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Mobile Apps Drive Future of Patient Care: Apps enable users to monitor chronic conditions outside medical facilities as part of daily routine.

It seems like there's an app for everything these days, and medical apps are no exception. A 2015 report estimated that over 500 million smartphone users were currently using some form of medical app, and a 2017 report estimated the industry made over 27 billion in profits in 2014. Not all medical apps are created equal, however.

Mobile health apps have gone beyond health and wellness apps, such as Fitbit, becoming an indispensible tool for patients with more serious health conditions. The FDA classifies mobile medical apps into three categories: unregulated, enforced discretion, and regulated. The "regulated" medical apps are treated the same as any other medical device, and are subject to all laws and regulations covering them. Currently, only 286 medical apps fit into this category.

Jeff Dachis, CEO of One Drop, a company devoted to the FDA approved app for diabetes management called One Drop (Figure 1), says there is still hesitancy in users to use such apps. "For patients, the biggest challenge in the adoption of health apps is a suspicion that an app will not be easy to use, and they will have trouble integrating the app into daily life."

Dachis asserts that when patients begin to use the app they typically continue. "People keep using One Drop because it quickly becomes an integral part of their diabetes care team." While healthcare providers are often still suspicious of apps for conditions like diabetes, where the patient needs to do much of the care themselves, the app helps bridge the gap between the patient and medical system. "One Drop acts as a care-extender, providing the education and support that patients need to manage diabetes between appointments."

Dachis has been clear about the technology he would like to see integrated within the One Drop app. "One thing that would make One Drop even more useful would be the ability to integrate with more connected devices, such as insulin pumps." The data any app can connect with is of crucial importance. "Diabetes is a data-driven condition, so the more data One Drop is able to pull into the app, the bigger the opportunity to provide our users with more robust coaching, data-driven insights, and automated decision support."

Because diabetes has become an acute problem for many, other mobile apps for monitoring diabetes have become available. For instance, Novo Nordisk's Cornerstones4Care (C4C) app enables patients with diabetes to track and measure their blood glucose, while also tracking activity data from current available diabetes and exercise devices. Additionally, the app includes resources to provide personalized support programs for specific individuals with diabetes. Within the first 14 days of the app's existence, 112 people accessed it.

In a similar vein, Diabetes Connect is a mobile app that enables diabetes patients to easily document and create diabetes documentation in just a few clicks. The user can input blood sugar, meals, insulin, medications, and other parameters, giving him/her a complete diary of diabetes-related information on hand at all times.

Heart disease is another chronic condition where apps are becoming available to help users monitor themselves. KardiaMobile (Figure 2), from Alive-Cor, is an FDA-cleared, clinical-grade personal EKG monitor that works with most smartphones and tablets. The app, which costs $99, includes a pair of electrodes and helps to capture a medical-grade EKG in 30 seconds. It instantly lets users know if their heart rhythm is normal or if atrial fibrillation is detected, and emails the EKG to the user or his or her doctor.

Not all apps diagnose diseases. Constant Therapy, from The Learning Corporation, gives elderly patients a mobile cognitive training app that integrates digital speech, language, and cognitive exercises. It enables patients to access brain exercises from their phone or tablet while remaining at home.

Constant Therapy has over 65 million brain exercises, making it one of the largest databases of speech, language, and cognitive exercises. It is designed to give the elderly much-needed cognitive training that caregivers cannot easily administer.

Dachis emphasizes the notion of the app being responsible for patients taking charge of their own care. "At One Drop, our goal is to support people with diabetes in their own self-care." Any data logged with the One Drop app can be shared with health care providers. The app is supported by the One Drop/Experts diabetes education and coaching program that focuses on providing education and support to people with diabetes.

The vast majority of medical apps fit into the "unregulated" category. While most of those apps are exercise trackers and heart rate monitors, not all of them are so benign. Unregulated apps are numerous in number versus FDA regulated ones--there's an estimated 40,000 of them out there.

Despite their lack of approval, companies have not stopped making claims about their apps to gain FDA approval that they don't have. For instance, one Seattle manufacturer was forced to pay $150,000 in settlement because of claims their app, UltimEyes, was "scientifically shown to improve vision." Two different apps, Mole Detective and MelApp, also falsely claimed the app could detect early stages of melanoma.

Dachis notes, "Many apps, including One Drop, are considered minimal risk, and the FDA has taken a relatively hands-off approach." Apps that are tangentially related to health--for such goals as smoking, weight loss, and physical activity--have been reviewed by the American Heart Association and the evidence "generally supports" their use.

According to Dachis, "The FDA has been very helpful in answering questions and helping app developers determine whether a premarket application is required." However, since this is limited to those apps that apply for FDA approval in the first place, it's hard to tell how many are deliberately trying to skirt those regulations.

Some apps, such as Constant Therapy, are designed to increase the cognitive potential of elderly citizens and aren't considered medical devices in the strictest sense, but are based on simple principles of brain development and degradation. The Learning Corporation states that its main goal is to enrich the connections between the elderly and their caregivers, as well as improve the quality of life amongst the homebound elderly.

"Enforcement discretion" apps are less clear in nature, and can be anything that provides coaching for a disease or condition to an arterial blood pressure calculator. These apps occupy less of the market than unregulated ones, and don't seem to make the elaborate claims that some of the unregulated ones do. Of course, there is always potential of the app being misconfigured and making an error in calculation.

With an estimated $77 billion in profits to be collected by sellers of mobile apps this year (and $189 billion estimated to be made by 2020), it's clear apps are becoming a central part of most people's lives. And while the regulated ones certainly fit in that category, the unregulated ones still have the potential to do harm.

By Annie Keller, Contributing Writer

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Title Annotation:Emphasis On Digital Medicine
Author:Keller, Annie
Publication:Medical Design Technology
Date:Nov 1, 2018
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