FDA lays out regulation of certain mobile medical apps

The Food and Drug Administration has proposed regulation of some medical applications that run on smartphones and other mobile computing devices that could affect the operations of other medical devices already under its governance.

The agency’s draft guidance released July 19 outlines its “current thinking” and focuses on a small subset of mobile medical apps because they can influence the performance or functionality, and potentially the safety, of currently regulated medical devices.

The mobile medical apps that FDA has in mind are those used as accessory to a medical device already regulated by the agency, such as one that enables a provider to make a diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or other mobile device.

The other set of apps under FDA’s scrutiny are those that transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. An example of this is an attachment of electrocardiograph (ECG) electrodes to a mobile platform to measure, store and display ECG signals to detect abnormal heart rhythms or if a patient is experiencing a heart attack.