The agency finally released a statement on what types of mobile health apps will fall under its scrutiny.
There are thousands of apps that allow consumers to track, monitor, and diagnose just about every aspect of their health. The crowded market has been largely unregulated--until now.
This week, the Food and Drug Administration announced its final guidlines for the development of some health apps.
According to the announcement, the agency will focus on regulating apps that, if used improperly, could potentially harm consumers.
The announcement gave some more details on what it plans to monitor:
“[We plan to focus on apps that] are intended to be used as an accessory to a regulated medical device--for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or transform a mobile platform into a regulated medical device--for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.”
The FDA will apply the same regulatory standards to these apps as it does to traditional medical devices in the categories.
“The guidance provides clarity about what will and will not be the focus of FDA’s regulatory oversight,” Corey Ackerman, president of health app marketplace Happitiquetold VentureBeat. ”It should allow developers and other stakeholders to have more regulatory certainty with respect to mobile app innovation in the health and medical industry.”
These new rules come two years after the FDA released draft guidelines of health apps. According to the release, the FDA cleared about 100 mobile health apps over the past ten years, 40 of which it cleared over the past two years.