Science & Society
Mobile Health: empowering patients and driving change Meghan Bradway1,2, Eirik A˚rsand1, and Astrid Grøttland1 1
Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, 9019, Norway US Department of State Bureau of Educational and Cultural Affairs and IIE: United States of America-Norway Fulbright Program, Oslo, 0253, Norway
2
Diabetes is a global epidemic, with insufficient medical management capacity. It is becoming increasingly relevant to develop sustainable methods of self-management and collaboration between clinical personnel and those living with diabetes. While there have been favorable advances in mobile self-management tools for the disease, few have been validated and acknowledged. Health policies are not being established as quickly as these tools are becoming available, and the public has taken action into their own hands.
Patient populations rising faster than clinician workforce The number of people diagnosed with diabetes increased to 387 million worldwide in 2014 [1]. The current rate of medical training only supplies four physicians for every 1000 patients worldwide [2]. Given such a disparity and the limited capacity of health services, there is a high risk of escalating undiagnosed and incompletely managed diabetic cases. Self-management has become a primary focus of health authorities and providers, with its potential to supplement care and decrease the demand for costly treatment through patient engagement in disease management. In recent years, the functionalities of self-management tools have evolved from largely clinician-guided analysis, to more diverse uses for patient-enabled analysis. Patient-initiated novel mobile health (mHealth) tools include mobile phonebased diabetes diaries, online and computer-based software, and wearable technology (‘wearables’), which offer users a means to understand how a variety of lifestyle and treatment choices impact their health outcomes. Disease-specific smartphone applications (‘apps’) are among the top five most common novel mHealth tools, preceded by fitness, medication, and wellness tracking. With the ability to accommodate multiple inputs, apps and wearables hold the potential to offer comprehensive and intuitive diabetes self-management. However, patients do not always have the background to efficiently interpret the data that they are collecting. The diversity of data-gathering functionalities, input sources, influence on patient decisions, and privacy concerns of these novel mHealth tools, also presents challenges with respect to integration within the healthcare system. Corresponding author: Bradway, M. ([email protected]). Keywords: mHealth; apps; diabetes; self-management; clinical integration. 1043-2760/ ß 2015 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.tem.2015.01.001
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Changing environment for health and wellness innovations There is a fundamental shift in healthcare systems around the world. Facilitated by the emphasis placed on selfmanagement, technological possibilities, and the global trend of increasingly commercial healthcare systems, those living with diabetes are becoming more empowered. Patient-interest groups, such as the International Diabetes Federation (IDF), provide a link between how individuals experience the challenges of the disease and how the world should approach these challenges [3]. Patient autonomy has reached a new level in Kuwait, where 3-month ‘formal training’ sessions grant individuals medical privileges in hopes of closing the gap between supply and demand of health services related to chronic diseases (http://blogs.msdn.com/b/healthblog/archive/2008/10/27/ patient-heal-thyself.aspx). With respect to treatment methodologies, this shift has introduced individuals as a new consumer target market. More mHealth and wellness tools are either being initially or solely marketed toward individuals for approval, as opposed to through clinical bodies or health authorities. An inexpensive and flexible development process has enabled the self-management functionalities of apps to be as focused or broad reaching as the developer desires. For example, private companies offering code-free development platforms are encouraging nonprogrammers, including physicians, to create apps for individual patients (http://mobistine.com/2-services). Furthermore, connecting to multiple devices has been made possible via Bluetooth. This communication between sensors, smartwatches, and smartphones, offers a more convenient way to enter and direct data from different sensing and monitoring devices into a central database on a mobile phone for patient support and review. This open and integrated market has made novel mHealth tools both possible and accessible. Benefiting your health and your wallet Given that mHealth and wellness tools can be distributed via the Internet and are often free, they are reducing the cost of self-management and are more available and affordable to a larger portion of the population, compared with expensive medical devices. In particular, mHealth apps, which are compatible with a patient’s own smartphone, have taken significant strides in overcoming many of the barriers that patients have to self-management, including usability, relevance to the patient’s lifestyle, compliance, and understanding of their disease through
Science & Society
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3
long-term usage. Due to the speed that such technology is being developed and released, little scientific research has been possible surrounding the consequences of using these tools. However, studies have shown that patients believe that this management option is effective in increasing their sense of control over their disease [4]. Successful studies have focused upon developing mobile phone app-based approaches to self-management that incorporate multiple functions, including tracking measurements that are most impacting to disease management (i.e., insulin, blood glucose, physical activity, and diet). Impatient patients take matters into their own hands With the evolution of data-storage capacities of mHealth devices, both adults and families of children with type 1 diabetes mellitus (T1DM) are storing an abundance of clinically relevant data through medical devices such as continuous glucose monitors (CGMs) and insulin delivery devices. Given that most of these data are meant to be analyzed by clinical personnel, those living with T1DM often have to wait until their scheduled consultations before gaining an in-depth understanding of their management progress. Frustrated by this process, members of Facebook group, ‘CGM in the Cloud’, share their experiences with a Cloud-based data storage system that allows easy access to CGM data via a smartphone or even smartwatch. Users report that this system gives them a sense of freedom and autonomy. They are able to remotely track their child’s glucose levels in real time and, also, because they no longer have to solely rely on the medical system, manage the challenges associated with T1DM (http:// diatribe.org/issues/69/sum-musings).
Unmet clinical challenge
Soluon idea by physician or developer
By offering an engaging and relevant platform for selfmanagement through development processes that are directed at end-users, these tools have enabled those living with diabetes to feel more empowered and, therefore, more motivated to make positive health choices [5]. However, there is a balance between an effective and useful amount of information and information overload. Those using novel data-gathering apps and tools are often overwhelmed with the number of app choices and many do not have the medical training to accurately interpret the data and assess their metabolic condition. While this new technology supports patient autonomy, apps and mobile tools cannot replace practical training in disease management and clinical guidance. Potential for integration and more informed consultations While the tools that are most accessible for individuals are not formally integrated into the medical system, they hold the potential to offer benefits to not only patients, but also care providers. By enabling patients to educate themselves as to what positively and negatively affects their clinical health outcomes, such tools have the potential to empower the patient to enter into a moreinformed conversation with their physicians. It has become increasingly common for patients to BYOD, or ‘bring your own device’, to their consultations [6]. This more collaborative care approach may strengthen the communication and relation between patients and their physicians, while enabling the latter to make more tailored and informed clinical recommendations. Therefore, new methods need to be proposed to structure this
Prototype
Patent
Design
Clinical animal tesng
Funding
Test
Redesign
Addional funding
FDA or NB approve device for medical use
CDRH or NB approve for market release
Clinical human tesng
IRB or WMA oversight of study
Study recruitment
Build Engineer engagement
TRENDS in Endocrinology & Metabolism
Figure 1. Medical device development process. A typical medical device costs innovators millions in USD, which is often personally funded, and requires 2–3 years for development. To reach clinical human trial stages requires additional funding from investors or interested parties in addition to approval by a regulatory body such as the US Food and Drug Administration (FDA) or independent organizations called ‘notified bodies’ (NB) in the European Union (EU), to approve device use. The World Medical Association (WMA) through the Helsinki Declaration requires that the Internal Review Board (IRB) ensures safe involvement of human subjects. Healthcare professionals are key because of their ability to integrate knowledge of the disease process with oversight of self-management product development to ensure effectiveness. For distribution within in the USA, approval by the US Center for Devices and Radiological Health (CDRH) of the FDA, or NBs within the EU, is categorized by the intention and perceived risk, each of which is subject to additional regulatory review and requirements. While developmental processes differ between countries in terms of time and cost, all require many years and extensive testing. Based upon [10].
115
Science & Society
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3
Unmet clinical challenge
Soluon idea by commercial developer or physician
Commerical app developement plaorm
Design
Integrate to mobile plaorms
Manage
Upgrade
Build
Release to market
TRENDS in Endocrinology & Metabolism
Figure 2. Novel mobile health (mHealth) tools development process. An example of a novel mHealth tool is the mobile phone-based application (app). Typically, through commercial app companies, app development requires little funding and may take weeks or months. It does not require regulatory approval before market release and may lack clinically relevant testing. Furthermore, many of the individuals developing the apps do not have a clinical background. Service management is solely the responsibility of the developer through the development platform company. Based upon http://www.mobilesmith.com/about-us/.
novel form of collaborative care, given the new patientoperated tools. Health authorities: a shift in roles The question now is, who will ensure the safety of such tools? Traditional medical device regulation processes require years and millions (USD) in funding (Figure 1). With this new so-called ‘quick-and-dirty’ development process for novel mHealth tools comes another consequence, that is, less focus on clinical and feasibility testing. There is less development and assurance of clinical relevance and safety through regulatory infrastructures (Figure 2). Instead of being sought after for approval, health authorities need to seek out the apps that are worth their endorsement [7]. There is also the matter of who will provide the support and updates required to be of continued value for users. The cost of maintaining these services raises the questions as to who should provide such financial compensation; the patient, the authorities, the hospitals, or a mixed model? Usually those who benefit from a solution will pay and, in this case, it can be argued that this could benefit all. Health authorities, such as the US FDA, have acknowledged the risks associated with poor development and maintenance of mobile apps. Due to the overwhelming and diverse nature of such tools, the FDA has decided to initiate limited policies for apps that fall within their current definition of ‘medical device’ and those that pose a ‘high risk’ to patients [8]. However, because most apps that are available to a large part of the population are not considered under this definition, the FDA is relinquishing responsibility for regulating the safe use of such tools. The Ministry of Health and Care Services in Norway have acknowledged the need for the healthcare system to keep up with this rapidly changing technological environment. 116
Without formal guidelines for successful integration, the healthcare system will not only be unable to reap the benefits of these tools, but also not remain relevant in the eyes of its patients [9]. Novel mHealth tools call for alliance between health authorities and patients Potential solutions should involve taking advantage of patient advocacy organizations and the greater role that patients now have in their health management. For example, by creating a protocol for how to choose and use these tools, then communicating this process to patients, clinicians, and through educational courses, the health authorities can evaluate a greater number of apps and also determine which are most relevant to patients through testing and user feedback [7]. Such an organized review process is only the beginning of how health authorities should approach this challenge and demand for integration of novel mHealth tools. Financing and sustainability plans also need to be initiated, to ensure that the potential benefits of these tools are realized for all parties involved. Acknowledgments The authors would like to thank Gunnar Hartvigsen for his input and strategic guidance during the planning stages of this paper. Also, a big thanks to the US–Norway Fulbright Program for their funding and the Norwegian Centre for Integrated Care and Telemedicine for their support.
References 1 International Diabetes Federation (2014) IDF Diabetes Atlas. (6th edn), International Diabetes Federation 2 Crisp, N. and Chen, L. (2014) Global supply of health professionals. N. Engl. J. Med. 370, 950–957 3 International Diabetes Federation (2014) International Diabetes Federation Response to the Public Consultation on the European Union Commission’s Green Paper on Mobile Health, International Diabetes Federation
Science & Society 4 Tatara, N. et al. (2013) Long-term engagement with a mobile selfmanagement system for people with type 2 diabetes. JMIR Mhealth Uhealth 1, e1 5 Hernandez-Tejada, M.A. et al. (2012) Diabetes empowerment, medication adherence and self-care behaviors in adults with Type 2 diabetes. Diabetes Technol. Ther. 14, 630–634 6 Healthcare, C.D.W. (2014) Smart Moved for Managing Healthcare Mobility: Rapid mHealth Growth Creates Opportunities and Challenges, CDW Healthcare
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3 7 Chan, S.R. and Misra, S. (2014) Certification of mobile apps for health care. JAMA 312, 1155–1156 8 US Food and Drug Administration (2014) Mobile Medical Applications, FDA 9 Blindheim, H.T. et al. (2014) . In Project Proposal (BP2)/Governance Documentation (BP3 and BP4) for MHealth (Olsen, R., ed.), Helsedirektorat 10 Kaplan, A.V. et al. (2004) Medical device development: from prototype to regulatory approval. Circulation 109, 3068–3072
117
Mobile Health: empowering patients and driving change Meghan Bradway1,2, Eirik A˚rsand1, and Astrid Grøttland1 1
Norwegian Centre for Integrated Care and Telemedicine (NST), University Hospital of North Norway, Tromsø, 9019, Norway US Department of State Bureau of Educational and Cultural Affairs and IIE: United States of America-Norway Fulbright Program, Oslo, 0253, Norway
2
Diabetes is a global epidemic, with insufficient medical management capacity. It is becoming increasingly relevant to develop sustainable methods of self-management and collaboration between clinical personnel and those living with diabetes. While there have been favorable advances in mobile self-management tools for the disease, few have been validated and acknowledged. Health policies are not being established as quickly as these tools are becoming available, and the public has taken action into their own hands.
Patient populations rising faster than clinician workforce The number of people diagnosed with diabetes increased to 387 million worldwide in 2014 [1]. The current rate of medical training only supplies four physicians for every 1000 patients worldwide [2]. Given such a disparity and the limited capacity of health services, there is a high risk of escalating undiagnosed and incompletely managed diabetic cases. Self-management has become a primary focus of health authorities and providers, with its potential to supplement care and decrease the demand for costly treatment through patient engagement in disease management. In recent years, the functionalities of self-management tools have evolved from largely clinician-guided analysis, to more diverse uses for patient-enabled analysis. Patient-initiated novel mobile health (mHealth) tools include mobile phonebased diabetes diaries, online and computer-based software, and wearable technology (‘wearables’), which offer users a means to understand how a variety of lifestyle and treatment choices impact their health outcomes. Disease-specific smartphone applications (‘apps’) are among the top five most common novel mHealth tools, preceded by fitness, medication, and wellness tracking. With the ability to accommodate multiple inputs, apps and wearables hold the potential to offer comprehensive and intuitive diabetes self-management. However, patients do not always have the background to efficiently interpret the data that they are collecting. The diversity of data-gathering functionalities, input sources, influence on patient decisions, and privacy concerns of these novel mHealth tools, also presents challenges with respect to integration within the healthcare system. Corresponding author: Bradway, M. ([email protected]). Keywords: mHealth; apps; diabetes; self-management; clinical integration. 1043-2760/ ß 2015 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.tem.2015.01.001
114
Trends in Endocrinology and Metabolism, March 2015, Vol. 26, No. 3
Changing environment for health and wellness innovations There is a fundamental shift in healthcare systems around the world. Facilitated by the emphasis placed on selfmanagement, technological possibilities, and the global trend of increasingly commercial healthcare systems, those living with diabetes are becoming more empowered. Patient-interest groups, such as the International Diabetes Federation (IDF), provide a link between how individuals experience the challenges of the disease and how the world should approach these challenges [3]. Patient autonomy has reached a new level in Kuwait, where 3-month ‘formal training’ sessions grant individuals medical privileges in hopes of closing the gap between supply and demand of health services related to chronic diseases (http://blogs.msdn.com/b/healthblog/archive/2008/10/27/ patient-heal-thyself.aspx). With respect to treatment methodologies, this shift has introduced individuals as a new consumer target market. More mHealth and wellness tools are either being initially or solely marketed toward individuals for approval, as opposed to through clinical bodies or health authorities. An inexpensive and flexible development process has enabled the self-management functionalities of apps to be as focused or broad reaching as the developer desires. For example, private companies offering code-free development platforms are encouraging nonprogrammers, including physicians, to create apps for individual patients (http://mobistine.com/2-services). Furthermore, connecting to multiple devices has been made possible via Bluetooth. This communication between sensors, smartwatches, and smartphones, offers a more convenient way to enter and direct data from different sensing and monitoring devices into a central database on a mobile phone for patient support and review. This open and integrated market has made novel mHealth tools both possible and accessible. Benefiting your health and your wallet Given that mHealth and wellness tools can be distributed via the Internet and are often free, they are reducing the cost of self-management and are more available and affordable to a larger portion of the population, compared with expensive medical devices. In particular, mHealth apps, which are compatible with a patient’s own smartphone, have taken significant strides in overcoming many of the barriers that patients have to self-management, including usability, relevance to the patient’s lifestyle, compliance, and understanding of their disease through
Science & Society
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3
long-term usage. Due to the speed that such technology is being developed and released, little scientific research has been possible surrounding the consequences of using these tools. However, studies have shown that patients believe that this management option is effective in increasing their sense of control over their disease [4]. Successful studies have focused upon developing mobile phone app-based approaches to self-management that incorporate multiple functions, including tracking measurements that are most impacting to disease management (i.e., insulin, blood glucose, physical activity, and diet). Impatient patients take matters into their own hands With the evolution of data-storage capacities of mHealth devices, both adults and families of children with type 1 diabetes mellitus (T1DM) are storing an abundance of clinically relevant data through medical devices such as continuous glucose monitors (CGMs) and insulin delivery devices. Given that most of these data are meant to be analyzed by clinical personnel, those living with T1DM often have to wait until their scheduled consultations before gaining an in-depth understanding of their management progress. Frustrated by this process, members of Facebook group, ‘CGM in the Cloud’, share their experiences with a Cloud-based data storage system that allows easy access to CGM data via a smartphone or even smartwatch. Users report that this system gives them a sense of freedom and autonomy. They are able to remotely track their child’s glucose levels in real time and, also, because they no longer have to solely rely on the medical system, manage the challenges associated with T1DM (http:// diatribe.org/issues/69/sum-musings).
Unmet clinical challenge
Soluon idea by physician or developer
By offering an engaging and relevant platform for selfmanagement through development processes that are directed at end-users, these tools have enabled those living with diabetes to feel more empowered and, therefore, more motivated to make positive health choices [5]. However, there is a balance between an effective and useful amount of information and information overload. Those using novel data-gathering apps and tools are often overwhelmed with the number of app choices and many do not have the medical training to accurately interpret the data and assess their metabolic condition. While this new technology supports patient autonomy, apps and mobile tools cannot replace practical training in disease management and clinical guidance. Potential for integration and more informed consultations While the tools that are most accessible for individuals are not formally integrated into the medical system, they hold the potential to offer benefits to not only patients, but also care providers. By enabling patients to educate themselves as to what positively and negatively affects their clinical health outcomes, such tools have the potential to empower the patient to enter into a moreinformed conversation with their physicians. It has become increasingly common for patients to BYOD, or ‘bring your own device’, to their consultations [6]. This more collaborative care approach may strengthen the communication and relation between patients and their physicians, while enabling the latter to make more tailored and informed clinical recommendations. Therefore, new methods need to be proposed to structure this
Prototype
Patent
Design
Clinical animal tesng
Funding
Test
Redesign
Addional funding
FDA or NB approve device for medical use
CDRH or NB approve for market release
Clinical human tesng
IRB or WMA oversight of study
Study recruitment
Build Engineer engagement
TRENDS in Endocrinology & Metabolism
Figure 1. Medical device development process. A typical medical device costs innovators millions in USD, which is often personally funded, and requires 2–3 years for development. To reach clinical human trial stages requires additional funding from investors or interested parties in addition to approval by a regulatory body such as the US Food and Drug Administration (FDA) or independent organizations called ‘notified bodies’ (NB) in the European Union (EU), to approve device use. The World Medical Association (WMA) through the Helsinki Declaration requires that the Internal Review Board (IRB) ensures safe involvement of human subjects. Healthcare professionals are key because of their ability to integrate knowledge of the disease process with oversight of self-management product development to ensure effectiveness. For distribution within in the USA, approval by the US Center for Devices and Radiological Health (CDRH) of the FDA, or NBs within the EU, is categorized by the intention and perceived risk, each of which is subject to additional regulatory review and requirements. While developmental processes differ between countries in terms of time and cost, all require many years and extensive testing. Based upon [10].
115
Science & Society
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3
Unmet clinical challenge
Soluon idea by commercial developer or physician
Commerical app developement plaorm
Design
Integrate to mobile plaorms
Manage
Upgrade
Build
Release to market
TRENDS in Endocrinology & Metabolism
Figure 2. Novel mobile health (mHealth) tools development process. An example of a novel mHealth tool is the mobile phone-based application (app). Typically, through commercial app companies, app development requires little funding and may take weeks or months. It does not require regulatory approval before market release and may lack clinically relevant testing. Furthermore, many of the individuals developing the apps do not have a clinical background. Service management is solely the responsibility of the developer through the development platform company. Based upon http://www.mobilesmith.com/about-us/.
novel form of collaborative care, given the new patientoperated tools. Health authorities: a shift in roles The question now is, who will ensure the safety of such tools? Traditional medical device regulation processes require years and millions (USD) in funding (Figure 1). With this new so-called ‘quick-and-dirty’ development process for novel mHealth tools comes another consequence, that is, less focus on clinical and feasibility testing. There is less development and assurance of clinical relevance and safety through regulatory infrastructures (Figure 2). Instead of being sought after for approval, health authorities need to seek out the apps that are worth their endorsement [7]. There is also the matter of who will provide the support and updates required to be of continued value for users. The cost of maintaining these services raises the questions as to who should provide such financial compensation; the patient, the authorities, the hospitals, or a mixed model? Usually those who benefit from a solution will pay and, in this case, it can be argued that this could benefit all. Health authorities, such as the US FDA, have acknowledged the risks associated with poor development and maintenance of mobile apps. Due to the overwhelming and diverse nature of such tools, the FDA has decided to initiate limited policies for apps that fall within their current definition of ‘medical device’ and those that pose a ‘high risk’ to patients [8]. However, because most apps that are available to a large part of the population are not considered under this definition, the FDA is relinquishing responsibility for regulating the safe use of such tools. The Ministry of Health and Care Services in Norway have acknowledged the need for the healthcare system to keep up with this rapidly changing technological environment. 116
Without formal guidelines for successful integration, the healthcare system will not only be unable to reap the benefits of these tools, but also not remain relevant in the eyes of its patients [9]. Novel mHealth tools call for alliance between health authorities and patients Potential solutions should involve taking advantage of patient advocacy organizations and the greater role that patients now have in their health management. For example, by creating a protocol for how to choose and use these tools, then communicating this process to patients, clinicians, and through educational courses, the health authorities can evaluate a greater number of apps and also determine which are most relevant to patients through testing and user feedback [7]. Such an organized review process is only the beginning of how health authorities should approach this challenge and demand for integration of novel mHealth tools. Financing and sustainability plans also need to be initiated, to ensure that the potential benefits of these tools are realized for all parties involved. Acknowledgments The authors would like to thank Gunnar Hartvigsen for his input and strategic guidance during the planning stages of this paper. Also, a big thanks to the US–Norway Fulbright Program for their funding and the Norwegian Centre for Integrated Care and Telemedicine for their support.
References 1 International Diabetes Federation (2014) IDF Diabetes Atlas. (6th edn), International Diabetes Federation 2 Crisp, N. and Chen, L. (2014) Global supply of health professionals. N. Engl. J. Med. 370, 950–957 3 International Diabetes Federation (2014) International Diabetes Federation Response to the Public Consultation on the European Union Commission’s Green Paper on Mobile Health, International Diabetes Federation
Science & Society 4 Tatara, N. et al. (2013) Long-term engagement with a mobile selfmanagement system for people with type 2 diabetes. JMIR Mhealth Uhealth 1, e1 5 Hernandez-Tejada, M.A. et al. (2012) Diabetes empowerment, medication adherence and self-care behaviors in adults with Type 2 diabetes. Diabetes Technol. Ther. 14, 630–634 6 Healthcare, C.D.W. (2014) Smart Moved for Managing Healthcare Mobility: Rapid mHealth Growth Creates Opportunities and Challenges, CDW Healthcare
Trends in Endocrinology and Metabolism March 2015, Vol. 26, No. 3 7 Chan, S.R. and Misra, S. (2014) Certification of mobile apps for health care. JAMA 312, 1155–1156 8 US Food and Drug Administration (2014) Mobile Medical Applications, FDA 9 Blindheim, H.T. et al. (2014) . In Project Proposal (BP2)/Governance Documentation (BP3 and BP4) for MHealth (Olsen, R., ed.), Helsedirektorat 10 Kaplan, A.V. et al. (2004) Medical device development: from prototype to regulatory approval. Circulation 109, 3068–3072
117
