WellDoc received approval from the Food & Drug Administration (FDA) on August 2 2010 to market the company’s DiabetesManager system. This signals the regulator’s openness to mobile health solutions — a market moment that may usher in the new-and-improved era of personal health management.
DiabetesManager uses the mobile phone as a platform for patients with Type 2 diabetes to gather, store and communicate personal health data such as blood glucose measurements; these data then feed into WellDoc’s algorithms that communicate personalized health coaching support back to patients in real-time. This process creates a closed-loop system that helps bolster patients’ decisions and behaviors throughout the day.
Health Populi’s Hot Points: Effectively managing diabetes requires a patient to make numerous, well-informed micr0-decisions every day. Mobile phones are a useful platform for this process, as they’re ubiquitous — and people love them. For more insights into the role of phones in health, take a look at my paper, How Smartphones Are Changing Health Care For Patients and Providers, published by the California HealthCare Foundation in April 2010.
While an “N” of 1 = 1. and WellDoc’s approval is for one product from one company, the approval of DiabetesManager represents a positive sign for the many developers of mobile health applications waiting in the wings for market approval.
The week that the FDA approved WellDoc’s DiabetesManager, the Agency also published a report on its 510(k) approval process for medical devices. The Agency understands the process isn’t ready for primetime when it comes to evaluating innovations — including but not limited to mHealth applications.
The more clarity the FDA offers in the area of mobile applications for health, the more investors will back these important new products and services and the sooner patients and health consumers will be empowered by these tools. That’s when both health care and health costs will be better managed.