Mobile health technology—also known as mHealth— is steadily creeping into the healthcare industry; it’s ushering in new patient engagement opportunities and creating broad conversations about device reliability and data security. In 2013, there were more than 43,000 health-related applications in the iTunes app store alone. More than 16,000 of those are directly related to patient health and treatment. But despite the growing number of health apps, wearable fitness trackers and biometric smart clothing, some experts argue that most of these commercial apps and devices are novelty items, and warn that the mHealth industry is still very young and has several potentially dangerous grey areas that still need to be addressed.
In consequence of limited functionality, questionable data security methods and unreliable readings, the current scope in which these tools are being used is limited. However, once the technology progresses and people implement the apps and devices into their daily routine, researchers said mHealth can push users to take control of their personal health and solve the timeless struggle of getting patients interested in their day-to-day well-being.
“I think the industry is embracing mHealth, or starting to, because they see a lot of potential to improve patient outcomes and increase their own ability to render cost-effective care,” Grant Leffingwell, a usability researcher at Battelle Memorial Institute, said. “But there are going to be some pitfalls as well if it’s not done right.”
As medical technologies steadily improve, health professionals are looking at ways to personalize and improve the treatment methods available to patients, which leads researchers to develop more intimate forms of outpatient care.
Throughout the last several years there has been a trend in the hospital and medical industries to decrease the amount of inpatient admissions (it was down to 111 admissions per 1,000 people in 2011 from 123 per 1,000 in 1991), and increase outpatient care, according to an analysis of American hospitals by Avalere Health. Outpatient care is cheaper and tends to be more effective because some patients can heal faster at home around their families and familiar comforts, rather than at a disease-festering clinical environment.
“I usually say that nobody wants to be in a hospital; the longer you’re there, the more you’re at risk for so many other things,” William Rusnak M.D., a family medicine resident physician in Philadelphia, said. “I think the hospital is probably one of the worst places for anybody to be on Earth, and the shorter duration you can be there the better—especially if you’re old, frail or your immune system is rather weak.”
This is why some experts, such as Scott Sheaf, a senior research scientist at Battelle, see mHealth becoming a popular patient management option for physicians. Sheaf said he foresees the technological trend getting people out of clinical environments and having a positive impact on patient health moving forward, but that big changes in outpatient care won’t be seen for another five to 10 years.
In the near term he predicts that doctors will see changes in patient behavior and treatment compliance, especially when it comes to chronic disease management.
“I think independent of all the perceived security, privacy and reliability issues you might be able to throw at these new mHealth devices, the positive aspect of all this is if you have something in your pocket that tracks the number of steps you take, or how far you’re running, or what your blood pressure is, or what your heart rate is, that in itself makes people think about their health and changing their behavior,” Sheaf said.
The FDA is slowly addressing various reliability and security issues that researchers are pointing out. It hasn’t officially announced regulations about the mHealth industry as a whole yet, but those rules are expected to arrive as the industry becomes further adopted by physicians and consumers. As of last year, the FDA has only approved roughly 100 healthcare and treatment apps out of the 16,000 health-specific apps in the iTunes store. An analysis of Google Play’s app store for Android devices hasn’t been completed. As more applications claiming to be medical devices flood the marketplace, the regulations they face are likely to become more stringent.
The FDA is providing guidance to developers and will exercise discretion in what they regulate, Leffingwell said. The regulatory agency’s model will be based on patient risk, which basically means if an app can be used for foreseeable misuse to cause harm to somebody, it gets more scrutiny. For example, if a developer creates a mobile health product that connects to an already regulated device, say an x-ray machine, then the FDA will want to regulate that product to ensure the same level of established standards are met. Likewise, an app that runs predictive algorithms to suggest treatment methods will also be under intense scrutiny. But a smart watch that tracks a user’s heart rate and estimates the calories they burned during a workout likely will not be touched.
The big challenge for the FDA is qualifying the promises these devices make about accuracy, and then deciding if the inaccuracies pose a threat. Despite the claims of perfection some devices and apps make, Sheaf said the sensors on many mHealth tools are not validated or calibrated to the extent of traditional medical devices, and consequently the results can be wildly inaccurate and unreliable—such is the case with many blood pressure and hormone analyzers—however, simpler tools can be very accurate—like pedometers and basic fitness trackers.
“If you’re making a clinical decision that can seriously injure or kill someone then you need some really good device accuracy,” Eric Hekler, an Arizona State University assistant professor who does mHealth research, said. “But if you’re talking about steps and the device is off a few steps each day, in that context, that poor accuracy isn't going to be nearly as problematic.”
In addition to regulating around foreseeable harm, FDA and HIPAA policies might also look at restricting the types of data mHealth devices collect and share, and the security methods included in those systems, Domingo Guerra, president and co-founder of the app risk-management service Appthority, said.
“App security becomes more important now because your data might be targeted by other vendors connected to the same device,” Guerra said. “In the past, medical devices had their own operating system and had a process of whitelisting what software can and can’t install on the same medical device. But now we see smartphones and wearables as an extension of medical devices, and having to coexist with other software on that same device is still pretty new.”
Because of this integration, experts say mHealth security in itself is becoming a complicated issue— one that the industry is in a grey area about.
Guerra pointed out that people might not pay attention to the levels of data access many apps give, and become surprised after using these for a few years and realizing that the app has access to their location, daily calendar, address book, texts, and call history—among other things. Plus, it’s entirely possible for applications to work in tandem with each other and feed off the information each individual app generates so long as they share system access. This means that when adding sensitive information—like somebody’s personal health information—into that mix, developers need to consider security from day one, he said.
In addition to what types of data and system access these devices are accessing are questions about what to do with the information itself.
“While strides are being made, there is still a lot left to be done before we have highly sophisticated and personalized mHealth systems that know us well and provide us with what we need when we need it and leave us alone when we don't need it," Hekler said.
Most systems today are tracking information and providing modest insights like how active one user is in comparison to others or giving simple diet and exercise recommendations. Truly personalized support just isn't there. Right now mHealth products are basically pumping out data and operating on a data mining approach, which presents its own set of security issues.
Researchers and developers get an abundance of information if users allow their devices to be data mined, but experts are concerned about how that information might be used against the very users it’s supposed to help.
On the positive side, Leffingwell said this access to mass data gives developers insights on how to encourage people to adopt healthier habits and reduce the need for costly medical attention on a wide scale, but a lot of people also have concerns over the long-term privacy violations associated with that approach because they don’t want corporations knowing their day-to-day health and adjusting things like their health and life insurance rates accordingly.
“One of the big problems with big data is the promise that your data can be de-identified, but any data scientist can tell you that it is very hard to truly de-identity data. Often, with just a few bits of information, a good data scientist can often triangulate down to a certain person,” Hekler said. “If we can’t triangulate the person we can probably get close, like the neighborhood you live in and the street. So promising that we can protect individuals with de-identified data is, sadly, often times a bit of a farce.”
Consequently, Guerra, Hekler and Sheaf said that the industry is having a conversation looking at the ways to educate users about the risks they’re taking when sharing data from mHealth devices. They all agree that users need to be aware that this technology opens the floodgates to more personal information than ever before, and users have to trust these apps’ security methods and trust that they will not be targets themselves by hackers who want that sensitive information.
But until the FDA steps in, these security and data usage choices will vary from developer to developer. Guerra said he thinks that developers will largely try skirting around the loose regulations currently in place through creative branding until rigorous classifications are made for them. “I think it’ll be similar to the government saying, ‘yes, you’re a lifestyle app, but you’re collecting this kind of data therefore you’re not just a lifestyle app, but a health app,’” he said. “Before regulation it’ll be open to interpretation, and after regulation it’ll be more dependent on what kind of data they’re getting access to.”
Assuming these hurdles are solved, what’s to keep patients using mHealth products?
If mHealth products require that patients do a lot of work, their results are going to suffer and the likelihood of continuous use decreases dramatically, Rusnak said. Patients will probably be more susceptible to using mHealth products if they don’t have a high learning curve or add menial tasks into their daily schedule, he said.
But Hekler said this alone isn’t enough, and he’s seen a drop off in fitness app engagement after about three months. He says the products need to provide a continuous amount of value compared to the amount of burden, even if it’s a small burden, being placed on people.
One method he is researching is creating a system that is smart enough to quiet down and adapt to something new once users get to a steady state. “Basically we're trying to build out systems that will only ping you if you need it,” Hekler said. “We are doing things like exploring how to have systems ramp up and ramp down to each person based on their own progress and achievements as well as set-backs and life circumstances.”
Despite all of the concerns, Rusnak said he thinks the way the industry is moving is a good thing and mHealth will help people get engaged with their personal health.
“I think the biggest challenge is having people become health-conscious,” Rusnak said. “But once people break that point of ‘I don’t care at all about my health,’ to ‘I’m going to start watching what I’m eating, and moving around and exercising,’ you’re already over the wall that you need to get over in the first place.”