Oversight, Regulation, and Payment for Mobile Health Apps

by Jilene Haas, PharmD Candidate; Michael Ernst, PharmD, BCGP, FCCP; and Michelle Fravel, PharmD, BCPS, FCCP, University of Iowa College of Pharmacy

As of October 2022, nearly 100,000 mobile health applications (apps) were available for download from the Apple App Store and Google Play Store.^1,2 These apps span a wide range of intended uses, from improving general well-being and fitness to medication adherence and aiding in the control of a disease. Pharmacists in the ambulatory care setting are increasingly likely to encounter patients using mobile health apps in their day-to-day practice. A survey conducted in January 2023 found that 40% of U.S. adults used at least one mobile health app, an increase from 34% in 2018.³ As the use of mobile health apps grows, it is important to understand how they are regulated and to identify apps with evidence of safety, accuracy, and effectiveness.

Federal Food and Drug Regulation of Medical Devices and Software Applications

In the United States, only a small subset of mobile health apps are regulated by the Food and Drug Administration (FDA). The FDA has regulatory authority over medical devices; however, not all mobile health apps meet the FDA’s definition of a medical device. Mobile health apps are considered medical devices only if they incorporate software functionality that is intended to diagnose a disease or health condition, or cure, mitigate, treat, or prevent a disease.⁴ Software functions that meet the definition of a medical device are subject to FDA oversight regardless of the platform on which they run (e.g., mobile phone, tablet, smartwatch). The vast majority of mobile health apps on the market do not meet the FDA’s definition of a medical device, including apps to log, record, track, evaluate, or make behavioral suggestions related to general fitness, health, or wellness.^4,5 In addition, apps that allow a user to record data (e.g., blood glucose, blood pressure, heart rate, weight) to share with a healthcare professional are not considered medical devices. Some medical devices, such as certain blood pressure cuffs or continuous glucose monitors, transmit data to an adjunct mobile health app – the associated app is considered a software component of the medical device and regulated as such.

The FDA regulates medical devices and mobile health apps based on the perceived risk to the user. Apps that pose low risk to patients are those intended to help patients self-manage their disease or health condition but do NOT provide specific treatment or treatment suggestions.⁴ Some examples include apps that coach patients with conditions such as cardiovascular disease, hypertension, diabetes, or obesity by promoting strategies for maintaining a healthy weight, optimal nutrition, exercise and fitness, managing salt intake, or prompting medication doses based on a pre-defined schedule.⁴ In the case of low-risk devices and apps, the FDA declines to enforce regulations. Examples of common mobile health apps that are considered low-risk and not regulated by the FDA include Noom®, MyFitnessPal^TM, Headspace®, and Calm®.

The FDA’s regulatory oversight focuses on mobile health apps whose functionality poses a risk to a patient’s safety if the software fails to function as intended. These apps perform patient-specific analysis and provide diagnostic information or treatment recommendations to patients, caregivers, or other users who are not health care professionals.⁴ While smartwatches (e.g., Apple Watch®, Galaxy Watch®, Fitbit®) are not regulated as medical devices, certain smartwatch apps are regulated by the FDA due to their potential risk to a patient’s safety, including apps that function as an electrocardiograph to record heart rhythms or as a blood oxygen saturation sensor.⁴

When an app is subject to FDA oversight, it is assigned a regulatory class based on the level of control necessary to provide reasonable assurance of its safety and efficacy. Class I devices and apps are low risk and subjected to general controls; Class II are moderate risk, subjected to general and special controls; and Class III are high risk, subjected to general controls and require premarket approval.^6,7 Due to their low risk, most Class I devices are exempt from premarket submission.⁶ Class II devices must demonstrate reasonable assurance of safety and efficacy, typically through a prospective clinical trial or by demonstrating substantial equivalence in function to an existing device previously cleared by the FDA.^6,8 Class III devices must apply for premarket approval, which requires clinical studies showing that the device’s possible benefits outweigh the risks, in addition to significantly helping a large portion of the target population.^6,9 The FDA differentiates between its multiple regulatory pathways by assigning different terms to devices, including “FDA-cleared”, “-granted”, “-authorized”, and “-approved”. Once mobile medical apps meet these regulatory requirements, they are subject to post-market monitoring similar to other medical devices, including adverse event reporting as well as potential recall and removal from the market.¹⁰

A small but unique subset of FDA-regulated mobile health apps are referred to as “digital therapeutics” (DTx). The term “digital therapeutic” is formally defined by the International Organization for Standardization (ISO) as “health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstratable positive therapeutic impact on a patient’s health.”¹¹ In addition to evaluating the safety and effectiveness for each digital therapeutic, the FDA determines whether a prescription is required to authorize its use by patients.  When a prescription is required, the mobile health app is considered a prescription digital therapeutic (PDTx).⁷ This terminology distinguishes DTx and PDTx from the thousands of mobile health apps available on the market.¹¹

As evidence-based therapeutic interventions, PDTx are a potential treatment option for a variety of diseases. They may be used as stand-alone treatments or concurrently with pharmacotherapy. The process to obtain a PDTx typically involves: (1) a clinician with prescribing authority writes a prescription for the product; (2) the prescription is sent either directly to the product manufacturer or a partnered platform to process payment; and (3) delivery of the physical PDTx or the mobile app authorization code to the patient. A recent analysis found that there were 20 FDA-regulated PDTx available on the market as of November 2022.¹² Examples include mobile apps that help patients self-manage basal insulin titration and cognitive behavioral therapy (CBT)-based interventions to improve irritable bowel syndrome (IBS) symptoms.^7,13 Additional available PDTx include a video game mobile app that helps treat attention deficit hyperactivity disorder (ADHD), a hypnotherapy mobile app, and an intravaginal motion sensor and app-based software program that guides pelvic floor muscle training in patients with urinary incontinence. ^7,13  See Table 1.

Table 1: Sample List of FDA-Regulated PDTx currently available in the United States^a,b

PDTx Product (Manufacturer)	Therapeutic Area	Description	Supporting Evidence	How to Obtainb
EndeavorRx®1 (Akili)	ADHD in patients aged 8-17 years	Immersive video game that targets attention and cognitive control via mobile app	Kollins et al.2,3	$99 for 30-day prescription FSA/HSA eligible
Freespira®4 (Freespira)	Panic disorder, PTSD	Breathing sensor paired with mobile app helps retrain breathing patterns	Ostacher et al.5Tolin et al.6Kaplan et al.7	Available through VA, employers, health insurance Cost not published
Insulia®8 (Voluntis)	T2DM	Self-management of basal insulin in adults with T2DM via mobile app	Franc et al.9Nevoret et al.10	$0 for 12 months through Insulia Savings Programc
iSage RxTM 11 (Amalgam Rx)	T2DM	Self-management of basal insulin in patients with T2DM aged ≥21 years via mobile app	Grdinovac et al.12Core titration algorithms studied in multiple trials13-18	Cost not published
Leva®19 (Axena Health)	Urinary incontinence	Vaginal motion sensor paired with mobile app guides pelvic floor muscle training in women	Weinstein et al.20,21	Covered by Cigna Healthcare insurance Cost not published
Luminopia®22 (Luminopia)	Amblyopia	Binocular therapy to rebalance optical input to the brain delivered via TV shows and movies on a VR headset	Xiao et al.23-25	Cost not published Product website resources include billing codes and appeal templates
Mahana IBSTM 26 (Mahana)	IBS	CBT to reduce IBS symptom severity delivered via mobile app	Everitt et al.27,28	$199 for 90-day prescription FSA/HSA eligible
NightWareTM 29 (NightWare)	PTSD-driven traumatic nightmares	Uses Apple Watch® sensors to analyze and interrupt nightmares without waking patient, improving sleep	Stephan et al.30Davenport et al.31	Available through VA and DoD Cost not published
Regulora®32 (metaMe Health)	IBS	Gut-directed hypnotherapy delivered via mobile app	Berry et al.33	$75 for 90-day prescription (or lower if covered by insurance)
RelieVRxTM 34 (Applied VR)	Chronic lower back pain	CBT delivered via VR headset for pain interference and reduction	Garcia et al.35,36 Maddox et al.37	$0 for 8-week prescription with VA benefits Cost for non-VA not published

Payment and Insurance Coverage

The global market for PDTx was valued at USD 6.2 billion in 2023, but it is forecasted to grow to USD 32.5 billion by 2030.¹⁴ Despite this expected growth, there are barriers to the widespread use and adoption of PDTx in the United States. First, there is currently a relatively small number of FDA-regulated PDTx compared to other mobile health apps.⁵ Clinical trials and FDA review of PDTx take significant time and funding, so PDTx cannot come to market as quickly as non-regulated mobile health apps. Another barrier is the challenge for clinicians and patients to identify available PDTx.¹² To compile a complete list would require cross-referencing multiple sources such as publicly available formularies; the Digital Therapeutics Alliance product library; the FDA’s 510(k) and De Novo databases; a web-based digital health repository known as Exits & Outcomes; and health news sources, like StatNews and the Pink Sheet.^7,12 A third barrier is the current payment model for PDTx. Medicare generally does not pay for software products since there is no existing benefit category.⁸ The Access to Prescription Digital Therapeutics Act is a bipartisan bill that was introduced in the Senate in 2022 and reintroduced in 2023, which aims to add PDTx to the list of services and products eligible for coverage under Medicare and Medicaid.^12,13,15,16 In addition, the bill directs the Centers for Medicare and Medicaid Services (CMS) to establish product-specific billing codes for PDTx.^13,15,16 A few PDTx manufacturers have worked independently with public or private insurers to obtain coverage for their products.^13,17 While this is a start, the U.S. has been slow to address digital therapeutic reimbursement. In contrast, Germany, for example, lists all digital therapeutics on the DiGA directory (Digitale Gesundheitsanwendungen, also known as Digital Health Applications in English), and these products are covered by all statutory health insurance plans.¹⁸

The Bottom Line

The vast majority of mobile health apps available to the general public in the U.S. are not regulated and, therefore, are not evaluated for safety or effectiveness. The FDA takes a risk-based approach, and currently, their regulatory focus is limited to those that meet their definition of a medical device and may pose a risk to patients if the software fails to function as intended. Prescription digital therapeutics are a small subset of health software that deliver evidence-based therapeutic interventions to patients. Even though there are barriers to the widespread adoption and use of PDTx in the U.S., it is important for pharmacists to understand how PDTx and mobile health apps are regulated. Mobile health apps and DTx/PDTx are likely to play a larger role in patient care in the future.

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