As we discussed in the blog about Apple's mHealth watch, wellness devices are not required to obtain FDA approval. So what could the non-FDA regulated apps have in common with extensively regulated medical devices? The User Experience. At this past September's Connected Heath Summit, panelists spoke about wellness app development transitioning to be "more about refining methods, validating outcomes, and improving the user experience". It is easy to take User Experience for granted, however this emphasis on user experience is particularly important. Consider the evolution of the technical term for user interface with the device, from EUD (End User Device to UI (User Interface) to UX (User Experience). The importance of UX has been skyrocketing over the recent years as the sorts of numbers of computers people interact with daily has exploded. Though developers are becoming accustomed to thinking about the UX, healthcare has nuances that compound UX design. One of the nuances is the greater data security risks. The other is the greater challenges in motivating users. FDA's medical devices have been wrestling with these for decades, and thus can shed 'lessons learned' light to "a less regulated industry".
By now most industry insiders have accepted that wellness apps have lower clinical risk, therefore not requiring FDA approval, yet the privacy and security risks remain just as risky. As we discussed in Authentication and Repudiation, clinical data has a consistent and reliable pattern, making it is easier to intercept. This creates the opening by which hackers can gain access to users' information on a device such as their cell phone, possibly including financial information. Even though developers can use more stringent technology than SSL to secure wellness apps data transmission, users also need to understand best practices to safeguard their devices. This is not a direct requirement for the developers, but the consequence of a breach places educating users about device safety into the 'best practices' category. Even simple steps, such as providing users the option for a quick "how to use this app" which includes the recommendation for the user to password protect their device and add options to sweep the device clean in the event of a theft, are part of educating users on the care of their device, which will enhance their security. Medical devices, especially medical Home Health devices, have for years been testing and validating user instructions and education of device use, maintenance and care, thus there are 'lessons learned' wellness apps can leverage.
A subtle yet critical area is Ease of Use Principles, which drives adoption of the device. While the mHealth industry so far has banked on the trend that people will want to know and control their health, thus expecting they would broadly adopt wellness apps and wearable technology to track their data, so far the adoption rates have not been as high as expected. Wellness app developers are experiencing that which health care providers have known for a long time, changing individuals' health behavior is hard. For wellness apps adoption rates show only 10% are consistent users, i.e. those that are already motivated to improve health. Converting non-motivated users is not just a business challenge, but also the critical component to changing healthcare outcomes in a meaningful way. This is again where wellness apps can learn from the highly regulated medical device industry.
This is the first part in a five part series, next week you can expect some lessons gained from the medical device industry, particularly focusing on mobile medical devices
- -- Vizma Carver, Founder and CEO, Carver Global Health Group LLC and ClearRoadmap™