The Era of mHealth: A Global Perspective

HTA QUARTERLY | SUMMER 2020

The Era of mHealth: A Global Perspective

By: Annie Yan, PharmD; Cynthiya Ruban, PhD, MS | Updated April 10, 2020

Technology has the potential to make healthcare delivery more effective, efficient, and patient-centric through improved access to an abundance of data. As digital health technology (DHT) innovations become increasingly inseparable from healthcare, a paradigm shift is imminent.

Digital health connects and empowers people and populations to manage health and wellness, augmented by accessible and supportive provider teams working within flexible, integrated, interoperable, and digitally enabled care environments that strategically leverage digital tools, technologies, and services to transform care delivery.

Digital Health Consumer Adoption

An annual survey of 4,000 US adults conducted by Rock Health, a venture fund that invests in digital health companies, and Stanford Center for Digital Health reported that adoption of digital health tools like telemedicine, wearables, and health apps has steadily climbed upwards over the past five years. In 2019, 44% of respondents tracked some aspect of their health digitally, and those who used digital tools shared health tracking information with their physician or other medical professional more frequently than those who used other tracking methods (Figure 1). Additionally, one in three respondents owned a wearable, and one in four wearable owners used it to manage a diagnosis.

Figure. 1. Tracking at Least One Health Metric/Indicator (2017–2019)

Tracking at Least One Health Metric/Indicator (2017–2019)

Source: RockHealth 2019.

Survey question: Do you currently keep track of any of the following? Responses: Weight, Heart rate, Blood pressure, Medications, Physical activity (steps, exercise, etc), Food/diet, Sleep, Blood sugar, Other
Survey question (asked for each metric that respondents track): How do you currently record the following: Weight, Heart rate, Blood pressure, Medications, Physical activity (steps, exercise, etc), Food/diet, Sleep, Blood sugar, Other? Responses: In a paper journal or log, In your head
Survey question (asked for each metric that respondents track): How do you currently record the following: Weight, Heart rate, Blood pressure, Medications, Physical activity (steps, exercise, etc), Food/diet, Sleep, Blood sugar, Other? Responses: With a wearable, Connective device (eg, smart scale, glucometer), or in an app that doesn’t connect to a wearable, In a digital journal or log
Survey question (if tracking any metric): With whom have you shared or discussed this data in the past year? Responses: Your physician, Another medical professional

Global mHealth Solutions Market Value Encompassed within the extensive rise of DHTs, mobile health (mHealth) plays an essential role in monitoring and sharing information via mobile technology (eg, mobile apps for diagnostic and treatment support). mHealth allows patients to keep track of their own health data in real time and inform healthcare providers in a single push of a button. With the drastic increase in utilization and integration of mHealth (and the data that can be obtained), the global mHealth market value is expected to surge rapidly (Figure 2).

Moreover, the increase in mHealth provides healthcare professionals and patients with increased access to data which allows all stakeholders (patients, providers, researchers, and pharmaceutical manufacturers) to obtain a more holistic view of patient health. This positions mHealth to enhance treatment pathways and diagnostic capabilities which can ultimately improve health outcomes and lower costs. This article will provide a global perspective of mHealth, describe opportunities to leverage mHealth, and contextualize mobile technology in terms of current health technology assessment (HTA) processes.

Opportunities for mHealth

Electronic Patient-Reported Outcome

Patient-reported outcomes (PROs) have traditionally been collected using paper questionnaires as a systematic way of measuring patients’ subjective views about their own health. In trials, PROs provide additional patient-centric data which are unique in capturing the patient’s own opinion on the impact of their disease, and its treatment, on their life. In our work with clients, we have seen that the increased use and accessibility of mobile devices has created substantial opportunity for mHealth to facilitate advancement in the integration of electronic PROs (ePROs) within clinical trials and electronic health records. Development and incorporation of validated ePROs (via mHealth) will allow all members of the provider team to communicate with patients to optimize care delivery, while collecting a plethora of data in the context of clinical trials.

Increase Medication Adherence

Medication adherence is a critical factor that impacts healthcare outcomes and costs, particularly for chronic conditions. In the US, it is estimated that at least half of the nation’s medication users are not taking their medication as prescribed, resulting in approximately $300 billion a year in avoidable healthcare expenses. mHealth represents a means of enhancing medication adherence, through features such as automated alerts to take medications, tracking doses, and supporting medication instructions. A study of 77 patients with tuberculosis compared adherence via wirelessly observed therapy, using a novel patient self-management system consisting of an edible ingestion sensor, vs directly observed therapy. Findings from this study revealed that wirelessly observed therapy using a mobile device to detect medication ingestion resulted in higher adherence compared to directly observed therapy by clinicians. This is an example of how using mHealth has the opportunity to increase medication adherence. In the future we expect to see mHealth play a vital role across many therapeutic areas as a means to increase medication adherence and allow clinicians to intervene more quickly.

Improve Patient-Provider Communication

Effective patient-provider communication is a key predictor of not only health outcomes, but also healthcare resource utilization and expenditures. According to a study using the Medical Expenditure Panel Survey, optimal patient-provider communication was associated with higher quality of care and cost savings. mHealth provides a platform for patients to stay connected with healthcare providers through secure messaging platforms, online scheduling capabilities, and remote access to personal clinical data. A study conducted at Kaiser Permanente Northern California, an integrated delivery network, assessed patient portal usage for over 165,000 patients with diabetes. The study found that use of mobile patient portals offering these services had led to higher patient engagement and fewer emergency department visits and preventable hospitalizations.

Spotlight on mHealth:
COVID 19 + Microsoft

The power of mHealth has been demonstrated recently by a collaboration between Microsoft and Swedish Health Services to build an app that helps hospital staff monitor resources for COVID-19-related care.

Swedish Health Services, the largest nonprofit health provider in the Seattle area, unveiled the COVID-19 Emergency Response (CERA) app to allow frontline hospital workers to use mobile devices to keep track of COVID-19 patients, protective gear, ventilator use, and other coronavirus-related information. The app syncs with hospital dashboards to help Swedish leaders gauge activity at its five care facilities, two emergency departments, and units in critical areas.

The CERA app has already helped clinicians convert a post-anesthesia room into an additional Intensive Care Unit and more than 400 Swedish clinicians are using the app. This is one example that demonstrates the clear utility of mobile technology and the opportunity to impact healthcare globally.

Kevin Brooks, Chief Operating Officer at Swedish First Hill

“This near real-time view of quickly changing data is empowering Swedish to better prepare for a COVID-19 surge and better manage the needs of our patients and caregivers.”

Payer and HTA Agency Perspectives

A number of frameworks evaluating the efficacy, safety, and/or cost-effectiveness of mHealth exist across North America, Europe, and Asia; however, the majority of them do not address all core components of an HTA, which typically includes current use, characteristics, efficacy, safety, and cost of the technology. Consequently, it is unclear whether these frameworks are used to guide reimbursement decisions. However, in the past couple of years, several European countries (eg, Belgium, France, and Germany) have begun developing frameworks specifically to support national reimbursement decisions for mHealth technology and other DHTs.

Reimbursement of mHealth technologies varies widely across payers and markets. Germany and Finland provide reimbursement for mHealth if the technology is used as part of an already reimbursable treatment. Conversely, France currently only provides reimbursement for three specific mHealth tools: remote monitoring of sleep apnea, a mobile app used for diabetes management, and a software used to detect relapse in lung cancer patients. In the US, the decision to evaluate some mHealth technologies over others depends heavily on the needs of individual payers and their external stakeholders. For example, the Centers for Medicare and Medicaid Services is currently considering reimbursement for three unrelated mHealth programs (regarding the COVID-19 pandemic, emergency department visits, and chronic pain), with the impetus for initiating these reviews being based on the current needs of various external providers, public health authorities, and lawmakers. As such, it appears that HTA agencies do not have a standard approach to evaluating DHTs for reimbursement purposes.

Challenges for mHealth

In markets across the globe, the widespread integration of mHealth into the healthcare system, and the data it produces, is in its infancy and developers face challenges associated with regulatory and reimbursement approval in multi-payer and single-payer HTAs.

The lack of consensus and clarity on how mHealth should be reimbursed places a heavy burden on payers to administer different policies for every mHealth technology that comes onto the market. Multiple reimbursement channels exist for mHealth due to the large variety of functions it can serve. For example, in the US, mHealth apps have been paid for by six different reimbursement channels, depending on whether these apps are viewed as drug therapy, part of a bundled treatment, a device, a lab test, part of a value-based payment bundle, or simply a consumer-facing tool. In the same vein, classification of mHealth technologies into standalone software, medical device, prescription drug use-related software, and other categories is still a topic of debate and will likely influence reimbursement decisions. These challenges, along with the lack of standardized HTA assessment frameworks for mHealth, will need to be navigated and addressed before mHealth receives payer coverage on a large scale.

Conclusions

mHealth, and the subsequent data that is generated from it, in combination with analytics, offers a wide array of exciting opportunities for all stakeholders (patients, providers, and manufacturers). These opportunities include, but are not limited to, the facilitation and acceleration of drug development, the advancement of diagnostic algorithms, the collection of patient-reported data, and a shift towards personalized medicine. Moreover, data obtained from mHealth can provide real-world safety information, inform predictive modelling, and assist comparative effectiveness research, all of which have the possibility to lead to significant benefits to patients. However, collaboration between healthcare providers, academic institutions, and the pharmaceutical industry will be essential to expand the use of mHealth and the subsequent impact the data can have on healthcare policy and delivery.

There are vast opportunities for mHealth to address unmet clinical need, develop endpoints that are more patient-centric, and heighten existing trial endpoints; however, thoughtful selection of the inclusion of technology-derived measures must be taken into consideration. As manufacturers are considering utilization of mHealth in pre-launch or post-launch initiatives, it is critical to develop a digital health roadmap to navigate the development, commercialization, and employing of mHealth to ensure maximum success.

The article should be referenced as follows:

Yan A, Ruban C. The era of mHealth: a global perspective. HTA Quarterly. Summer 2020. https://www.xcenda.com/insights/htaq-summer-2020-era-mhealth-global-perspective.

Sources

Browne SH, Umlauf A, Tucker AJ, et al. Wirelessly observed therapy compared to directly observed therapy to confirm and support tuberculosis treatment adherence: a randomized controlled trial. PLoS Med. 2019;4(16):e1002891.
Card R. Latta introduces legislation reducing barriers to non-opioid pain management alternatives. https://latta.house.gov/news/documentsingle.aspx?DocumentID=402293.
Coons SJ, Eremenco S, Lundy JJ, O’Donohoe P, O’Gorman H, Malizia, W. Capturing patient-reported outcome (PRO) data electronically: the past, present, and promise of ePRO measurement in clinical trials. The Patient-Patient-Centered Outcomes Research. 2015;8(4):301-309
Swedish Health Services Builds COVID-19 Emergency Response App with help from Microsoft. https://www.swedish.org/about/swedish-news-blog/2020/04/covid-emergency-response-app.
Liu X, Varshney U. Mobile health: A carrot and stick intervention to improve medication adherence. Decision Support Systems. 2020;128:113165.
The MedTech Week. Paying for digital health. https://medtechweek.eu/medtech-week-magazine-2019?read=paying-for-digital-health.
mHealth Sub-group. Report on national mHealth strategies. https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20161121_co22_en.pdf.
Moshi MR, Tooher R, Merlin T. Suitability of current evaluation frameworks for use in the health technology assessment of mobile medical applications: a systematic review. Int J Technol Assess Health Care. 2018;34(5):464-475.
Okunrintemi V, Spatz ES, Capua PD, et al. Patient-provider communication and health outcomes among individuals with atherosclerotic cardiovascular disease in the United States. Circulation. 2017;3(10):e003635.
Phaneuf A. How mHealth apps are providing solutions to the healthcare market’s problems. https://www.businessinsider.com/mhealth-apps-definition-examples.
Powell AC, Bowman MB, Harbin HT. Reimbursement of apps for mental health: findings from interviews. JMIR Ment Health. 2019;6(8):e14724.
Reed ME, Huang J, Brand RJ, et al. Patients with complex chronic conditions: health care use and clinical events associated with access to a patient portal. PLoS One. 2019;14(6):e0217636.
Rock Health. Digital Health Consumer Adoption Report 2019. https://rockhealth.com/reports/digital-health-consumer-adoption-report-2019/.
Snowdon A. HIMSS Defines Digital Health for the Global Healthcare Industry. https://www.himss.org/news/himss-defines-digital-health-global-healthcare-industry.
Weldring T, Smith SM. Article commentary: patient-reported outcomes (pros) and patient-reported outcome measures (PROMs). Health Services Insights. 2013;6:HSI-S11093.
Wicklund E. 2018. mHealth Scores High With Consumers in Boosting Medication Adherence. https://mhealthintelligence.com/news/mhealth-scores-high-with-consumers-in-boosting-medication-adherence.
Wicklund E. 2019a. CMS eyes reimbursements for mobile integrated healthcare programs. https://mhealthintelligence.com/news/cms-eyes-reimbursements-for-mobile-integrated-healthcare-programs.
Wicklund E. 2019b. With mHealth, patient portals improve the patient-provider connection. https://mhealthintelligence.com/news/with-mhealth-patient-portals-improve-the-patient-provider-connection.
Wicklund E. 2020. CMS updates FAQ document on Medicare coverage for telehealth. https://mhealthintelligence.com/news/cms-updates-faq-document-on-medicare-coverage-for-telehealth.

The Era of mHealth: A Global Perspective