FDA Suggests Possible iPhone Health App Regulation…Or Do They?



Don Witters, Chairman for the FDA Center for Devices and Radiological Health, gave a presentation at a healthcare IT conference last week during which he suggested that the FDA ought to have some regulatory jurisdiction over healthcare apps developed for the iPhone. His reasoning is that the FDA is responsible for all healthcare monitoring devices, including those that work on mobile phones.

When the issue of FDA-regulated iPhone apps initially came up at the conference, Witters said the iPhone didn’t meet the criteria for a medical device, which he defines as:

“…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.”

Loosely put, a mobile device is anything portable that’s used for diagnosing or treating a patient. Obviously, as a standalone device the iPhone doesn’t meet that definition. While it’s possible to add applications that can assist someone with medical diagnostics or healthcare maintenance, it’s really unlikely that an iPhone app — at least in the near future — would function as much more than a way to keep track of medical information or perhaps communicate with physicians.

At first Witter dismissed the idea that the FDA should be involved in regulating iPhone apps, but he quickly backtracked when questioned further and said part of the reason he was attending the conference was “to begin this dialog and see where [the FDA] fits.”

Now, before anyone gets worked into a frenzy, it’s important to realize that something like this is a long way off — if it ever happens at all. Witter himself admits that he isn’t sure how to go about developing regulatory standards, much less how to assure an iPhone app’s safety and efficacy.

Even if the FDA did get involved, the amount of negotiating that would have to happen with Apple (s aapl) about how to approve and distribute apps is enormous. Once those issues got sorted, then there are concerns over update processes, whether developers would need special certifications in order to develop medical applications, and how they would fit into any mandates President Obama puts into effect regarding digital medical records.

Talk about a can of worms. Given that consumer-oriented health apps developed for the iPhone aren’t likely to create life and death medical situations, it’s unlikely the FDA would elect to get involved in regulating them any more than they oversee similar apps developed for the desktop.

iPhone apps for healthcare workers aren’t a new phenomenon. They’ve been around almost as long as the iPhone itself. Paramedics use software like Life Support 360 to manage patient care algorithms or the native phone features to access patient case histories in the field. Physicians use apps like Epocrates to manage dosing, diagnostics, and other clinical information.

If the FDA hasn’t already gotten involved in regulating existing healthcare apps for the iPhone, I don’t see it happening any time soon. After all, they kind of have their hands full right now. What’s your view on this? Should the FDA establish any sort of regulations or standards for medial iPhone apps? Or should they butt out?



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The definition of medical device sounds overly broad. Consider a doctor testing the tracking of your eyes by asking you to follow a pencil or pen. Since the pen or pencil is used in diagnosis, does that mean that the FDA should regulate pens and pencils?

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