Intelligent Medicine Blog

BusinessWeek published an article today on the current and future use of wireless technology in medicine.  The article begins:

You can get wireless data access just about everywhere these days, from your bathtub to Barcelona’s city streets, so why not in your body? Well, soon you will-or at least, that’s the vision of a handful of emerging biotech companies. As the Boomer generation ages, companies eyeing the overburdened U.S. medical systems see opportunities to extend the reach of existing medical care, free up health resources for those who need them most, and encourage long-term health and fitness using technology.

Profiles are included for CardioNet (mobile cardiac monitoring), Triage Wireless (wearable physiologic monitoring), Proteus Biomedical (embedded sensors in pharmaceuticals and medical devices) and Apple (iPhone sensors and applications for mobile health).

Of note in the article is a reference to the FDA recently hinting that it may consider regulating iPhone and other mobile health applications.  The source is MobiHealthNews, which detailed a session including the FDA’s Don Witters at the TEPR+ health IT conference earlier this month.  Mr. Witters was asked about the iPhone and whether or not it and other mobile health applications would be considered regulated devices.  MobiHealthNews writes:

At times during the session, the tension in the room was palpable. Witters declared that the FDA has jurisdiction over any device that diagnoses, treats or prevents a disease. This led to one question 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?” Witters initial response was “No, I think that’s getting into information exchange-that’s different.” After the questioner thanked him and said that people probably just breathed a sigh of relief, Witters doubled-back. “Well, I think the real answer is ‘We don’t know.’ That’s why I’m here today to begin this dialog and see where [the FDA] fits.” So, the FDA could really be interested in inspecting iPhones for use as “wireless medical devices”? You bet.

The summary of Mr. Witter’s remarks goes on to say that his goal was to start a dialog to listen, discuss and begin to answer some of these important questions.  Let’s give high marks to the FDA for reaching out to begin a conversation with the mobile health industry and consumers.  There is a lot to discuss, as this Q&A attests.  Regulatory authorities clearly need to play an important role in defining the boundaries of what is inside and outside their domains, and mobile health and wellness experts need to advocate for definitions that maintain innovation and the rapid growth of this field for consumers and patients.