Friday, July 29, 2011

Is FDA Governance of Medical Mobile Apps Positive?

According to a Reuters report ( the FDA has announced that it will start regulating certain mHealth or mobile health applications. The FDA made it clear that they will not be looking into all medical and health apps, but only those that, “mimic the work of medical devices and could cause harm if they failed to perform as promised” according to Food and Drug Administration officials.

This policy shift has been long anticipated by many in the medical device space as seen through incremental shifts by the FDA. Such as the case of the radiology app it approved in Feb. 2011, which allowed for secure transmission of CT, MRI, PET, nuclear medicine, and PET images on the go.

The positive aspect of these newly published FDA guidelines:
1.       Clearer Guidelines: manufacturers and developers will now have a better understanding of the rules that govern their work and can develop within those parameters.
2.       Public Safety: consumers of mHealth apps regulated by the FDA, whether professionals or patients will have an added confidence level that those apps are safe and effective, results are reproducible and repeatable.  
The negative aspects of these newly published FDA guidelines:
1.       Higher Barriers: with increased regulation it becomes more difficult for developers to launch new innovation; new technology takes longer to reach the public.
2.       Increased Costs: the high cost of navigating through FDA regulation inevitably will be passed on to consumers. 

It should be noted that, “only a small number of the thousands of mobile apps would face FDA scrutiny under new draft guidelines, agency officials said. They fall into two categories: apps that serve as an accessory to an FDA-regulated device, and apps that turn a mobile platform into a medical device,” according to Lisa Richwine of Reuters. All in all, I view the announcement as a positive step in the proliferation of meaningful mHealth technologies and a milestone in health care technology innovation.

-Ghen Sugimoto