Sixty-seven-year-old Richard Macdonald had a taxing sleeping pattern, waking up every one or two hours throughout the night. He’s no insomniac — his condition is much more common and affects approximately 200,000 Americans. He’s the parent of a diabetic child.
“I used to get up in the middle of the night every couple of hours and do a blood test with her asleep,” saidMacdonald, who would finger-prick his 8-year-old daughter in order to measure her glucose levels. “I got down to where I could do it without waking her up.”
Nights are the scariest moments for Macdonald — if his daughter’s glucose levels fall too low, she could fall into a coma and die in her sleep. But he no longer needs to travel to his daughter’s room every two hours, because the company that manufactures her glucose-monitoring sensor released an app that allows Macdonald to track her glucose levels constantly.
“I have my clock, and I have my iPhone plugged into the top of the clock — it’s on all night. I just open one eye, look at it where I can see the time and her blood sugar number,” Macdonald said. “No more getting out of bed, no more traipsing into her room.”
Yes, there’s an app for that.
The app, produced by Dexcom, is one of many healthcare-oriented mobile apps in a recent trend toward making medical information available on phones. Mobile medical apps allow for medical information and services to transcend the doctor’s office, thereby giving users a constant reference for tracking and improving personal health. As apps have begun to flood the medical market, health experts and government agencies struggle to regulate these products to ensure that apps do not compromise patients’ health.
Dexcom’s app technology was first cleared for approval by the FDA in January 2015. The entire system consists of a sensor that penetrates just under the skin and continuously monitors glucose levels in the tissue, which then transmits to a monitoring device worn on the person. That device additionally connects to the person’s phone; the person can designate as many as five other people who can track the glucose levels in real-time through Dexcom’s app developed for the iPhone.
Dexcom’s Share technology is a unique blend of mobile apps paired with devices that allow people to track glucose levels constantly, erasing parents’ fears of the unknown during a child’s play time in between the finger pricks and blood tests. Other apps are usually stand-alone products that don’t rely on additional devices or hardware, and quite often they are free.
Although these apps have only existed for the past few years — in tandem with the advent of smartphones — similar program-based medical references have existed for computers, palm pilots and some mobile browsers for more than a decade.
Epocrates produced its first mobile “app” for PDAs in 1999 and has been a staple drug reference for physicians ever since, allowing doctors to determine proper doses and side effects for any drug. Such medical reference apps have become a necessity for medical students as well.
Denver Brown, 30, a student in BYU’s nurse practitioner program, uses Epocrates, as well as several other apps, to refer to proper medical treatment for patients while in clinical settings.
“It’s 100 percent necessary to provide thorough, long-term assessment when I’m not familiar with something,” Brown said. “I use these apps in a clinical setting every day, and I’ll never stop using them.”
History of medicine and phone apps
Balancing medical app benefits with safety
Healthcare apps have become more patient- and user-friendly with the popularity of smartphones, allowing people to find medical information and self-administer proper healthcare without having to consult a doctor. This recent change in doctor-patient communication raises issues as to the safety of apps that could potentially deter patients from seeking healthcare from their physicians.
The FDA issued new rules in January that define three classes of mobile medical apps and devices and the regulations imposed upon those apps. High- and intermediate-risk apps require approval by the FDA before entering the market, with some surveillance thereafter. Although some regulations exist for low-risk apps, the FDA announced it would not seek to enforce compliance with those regulations for each mobile medical app.
Some apps directly intend for patients to receive their healthcare for cheap. San Francisco-based app First Opinion was premised on the notion that the majority of visits to a doctor’s office are unnecessary and costly. Its goal is to help its users understand when such visits are necessary or not.
What else do these apps offer?
Utah native and BYU graduate McKay Thomas started First Opinion in 2014 shortly after he and his wife had their second child. Currently only available on iPhones, First Opinion allows users to text a network of doctors 24/7 on health concerns, even take and send pictures of things like rashes or skin lesions. A doctor responds on average within five minutes and, after some follow-up questions, gives the person advice as to what may cause the problem.
First Opinion is restricted to its namesake — only giving a doctor’s first opinion rather than an official diagnosis or a prescription. Such actions would require the company to comply with more FDA regulations to ensure that patients receive appropriate healthcare.
In order to ensure that First Opinion users get the right healthcare needs, the company has a selective hiring process for its doctors – only 1 percent of applicants receive employment.
Additionally, the majority of doctors in First Opinion’s network are of Indian heritage. When asked about the reason for this, Thomas said in an email that the company “decided to explore a more global view that would allow us to address the actual needs we were seeing from our users and at the same time make it more affordable, and in most cases free.”
Despite the array of medical apps available in the U.S. and other major markets, not all healthcare services can fit in one’s pocket. German healthcare company Caterna admits that its software program treating children with amblyopia — also known as lazy eye — would be inefficient as a phone or phablet app.
Caterna uses simple games and a series of patterns on the screen to train and therapeutically improve a child’s weak eye.
“Because the child has to move and focus the eye, it really only works on a computer with a large enough screen,” said Markus Müschenich, a mentor and investor in the company. Instead of creating a therapeutic app, Caterna created an app that allows parents and doctors to monitor a child’s progress.
Medical apps face problems in different markets
German healthcare companies manufacture products and apps at an increasing rate. Other German-based healthcare apps include Clue, a mobile journal for tracking menstruation cycles, and Klara, an app similar to First Opinion in that it allows users to send pictures of irritated areas of skin to a doctor for a professional opinion.
However, most apps that have price tags or other devices attached have difficulty becoming available in multiple markets. Caterna, for example, is prescribed by doctors in Germany and allows for patients to be reimbursed through health insurance. In other countries, patients have incompatible insurance and are forced to pay out-of-pocket for the program.
Likewise, Dexcom users in the U.S. typically pay only 20 percent for the glucose monitoring kit and the insurance company pays the rest. Although Dexcom is available in 35 other countries, non-U.S. patients also have to pay for the $800 device on their own.
Despite the difficulties achieving global availability, medical app developers are optimistic about the future of mobile medicine.
“This is testing the limits of what’s possible — it’s the bleeding edge,” said Thomas. “And it’s our job to be a good player. There are so many more things that we can do.”