Health apps: The regulation debate


When it comes to our smart phones 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?

There are apps 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 Dr. Brian Rothman can observe up to four operating rooms at once with Vigivu. This 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," said Rothman.

But some question the safety and privacy of health apps.

"I think we need to be cautious." said Clinical Consultant Debbie Gregory.

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," Gregory said.

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.

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.

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," Gregory said.

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.

Additional Information:

THEN AND NOW: Remember when your doctor would say, "take two of these and call me in the morning?" That was then, now it's "download this app and text me later." Development of mobile medical applications is opening new and innovative ways for technology to improve health and health care. Some doctors are beginning to prescribe smart-phone applications and medical devices they work with to help patients manage chronic illnesses, including heart disease, diabetes, and asthma. And your insurance might even pay for it as well. (SOURCE: http://www.dispatch.com; http://www.fda.gov/medicaldevices


MOBILE HEALTH: Consumers use mobile medical applications to manage their own health and wellness. Health care professionals are using these applications to improve and facilitate patient care. These applications include a wide range of functions from allowing individuals to monitor their calorie intake for healthy weight maintenance, to allowing doctors to view a patient's X-rays on their mobile communications device. Simple apps that help people with their fitness or remind them to take their pill prescriptions already are widely popular. But new device applications are taking mobile health — or mHealth as practitioners are calling it — to a new level. Some health apps that are widely becoming popular among doctors and patients are: 

  • OnTrack Diabetes: OnTrack is a free application that helps diabetics manage their diabetes by tracking various items such as blood glucose, food, medication, blood pressure (BP), pulse, exercise, and weight.
  • iHealth Blood Pressure Monitor: Has a cuff that connects to the phone helping you monitor your blood pressure.
  • SmartHeart: Works with a heart monitor harness that wirelessly transmits information to the phone.


The data gathered by these apps is analyzed, displayed and can be shared with physicians. And most of the apps even will suggest behavioral changes to improve test results. (SOURCE: http://www.fda.gov/medicaldevices; http://www.dispatch.com; https://play.google.com/store/apps)

FDA MOBILE APP REGULATION: The U.S. Food and Drug Administration plans to regulate medical devices connected to smartphones, but consumer devices such as the iPhone and app stores like iTunes and Google Drive will remain clear of oversight. Mobile apps that measure patients' vital signs or control devices such as CT scanners will be regulated, but mobile apps that provide access to electronic health records (EHRs) will be free of regulation. So far, the government agency has cleared more than 75 medical apps — many for doctors' use only. Many of the apps are free, but the devices can cost anywhere from $50 to $500. Insurance providers are starting to cover some of those costs. For a listing of FDA currently regulated devices go to http://www.fda.gov/medicaldevices/deviceregulationandguidance. (SOURCE: www.eweek.com; http://www.dispatch.com)