Source 4 Peterson, C., Adams, S. A., & DeMuro, P. R. (2015). mHealth: Don’t forget all the stakeholders in the business case. Medicine 2.0, 4(2), e4. doi:10.2196/med20.4349 Note: You will access this article from the Walden Library databases. 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. Keywords: Internet; mobile; mobile health; app; social media; health care market Introduction The evolution of the mobile health (mHealth) market reflects citizens’ interest in using mobile tools to manage their health, and a growing emphasis on patient engagement makes m
Health attractive to health care systems. In addition to encouraging patients to engage in low-threshold personal selfmanagement activities, mHealth affords the ability to link patient-generated data with electronic health records that incorporate various forms of clinical decision support systems. In addition to patients, care providers, and researchers, there are other stakeholders (including health plans, government payors, pharmaceutical and device manufacturers, platform/app providers and regulators) that have an interest in — and potentially significant influence over — the development of mHealth. NURS 6050 Nursing in Florida Presentation
Most studies on mHealth have focused on the development and uptake of mobile applications [ 1]. These often relate to the effects of patients’ mHealth use for condition management or examine the potential influence on care delivery and related costs. Other aspects of these applications have received less attention. We therefore give a quick overview of the primary mHealth stakeholders and then identify key issues that currently inhibit more widespread use of applications and platforms in health care or for health-related purposes. We then look at how governments are trying to change this through regulatory processes and point to a number of points that need to be addressed in future mHealth research. Stakeholders in mHealth Much has been written about mHealth’s potential to transform health care, regulations governing mHealth, particularly the regulation of mobile medical applications, and regulatory effects on technology development. NURS 6050 Nursing in Florida Presentation
We conducted a quick scan stakeholder analysis based on the framework of the health policy context of developed nations used in comparative health policy analysis [ 2]. Affected stakeholders include: 1. Patients: Patients are key stakeholders, using mobile devices to access health records and lab tests, and make appointments. They can participate in their care in the emerging patientcentered health care models, potentially experiencing improved care and fewer medical errors.
2. Families and caregivers: Families and others responsible for patients’ care seek improvements in care delivery and care coordination, reduced medical errors, and more efficient management of their loved one’s care.
3. Clinicians: Many clinicians appreciate the flexibility of mHealth devices and seek to improve care by accessing patients’ records, utilizing computerized physician order entry, and prescribing medications electronically. They must balance costs, security and ease of use.
4. Health care facilities: Hospital and health systems, ambulatory surgery centers, long-term care facilities, home health agencies, other ancillary providers, and community group homes seek improvements in operational efficiency, reductions in the cost of patient care delivery, the ability to facilitate quality measurement, and expanded reporting capabilities. NURS 6050 Nursing in Florida Presentation
5. Researchers: Researchers may use mHealth to generate more and potentially better data for use in clinical trials, comparative effectiveness research, and other areas. NURS 6050 Nursing in Florida Presentation
6. Policy actors: Policy makers and legislators may gain better data from which to make decisions and facilitate the development of aligned incentives for the stakeholders through use of mHealth.
7. Payors and purchasers (including health insurers): Payors and purchasers, including self-insured employer groups, look to mHealth to improve health outcomes, provide more readily available data, achieve greater efficiencies, and reduce medical errors.
8. Employers: Employers would like mHealth technologies to contribute to greater quality of care in a more cost-effective manner for their employees, for example through wellness programs, as well as improve patient care delivery and reduce absenteeism.
9. Additional stakeholders: Vendors, suppliers, distributors, small-to-medium enterprise app developers and consultants could potentially develop business via mHealth technologies, and major platform providers also benefit from these developments.
The diversity of business models coming from the various players also influences the mHealth market and thus user expectations, regulatory processes, etc. Mobile Health Market The scope of the mHealth market, projected to grow through the rest of the decade, foreshadows the possibilities. NURS 6050 Nursing in Florida Presentation
Mobile health is already a reality. Twenty-seven percent of US broadband users use at least one connected health device [ 8], and 25% of US citizens track personal health measures using a wearable fitness device (e.g., a smart watch) or an mHealth app [ 9]. NURS 6050 Nursing in Florida Presentation
Wireless baby monitoring devices that measure an infant’s respiration, position, and other characteristics are available
[ 10]. Patients have even begun developing apps for medical needs not addressed by the commercial market (e.g., remote blood glucose monitoring of children)
[ 11]. mHealth User Expectations Both patient and care providers believe mHealth has the potential to improve health. In an August 2014 survey [ 12] of 1,102 patients and 1,406 health care professionals, including 827 doctors, respondents shared several expectations:
1. Patients (84%) and physicians (64%) think technologies such as smartphones are appropriate for diagnosis 2. Patients (64%) and physicians (63%) would use smartphones in blood tests if possible 3. Patients (42%) and physicians (40%) hesitate to use digital technology due to privacy concerns Providers see value in the use of patient-generated data for agenda-setting, self-case assessment, and identification of barriers that patients face in managing their health
[ 13]. Providers also demonstrate confidence in mobile devices through their own use of devices; 65% of nurses report using a mobile device for professional purposes at work for 30 minutes daily, and 20% report using a device for 2+ hours daily
[ 14]. Despite the interest in mHealth, health care professionals report several concerns, including privacy, data security, funding, a lack of cases studies demonstrating efficacy and cost-effectiveness, and the need for more research
[ 15]. Providers also worry about the workload resulting from widespread uploading of patient-generated data into electronic medical records and safety issues related to data use
[ 16]. Privacy concerns, in particular, remain a barrier to large-scale adoption of mHealth. Only 30% of apps have privacy policies, and two-thirds of these policies are unrelated to the app itself, addressing rather the vendor or third parties. NURS 6050 Nursing in Florida Presentation
[ 17]. A 2013 Privacy Rights Clearinghouse study of health and fitness apps noted that user information frequently is shared with third parties without users’ knowledge, often without encryption. NURS 6050 Nursing in Florida Presentation
Key objectives include: 1. Clarify what vendors must do to comply with HIPAA
2. Publish routine regulatory guidance updates to address technology advances
3. Identify implementation standards
4. Clarify how HIPAA affects encrypted data cloud storage when providers cannot access it
5. Provide assistance for HIPAA compliance Several US regulatory agencies also seek to facilitate development of a mHealth environment.
In September 2013 the Food and Drug Administration (FDA) released guidance on medical mobile apps and their application to wearable devices, and in October 2014 issued guidance on the content of premarket submissions for managing medical device cybersecurity. Previous FDA guidances and draft guidances cover social media and Internet information sharing. The Federal Trade Commission addresses development and use of mHealth and mobile devices through data security regulations. Individual states protect consumers through narrower statutes, such as a California mHealth app initiative. NURS 6050 Nursing in Florida Presentation
[ 19]. European Union Initiatives In early 2014, the European Commission released the mHealth “Green Paper,” a pre-policy document for consulting with Member State stakeholders on 11 issues related to the development and use of mobile applications for health care. NURS 6050 Nursing in Florida Presentation
[ 20]. It was accompanied by a staff working document on the legal 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. NURS 6050 Nursing in Florida Presentation
[ 21]. Reports composed by the Advisory Groups for the Horizon 2020 Work programs 2016-17 were released later in the year [ 22]. Several reports referred to information and communication technologies (ICT) as an important area for investment. While these reports span topics broader than health and health care, ICT’s potential to make a difference in the health and well-being of individuals was a cross-cutting theme in most reports. These documents provide insight into the European Union’s (EU) strategic (research) priorities for the coming funding period. As a group these documents are optimistic, sharing a “promising ethos” of ICT more generally and mHealth in particular. NURS 6050 Nursing in Florida Presentation
That is, policy makers at the EU level anticipate the potential of these apps to increase access to primary care and prevention programs, improve quality of life, enable more efficient and sustainable health care, cut costs, and empower patients. The reports recognize that sustainable solutions require that intended users take an early, active role in development processes. The reports also point to the need for a greater role for small and medium enterprises in research and innovation and more insights from the social sciences and humanities in uptake and use evaluation. NURS 6050 Nursing in Florida Presentation
Issues on the Horizon As the mHealth environment evolves, several additional considerations will need to be addressed to support further development of mHealth, including:
1. Regulation of new products and services such as software as a service
2. Regulation of consumer- and patient-developed devices and apps
3. More research on how other processes that formal regulation (e.g. market mechanisms or industry self-regulation) govern developments in mHealth — especially quality assurance
4. Evolution of privacy and data management regulations for the regulation of commerce
5. Privacy-promoting technologies that allow users to interact with providers and exchange data with confidence. NURS 6050 Nursing in Florida Presentation
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. NURS 6050 Nursing in Florida Presentation
All authors participated on the Med 2.0 panel and in the writing, review, and approval of this manuscript. Conflicts of Interest None declared. Abbreviations EU: European Union FDA: Food and Drug Administration
HIPAA: Health Information Portability and Accountability Act ICT:
Information and communication technologies US: United States
References for NURS 6050 Nursing in Florida Presentation
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.
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-market1232.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. NURS 6050 Nursing in Florida Presentation
research2guidance. Mobile Health Market Report 2013-2017: The Commercialization of mHealth Applications (Vol 3). 2013. URL: http://research2guidance.com/product/mobile-health-market-report2013-2017/ [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-orfitness-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-devices1411762843?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/wolteis-kluwer-health-survey-linds-nurses-andhealthcare-institulions-acoepting-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-appsprivacy-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%5Fattachments/press/pdfs/n2630%5Fupdated%5Fmobile%5Fapps%5Finfo.p df [accessed 2015-02-12] [WebCite Cache ID 6WHLHK0qV] 20. European Commission. 2014.
Green paper on mobile health URL: http://ec.europa.eu/digitalagenda/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-staffworking-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] ~~~~~~~~ By Carolyn Petersen, MS, MBI, Mayo Clinic, Rochester, MN, United States; Samantha A Adams, PhD, Tilburg University, Tilburg, Netherlands and Paul R DeMuro, CPA, MBA, JD, PhD, MBI, CHC, FHFMA, FACMPE, Broad and Cassel, Fort Lauderdale, FL, United States Carolyn Petersen, MS, MBI Mayo Clinic Global Business Solutions 200 First St. SW Rochester, MN, 55905 United States Phone: 1 507 284 2511 Fax: 1 507 538 3827 Email: firstname.lastname@example.org Copyright of Journal of Medical Internet Research is the property of JMIR Publications Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder’s express written permission.
However, users may print, download, or email articles for individual use. Available online at www.sciencedirect.com Nurs Outlook 66 (2018) 379–385 www.nursingoutlook.org The impact of nurse practitioner regulations on population access to care Donna Felber Neff, PhD, RN, FNAPa,*, Sul Hee Yoon, PhDb, Ruth L. Steiner, PhDc, Ilir Bejleri, PhDb, Michael D. Bumbach, PhD, FNP-BCd, Damian Everhart, PhD, RNe, Jeffrey S. Harman, PhDf a College of Nursing, University of Central Florida, Orlando, FL Department of Urban and Regional Planning, University of Florida, Gainesville, FL c Center for Health and the Built Environment, Department of Urban and Regional Planning, University Of Florid…