The FTC has dipped its toe in the water of smartphone and ipad technology by announcing that it intends to regulate a “narrow subset” of smartphone medical devices that meet the definition of a “device” under Section 201(h) of the FD&C Act, 21 U.S.C. 321. In a recent news release it indicated that it intended to regulate those applications meeting the definition of device and 1) used as an accessory to an already regulated medical device or 2) that transforms a mobile platform into a regulated medical device. See 76 Fed. Reg. 43689. In its news release the FDA noted a study that indicated that 500 million smartphone users will be using health care applications in the near future. The FDA indicated that it intended to regulate those applications that create great risk when they do not work as intended. An example of a device that would be regulated is a smart phone that is converted to an ECG heart monitor.(i.e. Smartheart, a self service heart monitor).
Smartphone apps existing and under development seem to fall under four main categories. First, there are the burgeoning apps that provide medical information like Medscape, Micromedex or Epocrates. Second, those that provide connectivity and access to important medical data like Fujifilm Synapse Mobility, which provides for access to 2D and 3D radiological film to treat and diagnose patients. Third, there are those that actually serve as diagnostic devices such as the Smartheart monitor. Fourth there are those apps. that provide for the storage or personal health information like Medflash personal health and wellness management. All four categories will be providing major contributions to the arc of health care quality improvement in the future.
For those interested in monitoring new apps for physicians see imedicalapps.com.