Top Failures With Mobile Health Apps

As the medical device industry looks to enter the world of mobile apps, here are six common issues you should be ready to address.

27 May 2015

Smart, connected devices are more relevant in daily life than ever, and their demand keeps growing.  Some estimates suggest that in just five years, there will be four wireless devices for every person on the planet!  Like all industries, widespread adoption of mobile devices and apps in healthcare is a growing reality.  Yet, as the industry tries to navigate the mobile health app space, they may find a lot of confusion and uncertainty. As a result, app developers have run into several common issues as they attempt to roll out offerings in this space.

There are several areas that present challenges for would-be developers of mHealth apps.  Six of the most common are:

  1. Patient Safety and Security – Many mHealth apps contain personal data that most would consider sensitive like health readings, monitoring information, conditions, medications and vital statistics.  Given the added layer of regulatory guidelines on patient privacy, there is a clear need for careful consideration of protecting patients' security.  Thorough testing to make sure apps protect this information is essential.
  2. In-App Security – Also important is security within the app itself. Balancing the need for user control, security and managing social media interaction all need to be accounted for in developing mHealth apps through PINs, passwords, timeout features other offerings.
  3. Privacy Policy Gaps – As mentioned above, the personal, sensitive nature of the data collected in mobile health apps requires developers to abide by regulatory protocols like the U.S.'s Health Insurance Portability and Accountability Act (HIPAA).  While time consuming, the creation of a strong privacy policy is well worth the effort. Things to consider include privacy related to the app's function, collection and storage of data and how privacy will be protected.
  4. Lack of Expert Involvement – A physician or subject matter expert is essential to ensuring the app is useful, accurate, functional and on point for the industry. Consulting with these experts can help ensure that an app offers value to consumers and the industry.
  5. Usability Issues - Apps can offer surprises to developers and users alike.  Planning for usability issues—both those you can anticipate and those you cannot—is essential.  Knowing how you'll address both types of issues can save everyone a lot of headaches down the road.
  6. Lack of Regulatory and Testing Knowledge – In a highly regulated space like healthcare, a lack of knowledge about regulations and testing specifications can be detrimental. Understanding which apps require FDA review and having the necessary regulatory and testing frameworks in place can help you avoid unwanted FDA attention, losses or bad reviews from consumers.

Mobile Health app development is largely uncharted territory for developers and the healthcare community. Anticipating common issues and confronting them as soon as possible could mean the difference between a failed app and a successful product. 

For more information on these six common issues, and how to mitigate them in the development process, see this white paper on the Top 6 Failures in mHealth Apps.

Today's author is Delmar Howard, mHealth Program Manager. In his role as mHealth Program Manager for Intertek, Delmar Howard helps to create and manage mobile application testing programs. He has been directly involved in the design and implementation of several certification programs within the mobile and wireless industries, including the development of Intertek’s first mHealth application guidance program, as well as the company’s mHealth cyber security framework requirements. He is based in Intertek’s Blue Bell, Pennsylvania facility.