Medical devices were once the sole jurisdiction of hospitals and pharmacies. But the rapid intersection of consumer technology and healthcare technology has created mobile applications that put more health decisions into the hands of normal people — often with little regulatory oversight. Now, the ubiquity of these mobile medical apps has drawn the attention of the US Food and Drug Administration (FDA), which proposed new guidelines last week to regulate many of these programs as medical devices.

There are thousands of such apps currently on the market. Some allow users to input their own health data to manage their weight, running mileage or menstrual cycle; others are tailored specifically to physicians to help medical professionals review patient charts or offer diagnoses based on input patient statistics. The proliferation of medical apps even inspired the XPrize Foundation to create a $10 million award for a diagnostic medical device.

But the availability of these apps could be limited in the future if current apps fail to conform with the FDA’s proposed regulation, or new developers are scared away by its complexity. The new rules would require developers to submit their medical apps for FDA approval, following many of the same guidelines as medical devices. These include clinical trials, quality control guidelines for manufacturing, and adverse event reporting. The FDA will accept comments on the draft legislation for the next 90 days.

Not all medical apps would fall under the FDA’s new regulations, however. The agency calls “for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, wrote in a statement. These include apps that help a doctor make a diagnosis based on a medical image, for example, or any apps that serve as medical devices themselves.

But even those apps that aren’t implicitly medical devices can act like them under certain circumstances. If a doctor diagnoses a patient based on their self-collected data, is the app that enabled the data collection a medical device? “It’s not connected to a medical device, but you’ve made it a medical device because it’s decision support software,” Bradley Thompson, a health care and life sciences attorney with EpsteinBeckerGreen in Washington, DC, told Information Week.

Some of the apps that would undergo FDA review are simply digital versions of resources doctors already use. Doctors can enter patient data into an app which makes a diagnosis based on a formula — the “types of algorithms that exist in medical textbooks” in common use, according to David Albert, an Oklahoma cardiologist and the chairman of AliveCor, which developed an ECG measurement app. The FDA can’t regulate textbooks; but does reconstructing a textbook into an interactive application make it a medical device, he asks?

Albert suspects that the FDA may decide what defines a medical device by its marketing. “The FDA is very concerned with labels,” he says.

If the proposed regulations are enacted, some developers may have to repackage or relabel their products, suggests computer scientist Peter Bentley of the University College of London. Bentley developed and released his iStethoscope app in 2008, which lets users listen and record their own heartbeat. Although it was co-developed with cardiologists, Bentley thinks of his iStethoscope as a toy.

“My app is supposed to be for the general public to make them more aware of their heart,” he told Nature Medicine. “We still have to determine how, if necessary, to change the advertising and naming to make the intention of the app clearer.”

Although Albert always intended to push his ECG device through the FDA, he notes that many medical apps were made by “people who are app builders first and got into [the health] business second.” Anyone can develop an app and have it on sale internationally from the comfort of his or her own home. But if a casual developer has to worry about regulations or deal with paperwork, Bentley worries that they may never even start working on their idea, leaving the market to more advanced developers.

“If it’s only going to be the specialist medical device companies that will be able to do such apps in the future,” he says, “that would be a shame.”

Image: Juhan Sonin on flickr under Creative Commons