FDA Takes on Devicelike Mobile Apps

Qmed Staff

September 23, 2013

2 Min Read
FDA Takes on Devicelike Mobile Apps

FDA regulators announced that they would start regulatiing new gadgets and applications that make use of smart phones for biometric readings. Many of these medical app systems are designed ot assist users in monitoring their personal health.

As of now, industry analysts predict that there are 17,000 mobile medical apps available. This includes apps ranging from heart monitors to calorie counters.

Earlier today, regulators announced that most of these health care mobile apps aren't a risk to consumers in the event of a malfunction. Because of this, most health apps won't be regulated on a federal level. For its part, FDA regulators will concentrate on smartphone apps that turn them into devices like heart monitors. In addition, regulators will focus on medical devices that plug into cell phones and tablets. Many of these devices use an app to facilitate the easy analysis and transfer of biometric data.

The vast majority of health-related mobile apps are free of charge. Many early-stage apps are designed to assist users in performing very simple function. This can include counting calories, monitoring daily exercise levels and more. However, a significant number of new mobile apps use attachments that can measure a patient's vitals in ways usually reserved for the doctor's office.

As of now, these tools can be used to measure lung function, monitor irregular heartbeats and take photos of an eardrum. With a price tag of more than $100 for many of these devices, the quality of this equipment could be approaching that found in a traditional healthcare facility.However, a physician or qualified health professional isn't around when a patient uses these tools or his or her own. Because of this, patients or mobile apps could interpret life-critical information in an incorrect way. With proper regulatory control, FDA officials hope to avoid this type of scenario.As of now, FDA officials have approved 75 mobile medical applications. In total, FDA officials predict that 500 million smartphone users will make use of a mobile medical app in the next two years.In 2012, FDA regulators approved a $199 health monitoring device manufactured by AliveCor. The device is designed to attach to a smartphone's case and includes specialized finger electrodes. When a patient places his or her fingers on the electrodes, the device takes an EKG reading. Results can be emailed to a physician through a patient's smartphone.Another upcoming app could potentially benefit patients suffering from asthma. With the device, patients could measure their lung function by blowing into a specialized device attached to their phones."Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it," notes Dr. Jeffrey Shurin, FDA medical device center director.

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