Mobile health (mHealth) applications (apps) for smart phones and tablet computers are proliferating rapidly, ranging in complexity from products as simple as patient scheduling and point-of-care electronic physician note apps to sophisticated remote patient monitoring devices.
“The whole world of mobile health is really expanding very dramatically,” Richard J. Katz, MD, director of the Division of Cardiology at George Washington University Hospital in Washington, DC, told Clinical Advisor.
Smart phone apps are incredibly promising for the field of chronic disease management due to their pervasiveness and increasing attention by designers to things such as user experience and ease-of-use, according to Julie Kientz, PhD, director of the Computing for Healthy Living and Learning Lab at the University of Washington in Seattle.
“More and more frequently, medical professionals and technology researchers are teaming up to deliver best practices in a mobile format that can be there whenever the patient needs it, and serves as a convenient system for tracking data and receiving reminders for medications,” Kientz said in an interview.
There are many apps available in iTunes and the Android marketplace for clinical disease management, as well as patient self-management for conditions including asthma, diabetes, heart disease, cancer, and even autism and insomnia.
Currently, researchers at the University of Washington are developing an app for monitoring asthma by having patients simply breath into the smart phone’s microphone rather than using a spirometer, Kientz said. Canadian researchers have developed a wireless shoe insole that tracks foot pressure patterns to alert diabetic patients on their smart phone when they are putting too much pressure on their heels, a behavior that can lead to foot ulcers.2
Other apps are designed to help clinicians manage complex chronic diseases. For example, eOpioid is an iPhone and iPad app that helps clinicians calculate equivalent doses when transitioning patients from one opiate pain medication to another, and manage doses for patients who are taking multiple pain medications.3
In April 2012, there were 13,600 health apps, and by 2016 mHealth apps for patient monitoring are expected to be a $20 billion industry. As many as 90% of clinicians expected to be using smart phones as clinical tools by the end of 2012, and college courses on developing mHealth apps are already starting to appear. 1,3,4 Yet some worry that these rapid innovations are outpacing regulations and vigorous scientific assessment.
What technological platforms will dominate the field is still unclear, as smart phones use at least six different operating systems and tablet computer products continue to proliferate.3 Despite these uncertainties, mHealth apps are already having an impact on chronic disease management.
Wide variations in sophistication
The continuum of mHealth app’s technological sophistication is wide, from apps that offer simple, unidirectional tips and reminders to sophisticated, integrated bidirectional apps that track patient vital signs and interact with electronic health records (EHRs).
Examples of simple apps are those that use what Katz called the “alarm clock approach,” in which text messages are used to alert patients to perform certain health behaviors. These apps may or may not involve mechanisms that are connected to any other virtual or actual observer that communicate with patients for follow-up.
On the other end of the spectrum are comprehensive mHealth smart phone apps that interface with medical records portals. For example, these types of apps may help diabetes patients manage their glucose levels, diet and weight, while communicating via a web portal with clinicians, who then contact patients when red flags appear.5
“These more sophisticated systems are where mHealth apps will likely excel,” Katz said. “Successful mHealth apps are not just about mobile devices, but how technology enables patients to share information with and interact with their health care providers.”
One particularly challenging aspect of chronic disease management where apps may be especially successful is enhancing patient skills and self-management techniques. The more complex mHealth solutions have a better chance of achieving those goals, according to Katz.
“A diabetic patient has a complicated disease that requires monitoring of blood sugar, diet, and lifestyle activities like exercise, and taking and adjusting their medications. They also have standard-of-care goals to help minimize complications, such as having their eyes, feet, blood pressure and cholesterol monitored,” Katz said. “Patients need to be engaged in doing all these tasks and educated as to why it’s important.”
Despite this need, about 95% of health care apps currently on the market are consumer-only products. Most consumer mHealth apps are not created based on rigorous research and may be a waste of time and money, Kientz cautioned.
A recent analysis of mHealth diabetes apps found that despite a variety glucose self-monitoring apps on the market, there were relatively few advanced apps to help patients perform more complex activities such as tracking and managing weight, diet and exercise; controlling BP; and managing insulin levels. Few apps offered patient alerts and reminders, and few synchronized with EHRs.
In addition, persistent gaps remain between apps and evidence-based guidelines for diabetes management – most notably, for education functions that explain diabetes and its management to patients.7
A separate review of diabetes management app studies, found that many trials lacked sufficient sample sizes or intervention lengths to determine whether the results are actually clinically or statistically significant.8
But thorough testing and review takes time, and places research-based apps at a disadvantage in a rapidly evolving marketplace. “It may often take years to validate a mobile application, and by then, the technology may be obsolete. We need to find a balance between validation and time-to-release,” Kientz said.
Lack of standards
Results from clinical trials assessing health outcomes from mHealth app have been mixed, and apps do not always work as intended.
“The FDA does not currently regulate mHealth apps, so consumers and health care providers alike may have a difficult time distinguishing between those that have a research basis and those that were not thoroughly tested,” Kientz explained.
That leaves health care providers and consumers with an unregulated marketplace of largely-untested mHealth apps, some of which may be dangerous.
In 2011, the FDA released guidelines for regulatory oversight of mHealth apps. However, these guidelines only regulate apps that physically interface with medical devices that already fall under the agency’s regulatory jurisdiction, or apps that transform a mobile communications device into a medical device using attachments or sensors.6
Apps that use standard smart phone equipment like built-in speakers and cameras, are not regulated. Some clinicians feel this should change, at least when it comes to melanoma screening apps, many of which have not been scientifically validated. These products may give consumers a false sense of security, potentially leading to late detection of life-threatening tumors.
Another challenge for smart phone-based apps that use text messaging is HIPAA compliance and patient medical data security. “Most text messaging is not secure,” Katz said. “The communications industry is developing electronically secure text messaging, but it’s not yet widely available.”
However, this problem may be overcome by using messaging platforms within secure web-based mHealth systems, Katz added.
Bryant Furlow is a freelance medical writer and investigative health-care journalist based in Albuquerque, New Mexico.
- Versel N. “Wireless patient monitoring to be $20.9B business in U.S. by 2016. “ MobiHealthNews.com. July 18, 2012. Accessed: Nov. 2, 2012.
- Versel N. “Wireless shoe insert senses foot numbness that can lead to diabetic ulcers, amputation.” MobiHealthNews.com. July 16, 2012. Accessed: Nov. 2, 2012.
- Senior K. “Smart phones: new clinical tools in oncology?” Lancet Oncology. 2011;12:429-430.
- Versel N. “Florida Atlantic students devote a semester to mobile health.” MobiHealthNews.com. July 17, 2012. Accessed: Nov. 2, 2012.
- Katz R, Mesfin T, Barr K. Lessons from a community-based mHealth diabetes self-management program: “It’s not just about the cell phone.” Journal of Health Communication. 2012;17(1):67-72.
- U.S. Food and Drug Administration. FDA outlines oversight of mobile medical applications [news release].
- Chomutare T, Fernandez-Luque LF, Arsand E et al. “Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines.” Journal of Medical Internet Research. 2011;13(3):c65.
- Holtz B, Lauckner C. “Diabetes management via mobile phones: a systematic review.” Telemedicine and e-Health. 2012;18(3):175-184.