Health apps: The regulation conversation

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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)