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mHealth: Don’t Forget All the Stakeholders in the Business Case

mHealth: Don’t Forget All the Stakeholders in the Business Case Mobile health (mHealth) facilitates linking patient-generated data with electronic health records with clinical decision support systems. mHealth can transform health care, but to realize this potential it is important to identify the relevant stakeholders and how they might be affected. Such stakeholders include primary stakeholders, such as patients, families and caregivers, clinicians, health care facilities, researchers, payors and purchasers, employers, and miscellaneous secondary stakeholders, such as vendors, suppliers, distributors, and consultants, policy makers and legislators. The breadth and depth of the mHealth market make it possible for mHealth to have a considerable effect on people’s health. However, many concerns exist, including privacy, data security, funding, and the lack of case studies demonstrating efficacy and cost-effectiveness. Many American and European initiatives to address these concerns are afoot. (Med 2.0 2015;4(2):e4) doi: 10.2196/med20.4349 KEYWORDS Internet; mobile; mobile health; app; social media; health care market Most studies on mHealth have focused on the development and Introduction uptake of mobile applications [1]. These often relate to the effects of patients’ mHealth use for condition management or The evolution of the mobile health (mHealth) market reflects examine the potential influence on care delivery and related citizens’ interest in using mobile tools to manage their health, costs. Other aspects of these applications have received less and a growing emphasis on patient engagement makes mHealth attention. We therefore give a quick overview of the primary attractive to health care systems. In addition to encouraging mHealth stakeholders and then identify key issues that currently patients to engage in low-threshold personal self-management inhibit more widespread use of applications and platforms in activities, mHealth affords the ability to link patient-generated health care or for health-related purposes. We then look at how data with electronic health records that incorporate various governments are trying to change this through regulatory forms of clinical decision support systems. In addition to processes and point to a number of points that need to be patients, care providers, and researchers, there are other addressed in future mHealth research. stakeholders (including health plans, government payors, pharmaceutical and device manufacturers, platform/app Stakeholders in mHealth providers and regulators) that have an interest in – and potentially significant influence over – the development of Much has been written about mHealth’s potential to transform mHealth. health care, regulations governing mHealth, particularly the regulation of mobile medical applications, and regulatory effects http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 1 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al on technology development. We conducted a quick scan devices are expected to ship through 2019 [4], and the mHealth stakeholder analysis based on the framework of the health policy market is predicted to reach US$49 billion by 2020 [5]. mHealth context of developed nations used in comparative health policy will grow, too, in terms of users, with 3 million patients to be analysis [2]. Affected stakeholders include: monitored remotely by 2016 [6] and 50% of an estimated 3.4 billion smartphone users to have downloaded an app by 2018 1. Patients: Patients are key stakeholders, using mobile devices [7]. to access health records and lab tests, and make appointments. They can participate in their care in the emerging Mobile health is already a reality. Twenty-seven percent of US patient-centered health care models, potentially experiencing broadband users use at least one connected health device [8], improved care and fewer medical errors. and 25% of US citizens track personal health measures using a wearable fitness device (e.g., a smart watch) or an mHealth app 2. Families and caregivers: Families and others responsible for [9]. Wireless baby monitoring devices that measure an infant’s patients’ care seek improvements in care delivery and care respiration, position, and other characteristics are available [10]. coordination, reduced medical errors, and more efficient Patients have even begun developing apps for medical needs management of their loved one’s care. not addressed by the commercial market (e.g., remote blood 3. Clinicians: Many clinicians appreciate the flexibility of glucose monitoring of children) [11]. mHealth devices and seek to improve care by accessing patients’ records, utilizing computerized physician order entry, and mHealth User Expectations prescribing medications electronically. They must balance costs, Both patient and care providers believe mHealth has the security and ease of use. potential to improve health. In an August 2014 survey [12] of 4. Health care facilities: Hospital and health systems, ambulatory 1,102 patients and 1,406 health care professionals, including surgery centers, long-term care facilities, home health agencies, 827 doctors, respondents shared several expectations: other ancillary providers, and community group homes seek 1. Patients (84%) and physicians (64%) think technologies such improvements in operational efficiency, reductions in the cost as smartphones are appropriate for diagnosis of patient care delivery, the ability to facilitate quality measurement, and expanded reporting capabilities. 2. Patients (64%) and physicians (63%) would use smartphones in blood tests if possible 5. Researchers: Researchers may use mHealth to generate more and potentially better data for use in clinical trials, comparative 3. Patients (42%) and physicians (40%) hesitate to use digital effectiveness research, and other areas. technology due to privacy concerns 6. Policy actors: Policy makers and legislators may gain better Providers see value in the use of patient-generated data for data from which to make decisions and facilitate the agenda-setting, self-case assessment, and identification of development of aligned incentives for the stakeholders through barriers that patients face in managing their health [13]. use of mHealth. Providers also demonstrate confidence in mobile devices through their own use of devices; 65% of nurses report using a mobile 7. Payors and purchasers (including health insurers): Payors device for professional purposes at work for 30 minutes daily, and purchasers, including self-insured employer groups, look and 20% report using a device for 2+ hours daily [14]. to mHealth to improve health outcomes, provide more readily available data, achieve greater efficiencies, and reduce medical Despite the interest in mHealth, health care professionals report errors. several concerns, including privacy, data security, funding, a lack of cases studies demonstrating efficacy and 8. Employers: Employers would like mHealth technologies to cost-effectiveness, and the need for more research [15]. contribute to greater quality of care in a more cost-effective Providers also worry about the workload resulting from manner for their employees, for example through wellness widespread uploading of patient-generated data into electronic programs, as well as improve patient care delivery and reduce medical records and safety issues related to data use [16]. absenteeism. Privacy concerns, in particular, remain a barrier to large-scale 9. Additional stakeholders: Vendors, suppliers, distributors, adoption of mHealth. Only 30% of apps have privacy policies, small-to-medium enterprise app developers and consultants and two-thirds of these policies are unrelated to the app itself, could potentially develop business via mHealth technologies, addressing rather the vendor or third parties [17]. A 2013 and major platform providers also benefit from these Privacy Rights Clearinghouse study of health and fitness apps developments. The diversity of business models coming from noted that user information frequently is shared with third parties the various players also influences the mHealth market and thus without users’ knowledge, often without encryption [18]. Among user expectations, regulatory processes, etc. 43 fitness apps reviewed, 72% had a medium or high risk of privacy loss, with free apps the riskiest. Just 43% of the fitness Mobile Health Market apps had a privacy policy, of which half were accurate. The scope of the mHealth market, projected to grow through the rest of the decade, foreshadows the possibilities. The connected devices market has been estimated at US$16.4 billion by 2018 [3], nearly 100 million wearable remote monitoring http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 2 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al Reports composed by the Advisory Groups for the Horizon Initiatives to Regulate mHealth 2020 Work programs 2016-17 were released later in the year [22]. Several reports referred to information and communication The potential benefits of widespread mHealth use have technologies (ICT) as an important area for investment. While motivated governments to seek protection for both patients and these reports span topics broader than health and health care, health care professionals. ICT’s potential to make a difference in the health and well-being United States Initiatives of individuals was a cross-cutting theme in most reports. Members of Congress have expressed interest in modifying the These documents provide insight into the European Union’s Health Information Portability and Accountability Act (HIPAA) (EU) strategic (research) priorities for the coming funding to support market development while protecting US consumers. period. As a group these documents are optimistic, sharing a Key objectives include: “promising ethos” of ICT more generally and mHealth in particular. That is, policy makers at the EU level anticipate the 1. Clarify what vendors must do to comply with HIPAA potential of these apps to increase access to primary care and 2. Publish routine regulatory guidance updates to address prevention programs, improve quality of life, enable more technology advances efficient and sustainable health care, cut costs, and empower patients. The reports recognize that sustainable solutions require 3. Identify implementation standards that intended users take an early, active role in development 4. Clarify how HIPAA affects encrypted data cloud storage processes. The reports also point to the need for a greater role when providers cannot access it for small and medium enterprises in research and innovation and more insights from the social sciences and humanities in 5. Provide assistance for HIPAA compliance uptake and use evaluation. Several US regulatory agencies also seek to facilitate development of a mHealth environment. In September 2013 Issues on the Horizon the Food and Drug Administration (FDA) released guidance on medical mobile apps and their application to wearable devices, As the mHealth environment evolves, several additional and in October 2014 issued guidance on the content of premarket considerations will need to be addressed to support further submissions for managing medical device cybersecurity. development of mHealth, including: Previous FDA guidances and draft guidances cover social media 1. Regulation of new products and services such as software as and Internet information sharing. The Federal Trade a service Commission addresses development and use of mHealth and mobile devices through data security regulations. Individual 2. Regulation of consumer- and patient-developed devices and states protect consumers through narrower statutes, such as a apps California mHealth app initiative [19]. 3. More research on how other processes that formal regulation European Union Initiatives (e.g. market mechanisms or industry self-regulation) govern developments in mHealth – especially quality assurance In early 2014, the European Commission released the mHealth “Green Paper,” a pre-policy document for consulting with 4. Evolution of privacy and data management regulations for Member State stakeholders on 11 issues related to the the regulation of commerce development and use of mobile applications for health care [20]. 5. Privacy-promoting technologies that allow users to interact It was accompanied by a staff working document on the legal with providers and exchange data with confidence. framework regulating the development and use of apps in Europe and its adequacy to address the issues raised by apps considered “lifestyle and wellness” devices [21]. Acknowledgments Research reported in this publication was supported by the National Library of Medicine of the National Institutes of Health under Award Number T15LM007088. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health. All authors participated on the Med 2.0 panel and in the writing, review, and approval of this manuscript. Conflicts of Interest None declared. References 1. Lupton D. Apps as artefacts: Towards a critical perspective on mobile health and medical apps. Societies 2014;4(4):606-622. [doi: 10.3390/soc4040606] 2. Blank R, Burau V. Comparative Health Policy. 3rd edition. Houndmills (UK): Palgrave Macmillan; 2010. http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 3 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al 3. MarketsandMarkets, Mobile health apps & solutions market by connected devices (cardiac monitoring, diabetes management devices), health apps (exercise, weight loss, women’s health, sleep and meditation), medical apps (medical reference) - global trends & forecast to 2018. 2013 URL: http://www.marketsandmarkets.com/Market-Reports/ mhealth-apps-and-solutions-market-1232.html [accessed 2015-02-12] [WebCite Cache ID 6WHKOI7mG] 4. ABI Research Inc. Foundations Emerge for a Revolution in Remote Patient Monitoring. 2014. URL: https://www. abiresearch.com/press/foundations-emerge-for-a-revolution-in-remote-pati[WebCite Cache ID 6WHKYSdgI] 5. Grand View Research. mHealth Market Analysis and Segment Forecasts to 2020. 2014. URL: http://www. grandviewresearch.com/industry-analysis/mhealth-market[WebCite Cache ID 6WHKcyDRb] 6. Juniper Research Ltd. 2012. mHealth users of remote health monitoring to reach 3 million by 2016: smartphones play leading role URL: http://www.juniperresearch.com/viewpressrelease.php?pr=285 [accessed 2015-02-12] [WebCite Cache ID 6WHKhEoDQ] 7. research2guidance. Mobile Health Market Report 2013-2017: The Commercialization of mHealth Applications (Vol 3). 2013. URL: http://research2guidance.com/product/mobile-health-market-report-2013-2017/[WebCite Cache ID 6eC3Zwcy2] 8. Parks Associates A. Nearly 30% of U.S. Broadband Households Own and Use a Connected Health Device. 2014. URL: http://www.parksassociates.com/blog/article/chs-2014-pr17[WebCite Cache ID 6WHKpP2CM] 9. Pai A. 9 percent of US adults do not track health or fitness with devices or apps. Survey URL: http://mobihealthnews.com/ 36971/survey-74-9-percent-of-us-adults-do-not-track-health-or-fitness-with-devices-or-app [accessed 2015-02-12] [WebCite Cache ID 6eC3O8OAH] 10. Rest Devices, Inc. 2014. The mimo smart baby monitor URL: http://mimobaby.com/[WebCite Cache ID 6WHKx0nPQ] 11. Linebaugh K. Wall Street J Sep 26. 2014. Citizen hackers tinker with medical devices URL: http://www.wsj.com/articles/ citizen-hackers-concoct-upgrades-for-medical-devices-1411762843?KEYWORDS=kate+linebaugh [accessed 2015-02-12] [WebCite Cache ID 6WHL0MGP4] 12. WebMD. 2014. WebMD/Medscape digital technology survey reveals unique insights into how patients and physicians perceive the role, potential and risks associated with digital health technologies URL: http://investor.shareholder.com/ wbmd/releasedetail.cfm?ReleaseID=872030&CompanyID=WBMD[WebCite Cache ID 6WHL44JW0] 13. Nundy S, Lu CYE, Hogan P, Mishra A, Peek ME. Using Patient-Generated Health Data From Mobile Technologies for Diabetes Self-Management Support: Provider Perspectives From an Academic Medical Center. J Diabetes Sci Technol 2014 Jan 1;8(1):74-82. [doi: 10.1177/1932296813511727] [Medline: 24876541] 14. Wolters Kluwer Health. Wolters Kluwer Health Survey Finds Nurses and Healthcare Institutions Accepting Professional Use of Online Reference & Mobile Technology. 2014. URL: http://www.prnewswire.com/news-releases/ wolters-kluwer-health-survey-finds-nurses-and-healthcare-institutions-accepting-professional-use-of-online-reference--mobile-technology-274602791. html[WebCite Cache ID 6WHL8YN3N] 15. Whittaker R. Issues in mHealth: findings from key informant interviews. J Med Internet Res 2012;14(5):e129 [FREE Full text] [doi: 10.2196/jmir.1989] [Medline: 23032424] 16. Davidson E, Simpson CR, Demiris G, Sheikh A, McKinstry B. Integrating telehealth care-generated data with the family practice electronic medical record: qualitative exploration of the views of primary care staff. Interact J Med Res 2013;2(2):e29 [FREE Full text] [doi: 10.2196/ijmr.2820] [Medline: 24280631] 17. Sunyaev A, Dehling T, Taylor PL, Mandl KD. Availability and quality of mobile health app privacy policies. J Am Med Inform Assoc 2015 Apr;22(e1):e28-e33. [doi: 10.1136/amiajnl-2013-002605] [Medline: 25147247] 18. Privacy Rights Clearinghouse. Privacy Rights Clearinghouse releases study: mobile health and fitness apps: what are the privacy risks? 2013 URL: https://www.privacyrights.org/mobile-medical-apps-privacy-alert [accessed 2015-02-12] [WebCite Cache ID 6WHLE5hy8] 19. State of California Office of the Attorney General. September. 2013. Mobile applications and mobile privacy fact sheet URL: http://ag.ca.gov/cms_attachments/press/pdfs/n2630_updated_mobile_apps_info.pdf [accessed 2015-02-12] [WebCite Cache ID 6WHLHK0qV] 20. European Commission. 2014. Green paper on mobile health URL: http://ec.europa.eu/digital-agenda/en/news/ green-paper-mobile-health-mhealth [accessed 2015-02-12] [WebCite Cache ID 6WHLL9SoZ] 21. European Commission. 2014. Staff Working Document on the existing EU legal framework applicable to lifestyle and wellbeing apps URL: http://ec.europa.eu/digital-agenda/en/news/ commission-staff-working-document-existing-eu-legal-framework-applicable-lifestyle-and [accessed 2015-02-12] [WebCite Cache ID 6WHLQacNB] 22. European Commission. 2014. Horizon 2020 program website URL: http://ec.europa.eu/programmes/horizon2020/en [accessed 2015-02-12] [WebCite Cache ID 6WHLUQJkB] Abbreviations EU: European Union FDA: Food and Drug Administration HIPAA: Health Information Portability and Accountability Act http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 4 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al ICT: Information and communication technologies US: United States Edited by G Eysenbach; submitted 13.02.15; peer-reviewed by P Drews, MS Chan, T Dehling; comments to author 29.07.15; accepted 09.12.15; published 31.12.15 Please cite as: Petersen C, Adams SA, DeMuro PR Med 2.0 2015;4(2):e4 URL: http://www.medicine20.com/2015/2/e4/ doi: 10.2196/med20.4349 PMID: 26720310 ©Carolyn Petersen, Samantha A. Adams, Paul R. DeMuro. Originally published in Medicine 2.0 (http://www.medicine20.com), 31.12.2015. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in Medicine 2.0, is properly cited. The complete bibliographic information, a link to the original publication on http://www.medicine20.com/, as well as this copyright and license information must be included. http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 5 (page number not for citation purposes) XSL FO RenderX http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Medicine 2.0 JMIR Publications

mHealth: Don’t Forget All the Stakeholders in the Business Case

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Abstract

Mobile health (mHealth) facilitates linking patient-generated data with electronic health records with clinical decision support systems. mHealth can transform health care, but to realize this potential it is important to identify the relevant stakeholders and how they might be affected. Such stakeholders include primary stakeholders, such as patients, families and caregivers, clinicians, health care facilities, researchers, payors and purchasers, employers, and miscellaneous secondary stakeholders, such as vendors, suppliers, distributors, and consultants, policy makers and legislators. The breadth and depth of the mHealth market make it possible for mHealth to have a considerable effect on people’s health. However, many concerns exist, including privacy, data security, funding, and the lack of case studies demonstrating efficacy and cost-effectiveness. Many American and European initiatives to address these concerns are afoot. (Med 2.0 2015;4(2):e4) doi: 10.2196/med20.4349 KEYWORDS Internet; mobile; mobile health; app; social media; health care market Most studies on mHealth have focused on the development and Introduction uptake of mobile applications [1]. These often relate to the effects of patients’ mHealth use for condition management or The evolution of the mobile health (mHealth) market reflects examine the potential influence on care delivery and related citizens’ interest in using mobile tools to manage their health, costs. Other aspects of these applications have received less and a growing emphasis on patient engagement makes mHealth attention. We therefore give a quick overview of the primary attractive to health care systems. In addition to encouraging mHealth stakeholders and then identify key issues that currently patients to engage in low-threshold personal self-management inhibit more widespread use of applications and platforms in activities, mHealth affords the ability to link patient-generated health care or for health-related purposes. We then look at how data with electronic health records that incorporate various governments are trying to change this through regulatory forms of clinical decision support systems. In addition to processes and point to a number of points that need to be patients, care providers, and researchers, there are other addressed in future mHealth research. stakeholders (including health plans, government payors, pharmaceutical and device manufacturers, platform/app Stakeholders in mHealth providers and regulators) that have an interest in – and potentially significant influence over – the development of Much has been written about mHealth’s potential to transform mHealth. health care, regulations governing mHealth, particularly the regulation of mobile medical applications, and regulatory effects http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 1 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al on technology development. We conducted a quick scan devices are expected to ship through 2019 [4], and the mHealth stakeholder analysis based on the framework of the health policy market is predicted to reach US$49 billion by 2020 [5]. mHealth context of developed nations used in comparative health policy will grow, too, in terms of users, with 3 million patients to be analysis [2]. Affected stakeholders include: monitored remotely by 2016 [6] and 50% of an estimated 3.4 billion smartphone users to have downloaded an app by 2018 1. Patients: Patients are key stakeholders, using mobile devices [7]. to access health records and lab tests, and make appointments. They can participate in their care in the emerging Mobile health is already a reality. Twenty-seven percent of US patient-centered health care models, potentially experiencing broadband users use at least one connected health device [8], improved care and fewer medical errors. and 25% of US citizens track personal health measures using a wearable fitness device (e.g., a smart watch) or an mHealth app 2. Families and caregivers: Families and others responsible for [9]. Wireless baby monitoring devices that measure an infant’s patients’ care seek improvements in care delivery and care respiration, position, and other characteristics are available [10]. coordination, reduced medical errors, and more efficient Patients have even begun developing apps for medical needs management of their loved one’s care. not addressed by the commercial market (e.g., remote blood 3. Clinicians: Many clinicians appreciate the flexibility of glucose monitoring of children) [11]. mHealth devices and seek to improve care by accessing patients’ records, utilizing computerized physician order entry, and mHealth User Expectations prescribing medications electronically. They must balance costs, Both patient and care providers believe mHealth has the security and ease of use. potential to improve health. In an August 2014 survey [12] of 4. Health care facilities: Hospital and health systems, ambulatory 1,102 patients and 1,406 health care professionals, including surgery centers, long-term care facilities, home health agencies, 827 doctors, respondents shared several expectations: other ancillary providers, and community group homes seek 1. Patients (84%) and physicians (64%) think technologies such improvements in operational efficiency, reductions in the cost as smartphones are appropriate for diagnosis of patient care delivery, the ability to facilitate quality measurement, and expanded reporting capabilities. 2. Patients (64%) and physicians (63%) would use smartphones in blood tests if possible 5. Researchers: Researchers may use mHealth to generate more and potentially better data for use in clinical trials, comparative 3. Patients (42%) and physicians (40%) hesitate to use digital effectiveness research, and other areas. technology due to privacy concerns 6. Policy actors: Policy makers and legislators may gain better Providers see value in the use of patient-generated data for data from which to make decisions and facilitate the agenda-setting, self-case assessment, and identification of development of aligned incentives for the stakeholders through barriers that patients face in managing their health [13]. use of mHealth. Providers also demonstrate confidence in mobile devices through their own use of devices; 65% of nurses report using a mobile 7. Payors and purchasers (including health insurers): Payors device for professional purposes at work for 30 minutes daily, and purchasers, including self-insured employer groups, look and 20% report using a device for 2+ hours daily [14]. to mHealth to improve health outcomes, provide more readily available data, achieve greater efficiencies, and reduce medical Despite the interest in mHealth, health care professionals report errors. several concerns, including privacy, data security, funding, a lack of cases studies demonstrating efficacy and 8. Employers: Employers would like mHealth technologies to cost-effectiveness, and the need for more research [15]. contribute to greater quality of care in a more cost-effective Providers also worry about the workload resulting from manner for their employees, for example through wellness widespread uploading of patient-generated data into electronic programs, as well as improve patient care delivery and reduce medical records and safety issues related to data use [16]. absenteeism. Privacy concerns, in particular, remain a barrier to large-scale 9. Additional stakeholders: Vendors, suppliers, distributors, adoption of mHealth. Only 30% of apps have privacy policies, small-to-medium enterprise app developers and consultants and two-thirds of these policies are unrelated to the app itself, could potentially develop business via mHealth technologies, addressing rather the vendor or third parties [17]. A 2013 and major platform providers also benefit from these Privacy Rights Clearinghouse study of health and fitness apps developments. The diversity of business models coming from noted that user information frequently is shared with third parties the various players also influences the mHealth market and thus without users’ knowledge, often without encryption [18]. Among user expectations, regulatory processes, etc. 43 fitness apps reviewed, 72% had a medium or high risk of privacy loss, with free apps the riskiest. Just 43% of the fitness Mobile Health Market apps had a privacy policy, of which half were accurate. The scope of the mHealth market, projected to grow through the rest of the decade, foreshadows the possibilities. The connected devices market has been estimated at US$16.4 billion by 2018 [3], nearly 100 million wearable remote monitoring http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 2 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al Reports composed by the Advisory Groups for the Horizon Initiatives to Regulate mHealth 2020 Work programs 2016-17 were released later in the year [22]. Several reports referred to information and communication The potential benefits of widespread mHealth use have technologies (ICT) as an important area for investment. While motivated governments to seek protection for both patients and these reports span topics broader than health and health care, health care professionals. ICT’s potential to make a difference in the health and well-being United States Initiatives of individuals was a cross-cutting theme in most reports. Members of Congress have expressed interest in modifying the These documents provide insight into the European Union’s Health Information Portability and Accountability Act (HIPAA) (EU) strategic (research) priorities for the coming funding to support market development while protecting US consumers. period. As a group these documents are optimistic, sharing a Key objectives include: “promising ethos” of ICT more generally and mHealth in particular. That is, policy makers at the EU level anticipate the 1. Clarify what vendors must do to comply with HIPAA potential of these apps to increase access to primary care and 2. Publish routine regulatory guidance updates to address prevention programs, improve quality of life, enable more technology advances efficient and sustainable health care, cut costs, and empower patients. The reports recognize that sustainable solutions require 3. Identify implementation standards that intended users take an early, active role in development 4. Clarify how HIPAA affects encrypted data cloud storage processes. The reports also point to the need for a greater role when providers cannot access it for small and medium enterprises in research and innovation and more insights from the social sciences and humanities in 5. Provide assistance for HIPAA compliance uptake and use evaluation. Several US regulatory agencies also seek to facilitate development of a mHealth environment. In September 2013 Issues on the Horizon the Food and Drug Administration (FDA) released guidance on medical mobile apps and their application to wearable devices, As the mHealth environment evolves, several additional and in October 2014 issued guidance on the content of premarket considerations will need to be addressed to support further submissions for managing medical device cybersecurity. development of mHealth, including: Previous FDA guidances and draft guidances cover social media 1. Regulation of new products and services such as software as and Internet information sharing. The Federal Trade a service Commission addresses development and use of mHealth and mobile devices through data security regulations. Individual 2. Regulation of consumer- and patient-developed devices and states protect consumers through narrower statutes, such as a apps California mHealth app initiative [19]. 3. More research on how other processes that formal regulation European Union Initiatives (e.g. market mechanisms or industry self-regulation) govern developments in mHealth – especially quality assurance In early 2014, the European Commission released the mHealth “Green Paper,” a pre-policy document for consulting with 4. Evolution of privacy and data management regulations for Member State stakeholders on 11 issues related to the the regulation of commerce development and use of mobile applications for health care [20]. 5. Privacy-promoting technologies that allow users to interact It was accompanied by a staff working document on the legal with providers and exchange data with confidence. framework regulating the development and use of apps in Europe and its adequacy to address the issues raised by apps considered “lifestyle and wellness” devices [21]. Acknowledgments Research reported in this publication was supported by the National Library of Medicine of the National Institutes of Health under Award Number T15LM007088. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Health. All authors participated on the Med 2.0 panel and in the writing, review, and approval of this manuscript. Conflicts of Interest None declared. References 1. Lupton D. Apps as artefacts: Towards a critical perspective on mobile health and medical apps. Societies 2014;4(4):606-622. [doi: 10.3390/soc4040606] 2. Blank R, Burau V. Comparative Health Policy. 3rd edition. Houndmills (UK): Palgrave Macmillan; 2010. http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 3 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al 3. MarketsandMarkets, Mobile health apps & solutions market by connected devices (cardiac monitoring, diabetes management devices), health apps (exercise, weight loss, women’s health, sleep and meditation), medical apps (medical reference) - global trends & forecast to 2018. 2013 URL: http://www.marketsandmarkets.com/Market-Reports/ mhealth-apps-and-solutions-market-1232.html [accessed 2015-02-12] [WebCite Cache ID 6WHKOI7mG] 4. ABI Research Inc. Foundations Emerge for a Revolution in Remote Patient Monitoring. 2014. URL: https://www. abiresearch.com/press/foundations-emerge-for-a-revolution-in-remote-pati[WebCite Cache ID 6WHKYSdgI] 5. Grand View Research. mHealth Market Analysis and Segment Forecasts to 2020. 2014. URL: http://www. grandviewresearch.com/industry-analysis/mhealth-market[WebCite Cache ID 6WHKcyDRb] 6. Juniper Research Ltd. 2012. mHealth users of remote health monitoring to reach 3 million by 2016: smartphones play leading role URL: http://www.juniperresearch.com/viewpressrelease.php?pr=285 [accessed 2015-02-12] [WebCite Cache ID 6WHKhEoDQ] 7. research2guidance. Mobile Health Market Report 2013-2017: The Commercialization of mHealth Applications (Vol 3). 2013. URL: http://research2guidance.com/product/mobile-health-market-report-2013-2017/[WebCite Cache ID 6eC3Zwcy2] 8. Parks Associates A. Nearly 30% of U.S. Broadband Households Own and Use a Connected Health Device. 2014. URL: http://www.parksassociates.com/blog/article/chs-2014-pr17[WebCite Cache ID 6WHKpP2CM] 9. Pai A. 9 percent of US adults do not track health or fitness with devices or apps. 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Horizon 2020 program website URL: http://ec.europa.eu/programmes/horizon2020/en [accessed 2015-02-12] [WebCite Cache ID 6WHLUQJkB] Abbreviations EU: European Union FDA: Food and Drug Administration HIPAA: Health Information Portability and Accountability Act http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 4 (page number not for citation purposes) XSL FO RenderX MEDICINE 2.0 Petersen et al ICT: Information and communication technologies US: United States Edited by G Eysenbach; submitted 13.02.15; peer-reviewed by P Drews, MS Chan, T Dehling; comments to author 29.07.15; accepted 09.12.15; published 31.12.15 Please cite as: Petersen C, Adams SA, DeMuro PR Med 2.0 2015;4(2):e4 URL: http://www.medicine20.com/2015/2/e4/ doi: 10.2196/med20.4349 PMID: 26720310 ©Carolyn Petersen, Samantha A. Adams, Paul R. DeMuro. Originally published in Medicine 2.0 (http://www.medicine20.com), 31.12.2015. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in Medicine 2.0, is properly cited. The complete bibliographic information, a link to the original publication on http://www.medicine20.com/, as well as this copyright and license information must be included. http://www.medicine20.com/2015/2/e4/ Med 2.0 2015 | vol. 4 | iss. 2 | e4 | p. 5 (page number not for citation purposes) XSL FO RenderX

Journal

Medicine 2.0 – JMIR Publications

Published: Dec 31, 2015

Keywords: Internet; mobile; mobile health; app; social media; health care market

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