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Emergence of Application-based Healthcare

August 5, 2022
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Introduction

The demand for digital healthcare, including both telemedicine and healthcare-related software applications (apps), has accelerated drastically during the COVID-19 pandemic. In 2020, more than 90,000 healthcare apps became available. Currently, more than 350,000 healthcare apps are available on the global market.1 Patients have widespread access to many types of healthcare apps, which hold promise for increasing access to care. However, the absence of meaningful clinical evaluation for many of these apps2,3 raises potential patient safety issues.

Landscape of App-based Healthcare

Apps are software programs that perform tasks such as sending reminders to take medications, providing education, or enabling a person to record blood pressure measurements. Health apps are commonly used on mobile devices such as smartphones (e.g., an iPhone or Android), tablets (e.g., iPad), and smartwatches (e.g., Apple Watch or FitBit). Smartwatches are devices that run apps and are worn on the wrist. These devices are called wearables.

Healthcare apps are personalized for the type of end-user. Patient-facing apps are directed at the patient for the purpose of self-care, which can include education or information about general wellness or specific disease states. Some apps function to direct patient self-care that involves monitoring health status (e.g., monitoring blood sugar levels)4 or treatment that directs the patient to take specific actions for addressing their own health (e.g., medication adherence).5 Clinician-facing apps provide medical education or information from a treatment perspective (e.g., clinical drug information).6 Clinician-facing apps might assist with diagnosis of a disease or help clinicians tailor appropriate preventive care (e.g., calculating stroke risk factor scores).7 Some healthcare apps are a hybrid between patient-facing and clinician-facing and function to communicate between patient and clinician (e.g., patient-measured vitals are recorded and communicated to the clinician through the app).8 The recent increase in the demand for digital healthcare will likely spur innovation in healthcare app design. This technology holds promise for increasingly sophisticated products.

The U.S. Food and Drug Administration (FDA) provides regulatory oversight to help ensure the safety of patients using healthcare apps. Apps designed for a medical purpose, even if not integrated into a device, may be deemed a medical device by the FDA and referred to as software as a medical device (SaMD). In contrast, software apps that are integrated into medical equipment or smart medical devices are referred to as software in a medical device (SiMD). The FDA’s guidance9,10 for healthcare app developers continues to evolve alongside technological advances.

Development of Safe, Efficacious, and Equitable App-based Healthcare Products

The design of safe and effective healthcare apps involves several key components: operability, privacy, security, and content. A human-centered approach that focuses on heterogenous user populations is required to yield a satisfactory app user experience and to produce an app with a high degree of operability (i.e., ease with which a person can effectively use an app) across diverse user populations. Patient privacy must be safeguarded to protect confidential patient health information. Securing the software programming and platform system that runs the app is necessary to prevent any external threats (e.g., hackers) that could alter how the app performs in a potentially unsafe manner. Finally, the content of the app requires rigorous, ongoing attention from clinical experts in the appropriate fields of medicine. To function in a safe and effective manner, the clinical content of an app must be maintained to reflect the most current evidence-based treatment guidelines. Technological innovation for app design must be balanced with the need to maintain operability, privacy, security, and content.

More rigorous clinical evaluation of healthcare apps is needed. A potential patient safety issue is consumer-level healthcare apps that have been created without meaningful clinician oversight and clinical evaluation.11,12 A study conducted on the instant blood pressure app manufactured by AuraLife (no longer available) found the app to be clinically inaccurate despite study participants’ perception that it was accurate.13 Researchers note the app systematically under-reported blood pressure levels, misclassifying pateints who were hypertensive as non-hypertensive, which exposes these patients to potential harms from the sequalae of under-treated hypertension, such as stroke, or myocardial infarction. The researchers hypothesized that user experience may have been enhanced by inaccurately low blood pressure readings, which contributed to the popularity of the app. The results of this study illustrate that potentially serious patient safety issues might have resulted with use of widely available healthcare apps and underscore the need for more transparent clinical evaluation. Overall, clinical information provided by healthcare apps must be assessed from many angles to ensure safe use.14 In addition to the risks posed from incorrect or incomplete information, safe app design must also include consideration of how patients will use the clinical information provided by the app. For example, when clinical information is provided that suggests a possible danger to a patient’s health, the appropriate patient response (e.g., to seek medical attention) must be clear and explicit.

Another major area of healthcare app design and deployment that needs to be addressed is equity. App end users, particularly those in marginalized groups, who have low health literacy or little practical experience with technology, might have difficulty using these apps. This risk is further compounded by issues with limited access to WiFi or a platform device (e.g., smartphone or tablet). This lack of reliable access to technology components creates potential for harm among patients who then may not be able to access care provided through these apps and could further widen care disparities. App evaluation frameworks that include equity considerations should be prioritized in the app design process as recognized in a study of mental health apps.15 Other steps that can be taken to address these issues are to consult with stakeholders such as the National Digital Inclusion Alliance16 and to explore technology loaner programs17 that may bridge the technology access gap.

Future Directions

The future of app-based healthcare, coupled with the use of devices and wearables, is an exciting area of expansion for patients and clinicians. App-based healthcare has enormous potential for enhancing care delivery and revolutionizing traditional healthcare, but caution must be taken to ensure that the healthcare provided through this mode is safe, effective, and equitable. Rigorous testing of products developed under these efforts is paramount to meeting this objective. Sustainable reimbursement and payment mechanisms to healthcare facilities and healthcare providers for app-based healthcare products are needed. Additionally, a standardized equity framework should be developed and applied to app-based product development to reduce health inequities. When viewed through the lens of safety, patients need guidance and high-quality information that is easily understood and accessible to drive informed decisions that will maximize their safe use of these products. Balancing technological innovation and patient safety will be key to developing healthcare apps that are safe for patients.

Authors

Francoise A. Marvel, MD
Assistant Professor of Medicine
Co-Director, Johns Hopkins Digital Health Innovation Lab
Core Faculty, Johns Hopkins Ciccarone Center for the Prevention of Cardiovascular Disease
Division of Cardiology, Johns Hopkins Hospital
Chief Executive Officer and Co-Founder, Corrie Health, Inc.
Baltimore, MD

Paul Dowell, PharmD, PhD
Senior Researcher
AIR
Columbia, MD

Sarah E. Mossburg, RN, PhD
Senior Researcher
AIR
Crystal City, VA

References

1. IQVIA. Digital Health Trends 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021. Accessed June 24, 2022.

2. Millenson ML, Baldwin JL, Zipper L, et al. Beyond Dr. Google: the evidence on consumer-facing digital tools for diagnosis. Diagnosis. 2018;5(3):95-105.

3. Grundy QH, Wang Z, Bero LA. Challenges in assessing mobile health app quality: a systematic review of prevalent and innovative methods. Am J Prev Med. 2016;51:1051-1059.

4. One Drop. https://onedrop.today/. Accessed June 24, 2022.

5. Medisafe. https://www.medisafe.com/. Accessed June 24, 2022.

7. SEAL CHA2DS2-VASc. https://med.stanford.edu/seal/explore-seal-app/seal-app.html. Accessed June 24, 2022.

9. FDA Policy for Device Software Functions and Mobile Medical Applications. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-device-software-functions-and-mobile-medical-applications. Accessed June 24, 2022.

10. Content of Premarket Submissions for Device Software Functions. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions. Accessed June 24, 2022.

11. Millenson ML, Baldwin JL, Zipper L, et al. Beyond Dr. Google: the evidence on consumer-facing digital tools for diagnosis. Diagnosis. 2018;5(3):95-105.

12. Grundy QH, Wang Z, Bero LA. Challenges in assessing mobile health app quality: a systematic review of prevalent and innovative methods. Am J Prev Med. 2016;51:1051-1059.

13. Plante TB, O’Kelly AC, Urrea B, et al. User experience of instant blood pressure: exploring reasons for the popularity of an inaccurate mobile health app. Npi Digital Med. 2018;1(31):1-6.

14. Akbar S, Coiera E, Magrabi F. Safety concerns with consumer-facing mobile health applications and their consequences: a scoping review. J Am Med Inform Assoc. 2020;27(2):330-340.

15. Ramos G, Ponting C, Labao JP, et al. Considerations of diversity, equity, and inclusion in mental health apps: a scoping review of evaluation frameworks. Behav Res Ther. 2021;147:1-15.

16. National Digital Inclusion Alliance. https://www.digitalinclusion.org/definitions/. Accessed June 24, 2022.

17. Yang WE, Spaulding EM, Lumelsky D, et al. Strategies for the successful implementation of a novel iPhone loaner system (iShare) in mHealth interventions: Prospective study. JMIR Mhealth Uhealth. 2019;7(12):1-14.

This project was funded under contract number 75Q80119C00004 from the Agency for Healthcare Research and Quality (AHRQ), U.S. Department of Health and Human Services. The authors are solely responsible for this report’s contents, findings, and conclusions, which do not necessarily represent the views of AHRQ. Readers should not interpret any statement in this report as an official position of AHRQ or of the U.S. Department of Health and Human Services. None of the authors has any affiliation or financial involvement that conflicts with the material presented in this report. View AHRQ Disclaimers
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