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.

4 Comments on Mobile health and the FDA: what WellDoc’s approval means for mHealth

Two (Or More?) Faces of Mobile Health « Healthcare 311 News said : Guest Report 9 years ago

[...] Mobile Health and the FDA: What WellDoc’s Approval Means for mHealth (Jane Sarasohn-Kahn, HealthPopuli, 8/10/10; immediate access) [...]

Rajesh said : Guest Report 9 years ago

I agree with your discussion. I still feel that as professionals instead of focusing on the 'business' aspect of healthcare, we should direct our efforts in making our clinical skills more sound. Below is a nice website, where you can start. Rajesh http://www.Rxnotes.net 1. Central searchable repository of a pharmacists 'curb-side' notes. 2. Transition between hospital and retail settings. 3. For access from anywhere, when I do not have direct access to my references/websites.

David Doherty, 3G Doctor said : Guest Report 9 years ago

It's worth noting that MedApps received clearance (510(k) Submission) from the FDA on the "MedApps Solutions for diabetes (glucose meters)" way back in July 2007.

Tweets that mention Mobile health and the FDA: what WellDoc’s approval means for mHealth | Health Populi -- Topsy.com said : Guest Report 9 years ago

[...] This post was mentioned on Twitter by healthythinker, Blausen Group. Blausen Group said: RT @healthythinker: What FDA approval of WellDoc's DiabetesManager means for #mHealth mobile health .. http://tinyurl.com/2d6kv3f [...]

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