Institute For The Future

Is your iPhone a Medical Device? Who knew?!

I came across an interesting item about a recent presentation given by Don Witters from the FDA Center for Devices and Radiological Health (CDRH), but before I could write about it, I had to answer several questions for myself.  First, I had to figure out what TEPR+ (the name of the event Witters was attending) stood for.  Turns out that TEPR is the acronym for "Toward an Electronic Patient Record" Conference, sponsored by the Medical Records Institute (MRI) (though I learned that here, not from the MRI website). 

Next, I wanted to know something about CDRH.  Turns out that CDRH is the branch of the FDA that "is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary human exposure to man-made radiation from medical, occupational and consumer products."  Seems like a bit of an odd combination--inspecting medical devices and radiation-emitting products--but perhaps not. 

Among its many responsibilities, CDRH reviews requests to research, manufacture, and market thousands of medical devices, from heart pacemakers to contact lenses.  As reported in MobileHealthNews (MHN), Witters explained at TEPR that a medical device is

 

an implementation, product, apparatus or other component or accessory, which is used in the diagnosis, cure, mitigation, treatment, prevention of disease or effects any structure of the body–that could actually include some information technologies and performance technologies–but usually it’s something that is performed on the patient, touches the patient or is performed between physician and patient.

 

He also declared that the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease.

This raised some interesting questions from the audience. “'So an MRI app for an iPhone is a wireless medical device? Or a patient reporting their blood glucose level by text messaging their physician who then adjusts their insulin dosage with a return SMS?'”  According to MHN, Witters initially responded that he thought these examples constituted information exchange, which would be different.  But he then backpedaled and indicated that the FDA could consider iPhones to be wireless medical devices.  

Witters was then asked about a blood glucose monitoring device

that connects to Motorola's RAZR phone and has received FDA-approval.  (I'm not sure if the question was referring to the GlucoPhone.)  Witters noted that he was not on the team that approved the device so he didn’t know whether they inspected the RAZR as part of the wireless medical device system; he stated that he would have included the RAZR in his inspection. 

Obviously, the myriad of consumer-oriented health and fitness apps available for the iPhone are not about to be regulated by the FDA. Consumers will have to determine which apps are any good (see this recent list of the top 100, according to one source). I've written about several medical professional-oriented smartphone or iPhone apps (here and here, for example), and I know others are available.  Should the FDA step in to regulate these?  Will it?