Take a scroll through your smartphone’s app store, and you’ll find a wide array of applications on everything from fitness and nutrition tracking to fitness coaching and physiological monitoring available for download. But an increasing number of apps aren’t just for wellness: They are medical devices for serious health concerns such as diabetes mellitus, asthma, depression and substance use disorders.
With 85% of adults in the United States owning a smartphone in 2021, there’s no question that smartphones and access to apps are nearly ubiquitous. But as a medical policy maker you probably have a lot of questions about medical apps: What are these apps, when do they need a prescription, and do they work?
Mobile Medical Apps
Mobile medical applications (MMAs) are apps that the Food and Drug Administration (FDA) define as a medical device. MMAs can be accessories to a regulated medical device, or downloads that transform any smartphone, laptop computer, or tablet into a regulated medical device.
The FDA regulates medical apps that are used to treat or diagnose disease, support clinical decisions, and/or inform patient care management. For example, a Fitbit used by a runner to track heart rates for fitness purposes is not a medical device. However, when a new function to detect irregular heart rhythms loads Fitbit’s phone app with photoplethysmography analysis software, the Fitbit becomes an mobile medical app and is regulated by the FDA as a Class II device accordingly.
- MMAs have been created and marketed for a wide range of indications, and their features are tailored to the needs of patients, such as the following Symptom tracking
- Customized self-care instructions
- Glucose tracking and insulin dose calculation
- Cognitive behavioral therapy
- Treatment protocol adherence support
- Reporting on patient health status for physicians
When do Apps Become Prescription Medical Devices?
When the manufacturer applies and obtains prescription status from the FDA, the app is available only by prescription from a licensed clinician. This means that the patient might be able to download the app to their phone but won’t be able to log in and use it without clinical prescription and oversight. MMAs available by prescription are called Prescription Digital Therapeutics (PDTs). PDTs are not explicitly defined by the FDA nor are they regulated in a separate category from medical apps. The only material differentiator is availability by prescription.
A Path for Payment
Introducing a prescription creates a new pathway for payment. While over-the-counter drugs and devices are typically paid for by the patient, prescription drugs and devices are more commonly subject to consideration for payment by a third party if the prescriptions are determined to be “medically appropriate.” This is a term consumer are starting to hear more often that behind the scenes of healthcare payments, begins with evidence. This shift creates a new responsibility of payers to evaluate the medical appropriateness of the ever-increasing number of medical apps available by prescription.
Just as for many devices, manufacturers of MMAs that obtain FDA clearance for marketing sometimes have not proven they do the things their manufacturers say they do. This is because MMAs are typically cleared for marketing through the FDA’s 510 k pathway. Manufacturers seeking FDA clearance don’t have to prove that MMAs work: They just need to prove substantial equivalence to other devices already on the market. This might be based on configuration or features alone, without any clinical trials.
How Payers can Evaluate Safety and Efficacy
With low barriers to market entry or dissemination, new medical apps are constantly entering the U.S. market. Market research indicates additional drivers include clinician use, social medial, and general adoption of smart technologies. The medical literature is proliferating almost as quickly as the apps themselves. Thousands of publications on MMAs and PDTs have been indexed in PubMed in the last couple of years alone.
Despite the explosion of literature, the ability to draw evidence-based conclusions regarding the effectiveness of MMAs/PDTs of any one device is often limited by the small number of publications addressing any particular device. Informing evidence-based conclusions about medical appropriateness, safety, and efficacy requires meticulous and systematic research of the overall body of evidence; and the balance of benefits and harms.
The crush of new medical apps entering the market and making claims impacting patient health is a reality for payers today – and market research projects exponential growth of almost 40 Billion USD worldwide by 2029. To inform effective policy, payers will need to adapt quickly to manage the flood of new MMAs, increasing patient demand for them, and challenges in evaluating the clinical literature to determine if they really confer the benefits the manufacturers contend that they do.
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Hayes, a symplr company, provides an unbiased investigation into manufacturer claims, and uses clinical evidence to substantiate or refute those claims. If you would like to access and use this clinical evidence so you can focus on making robust policies and manage the flood of prior authorization requests and appeals, contact us.