Off-the-shelf mobile monitoring devices linked to downloadable smartphone applications are gaining credibility among clinicians as clinical tools. A study released last week shows consumers using a mobile device coupled with a smartphone app can detect atrial fibrillation.
Just 30 days into a six-month study of 865 adults who used an electronic cardiogram sensor attached to a smartphone and read by a mobile medical application, 73% of users said “they were more aware of their heart rate and behavior,” according to a report by Dr. Leslie Saxon, lead author of the study and executive director of the University of Southern California Center for Body Computing.
Study participants were each given a mobile ECG sensor from AliveCor that attaches to the back of a smartphone or other mobile device. When the device is held in a user's hand or placed on their chest, the monitor takes 30-second ECG readings. It transmits them to the phone app, where the readings are graphically displayed.
The wireless setup also detected 185 episodes of atrial fibrillation in 93 participants, or 11% of those studied. It can, at the patient's bidding, send the reading to a patient-controlled data account in the cloud. For a fee, the company offers near real-time access to a clinician 24/7 for what's called an “over-read” of the data, basically a Web-based consult.
The study has been continued and expanded to nearly 2,000 individuals, Saxon said. Her findings were presented last week to the Heart Rhythm Society at its annual meeting. The device and app Saxon used were manufactured and developed by AliveCor, a San Francisco-based company. A handful of similar devices and mobile apps—less than six, Saxon said—are in the field from other manufacturers, but she's aware of more research on the AliveCor products than the others.
On the flight home to Los Angeles, Saxon, a cardiac electro-physiologist, used the device and its related mobile app twice to examine passengers who fell ill en route. Saxon said she felt confident using the system because she's tested it with clinicians and members of the USC football team against a standard, bulky, 12-lead monitor.
The more powerful idea isn't that a trained heart specialist can use an effective, mobile diagnostic support tool on an airplane, but that regular people can use it too, anywhere, to monitor and diagnose themselves and others, as happened several times with individuals in the study group, who, Saxon said, handed the device over to friends not feeling well, for a scan and a read.
“This is going to be a profound disruption of healthcare,” Saxon said. "We're becoming more like our cars, were we strive for some artificial sensor to tell us when we're going to get sick. I'm driving to a dinner and my car just told me my right front tire is low on air. I want to know that.”
Triaging the data at the device and the provider levels, rearranging provider workflows, reordering patient-provider relationships, Saxon said, will all be at play.
“It's a radically different model and there are going to be some disruptions,” Saxon said. “But it's fantastic. I'll look back on these days and laugh at how crude we were.”
In March 2013, the Food and Drug Administration issued a 43-page guidance on how it planned to regulate the rapidly proliferating number of mobile medical applications emerging on the market. The agency emphasized a regulatory light touch to try and balance both innovation and consumer safety. The guidance was updated in February.
According to the FDA's website, which pointed to global industry estimates, 500 million people this year will use a healthcare application on a smartphone.
If a mobile app is intended to perform a medical-device function—that is, the diagnosis, treatment, cure or prevention of disease—the FDA considers the software to be a mobile medical app subject to possible agency regulation. The FDA doesn't track how many mobile apps it has approved for use, according to a spokeswoman.
Four AliveCor mobile applications for heart monitoring have received FDA clearance since November 2012.
The device costs about $75. The corresponding AliveECG mobile app is available free for mobile devices with either the Apple iOS or Android operating systems.
According to the not-for-profit Atrial Fibrillation Association-USA, atrial fibrillation, the most common form of arrhythmia, affects about 2.5 million people in this country. Patients with an atrial fibrillation-related stroke are more likely to remain in the hospital longer and 50% more likely to remain disabled than patients who have a stroke unrelated to atrial fibrillation.
