April 20, 2012
A Food and Drug Administration July 19, 2011, press release announced: FDA outlines oversight of mobile medical applications. The release listed various apps being considered for regulation and how the regulations would be enforced. The final regulations are open to public comment.
Mobile medical health apps, which are used as an accessory to a regulated FDA device or those that transform a smart phone into a regulated device using sensors or other devices, are unique to the FDA regulation process. These apps are not a food, drug device or procedure. However, mobile health apps fall under FDA’s purview because they function as part of device technology. Mobile health apps’ widespread use has caused the FDA to seek regulation to protect the public from apps that could endanger the public.
If smart phones or tablets are used as an EKG machine or a way to test blood sugar, those apps will be regulated. If you’re a smart phone or tablet to use to chart a patient’s diet and exercise program then those apps will not be regulated.
For the healthcare community this regulation might alternately appear to be much ado about nothing or vitally important. These created apps, in order to be useful in healthcare, must be accurate. Poorly calibrated devices can be dangerous to the public. But this is only a small part of the equation.
App creation is traditionally a fairly fast process. The developer sees a need and creates an app to fill it before anyone else does in order to maximize profits. However, when an FDA regulation is introduced, the process is delayed. According to an article in the New American, a popular oncology app, called Mobile MIM took two and a half years and $170,000 to create and acquire FDA approval. Most app developers have neither that kind of money or time to devote to a single app.
The return on such an investment could be problematic. According to an article in the Washington Times, the requirement for FDA approval could potentially create an environment where new apps are not created or are significantly delayed either because the lengthy approval time or because the costs of approval are so great that developers move on to faster and more lucrative markets.
The FDA itself addressed this issue in a second press release issued to clarify the previous release:
“The FDA encourages further development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information very quickly. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of mobile medical applications with a clear and predictable outline of our expectations.”
In short, the FDA will oversee the creation of these apps so that patients are protected and doctors are able to safely use these apps in their practices.