messages more quickly. COVID-19 survivors who are at greater risk for a chronic disease, and 3. individuals with chronic disease, pre-COVID. These can be categorized into the following themes: more systematic and structured guidelines for digital health app development and assessment (recommendations 1ac; 3d, e), improved consistency and accessibility of safety reports and app documentation (2a, b, d), greater investment in gathering of clinical data to provide evidence on digital health interventions (4a, b; 5a, b), increased accessibility for all consumer populations to use diabetes mobile apps confidentially and securely (2c, g; 3c). In 2017, an estimated 12 million people 65 years of age and 193,000 people <20 years of age had diabetes in the U.S. (75). In addition to gamifying telemedicine and digital health solutions to increase uptake, long term use and adherence, we argue that contextualizing and personalizing these solutions are equally important. Himes BE, Leszinsky L, Walsh R, Hepner H, Wu AC. Experts believe that technology has a lot of potential for clients and clinicians alike. These fears are substantiated by the high prevalence (six out of 10) of Americans with a chronic disease and it is estimated that COVID-19 survivors who are at increased risk of developing chronic health conditions and diseases will increase the prevalence of chronic disease (24). Using technology to deliver health care has several advantages, including cost savings, convenience, and the ability to provide care to people with mobility limitations, or those in rural areas who don't have access to a local doctor or clinic. Introduction. In Germany, medical apps are classified as medical devices if they follow EU guidelines and the German Medical Devices Act and are CE-marked (44). is partner of Profil Institut fr Stoffwechselforschung in Neuss, Germany, and of ProSciento in San Diego, CA. The unfortunate fragmentation and poor access to care replete in the current US healthcare system, amplified by COVID, can corrected through telemedicine and digital health solutions. Patients can use telemedicine through the MyChart online platform or mobile app, and request a virtual visit with many Johns Hopkins doctors, practitioners and therapists. Digital health apps can be generally broken down into three categories: those used for tracking wellness, those that function as stand-alone medical devices (e.g., for titrating insulin), and those that display, download, and/or use data from medical devices that diagnose, prevent, monitor, or treat a condition (e.g., blood glucose monitoring, CGM, insulin pump or automated insulin delivery [AID] system [also known as closed-loop control system]) (8). No honoraria were received by members of the ADAEASD Diabetes Technology Committee (AEDTC) for writing this manuscript or attending the associated meetings. We envision an ongoing role of the EASD, ADA, and other professional medical associations in supporting and expanding the field of diabetes digital health technology in the march to integration and continued automation. At least one nationwide health care service now provides a digital health apps certification program. When patients' HbA1C targets are met they will feel they have mastered a task (26). HHS Vulnerability Disclosure, Help To ensure a deep understanding of users and how they will engage with a digital health solution, we must first develop an idiographic profile of users and then script their user journey based on their unique characteristics and needs. These features also considers all user interactions as opportunities to know them better and to more deeply personalize their medical journey. Because of the potential adverse impact of sharing sensitive health data, app developers should implement and fully disclose their privacy policies to users. Patient involvement and self-management are the key to diabetes care, but there is a fine line between empowerment and unregulated harm. Disadvantages include: reduced statistical efficiency relative to IRTs 46; overmatching; and . Because the majority of mobile health apps are not subject to regulation, data for assessment of accuracy, defined as the ability to correctly differentiate patient and healthy cases (the sum of true positive and true negative cases divided by the sum of all cases) (65), often may not be available. The authors point out that in the absence of regulation, the responsibility for any adverse consequences of using these apps falls on the individual clinician (68). More health care providers are offering to see patients by computer and smartphone. Comfort and Convenience With telemedicine, you don't have to drive to the doctor's office or clinic, park, walk or sit in a waiting room when you're sick. Establishing employee health and wellness programs is crucial for corporations for many reasons: it can help reducing employee turnovers, cuts health care costs, and supports maintaining a better employer branding. Thomas KL, Shah BR, Elliot-Bynum S, Thomas KD, Damon K, Allen LaPointe NM, et al.. Patients and consumers can use digital health technologies to better manage and track their. Zhao et al. Both medical and consumer health technologies have a promising future in improving the health and overall wellbeing of individuals. The EMA and the FDA are each responsible for pharmaceutical regulation, but only the FDA regulates both pharmaceuticals and medical devices. low creativity. Other digital health solutions have utilized gamified elements to increase social support and relatedness to improve chronic disease management (8, 27). Improve access, Reduce costs, Increase quality, and Make medicine more personalized for patients. Telemedicine, also known as telehealth, offers many advantages, including: With telemedicine, you dont have to drive to the doctors office or clinic, park, walk or sit in a waiting room when youre sick. Don't miss your FREE gift. As a result, other stakeholders in the diabetes community should work with and alongside HCPs in addressing this issue. It is feared that the addition of COVID-19 survivors to the pool of chronic disease patients will burden an already precarious healthcare system struggling to meet the needs of chronic disease patients. A.L.P. found these apps to positively affect outcomes, such as HbA1c, hypoglycemia incidence, and diabetes self-care measures, in the short term. A successful contextualization of a telemedicine and digital health solution can be seen in our digital social care navigator program which helps patients navigate contextual barriers to healthcare. L.H. Cite Get Permissions Digital health technology, especially digital and health applications ("apps"), have been developing rapidly to help people manage their diabetes. Advantages Of Wellness Programs: Advantages of wellness programs include improved morale and enhanced work ethic, reduced absenteeism, reduced health care costs due to fewer sick days taken off . All authors were responsible for drafting the article and revising it critically for important intellectual content. (31) reviewed mobile medical apps that were commercially available to people with diabetes in the U.S. or EU. An official website of the United States government. COVID-19, gamification, digital health, chronic condition, digital health (eHealth). However, longer-term clinical evidence is needed to more accurately assess the effectiveness of diabetes apps. 3. International and national professional societies should: a. bring people with diabetes, HCPs, manufacturing companies, and regulatory authorities together to facilitate digital health technology interventions, b. encourage academia and medical associations to advance research in digital health app effectiveness, safety, and outcomes, c. help set expectations for HCPs and consumers regarding the strengths and limitations of digital technology, d. provide evidence-based guidelines on the effectiveness of digital health interventions, e. recommend appropriate forms of structured education required for HCPs to support people with diabetes to benefit from the best digital health (HCPs cannot be trained in the use of each app; however, they can be supported in maintaining a basic understanding of what apps can do and how they are used), f. maintain a list of endorsed apps that have passed a threshold of accuracy, dependability, and ease of use for both people with diabetes and HCPs. However, more data and long-term studies are needed (31). Worldwide. Duality of Interest. physical inactivity and obesity. Heneka MT, Golenbock D, Latz E, Morgan D, Brown R. Immediate and long-term consequences of COVID-19 infections for the development of neurological disease. Telemedicine can give some specialty practitioners an advantage because they can see you in your home environment. National Evaluation System for health Technology (NEST), Lecture presented at Diabetes Technology Meeting, Digital medicines march on chronic disease, Submitting documents using real-world data and real-world evidence to FDA for drugs and biologics: guidance for industry, Use of real-world evidence to support regulatory decision-making for medical devices: guidance for industry and food and drug administration staff. The reality is that this goal cannot be accomplished without a robust digital health strategy. Earlier in 2019, Kebede and Pischke (13) conducted a study that aimed to identify the most popular diabetes apps via a web-based survey among people with diabetes on social media. There are very few data on long-term benefits, and even high-quality short-term data are limited (31). Before Most health systems were unable to meet the basic needs of chronic disease patients, many of whom were not even receiving sufficient care and support from the health system, pre-COVID. Peer support in prevention, chronic disease management, and well-being, Principles and Concepts of Behavioral Medicine: A Global Handbook, Personalized strategies to activate and empower patients in health care and reduce health disparities. J.R.P. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. This article is being simultaneously published in Diabetologia (https://doi.org/10.1007/s00125-019-05034-1) and Diabetes Care (https://doi.org/10.2337/dci19-0062) by the European Association for the Study of Diabetes and the American Diabetes Association. Patients' satisfaction with and preference for telehealth visits. increased communication and cooperation across stakeholder groups (1dg; 2e, f; 3a, b, f; 6ac; 7ac). Chavez et al. Although it is important for HCPs to stay up to date on the digital health app landscape, we acknowledge that it is unrealistic for HCPs to meet this expectation on top of their high workload burden. Your health information is securely preserved. Here are just a few: By digitising documents you don't have to obtain test results, such as blood tests, in-person - no more waiting in queues for 5-minute appointments! Mobile health and inhaler-based monitoring devices for asthma management, How technology in care at home affects patient self-care and self-management: a scoping review. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group. The concept of capitation prepaid health care premiums allocated to contracted provider groups for all coverage or specialty-services coverage of a defined enrollee population became prevalent in the late 1980s and early 1990s. Magid DJ, Olson KL, Billups SJ, Wagner NM, Lyons EE, Kroner BA. Types of digital health apps used for managing diabetes. In 2017, the IMDRF published guidance on gathering evidence for clinically meaningful SaMDs, elaborating on valid clinical association, analytical validation, and clinical validation (58). For example, the challenge of HCPs losing clients to follow-up can be addressed by sending alerts and reminders; this intervention is categorized under client communication systems (59). Another reason for the relatively few RCTs is that the typically lower commercial value and shorter life cycles of these products do not support the high cost and time involved in conducting RCTs. Weighing the Benefits and Risks. While gamification can certainly incentivize consumers to better monitor their health, it is not a one-size-fits-all solution. He was formerly the Group Leader of the Division of Metabolism and Endocrine Drug Products at the FDA. Gamification of a digital health solution is not a one-size-fits-all approach and is one of many possible strategies to improve engagement and use of telemedicine and digital health solutions. The Diabetes Technology Working Group of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) aims to complement already published reviews, position statements, and guidelines on digital health apps (3235) by reviewing their benefits and risks while providing approaches to handle the challenges they pose. Diabetes apps have enormous potential, given that more than 2.7 billion individuals in the world use smartphones (25) and about 0.5 billion people already use mobile apps for diet, physical activity, and chronic disease management (26). Digital health technology, especially digital and health applications (apps), have been developing rapidly to help people manage their diabetes. Of these 23 articles, there were only 10 described studies relevant to diabetes management. Schmidt-Kraepelin M, Toussaint PA, Thiebes S, Hamari J, Sunyaev A. Archetypes of gamification: analysis of mhealth apps. As a result, developing apps to be used in medical studies may be a less attractive business model for mobile health app developers. Consequently, apps targeted for older people with diabetes must be designed with their expected level of technology proficiency kept in mind. The document organizes digital health technologies into interventions for clients, HCPs, health system or resource managers, and data services. However, these solutions are not panaceas as they are replete with several limitations, such as low uptake, poor engagement, and low long-term use. Gamification, which is just one strategy of many to improve adherence and engagement, is defined as the use of game design elements in non-game contexts (22). Instead, you can access your test results and reports online. Overall, telemedicine has allowed providers to virtually deliver high-quality healthcare at a faster rate and provide more convenient wellness visits for patients. However, all of these studies also conclude that more rigorous, larger sample, and longer-term RCTs are required to distinguish the effect of these apps from possible concomitant effects. Of these 11 RCTs, only 5 were associated with clinically significant but small improvements in HbA1c. Applications of digital technology in COVID-19 pandemic planning and response. Contextualizing and personalizing chronic disease management experience provide a level of precision that can obviate barriers to healthcare and healthy lifestyle. Finding real value from digital diabetes health: is digital health dead or in need of resuscitation? Stephanie Watson was the Executive Editor of the Harvard Womens Health Watch from June 2012 to August 2014. The security of personal health data transmitted electronically is a concern. All of these apps recorded blood glucose levels. This web of interconnected issues cannot be solved by one party alone; rather, commitment from regulators, industry, clinical experts, and funding and patient organizations is needed for the necessary clinical evidence to be gathered. The .gov means its official. Chronic disease management became even more dire in order to meet the high burden of: 1. While digital solutions cannot completely replace all of the rich experience that comes with a face-to-face encounter, and fix healthcare inequities there are some advantages. Corresponding author: G. Alexander Fleming. 2019 by the American Diabetes Association. Offer primary care for many conditions. poor sleep quality. Conclusion. Increased Revenue With the help of healthcare digitisation, doctors are able to bill for uncompensated phone calls or text while extending hours to see more patients. Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJL, et al.. Funding. The group has released several influential documents. This access also allows doctors and patients to connect after hours and on weekends. Plus, get a FREE copy of the Best Diets for Cognitive Fitness. Furthermore, those from remote regions and areas of extreme socioeconomic deprivation may not have access to smartphone technology. Real-world performance: Postlaunch product-monitoring efforts on product-specific real-world performance analytics (RWPA). It allows them to prioritize sustainable and inclusive health measures like wellness, care, post-care approaches, diagnosis, etc. Virtual visits can be easier to fit into your busy schedule. National Library of Medicine Bridge the gap: reducing inequity in hospital readmissions for African American patients with heart failure through quality improvement initiatives. It is important to note that many of these apps have more than one feature, and not all are solely for managing diabetes. Digital Health has been gaining momentum because it is . In addition to the above-mentioned efforts of WHO and IMDRF to classify digital health technology, issues remain that professional organizations need to address. Rockville, MD, Agency for Healthcare Research and Quality, Mobile devices and apps for health care professionals: uses and benefits, Part 1: simple definition and calculation of accuracy, sensitivity and specificity, Smart phone apps: smart patients, steer clear, Mobile apps for the management of diabetes, Evaluation of the accuracy of smartphone medical calculation apps, Decision support and alerts of apps for self-management of blood glucose for type 2 diabetes, Content analysis of mobile health applications on diabetes mellitus, Evaluation and evolution of diabetes mobile applications: key factors for health care professionals seeking to guide patients, Department of Health and Human Services, Centers for Disease Control and Prevention, National Diabetes Statistics Report, 2017: Estimates of Diabetes and Its Burden in the United States, Evaluating success for behavorial change in diabetes via mHealth and gamification: mySugrs keys to retention and patient engagement, Poster presented at Advanced Technologies and Treatments for Diabetes, 27 February3 March, Medtronic launches patient engagement program that leverages gamification to help motivate and engage patients living with diabetes, UnitedHealthcare adds Apple Watch to Motion physical activity incentives program; people with diabetes 40% more likely to enroll in Motion November 21, A systematic review of gamification in e-Health, Privacy policies of android diabetes apps and sharing of health information, Cybersecurity for connected diabetes devices, Standard for Wireless Diabetes Device Security (DTSec). Bollyky JB, Bravata D, Yang J, Williamson M, Schneider J. 7. All of the following activities and services are possible with the help of telehealth: Telehealth offers a convenient and cost-effective way to see your doctor without having to leave your home, but it does have a few downsides. One strategy that has been successfully used to increase initial uptake of telemedicine and digital health solution is the use of onboarding quizzes and surveys. Vaccines & Boosters | Testing | Visitor Guidelines | Coronavirus. Other topics not covered here that warrant future attention are apps specific to gathering clinical evidence and apps that support general electronic medical record systems. One successful use of gamification in chronic disease management is observed in the secondary prevention of diabetic complications through the optimization of glycemic control to lessen diabetic complications and improvement of patients' quality of life. [] a. establish and update standards to be met by digital health technology developers at premarketing and postmarketing stages, such as elements of clinically validated information (not necessarily from RCTs), service systems to support users, effectiveness variables to enhance outcomes, and functions to transmit data to other devices, while also supporting market innovation, b. provide a regulatory paradigm, such as that outlined by IMDRF, which is tailored specifically to software, taking the short product life cycle and rapid turnover of updates into account, c. provide guidance for obtaining and promoting evidence of safety, effectiveness, and other performance measures, d. find ways to evaluate the security, accuracy, and reliability of digital health apps (e.g., by recognizing and following the DTSec model), including supporting companies (often small) to generate real-world data when they have a product that has achieved a certain standard, e. provide, publicize, and maintain a single publicly accessible international database of available digital health apps and their utility/quality, including harmonizing the parameters that would measure utility/quality and how these parameters would be assessed (84), f. publish an annual summary of regulatory activities, a. comply with regulations, industry standards, and best practices established for digital health app development and marketing, such as providing a regularly updated flowchart that describes the decision-making process for releasing app updates; a broader plan for software maintenance and testing; and plans for obsolescence for when a specific mobile device model or operating system for which the app has been validated is discontinued (16), b. include sufficient documentation, training modules, and help-desk resources to ensure optimal use, c. provide interfaces that are user-friendly across all demographic groups and can be personalized with real-time insights and suggestions for individual users (taking their socioeconomic status into account, especially around health literacy), d. report all safety-related data promptly and transparently to the regulatory authorities, e. cooperate with academics and HCPs to provide balanced and adequate information for people with diabetes and package the output data in standardized formats for ease of access in electronic health records, f. enable users to opt to submit their data anonymously to track outcomes and demographics following a crowd-sourcing model, g. incorporate high degrees of data security and patient confidentiality (e.g., by adhering to the DTSec model).

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