Are New Healthcare Tools Safe For Chronic Kidney Disease Patients? - New FDA Rules

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Nephrologists and patients are finding that mobile apps, ranging from Dialysis Treatment Trackers to Heart Monitors and Blood Pressure Devices, can serve as fast, effective and efficient tools which allow individuals with CKD more control over their healthcare. However, are they safe?

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Mobile Medical Device Applications, better known as Health Apps, are popping up all over the Chronic Kidney Disease (CKD) Community. CKD patients are incorporating them into their daily lives to improve their treatment and health outcomes. More specifically, people with CKD are using them to monitor individualized aspects of their health, fill gaps in their medical care, and take more responsibility for their personal well-being.

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Yesterday, the US Food and Drug Administration (FDA) released its guidelines on the various regulations around mobile health apps, after more than two years of issuing its draft recommendations. Today, there are approximately 40,000 Mobile Health Apps available for download on iPhone, iPad, Android and other smartphones and tablets. But most of these apps were developed outside the scope of FDA regulation. Although the vast majority of the Apps do not pose much of a risk to consumers if they malfunction and will not be federally regulated, the agency will focus on a handful of apps that turn mobile devices into "medical divices."

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The FDA said that the same regulatory standards that it applied to other medical tools will apply to two broad categories of Apps including those intended to be used as “an accessory to a regulated medical device” such as an App that enables medical communication directly between a CKD patient and his or her  Nephrologist. Also Apps that “transform a mobile platform into a regulated medical device” will be reviewed. For example, Apps that turn smartphones into an Electrocardiography (ECG) machine that can detect abnormal heart rhythms or determine heart health and the risk of heart attack in a person with CKD.

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Already having approved 75 Mobile Medical Applications, the FDA estimates that 500 million smartphone users worldwide will use some type of health app by 2015. Though most general health apps can be downloaded to your device for free, the FDA recently approved the sale of a $199.00 heart monitor. It has an attachment that snaps on like a smart phone case that after holding your smartphone for 30 seconds can give you an EKG reading (essential medical test that checks for problems with the heart's electrical activity). CKD patients can then easily email the report to their Nephrologists. This could potentially save CKD patients time from traveling to yet another doctor's appointment, money on gas and other expenses as well as limit risk of hospital related infections.  Other applications in development will allow people with CKD who also have asthuma to measure their lung function by blowing on their phone, rather than using special machines usually found in their doctor's office.

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Healthcare is in the middle of a mobile revolution. believes that Mobile Apps can help people with CKD better manage their own health and wellness, and gain access to useful information whenever and wherever they need it.

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"11 Super Mobile Medical Apps." InformationWeek: The Business Value of Technology.

"Mobile Health Apps: Safe And Effective?" Healthcare Technology Online.