A week ago, MobiHealthNews shot down the myth that the U.S. Food and Drug Administration (FDA) plans to start regulating mobile medical apps. In reality, the FDA has been regulating mobile software for years.
Way back in 1997, Data Critical, a company bought by GE Healthcare in 2001, earned FDA 510(k) clearance for its RhythmStat XL software that wirelessly transmits ECG data from a heart monitor to a handheld device, in this case a Psion palmtop computer.
The inventor of RhythmStat—and founder of Data Critical—is a familiar name in mobile healthcare, Dr. David E. Albert. Most recently, Albert has been in the news for his newest creation, the iPhone ECG, which generated a lot of buzz at the Consumer Electronics Show in January.
Albert actually has been thinking about marrying a single-lead ECG to a mobile device since the time of RhythmStat. “The idea is 13-14 years old,” he tells MobiHealthNews. “Quite frankly, we could not implement it because the technology didn’t exist in the 1990s.”
The advent of the iPhone in 2007, which caused an explosion in mobile app development, changed that, in a perfect example of Moore’s Law. “People take for granted what we have today,” Albert says. “The iPhone is more powerful than the computer you had in 2000.”
Technically, Albert and his Oklahoma City-based company, AliveCor, can’t implement the iPhone ECG commercially just yet because the product doesn’t have regulatory approval. AliveCor is seeking FDA clearance in the U.S. and a CE mark so the company can sell the device in Europe, and Albert expects the iPhone ECG to be available globally no later than the third quarter.
Already, some other versions are under development. MobiHealthNews reported in January that the system should be compatible with Android smartphones, pending regulatory clearance for each model. A glance at the AliveCor website hints at iPad compatibility as well. “We will make a credit card-sized device that will allow this to work with any tablet, any smartphone, any laptop in the future,” Albert said for the earlier story.
“Today, the case is made for the iPhone 4,” he adds in a new interview. “But next time we show the product, we’ll show the iPad.”
To call Albert bullish about the iPad would be an understatement. “I think tablets are going to become the one must-have in clinical medicine,” he says. “I see the iPad, not the smartphone, as the main clinical device.”
Albert believes Apple has already won the tablet battle among physicians. “Nobody has anything but iPads,” he says. “Game over.”
Soon, tablets will enter the realm of home monitoring of the elderly as well, Albert believes, because of the large screen and simple user interface. “Don’t expect Grandma to use a computer, don’t expect Grandma to use a smartphone and don’t expect a computer to recognize Grandma’s speech,” Albert says. But, he explains, “Grandma can push a screen button.”
In the future, expect to pay for home health monitoring on the same bill as other home monitoring services such as smoke detectors and security alarms, says Albert. (One of his other companies, Lifetone Technology, makes a bedside fire alarm.)