The FDA (Food and Drug Administration) has announced that it will begin to regulate medical applications that work with smartphones. As part of this initiative, the American agency has published a guide for developers of health apps.
The agency stated that it intends to focus its regulatory oversight on applications that might present a risk to patients if they don’t work properly.
“Some mobile applications present minimal risks to consumers or patients but others may cause considerable danger if they don’t work properly. The regulations defined by the FDA protect patients and encourage innovation,” said Doctor Jeffrey Shuren, the Director of the Center for Health Devices and Radiology at the FDA.
Although the agency clarified that it will not regulate sale or consumption, the oversight will be focused on applications that are designed to be used as an accessory to a regulated medical device. For example, this would include an application that allows health professionals to make a specific diagnosis through the visualization of a medical image from a PACS system on a smartphone or mobile tablet. It would also address those that are aimed at transforming a mobile platform into a regulated medical device, for example an application that can make a smartphone into an electrocardiogram machine (ECG) to detect abnormal heart rhythms or to determine whether a patient is suffering a heart attack.
So far, almost 100 mobile health applications have been approved and from now on, those that are submitted for assessment by the FDA will be subject to the same regulatory guidelines that the agency applies to other medical devices.
In 2015, the organization anticipates that there will be around 500 million users of smartphones using medical applications to monitor their health-related issues.
Source: FDA
Related news: Directory of Mobile Health Applications Released
