Mobile Apps are Experiencing Explosive Growth, but a Smart Approach is Needed

Mobile Apps

There’s no denying the reach and staying power of mobile healthcare applications. Here are some facts to consider:

  • According to Manhattan Research in 2013, 95 million Americans used mobile phones for health information or to access health tools–up 27 percent from 75 million in the previous year. 38 percent of online smartphone users agree that the device is “essential” for finding health and medical info[i].
  • According to Health Affairs and the Robert Wood Johnson Foundation, the number of healthcare apps is predicted to grow at a rate of 25 percent each year for the foreseeable future. Industry experts suggest that by 2018, half of the 3.4 billion mobile device users worldwide will download a health app[ii].
  • According to an IMS Institute for Healthcare Informatics Report, in December 2013, there were about 43,700 health-related apps available in Apple’s iTunes app store[iii].

In many cases, mobile health applications are exponentially proving their worth, particularly in mental and behavioral health. Mobile applications can drive high levels of consumer engagement and with that engagement comes greater visibility on the part of clinicians into the current state of the individuals receiving care. Mobile applications can give a person ownership over his or her care, and the feeling of empowerment that comes with ownership.

But this only applies to apps that are properly designed, effectively executed, and part of a greater coordinated care platform. Unfortunately, there are still significant health-related apps that are failing to meet this bar of excellence. According to the IMS Institute, a study of the nearly 43,700 purported health or medical apps available on Apple’s iTunes app store showed that only 54% were “genuine” healthcare apps. Most of the consumer-focused healthcare apps were “simple in design and do little more than provide information.” Only 159 of the consumer apps could actually track or capture user-entered data[iv].

The shadowy performance of some of these applications has caused the Food and Drug Administration to take notice. The FDA intends to exercise regulatory authority on mobile apps that meet the following criteria[v]:

  1. Mobile apps that are an extension of one or more medical devices by connecting to such device(s) for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.
  2. Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices. Mobile apps that use attachments, display screens, sensors or other such similar components to transform a mobile platform into a regulated medical device are required to comply with the device classification associated with the transformed platform.
  3. Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations. These types of mobile medical apps are similar to or perform the same function as those types of software devices that have been previously cleared or approved.

While these measures will cover a certain level of mobile apps, there is still a gray area where many unregulated applications will continue to reach the marketplace.

Strategies for Effective Mobile App Development

So what are some hallmarks of sound mobile design? What types of app development will reach and help individuals? We recommend that the overarching goal for an effective app in mental and behavioral health is one that is designed to enable consumers to participate and remain an active stakeholder in designing, monitoring and documenting compliance with their care plan. An effective app should support and monitor the entire consumer lifecycle, including assessment, care planning, service delivery, progress monitoring, and consumer/family engagement.

The thought process in building an app should be, “How can we place the consumer, as well as their supporting family—anyone in the circle of care, support and accountability—at the center of their care plan’s goals and objectives? How can a mobile app help facilitate this?”

Once this is achieved, then the goal is to extend the reach of this app to every part of the care continuum. Only when it is part of a comprehensive, integrated approach to care will the app deliver value to both clinicians and the individual, and b

[i] “U.S. Mobile Health Audience Jumps to 95 million adults—New Research Highlights Mobile Opportunities for Pharma Marketers,” Manhattan Research, (October 24th, 2013),

[ii] Brooke Borel, “mHealth and FDA Guidance,” Health Affairs and the Robert Wood Johnson Foundation, (December 5th, 2013),

[iii] Joseph Conn, “No Longer a Novelty, Medical Apps are Increasingly Valuable to Clinicians and Patients,” Modern Healthcare, (December 14, 2013),

[iv] Joseph Conn, “No Longer a Novelty, Medical Apps are Increasingly Valuable to Clinicians and Patients,” Modern Healthcare, (December 14, 2013),

[v] “Mobile Medical Application: Guidance for Industry and Food and Drug Administration Staff,” Food and Drug Administration, (September 25th, 2013),


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