When it comes to our smartphones and tablets many of us are absolutely obsessed with apps! Tens of millions are downloaded every day and some experts project more than 50 billion app downloads in 2013.
While most of us use apps for entertainment or exercise, some health apps serve a much more serious purpose.
Now the question is: How should they be regulated?
An app to spot ear infections, an app that turns your phone into a mobile heart monitor. An app in the works that helps detect tumors. More and more doctors are using their smartphones and tablets as tools to help patients. A recent survey found in one year, the number of doctors who collected data at the bedside with mobile devices went up from 30 to 45-percent. Doctors using devices to capture visuals of patient data increased 14-percent. And those who monitored data from medical devices climbed by seven-percent.
Anesthesiologist Doctor Brian Rothman can observe up to four operating rooms at once with Vigivu. The app, he helped create, allows him to keep track of patients' medication, vital signs, and get notifications if those vitals go out of range. "We have such a demand to be everywhere for our patients. It brings information to me."
But some question the safety and privacy of health apps. "I think we need to be cautious."
Clinical Consultant Debbie Gregory specializes in technology planning for hospitals. She has some concerns. "We have to remember that there is a patient behind all the data and behind those devices. How are we going to regulate these? Who's going to be regulated?"
The FDA put draft guidelines in place for health apps in 2011 and today many are FDA cleared. But there are still no final guidelines.
Three days of hearings were recently held to debate what medical apps should be regulated and the FDA's role. "They knew framework to do that should be created."
FDA's Office of Device Evaluation Director Christy Foreman testified. "While many mobile apps carry minimal risks, others can pose significant risks to patients if they don't operate correctly."
The agency proposed regulating a small subset of health apps that turn mobile devices into medical devices. For example, an app that allows smartphones to take a diabetic's blood glucose reading may have to get approval. But apps considered low-risk, like those containing general medical information will not be regulated. Doctor Rothman and Gregory agree the new proposed rules are a step in the right direction as the health app trend continues to grow. "It's really transforming healthcare as we see it today."
But we'll have to wait and see if that step really does benefit patients.
The FDA plans to put the new health app regulations in place by October first. After that, officials say they will put a list of approved health apps on the agency's website.