Brian Fitzgerald, deputy director of FDA’s Division of Software and Electrical Engineering, was also a panelist at USC’s Body Computing 3.0 conference. He was peppered with questions about how FDA would regulate some of the technology being discussed. Fitzgerald said that innovations in the medical device space probably wouldn’t need many additional regulations, but that “there is a need for us to rethink the basic models of what we do and try to calibrate them for the 21st century.” However, he admitted that “we need to step up.” Although FDA has touched on the issue in the past, especially in light of all the things people can do with iPhones, Fitzgerald reiterated that cell phones will not be regulated as medical devices. “Sometimes a phone is just a phone.”
And as iPhone fanatics in the device world will tell you, there are some cool medical iPhone apps (MD&DI has discussed some of them previously).
The Beating Heart iPhone app, for example, was created to increase health awareness in young people. Data such as one’s heart rate can be pulled from a patch worn on the skin and shared with others via SMS, Facebook, Twitter, and e-mail. Conference organizers used the current Twilight craze to illustrate how the app could be used in more creative ways. For example, users could send photos of popular Twilight heartthrobs Edward and Jacob to their friends to see what their heart rates are after viewing the photo. The app was developed by an engineering team at USC and Corventis (San Jose), a maker of wireless cardiovascular products.
Another iPhone app from Boston Scientific, Latitude, makes life for the physician a little bit easier. Leslie Saxon, conference organizer and chief of the cardiovascular division of USC’s Keck School of Medicine, called the process of accessing different systems to get all the relevant information on a patient “enormously oppressive.” Latitude compiles patient information from disparate sources into one easy-to-read dossier. Of course, it provides vitals such as name, DOB, and contact information. But what about a pacemaker’s battery level? “Device battery has reached end of life,” an example message said. Looks like the bases are covered.
