FDA Gives Guidance to Health Tracker, Behavior Mod Apps
You are the cookie, my friends. In the emerging world of wearable technology and sensor-rich smartphones, your physical movements are more trackable and invaluable than any surfing habits. The new iPhone 5S, with a co-processor dedicated to motion detection and calculation, is the leading edge of tech that will make devices contextually, situationally aware in ways unimaginable just a few years ago. Apple has already promised that its 5S technology will make it possible for the iPhone to track your physical activity throughout the day and night in order to power a new level of intimate app programming.
We are approaching a stage where not only your location but your actual physical state (sleeping, walking, running, driving) will inform the kinds of data your phone will float to the top, and the kinds of services it will offer.
And these devices will also become platforms for a new generation of health monitoring, fitness management and behavior modification applications (many from brand marketers and health-related industries) that leverage personal activity/functions data from device sensors. And so app programmers are getting very close to the body and close to the realms regulated by the Food and Drug Administration. With access to movement and personal function information, marketers may well ask, what is the difference between a benign activity monitor and a medical device that is strictly regulated?
The FDA just issued guidelines of what it will and won’t be monitoring in the market, and it seems to give developers a wide berth. Foremost, the FDA is claiming jurisdiction over “the small subset of mobile apps that meet the regulatory definition of a device and that 1) are intended to be used as an accessory to a regulated medical device, or 2) transform a mobile platform into a regulated medical device.”
Basically the FDA is taking a “risk” approach, looking only at apps that pose a risk to the patient if they do not operate as expected or apps that interact with regulated medical devices. This leaves a large swath of apps for which the FDA will “exercise enforcement discretion,” which means it will not require makers to submit pre-market review applications or to have the apps registered with the FDA. Generally, the FDA includes in this category lower-risk programs apps that:
-- Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
-- Provide patients with simple tools to organize and track their health information;
-- Provide easy access to information related to health conditions or treatments;
-- Help patients document, show or communicate potential medical conditions to health care providers;
-- Automate simple tasks for health-care providers; or
-- Enable patients or providers to interact with personal health records or electronic health record systems.
The specific kinds of apps considered low-risk but still of interest to the FDA include those that offer behavioral skills, reminders, motivation, education. Apps that use geolocation to warn people with environmental conditions of possible asthmatic or allergic areas are also mentioned, as well as those that provide drug interaction information. Other functions like medication reminders, health information records access, risk factor screening, symptom recording and emergency calls are also included. A more comprehensive list is at the FDA site.
The regulations speak to the new world of technology and marketing we are entering. When we speak of mobile media as uniquely intimate, that has multiple implications. The range of services marketers now can use to add value to consumers’ lives has escalated dramatically. But this new capability also puts them into new areas of responsibility towards consumers -- and regulators.