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Consumer Mobile Health Apps: Current State, Barriers, and Future Directions
PM R 9 (2017) S106-S115
www.pmrjournal.org
Clinical Informatics in Physiatry
Consumer Mobile Health Apps: Current State, Barriers, and Future Directions Cheng-Kai Kao, MD, David M. Liebovitz, MD
Abstract This paper discusses the current state, barriers, and future directions of consumer-facing applications (apps). There are currently more than 165,000 mobile health apps publicly available in major app stores, the vast majority of which are designed for patients. The top 2 categories are wellness management and disease management apps, whereas other categories include selfdiagnosis, medication reminder, and electronic patient portal apps. Apps specific to physical medicine and rehabilitation also are reviewed. These apps have the potential to provide low-cost, around-the-clock access to high-quality, evidence-based health information to end users on a global scale. However, they have not yet lived up to their potential due to multiple barriers, including lack of regulatory oversight, limited evidence-based literature, and concerns of privacy and security. The future directions may consist of improving data integration into the health care system, an interoperable app platform allowing access to electronic health record data, cloud-based personal health record across health care networks, and increasing app prescription by health care providers. For consumer mobile health apps to fully contribute value to health care delivery and chronic disease management, all stakeholders within the ecosystem must collaborate to overcome the significant barriers.
Introduction Mobile devices, especially smartphones, have revolutionized people’s lives, including the way they seek medical information. According to a global survey in 2015, 72% of all U.S. adults owned a smartphone [1], up from 63% in 2012, and 62% had used their smartphones to look up information for a health condition, up from 53% in 2012 [2]. The penetration rate of smartphone continues to increase. It is estimated by 2020, there will be 6.1 billion smartphone users globally, comprising approximately 80% of the world’s population [3,4]. The term “app,” short for “application,” refers to a self-contained program or piece of software that is designed to fulfill a particular purpose and usually optimized to run on mobile devices, such as smartphones, tablet computers, and some wearable devices like smart watches. Mobile health (mHealth) apps are health-related applications that aim to improve patients’ health though multiple different functionalities and designs. There are currently more than 165,000 mHealth apps (including free and paid) publicly available in major app stores, and some academic medical
centers also are developing apps on their own [5]. The mHealth market now embraces about 45,000 app developers, and more than 3 billion mHealth apps were downloaded in 2015 [6]. By 2017, it is projected that 50% of the mobile phone users will have downloaded at least one mHealth app [7]. The mHealth apps have the potential to provide lowcost, around-the-clock access to high-quality, evidencebased health information to end users on a global scale and improve compliance with treatment protocols via behavior change models [8]. The impact of mHealth apps can be enormous on many important healthrelated domains, including chronic disease management, mental health, and patient education and empowerment. The high hope for mHealth is to strengthen the iron triangle of health caredenhance quality, decrease cost, and improve access [9]. However, the accuracy of the health information contained in most of these apps is not scrutinized by regulatory bodies, which could compromise users’ health and safety [10]. Literature regarding the efficacy of mHealth apps is still evolving. Because of the lack of formal vetting processes and well-established clinical evidence
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of their effects, health care providers have been hesitant to recommend or “prescribe” mHealth apps to their patients [11]. Thus, the mHealth app market today still sits in the hype phase and remains mostly patientdriven, with its unlimited potentials yet to be realized. Therefore, it is vital for today’s health care professionals to learn the current state, barriers, and future directions of mHealth apps and eventually take the leading role to drive the change. Current State The vast majority of mHealth apps on the market are designed for consumers [5]. The proliferation of smartphones and consumer interest in taking a more active role in personal health has fueled this growth. Among all stakeholders in the health care industry, patients are the ones for whom mHealth apps show the biggest impact today [6]. Currently, the top 2 categories of consumer-facing mHealth apps are wellness management (such as fitness, lifestyle modification, and diet and nutrition), and chronic disease management (such as mental health, diabetes, and cardiovascular diseases) [5]. The other categories include self-diagnosis, medication reminders, and electronic patient portal apps. Apps specific to physical medicine and rehabilitation also are reviewed. Table 1 [12-19] provides examples of the types of mHealth apps that currently are available. Wellness Management Apps Wellness management apps, including fitness, lifestyle modification, and diet and nutrition apps, account for about two thirds of all consumer-facing apps [5]. These apps often use smartphone features to automatically collect data, such as global positioning system (ie, GPS) to track jogging distance, and built-in camera to allow photo diaries of daily food and drink. A significant amount of the wellness management apps are connected with external devices (such as digital weight scales, blood pressure monitor, and heart rate monitor), which collect, record, and transmit patient data automatically, reflecting the growing consumer interest in the use of mobile devices for the purpose of health. A high percentage of these apps provide a mechanism for social networking to increase motivation. Of the top mHealth apps, 65% connect to social media, underscoring the importance of this feature for consumer engagement [5]. By providing tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity, the fitness and lifestyle modification apps show a positive impact on promoting a healthy lifestyle to consumers [20]. Many of these apps have a favorable consumer rating. The diet and nutrition apps provide functions such as counting calories,
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creating food diaries, tracking exercise, and documenting weight. Currently, there are mixed results regarding the efficacy of the wellness management apps. In a review of apps, Rivera et al [21] found that commercial mHealth apps for weight management lack important evidencebased features, do not involve health care experts in the development process, and have not undergone rigorous scientific testing. Some systemic reviews revealed an overall advantage to using these apps but also called for more high-quality controlled trials to test the efficacy of specific app features to distinguish effective from ineffective components [22,23]. Disease-Management Apps Nearly one quarter of mHealth apps focus on disease management, such as diabetes, asthma, and mental health diseases, reflecting the growing interest in the use of mHealth apps for chronic disease management. Diabetes mellitus is one of the earliest developed and most studied areas of mHealth applications. There are hundreds of diabetes apps offering a variety of functions, including home blood glucose recording, medication or insulin administration logs, prandial insulin reminders and dose calculators, and integrated communication between patients and health care providers. For example, several diabetes apps can remind the patient to check and log their blood sugar (BS) in the morning, then give patients instructions such as drinking juice if the BS is low or guidance to self-administer a recommended dose of insulin if the BS is high, and then remind the patient to check the BS again to ensure it has improved. The app also may collect information like weekly weights, food diary entries with calorie counts, medication compliance, and physical activity. Health care providers with access to these diaries can later formulate personalized feedback to the patient. Welldoc’s BlueStar [13] is the first mobile prescription-only app for type 2 diabetes and has a randomized controlled trial that included 163 patients and showed the mean declines in HbA1c were 1.9% in the treatment group versus 0.7% in the usual-care group, a difference of 1.2% (P < .001) over 12 months [24]. This result is a significant one, especially considering its low cost (compared with the cost of new drug development) and broad access (accessible to anyone with a smartphone). Some insurers had agreed to reimburse for use of WellDoc’s mobile-enabled diabetes management program [25]. In patients with medical diseases characterized by life-threatening flares, disease management apps allow patients to keep a symptom diary and track the frequency of the usage of rescue medications, along with geographical data if needed. For example, in patients with asthma, monitoring respiratory symptoms and the trend of peak flows can alert patients and providers to
Consumer Mobile Health Apps
S108 Table 1 Examples of consumer mHealth apps* Category
Example App
Description and Functions
Wellness management
Calorie counter and diet tracker [12]
Disease management
BlueStar diabetes [13]
The app allows consumers to track keep track of diets and exercises and manage their weights. Allow patients to enter personal food and exercise diaries Contain a substantial food database that allows barcode scanning for quick and accurate entries of food Provide daily personalized advice towards the goal set by the consumers Leverage social network to increase motivation for adherence The app gives patients with type 2 diabetes a guided plan to help manage their glucose levels. Prescription-only Allow patients to log their glucose levels at home Provide instructions for hyperglycemia and hypoglycemia events Allow patients to enter their food diaries Allow patients to share the report with prescribers The app allows patients with asthma to keep track of their peak flows and symptoms and provides an action plan during asthma attacks. Remind patients to use inhalers as scheduled Allow patients to log their peak flow measurements and symptoms with date/time and triggers Provide an action plan with instructions during asthma attacks Gather anonymous data for researchers to better correlate asthma with environmental factors, triggers, and climate change The app provides a symptom checker that serves as a basic patient self-diagnosis tool. Allow patients to enter their symptom characteristics and then generate a list of possible diagnoses sorted by probability Provide patient education information for each possible condition Advise patients to seek emergency medical attention if warning symptoms are entered Provide a substantial database of patient education materials regarding diseases and medications on demand The app functions as a digital pillbox that allows patients to manage their medications effectively. Allow patients to enter their current medications’ dosage, frequency, and amount Remind patients to take the medication based on the schedule Remind patients for medication refills Allow patients to enter medication diaries to document drug responses and side effects The apps allow patients to access a portion of their medical records and also serve as a communication tool between providers and patients. Allow patients to view laboratory results, imaging studies, current medications, and upcoming appointments Allow patients to send messages to their providers for acute issues, unresolved symptoms, or medication refills Allow providers to send reminders of preventive screening tests or vaccinations to patients The app allows physical medicine and rehabilitation providers and therapists to prescribe home physical exercises to patients. Prescription-only Provide pictures, descriptions, and videos to demonstrate each exercise Remind patients to do the exercises based on their therapy schedule Allow patients to record their exercises and send to their providers Allow patients to keep track of their progress Collect direct patient feedback regarding pain and difficulty during the therapy
AsthmaMD [14]
Self-diagnosis
WebMD [15]
Medication reminder
MediSafe [16]
Electronic patient portal
Epic MyChart [17] Cerner HealtheLife [18]
Physical medicine and rehabilitation
Patient Pal Pro [19]
* Disclaimer: The aforementioned apps serve as examples for each category and are not specifically endorsed by the authors.
suspected disease exacerbations, thereby facilitating prompt intervention. AsthmaMD app [14] is one such app that allows patients to track their peak flow and symptoms and also gathers data for the researchers to understand the correlation between the environment and asthma. Propeller Health app [26] pairs with a Bluetooth sensor attached to the patient’s inhaler and automatically documents every time when the
patient uses the inhaler to keep track of medication adherence. Mental health is another popular area in which abundant research is ongoing to study behavior changes, the early detection of psychiatric diseases, and control of symptoms via the use of mHealth apps. The most commonly addressed conditions include autism, depression, anxiety, attention deficit hyperactivity
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disorder, and Alzheimer disease [5]. Autism-spectrum disorders, often detected in late stage, are estimated to cost the United States 461 billion dollars by 2025, more than stroke, hypertension, and diabetes. Autism apps constitute the largest category of mental health apps and reflect a broad set of initiatives around management of autism. These autism apps not only can provide an app-based learning environment that accommodates different learning styles and paces based on learners’ responses [27] but also can make the smartphones or tablet computers speech-generating devices to facilitate communication [28]. There are also plenty of mental health apps designed to assist patients with depression. However, studies revealed few of the depression apps use evidencebased principles like cognitive behavioral therapy or behavioral activation despite these being the gold standard of first-line psychological treatments [29]. Furthermore, the app market is quite volatile, with a depression app disappearing from app stores every 2.9 days on average [30]. Self-Diagnosis Apps There has been a growing trend for consumer use of apps to attempt initial self-diagnosis without a medical visit [5]. These apps can be particularly helpful in emergency, or remote, resource-limited settings. For example, the WebMD app [15] provides a symptom checker that allows patients to select their symptoms, and then it generates a list of possible diagnoses sorted by probability along with patient education information for each condition. If the patient enters a warning symptom, eg, severe chest pain, the app pops up an alert to advise the consumer to seek emergency medical attention. One study reviewed 23 symptom checker apps and found there remained deficits in both triage and diagnosis, and thus the triage advice from symptom checkers generally is risk averse, encouraging users to seek care for conditions in which self-care may be reasonable [10]. Another example is the wireless information system for emergency responders (ie, WISER) developed by National Library of Medicine to assist lay persons in hazardous material incidents or bioterror attacks [31]. The system includes an app that not only provides emergency protocols for reference but also has a chemical identifier that helps quickly differentiate among toxic substances in emergency situations based on the chemical’s properties and patient symptoms [32]. Despite the growing interests in this category, enormous risks may also arise without a proper vetting process. For example, there are several apps on the market that allow consumers to use a camera-enabled smartphone to take photographs of suspicious skin lesions and advise the nonclinician users whether the skin lesions are benign or malignant. These applications are currently not subject to any sort of regulatory oversight.
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A study in JAMA Dermatology in 2013 analyzed 4 of these apps and concluded that the performance of smartphone applications in assessing melanoma risk was highly variable, and 3 of 4 smartphone applications incorrectly classified 30% or more of melanomas as unconcerning [33]. These unvalidated mHealth apps may cause significant harm to patients by delaying a timely medical diagnosis. Medication Reminder Apps Medication noncompliance has been a common health care challenge. Poor adherence causes approximately 33%-69% of medication-related hospitalizations and accounts for 100 billion U.S. dollars in annual health care costs [34]. Irrespective of disease, medication complexity, or how adherence is measured, the average adherence rate to chronic medication therapy is approximately 50% [35]. Medication reminder apps allow patients to enter their medication list manually or by scanning the barcode on the prescription bottles, provide a visualized medication calendar, and automatically send notifications to patients when they are due for medication doses. Several studies describe potential benefits of medication reminder apps on improving medication adherence [36,37], particularly in the younger generation [38], but also show inconsistent quality across these apps, which warrants more studies to prove the efficacy and the effective features [39,40]. Electronic Patient Portal Apps The major electronic health record (EHR) companies have developed their respective mobile solutions for both patients and providers. These apps provide patients with similar access to the electronic patient portal from their mobile devices, which allow patients to access a portion of their medical records, including laboratory results, imaging studies, current medications, and upcoming appointments. They also serve as a 2-way communication tool that allows patients to report to their care providers any unresolved or new symptoms and request medication refills, whereas the providers can answer patients’ questions and send reminders of preventive screening tests and vaccinations, scheduled procedures or studies, and upcoming outpatient appointments. One survey showed a trend of chronically ill patients having a more positive view of patient portals [41], but more studies are required to prove their value in enhancing patient communication, education and empowerment, and their potential in reducing miscommunication and unnecessary patient visits. Physical Medicine and Rehabilitation Apps In the field of rehabilitation, mHealth apps can provide tools to monitor the effects of home exercise
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Consumer Mobile Health Apps
programs, collect patient-reported measures, provide feedback on posture and body mechanics, supply educational material, and prompt patients with motivating messages [42]. For example, Patient Pal Pro app [19] allows rehabilitation providers to prescribe home physical exercises to the patients via its Web portal. Each exercise on the app comes with a picture along with a description and a video to ensure the patients perform the exercises correctly, and the app also allows patients to record their exercises at home for providers to review later. The app also tracks the progress of the exercises and sends reminders to the patients based on the schedule. Several studies have demonstrated promising outcomes of leveraging mHealth technology in this field. Based on the preliminary results from a study at Mayo, patients who attended cardiac rehabilitation and used a smartphone-based app to record daily measurements, such as weight and blood pressure, had greater improvements in these cardiovascular risk factors and were less likely to be readmitted to the hospital within 90 days of discharge (20%), compared with patients who only attended cardiac rehabilitation (60%) [43]. Another study revealed potential benefits of mHealth apps on tablet computers to provide a way to facilitate selftraining of repetitive, task-oriented, isolated finger and hand movements to improve hand dexterity and function after stroke [44]. There are similar applications for use of tablets in training visual-motor integration skills among children with special needs [45]. Barriers Despite the rapid expansion of mHealth apps, there are still significant barriers to expanding the role and efficacy of mHealth apps in improving the health of consumers and ultimately population health, including lack of regulatory supervision, limited evidence-based literature, and privacy and security concerns. Lack of Regulatory Supervision The biggest challenge that limits the potentials of mHealth apps is lack of proper regulation to ensure their accuracy, quality, and performance [46]. Governmental agencies, third-party companies, professional societies, and mHealth researchers [47,48] have tried to come up with standards and systematic methods to evaluate and certify mHealth apps. There are also online app clearinghouses such as iMedicalApps [49] that recommend apps based on editorial reviews. So far, there remains no consensus in terms of the best approach. The Food and Drug Administration [50] issued mHealth app guidance [51] in 2013, which explained its tailored, risk-based approach that only focuses on the small subset of mobile apps that (1) are intended to be used as an accessory to a regulated medical device or
(2) transform a mobile platform into a regulated medical device (eg, an app that turns a smartphone into a portable ultrasound or an electrocardiography machine). The agency essentially left the regulation of the vast majority of mHealth apps to the marketplace. Happtique [52] (now acquired by SocialWellth [53]) was a company that attempted to provide the first mHealth app certification program and prescribing platform to address the unregulated market where Food and Drug Administration left off. It spent 3 years to develop and finally release the Happtique Health App Certification Program in 2013, with rigorous guidelines that covered interoperability, privacy, security, and content standards [52]. The pay-for-certification model of Happtique Health App Certification Program was to charge the mHealth app developers for certification of their apps, build out Happtique’s own library of clinically vetted apps, and then sell access to the library to health care systems so that providers could “prescribe” mHealth apps to support disease management, improve medication adherence, and help patients make healthy lifestyle changes [54]. However, app developers were not lining up to apply for certification in the volumes that Happtique anticipated. In late 2013 when the company unveiled its first batch of certified apps, there were only 19 mHealth apps. Furthermore, several of these apps were hacked within 2 weeks, and consumer data were exposed. The company unfortunately shut down the app library just 2 weeks after launching. Similarly, the United Kingdom’s National Health Service (NHS) [55] launched the Health Apps Library as part of their NHS Choices program in 2013. It was pitched as a pilot program to guide patients and clinicians to safe, effective mHealth apps. The NHS Health Apps Library only provides links to third-party stores hosting the actual apps. Developers can submit their apps for review and possible listing in the Library. Visitors also can review and rate apps in the NHS Health Apps Library. However, concerns were raised regarding the security and effectiveness aspects of the 230 mHealth apps NHS certified. One study examined 79 NHSendorsed apps and found none of the apps stored personal information on the mobile device in an encrypted manner. Furthermore, 66% of the apps sending identifying information over the Internet did not use encryption [56]. Another study found only 4 of the 14 mHealth apps listed in the NHS apps library that were related to the management of depression and anxiety provided any evidence of patient-reported outcomes to substantiate claims of effectiveness [57]. The NHS Health Apps Library was eventually shut down in 2015 [58]. The app-vetting process is undoubtedly very resource-intense. In a market defined by a low barrier to entry and minimal startup costs, the reality is that the number of apps will far outpace any centralized evaluation mechanism. One potential solution may be an open, crowd-sourced app rating system with validated
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sets of standards that enables verified health care professionals to examine the clinical content and general consumers to grade the usability. Limited Evidence-Based Literature Given the recent development of mHealth apps, formal literature citing the efficacy of these apps remains limited. The most notable and positive evidence generated to date is in the areas of type II diabetes, cardiovascular health, obesity, multiple sclerosis, and mental health [5]. The number of clinical trials using mobile apps has more than doubled between 2013 and 2015, increasing from 135 to 300 [5]. The body of evidence that supports the use of mHealth apps to improve health outcomes and help manage costs is expanding. However, given that large-scale randomized controlled trials frequently span at least 3-5 years from conception to publication, this gold standard is poorly suited for a constantly evolving target such as mHealth apps. By the time the clinical trials are published, there can be substantial differences between the tested version and the current version of the app. To date, there are only a handful of systematic reviews of mobile app efficacy supported by randomized controlled trials. Although some meta-analytic studies demonstrated the efficacy of wellness management mHealth apps targeting physical activity and weight loss [59,60], the evidence base for other types of mHealth apps remains poor, and many studies show mixed results [61]. Given the enormous heterogeneity of mHealth apps in terms of content accuracy, usability design, and therapeutic mechanism, we need not only large trials to broadly evaluate apps of the same categories but also in-depth studies to understand the effective components of these apps and lay the foundation for future app development. The challenge for the field is to develop an evidence-establishing process that not only matches the rigor of a randomized controlled trial but also is fast enough to keep pace with the speed of evolution of mHealth, if it is to have meaningful impact in informing payers, providers, policy makers, and patients [62]. Privacy and Security Concerns With the rapidly increasing use of mHealth apps, the amount of personal health information collected and stored, including patients’ self-reported data and data from external devices, also are exploding. However, as consumers value control of their personally identifiable data [63] and the Federal Trade Commission recommends provision of privacy policies for mobile apps [64], little attention has been paid to the information security and privacy policies and practices of mHealth app vendors. One study revealed that of the 600 most commonly used apps, only 183 (30.5%) had privacy
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policies, and two thirds of the privacy policies did not specifically address the app itself [65]. Several studies and reports have shown the currently mHealth app developers often fail to provide app privacy policies and called for a focus on a more rigorous examination of privacy and security aspects of mHealth apps [56,66-70]. The data security in the fast-paced environment of mHealth app development is another concern. The Bitglass Healthcare Breach report claims in 2015 more than 111 million of individuals’ data was lost due to hacking or incidents in the United States alone, with an average cost of 363 U.S. dollars per lost or stolen medical record [71]. It is important for the developers to ensure the security of the applications is well-tested before release to mitigate potential system vulnerabilities, such as data storage, encryption, and authentication processes [72]. Future Directions Despite the current limitations of mHealth apps, there still exists great potential for the future evolution of these applications, including integration of mobile health information into a health care system’s EHR, applications extending across EHRs, and development of personal health records. Integration of Mobile Health Information Into the Health Care System Connectivity and communication of consumer mHealth apps with provider EHRs is starting to increased. In the Healthcare Information and Management Systems Society mobile technology survey, 67% of the respondents reported their hospital accept some portion of data uploaded from patients’ mobile health apps into the hospital’s electronic medical record system [73]. The most common types of patient-generated data were steps, pulse, and weight [74]. In the future at health care facilities, reviewing data uploaded from patients’ mHealth apps may become a part of routine during an office visit, filling in the missing pieces of information between encounters and potentially reducing providers’ documentation time [74]. Issues still exist regarding how to manage the potentially large amounts of patient-generated data for importing into an EHR, especially in regard to reviewing and validating patientgenerated data as well as determining the data elements to import. The amount of data providers manage may decrease over time, as software vendors develop mathematical algorithms to sort through patientgenerated data automatically, alerting clinicians when a medical issue needs to be addressed. However, not all of the pieces are aligned yet due to lack of system integration and standards for patient-generated data.
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Consumer Mobile Health Apps
Apps Extending Across EHRs In early 2010, Harvard Medical School and Boston Children’s Hospital began an interoperability project, called Substitutable Medical Applications and Reusable Technologies (SMART), with the distinctive goal of developing a platform to enable software developers to create apps that seamlessly and securely run across the health care system across different EHR systems. Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) is a draft standard for exchanging EHRs, created by the Health Level Seven International health care standards organization [75]. In 2013, SMART adopted the FHIR clinical data models and the application program interface. The new platform is called SMART on FHIR [76]. Major EHR companies like Epic [77] and Cerner [78] have adopted the concept of SMART on FHIR to allow app developers to access their EHR data and unleash creativity to produce solutions that better engage consumers and enhance provider-patient communication. Most of these apps are starting as provider-facing applications in the EHR, but consumer-facing apps are on the horizon. SMART on FHIR opens up innovation in health care that has not been possible previously. For example, health care organizations no longer need to wait for the EHR vendors to adapt new ideas into their mobile solutions. Instead, they can take advantage of an innovative idea with an app, as long as their EHR is SMART on FHIR compatible. This greatly expands the pool of developers and allows organizations to create specific apps to meet their internal needs. There has already been a growing trend of development of health care organization-specific apps. In the Healthcare Information and Management Systems Society mobile technology survey, about 61% of the 238 respondents said their institutions currently offer organizationspecific apps for patients or are developing one. With SMART on FHIR, the organization will be able to develop apps customized for both providers and patients for clinical care and research purposes leveraging the big data from EHR. Cloud-Based Personal Health Record (PHR) Across Health Care Networks Compared with the electronic patient portal apps, which typically provide patients with access to health records of only one single hospital or network, a PHR is patient-centric and can potentially store all the medical records for one patient across multiple health care networks and even countries. One study mentioned 19 apps that allow patients to store PHRs on their mobile devices [79]. These apps act as a platform for personal health data, including data from mobile health devices, putting consumers in control of their health information, with the ability to securely share it with clinicians,
caregivers, family members, or others, as needed. The functionality and data elements of these apps are still limited, and most of the health information they store are patient-generated fitness data, but as the mobile market continues to expand, PHR systems have the potential to play a more important role in the future health information exchange (HIE). Currently, HIEs have been difficult to implement across health care systems with different EHRs [80], partially because the medical records have been hospital or provider-centered, so the process becomes very inefficient when multiple systems are involved. A true HIE should naturally be patient-centered and patientinitiated [81]. For example, each patient should have a cloud-based PHR system hosted by third-party companies that stores both patient-reported data and selected EHR records including visit summaries and major laboratory and imaging reports. The patient would have the right to save a copy of essential digital health records to their PHR of choice each time after a clinical encounter and could share records securely with selected recipients. There have been similar attempts to integrate essential health records in one place, such as Google “Health” and Microsoft “HealthVault” [82]. However, they failed to achieve this potential because of limited consumer adoption and lack of partnership with EHR companies and health care providers [83,84]. Google eventually discontinued the Google Health service in 2013 and only focuses on the fitness data now [85]. With increasing consumer awareness of mobile health over the last few years, however, third-party companies like Apple, which has indicated a keen interest in health care with its research toolkits, partnering with major EHR vendors like Epic, and recently acquiring PHR startups like Gliimpse, may suggest more determined efforts to break down the silos again [86,87]. App Prescription The number and variety of mHealth apps available present an overwhelming number of options for consumers, and without guidance from their health care providers, patients may either choose the most popular apps or try several apps in an effort to self-determine the best app for their particular situation. This is reflected in available download information, which shows that just 36 apps account for nearly one half of all downloads, whereas 40% of apps have fewer than 5000 downloads [5]. The term “prescribe” is used in a manner to differentiate between an informal recommendation of mHealth apps by health care providers and a “prescriptive” specific recommendation to patients for use of an mHealth app as part of treatment protocols. There is growing interest in the role of prescribing apps to patients. A 2015 survey by Research Now found that 16%
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of physicians were prescribing mHealth apps, but 46% of the respondents expected to do so within 5 years [88]. Industry-reported data showed the typical 30-day retention rates for mHealth apps prescribed by a provider are 10% greater than average and 30% greater for fitness apps [5,89], indicating the positive relationship of providers’ involvement and patients’ compliance with the mHealth app. However, barriers continue to exist, impeding full adoption of mHealth apps in a prescriptive and integrated manner. These barriers include lack of scientific evidence, lack of integration into workflow systems, lack of regulatory supervision, and lack of reimbursement for mHealth solutions from insurance companies. A well-defined app certification process and more mHealth research to validate the efficacy are vital to overcome these barriers. Conclusion The consumer mHealth app market has long been isolated, unregulated, and patient-driven. During the past few years, there has been slow but steady progress across the key components that are necessary for achieving great success, including accumulating clinical studies to establish evidence, maturing app interoperability with centralized mHealth databases, expanding data integration with EHR via SMART on FHIR, and growing clinician and payor awareness of the potentials of mHealth. It is anticipated that efforts will continue to accelerate, as reimbursement moves towards valuebased payment models, and evidence increases around the added value of mHealth apps in population health management. The effort for comprehensive implementation is not small. All stakeholders within the mHealth ecosystem, including consumers, providers, health care organizations, payers, and EHR vendors, must collaborate to overcome barriers so that mHealth apps can fully contribute value to health care delivery and chronic disease management.
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Disclosure C.-K.K. Department of Medicine, University of Chicago, 5841 South Maryland Avenue, MC-5000, W314, Chicago, IL 60637. Address correspondence to: C.-K.K.; e-mail: [email protected] Disclosure: nothing to disclose
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D.M.L. Department of Medicine, University of Chicago, Chicago, IL Disclosure: nothing to disclose Submitted for publication October 15, 2016; accepted February 7, 2017.
www.pmrjournal.org
Clinical Informatics in Physiatry
Consumer Mobile Health Apps: Current State, Barriers, and Future Directions Cheng-Kai Kao, MD, David M. Liebovitz, MD
Abstract This paper discusses the current state, barriers, and future directions of consumer-facing applications (apps). There are currently more than 165,000 mobile health apps publicly available in major app stores, the vast majority of which are designed for patients. The top 2 categories are wellness management and disease management apps, whereas other categories include selfdiagnosis, medication reminder, and electronic patient portal apps. Apps specific to physical medicine and rehabilitation also are reviewed. These apps have the potential to provide low-cost, around-the-clock access to high-quality, evidence-based health information to end users on a global scale. However, they have not yet lived up to their potential due to multiple barriers, including lack of regulatory oversight, limited evidence-based literature, and concerns of privacy and security. The future directions may consist of improving data integration into the health care system, an interoperable app platform allowing access to electronic health record data, cloud-based personal health record across health care networks, and increasing app prescription by health care providers. For consumer mobile health apps to fully contribute value to health care delivery and chronic disease management, all stakeholders within the ecosystem must collaborate to overcome the significant barriers.
Introduction Mobile devices, especially smartphones, have revolutionized people’s lives, including the way they seek medical information. According to a global survey in 2015, 72% of all U.S. adults owned a smartphone [1], up from 63% in 2012, and 62% had used their smartphones to look up information for a health condition, up from 53% in 2012 [2]. The penetration rate of smartphone continues to increase. It is estimated by 2020, there will be 6.1 billion smartphone users globally, comprising approximately 80% of the world’s population [3,4]. The term “app,” short for “application,” refers to a self-contained program or piece of software that is designed to fulfill a particular purpose and usually optimized to run on mobile devices, such as smartphones, tablet computers, and some wearable devices like smart watches. Mobile health (mHealth) apps are health-related applications that aim to improve patients’ health though multiple different functionalities and designs. There are currently more than 165,000 mHealth apps (including free and paid) publicly available in major app stores, and some academic medical
centers also are developing apps on their own [5]. The mHealth market now embraces about 45,000 app developers, and more than 3 billion mHealth apps were downloaded in 2015 [6]. By 2017, it is projected that 50% of the mobile phone users will have downloaded at least one mHealth app [7]. The mHealth apps have the potential to provide lowcost, around-the-clock access to high-quality, evidencebased health information to end users on a global scale and improve compliance with treatment protocols via behavior change models [8]. The impact of mHealth apps can be enormous on many important healthrelated domains, including chronic disease management, mental health, and patient education and empowerment. The high hope for mHealth is to strengthen the iron triangle of health caredenhance quality, decrease cost, and improve access [9]. However, the accuracy of the health information contained in most of these apps is not scrutinized by regulatory bodies, which could compromise users’ health and safety [10]. Literature regarding the efficacy of mHealth apps is still evolving. Because of the lack of formal vetting processes and well-established clinical evidence
1934-1482/$ - see front matter ª 2017 by the American Academy of Physical Medicine and Rehabilitation http://dx.doi.org/10.1016/j.pmrj.2017.02.018
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of their effects, health care providers have been hesitant to recommend or “prescribe” mHealth apps to their patients [11]. Thus, the mHealth app market today still sits in the hype phase and remains mostly patientdriven, with its unlimited potentials yet to be realized. Therefore, it is vital for today’s health care professionals to learn the current state, barriers, and future directions of mHealth apps and eventually take the leading role to drive the change. Current State The vast majority of mHealth apps on the market are designed for consumers [5]. The proliferation of smartphones and consumer interest in taking a more active role in personal health has fueled this growth. Among all stakeholders in the health care industry, patients are the ones for whom mHealth apps show the biggest impact today [6]. Currently, the top 2 categories of consumer-facing mHealth apps are wellness management (such as fitness, lifestyle modification, and diet and nutrition), and chronic disease management (such as mental health, diabetes, and cardiovascular diseases) [5]. The other categories include self-diagnosis, medication reminders, and electronic patient portal apps. Apps specific to physical medicine and rehabilitation also are reviewed. Table 1 [12-19] provides examples of the types of mHealth apps that currently are available. Wellness Management Apps Wellness management apps, including fitness, lifestyle modification, and diet and nutrition apps, account for about two thirds of all consumer-facing apps [5]. These apps often use smartphone features to automatically collect data, such as global positioning system (ie, GPS) to track jogging distance, and built-in camera to allow photo diaries of daily food and drink. A significant amount of the wellness management apps are connected with external devices (such as digital weight scales, blood pressure monitor, and heart rate monitor), which collect, record, and transmit patient data automatically, reflecting the growing consumer interest in the use of mobile devices for the purpose of health. A high percentage of these apps provide a mechanism for social networking to increase motivation. Of the top mHealth apps, 65% connect to social media, underscoring the importance of this feature for consumer engagement [5]. By providing tools for monitoring diet and physical activity while instructing and encouraging healthy diet and physical activity, the fitness and lifestyle modification apps show a positive impact on promoting a healthy lifestyle to consumers [20]. Many of these apps have a favorable consumer rating. The diet and nutrition apps provide functions such as counting calories,
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creating food diaries, tracking exercise, and documenting weight. Currently, there are mixed results regarding the efficacy of the wellness management apps. In a review of apps, Rivera et al [21] found that commercial mHealth apps for weight management lack important evidencebased features, do not involve health care experts in the development process, and have not undergone rigorous scientific testing. Some systemic reviews revealed an overall advantage to using these apps but also called for more high-quality controlled trials to test the efficacy of specific app features to distinguish effective from ineffective components [22,23]. Disease-Management Apps Nearly one quarter of mHealth apps focus on disease management, such as diabetes, asthma, and mental health diseases, reflecting the growing interest in the use of mHealth apps for chronic disease management. Diabetes mellitus is one of the earliest developed and most studied areas of mHealth applications. There are hundreds of diabetes apps offering a variety of functions, including home blood glucose recording, medication or insulin administration logs, prandial insulin reminders and dose calculators, and integrated communication between patients and health care providers. For example, several diabetes apps can remind the patient to check and log their blood sugar (BS) in the morning, then give patients instructions such as drinking juice if the BS is low or guidance to self-administer a recommended dose of insulin if the BS is high, and then remind the patient to check the BS again to ensure it has improved. The app also may collect information like weekly weights, food diary entries with calorie counts, medication compliance, and physical activity. Health care providers with access to these diaries can later formulate personalized feedback to the patient. Welldoc’s BlueStar [13] is the first mobile prescription-only app for type 2 diabetes and has a randomized controlled trial that included 163 patients and showed the mean declines in HbA1c were 1.9% in the treatment group versus 0.7% in the usual-care group, a difference of 1.2% (P < .001) over 12 months [24]. This result is a significant one, especially considering its low cost (compared with the cost of new drug development) and broad access (accessible to anyone with a smartphone). Some insurers had agreed to reimburse for use of WellDoc’s mobile-enabled diabetes management program [25]. In patients with medical diseases characterized by life-threatening flares, disease management apps allow patients to keep a symptom diary and track the frequency of the usage of rescue medications, along with geographical data if needed. For example, in patients with asthma, monitoring respiratory symptoms and the trend of peak flows can alert patients and providers to
Consumer Mobile Health Apps
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Example App
Description and Functions
Wellness management
Calorie counter and diet tracker [12]
Disease management
BlueStar diabetes [13]
The app allows consumers to track keep track of diets and exercises and manage their weights. Allow patients to enter personal food and exercise diaries Contain a substantial food database that allows barcode scanning for quick and accurate entries of food Provide daily personalized advice towards the goal set by the consumers Leverage social network to increase motivation for adherence The app gives patients with type 2 diabetes a guided plan to help manage their glucose levels. Prescription-only Allow patients to log their glucose levels at home Provide instructions for hyperglycemia and hypoglycemia events Allow patients to enter their food diaries Allow patients to share the report with prescribers The app allows patients with asthma to keep track of their peak flows and symptoms and provides an action plan during asthma attacks. Remind patients to use inhalers as scheduled Allow patients to log their peak flow measurements and symptoms with date/time and triggers Provide an action plan with instructions during asthma attacks Gather anonymous data for researchers to better correlate asthma with environmental factors, triggers, and climate change The app provides a symptom checker that serves as a basic patient self-diagnosis tool. Allow patients to enter their symptom characteristics and then generate a list of possible diagnoses sorted by probability Provide patient education information for each possible condition Advise patients to seek emergency medical attention if warning symptoms are entered Provide a substantial database of patient education materials regarding diseases and medications on demand The app functions as a digital pillbox that allows patients to manage their medications effectively. Allow patients to enter their current medications’ dosage, frequency, and amount Remind patients to take the medication based on the schedule Remind patients for medication refills Allow patients to enter medication diaries to document drug responses and side effects The apps allow patients to access a portion of their medical records and also serve as a communication tool between providers and patients. Allow patients to view laboratory results, imaging studies, current medications, and upcoming appointments Allow patients to send messages to their providers for acute issues, unresolved symptoms, or medication refills Allow providers to send reminders of preventive screening tests or vaccinations to patients The app allows physical medicine and rehabilitation providers and therapists to prescribe home physical exercises to patients. Prescription-only Provide pictures, descriptions, and videos to demonstrate each exercise Remind patients to do the exercises based on their therapy schedule Allow patients to record their exercises and send to their providers Allow patients to keep track of their progress Collect direct patient feedback regarding pain and difficulty during the therapy
AsthmaMD [14]
Self-diagnosis
WebMD [15]
Medication reminder
MediSafe [16]
Electronic patient portal
Epic MyChart [17] Cerner HealtheLife [18]
Physical medicine and rehabilitation
Patient Pal Pro [19]
* Disclaimer: The aforementioned apps serve as examples for each category and are not specifically endorsed by the authors.
suspected disease exacerbations, thereby facilitating prompt intervention. AsthmaMD app [14] is one such app that allows patients to track their peak flow and symptoms and also gathers data for the researchers to understand the correlation between the environment and asthma. Propeller Health app [26] pairs with a Bluetooth sensor attached to the patient’s inhaler and automatically documents every time when the
patient uses the inhaler to keep track of medication adherence. Mental health is another popular area in which abundant research is ongoing to study behavior changes, the early detection of psychiatric diseases, and control of symptoms via the use of mHealth apps. The most commonly addressed conditions include autism, depression, anxiety, attention deficit hyperactivity
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disorder, and Alzheimer disease [5]. Autism-spectrum disorders, often detected in late stage, are estimated to cost the United States 461 billion dollars by 2025, more than stroke, hypertension, and diabetes. Autism apps constitute the largest category of mental health apps and reflect a broad set of initiatives around management of autism. These autism apps not only can provide an app-based learning environment that accommodates different learning styles and paces based on learners’ responses [27] but also can make the smartphones or tablet computers speech-generating devices to facilitate communication [28]. There are also plenty of mental health apps designed to assist patients with depression. However, studies revealed few of the depression apps use evidencebased principles like cognitive behavioral therapy or behavioral activation despite these being the gold standard of first-line psychological treatments [29]. Furthermore, the app market is quite volatile, with a depression app disappearing from app stores every 2.9 days on average [30]. Self-Diagnosis Apps There has been a growing trend for consumer use of apps to attempt initial self-diagnosis without a medical visit [5]. These apps can be particularly helpful in emergency, or remote, resource-limited settings. For example, the WebMD app [15] provides a symptom checker that allows patients to select their symptoms, and then it generates a list of possible diagnoses sorted by probability along with patient education information for each condition. If the patient enters a warning symptom, eg, severe chest pain, the app pops up an alert to advise the consumer to seek emergency medical attention. One study reviewed 23 symptom checker apps and found there remained deficits in both triage and diagnosis, and thus the triage advice from symptom checkers generally is risk averse, encouraging users to seek care for conditions in which self-care may be reasonable [10]. Another example is the wireless information system for emergency responders (ie, WISER) developed by National Library of Medicine to assist lay persons in hazardous material incidents or bioterror attacks [31]. The system includes an app that not only provides emergency protocols for reference but also has a chemical identifier that helps quickly differentiate among toxic substances in emergency situations based on the chemical’s properties and patient symptoms [32]. Despite the growing interests in this category, enormous risks may also arise without a proper vetting process. For example, there are several apps on the market that allow consumers to use a camera-enabled smartphone to take photographs of suspicious skin lesions and advise the nonclinician users whether the skin lesions are benign or malignant. These applications are currently not subject to any sort of regulatory oversight.
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A study in JAMA Dermatology in 2013 analyzed 4 of these apps and concluded that the performance of smartphone applications in assessing melanoma risk was highly variable, and 3 of 4 smartphone applications incorrectly classified 30% or more of melanomas as unconcerning [33]. These unvalidated mHealth apps may cause significant harm to patients by delaying a timely medical diagnosis. Medication Reminder Apps Medication noncompliance has been a common health care challenge. Poor adherence causes approximately 33%-69% of medication-related hospitalizations and accounts for 100 billion U.S. dollars in annual health care costs [34]. Irrespective of disease, medication complexity, or how adherence is measured, the average adherence rate to chronic medication therapy is approximately 50% [35]. Medication reminder apps allow patients to enter their medication list manually or by scanning the barcode on the prescription bottles, provide a visualized medication calendar, and automatically send notifications to patients when they are due for medication doses. Several studies describe potential benefits of medication reminder apps on improving medication adherence [36,37], particularly in the younger generation [38], but also show inconsistent quality across these apps, which warrants more studies to prove the efficacy and the effective features [39,40]. Electronic Patient Portal Apps The major electronic health record (EHR) companies have developed their respective mobile solutions for both patients and providers. These apps provide patients with similar access to the electronic patient portal from their mobile devices, which allow patients to access a portion of their medical records, including laboratory results, imaging studies, current medications, and upcoming appointments. They also serve as a 2-way communication tool that allows patients to report to their care providers any unresolved or new symptoms and request medication refills, whereas the providers can answer patients’ questions and send reminders of preventive screening tests and vaccinations, scheduled procedures or studies, and upcoming outpatient appointments. One survey showed a trend of chronically ill patients having a more positive view of patient portals [41], but more studies are required to prove their value in enhancing patient communication, education and empowerment, and their potential in reducing miscommunication and unnecessary patient visits. Physical Medicine and Rehabilitation Apps In the field of rehabilitation, mHealth apps can provide tools to monitor the effects of home exercise
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programs, collect patient-reported measures, provide feedback on posture and body mechanics, supply educational material, and prompt patients with motivating messages [42]. For example, Patient Pal Pro app [19] allows rehabilitation providers to prescribe home physical exercises to the patients via its Web portal. Each exercise on the app comes with a picture along with a description and a video to ensure the patients perform the exercises correctly, and the app also allows patients to record their exercises at home for providers to review later. The app also tracks the progress of the exercises and sends reminders to the patients based on the schedule. Several studies have demonstrated promising outcomes of leveraging mHealth technology in this field. Based on the preliminary results from a study at Mayo, patients who attended cardiac rehabilitation and used a smartphone-based app to record daily measurements, such as weight and blood pressure, had greater improvements in these cardiovascular risk factors and were less likely to be readmitted to the hospital within 90 days of discharge (20%), compared with patients who only attended cardiac rehabilitation (60%) [43]. Another study revealed potential benefits of mHealth apps on tablet computers to provide a way to facilitate selftraining of repetitive, task-oriented, isolated finger and hand movements to improve hand dexterity and function after stroke [44]. There are similar applications for use of tablets in training visual-motor integration skills among children with special needs [45]. Barriers Despite the rapid expansion of mHealth apps, there are still significant barriers to expanding the role and efficacy of mHealth apps in improving the health of consumers and ultimately population health, including lack of regulatory supervision, limited evidence-based literature, and privacy and security concerns. Lack of Regulatory Supervision The biggest challenge that limits the potentials of mHealth apps is lack of proper regulation to ensure their accuracy, quality, and performance [46]. Governmental agencies, third-party companies, professional societies, and mHealth researchers [47,48] have tried to come up with standards and systematic methods to evaluate and certify mHealth apps. There are also online app clearinghouses such as iMedicalApps [49] that recommend apps based on editorial reviews. So far, there remains no consensus in terms of the best approach. The Food and Drug Administration [50] issued mHealth app guidance [51] in 2013, which explained its tailored, risk-based approach that only focuses on the small subset of mobile apps that (1) are intended to be used as an accessory to a regulated medical device or
(2) transform a mobile platform into a regulated medical device (eg, an app that turns a smartphone into a portable ultrasound or an electrocardiography machine). The agency essentially left the regulation of the vast majority of mHealth apps to the marketplace. Happtique [52] (now acquired by SocialWellth [53]) was a company that attempted to provide the first mHealth app certification program and prescribing platform to address the unregulated market where Food and Drug Administration left off. It spent 3 years to develop and finally release the Happtique Health App Certification Program in 2013, with rigorous guidelines that covered interoperability, privacy, security, and content standards [52]. The pay-for-certification model of Happtique Health App Certification Program was to charge the mHealth app developers for certification of their apps, build out Happtique’s own library of clinically vetted apps, and then sell access to the library to health care systems so that providers could “prescribe” mHealth apps to support disease management, improve medication adherence, and help patients make healthy lifestyle changes [54]. However, app developers were not lining up to apply for certification in the volumes that Happtique anticipated. In late 2013 when the company unveiled its first batch of certified apps, there were only 19 mHealth apps. Furthermore, several of these apps were hacked within 2 weeks, and consumer data were exposed. The company unfortunately shut down the app library just 2 weeks after launching. Similarly, the United Kingdom’s National Health Service (NHS) [55] launched the Health Apps Library as part of their NHS Choices program in 2013. It was pitched as a pilot program to guide patients and clinicians to safe, effective mHealth apps. The NHS Health Apps Library only provides links to third-party stores hosting the actual apps. Developers can submit their apps for review and possible listing in the Library. Visitors also can review and rate apps in the NHS Health Apps Library. However, concerns were raised regarding the security and effectiveness aspects of the 230 mHealth apps NHS certified. One study examined 79 NHSendorsed apps and found none of the apps stored personal information on the mobile device in an encrypted manner. Furthermore, 66% of the apps sending identifying information over the Internet did not use encryption [56]. Another study found only 4 of the 14 mHealth apps listed in the NHS apps library that were related to the management of depression and anxiety provided any evidence of patient-reported outcomes to substantiate claims of effectiveness [57]. The NHS Health Apps Library was eventually shut down in 2015 [58]. The app-vetting process is undoubtedly very resource-intense. In a market defined by a low barrier to entry and minimal startup costs, the reality is that the number of apps will far outpace any centralized evaluation mechanism. One potential solution may be an open, crowd-sourced app rating system with validated
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sets of standards that enables verified health care professionals to examine the clinical content and general consumers to grade the usability. Limited Evidence-Based Literature Given the recent development of mHealth apps, formal literature citing the efficacy of these apps remains limited. The most notable and positive evidence generated to date is in the areas of type II diabetes, cardiovascular health, obesity, multiple sclerosis, and mental health [5]. The number of clinical trials using mobile apps has more than doubled between 2013 and 2015, increasing from 135 to 300 [5]. The body of evidence that supports the use of mHealth apps to improve health outcomes and help manage costs is expanding. However, given that large-scale randomized controlled trials frequently span at least 3-5 years from conception to publication, this gold standard is poorly suited for a constantly evolving target such as mHealth apps. By the time the clinical trials are published, there can be substantial differences between the tested version and the current version of the app. To date, there are only a handful of systematic reviews of mobile app efficacy supported by randomized controlled trials. Although some meta-analytic studies demonstrated the efficacy of wellness management mHealth apps targeting physical activity and weight loss [59,60], the evidence base for other types of mHealth apps remains poor, and many studies show mixed results [61]. Given the enormous heterogeneity of mHealth apps in terms of content accuracy, usability design, and therapeutic mechanism, we need not only large trials to broadly evaluate apps of the same categories but also in-depth studies to understand the effective components of these apps and lay the foundation for future app development. The challenge for the field is to develop an evidence-establishing process that not only matches the rigor of a randomized controlled trial but also is fast enough to keep pace with the speed of evolution of mHealth, if it is to have meaningful impact in informing payers, providers, policy makers, and patients [62]. Privacy and Security Concerns With the rapidly increasing use of mHealth apps, the amount of personal health information collected and stored, including patients’ self-reported data and data from external devices, also are exploding. However, as consumers value control of their personally identifiable data [63] and the Federal Trade Commission recommends provision of privacy policies for mobile apps [64], little attention has been paid to the information security and privacy policies and practices of mHealth app vendors. One study revealed that of the 600 most commonly used apps, only 183 (30.5%) had privacy
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policies, and two thirds of the privacy policies did not specifically address the app itself [65]. Several studies and reports have shown the currently mHealth app developers often fail to provide app privacy policies and called for a focus on a more rigorous examination of privacy and security aspects of mHealth apps [56,66-70]. The data security in the fast-paced environment of mHealth app development is another concern. The Bitglass Healthcare Breach report claims in 2015 more than 111 million of individuals’ data was lost due to hacking or incidents in the United States alone, with an average cost of 363 U.S. dollars per lost or stolen medical record [71]. It is important for the developers to ensure the security of the applications is well-tested before release to mitigate potential system vulnerabilities, such as data storage, encryption, and authentication processes [72]. Future Directions Despite the current limitations of mHealth apps, there still exists great potential for the future evolution of these applications, including integration of mobile health information into a health care system’s EHR, applications extending across EHRs, and development of personal health records. Integration of Mobile Health Information Into the Health Care System Connectivity and communication of consumer mHealth apps with provider EHRs is starting to increased. In the Healthcare Information and Management Systems Society mobile technology survey, 67% of the respondents reported their hospital accept some portion of data uploaded from patients’ mobile health apps into the hospital’s electronic medical record system [73]. The most common types of patient-generated data were steps, pulse, and weight [74]. In the future at health care facilities, reviewing data uploaded from patients’ mHealth apps may become a part of routine during an office visit, filling in the missing pieces of information between encounters and potentially reducing providers’ documentation time [74]. Issues still exist regarding how to manage the potentially large amounts of patient-generated data for importing into an EHR, especially in regard to reviewing and validating patientgenerated data as well as determining the data elements to import. The amount of data providers manage may decrease over time, as software vendors develop mathematical algorithms to sort through patientgenerated data automatically, alerting clinicians when a medical issue needs to be addressed. However, not all of the pieces are aligned yet due to lack of system integration and standards for patient-generated data.
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Apps Extending Across EHRs In early 2010, Harvard Medical School and Boston Children’s Hospital began an interoperability project, called Substitutable Medical Applications and Reusable Technologies (SMART), with the distinctive goal of developing a platform to enable software developers to create apps that seamlessly and securely run across the health care system across different EHR systems. Fast Healthcare Interoperability Resources (FHIR, pronounced “fire”) is a draft standard for exchanging EHRs, created by the Health Level Seven International health care standards organization [75]. In 2013, SMART adopted the FHIR clinical data models and the application program interface. The new platform is called SMART on FHIR [76]. Major EHR companies like Epic [77] and Cerner [78] have adopted the concept of SMART on FHIR to allow app developers to access their EHR data and unleash creativity to produce solutions that better engage consumers and enhance provider-patient communication. Most of these apps are starting as provider-facing applications in the EHR, but consumer-facing apps are on the horizon. SMART on FHIR opens up innovation in health care that has not been possible previously. For example, health care organizations no longer need to wait for the EHR vendors to adapt new ideas into their mobile solutions. Instead, they can take advantage of an innovative idea with an app, as long as their EHR is SMART on FHIR compatible. This greatly expands the pool of developers and allows organizations to create specific apps to meet their internal needs. There has already been a growing trend of development of health care organization-specific apps. In the Healthcare Information and Management Systems Society mobile technology survey, about 61% of the 238 respondents said their institutions currently offer organizationspecific apps for patients or are developing one. With SMART on FHIR, the organization will be able to develop apps customized for both providers and patients for clinical care and research purposes leveraging the big data from EHR. Cloud-Based Personal Health Record (PHR) Across Health Care Networks Compared with the electronic patient portal apps, which typically provide patients with access to health records of only one single hospital or network, a PHR is patient-centric and can potentially store all the medical records for one patient across multiple health care networks and even countries. One study mentioned 19 apps that allow patients to store PHRs on their mobile devices [79]. These apps act as a platform for personal health data, including data from mobile health devices, putting consumers in control of their health information, with the ability to securely share it with clinicians,
caregivers, family members, or others, as needed. The functionality and data elements of these apps are still limited, and most of the health information they store are patient-generated fitness data, but as the mobile market continues to expand, PHR systems have the potential to play a more important role in the future health information exchange (HIE). Currently, HIEs have been difficult to implement across health care systems with different EHRs [80], partially because the medical records have been hospital or provider-centered, so the process becomes very inefficient when multiple systems are involved. A true HIE should naturally be patient-centered and patientinitiated [81]. For example, each patient should have a cloud-based PHR system hosted by third-party companies that stores both patient-reported data and selected EHR records including visit summaries and major laboratory and imaging reports. The patient would have the right to save a copy of essential digital health records to their PHR of choice each time after a clinical encounter and could share records securely with selected recipients. There have been similar attempts to integrate essential health records in one place, such as Google “Health” and Microsoft “HealthVault” [82]. However, they failed to achieve this potential because of limited consumer adoption and lack of partnership with EHR companies and health care providers [83,84]. Google eventually discontinued the Google Health service in 2013 and only focuses on the fitness data now [85]. With increasing consumer awareness of mobile health over the last few years, however, third-party companies like Apple, which has indicated a keen interest in health care with its research toolkits, partnering with major EHR vendors like Epic, and recently acquiring PHR startups like Gliimpse, may suggest more determined efforts to break down the silos again [86,87]. App Prescription The number and variety of mHealth apps available present an overwhelming number of options for consumers, and without guidance from their health care providers, patients may either choose the most popular apps or try several apps in an effort to self-determine the best app for their particular situation. This is reflected in available download information, which shows that just 36 apps account for nearly one half of all downloads, whereas 40% of apps have fewer than 5000 downloads [5]. The term “prescribe” is used in a manner to differentiate between an informal recommendation of mHealth apps by health care providers and a “prescriptive” specific recommendation to patients for use of an mHealth app as part of treatment protocols. There is growing interest in the role of prescribing apps to patients. A 2015 survey by Research Now found that 16%
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of physicians were prescribing mHealth apps, but 46% of the respondents expected to do so within 5 years [88]. Industry-reported data showed the typical 30-day retention rates for mHealth apps prescribed by a provider are 10% greater than average and 30% greater for fitness apps [5,89], indicating the positive relationship of providers’ involvement and patients’ compliance with the mHealth app. However, barriers continue to exist, impeding full adoption of mHealth apps in a prescriptive and integrated manner. These barriers include lack of scientific evidence, lack of integration into workflow systems, lack of regulatory supervision, and lack of reimbursement for mHealth solutions from insurance companies. A well-defined app certification process and more mHealth research to validate the efficacy are vital to overcome these barriers. Conclusion The consumer mHealth app market has long been isolated, unregulated, and patient-driven. During the past few years, there has been slow but steady progress across the key components that are necessary for achieving great success, including accumulating clinical studies to establish evidence, maturing app interoperability with centralized mHealth databases, expanding data integration with EHR via SMART on FHIR, and growing clinician and payor awareness of the potentials of mHealth. It is anticipated that efforts will continue to accelerate, as reimbursement moves towards valuebased payment models, and evidence increases around the added value of mHealth apps in population health management. The effort for comprehensive implementation is not small. All stakeholders within the mHealth ecosystem, including consumers, providers, health care organizations, payers, and EHR vendors, must collaborate to overcome barriers so that mHealth apps can fully contribute value to health care delivery and chronic disease management.
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Disclosure C.-K.K. Department of Medicine, University of Chicago, 5841 South Maryland Avenue, MC-5000, W314, Chicago, IL 60637. Address correspondence to: C.-K.K.; e-mail: [email protected] Disclosure: nothing to disclose
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D.M.L. Department of Medicine, University of Chicago, Chicago, IL Disclosure: nothing to disclose Submitted for publication October 15, 2016; accepted February 7, 2017.