Can you trust your healthcare app?

Your smartphone can bring a car to your door, connect with loved ones around the world, and help you order pizza without speaking to a single human in the process. But then you hear reports of a corporate hack or major credit card breach at a store you frequent, and you quickly remember the risks you take with the technology.

As technology has advanced it has changed more than just our take-out habits and communication preferences, it is also redefining our health. With fitness trackers and medical devices that can plug into your smartphone, more and more people are able to track their health in ways they never could have done before. But there are dangers lurking in the seemingly harmless bracelets and health apps you find in the Apple App Store and the Google Play Store.

The concern isn’t really with apps that let you track your calorie intake and weight, but those that claim to have legitimate health benefits, but no FDA approval to back it up. In an editorial, Nathan Cortez, associate dean of research at Southern Methodist University Law School, points out in a study from the New England Journal of Medicine that in 2013, mhealth – or mhealth – apps brought in 2.4 billion. of dollars, but in 2017 that figure is expected to increase to $ 26 billion. Cortez points out that this is an unregulated market, and while some of these apps come with fairly low risk, there are other apps that promise certain health benefits that aren’t evaluated by professionals in the industry. health sector.

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There are certainly legitimate apps that can help you track serious medical conditions, but these apps are often designed in conjunction with lawyers and healthcare professionals. For example, in February 2011, the FDA first approved a healthcare app. The medical app is designed to allow doctors to view x-rays on a smartphone or tablet.

However, for every mHealth application approved by the FDA, there are a large number of applications that are not. And that’s what is raising awareness around the need for regulation in mHealth. “The FTC, for example, can examine the various medical claims made by these wearable devices to determine if there is substantial evidence behind the claims. Unfounded claims can mislead device users and potentially cause harm, ”says Anura Fernando, senior mHealth engineer at UL; a company focused on developing safe and secure portable products.

What medical apps can you trust?

While there are certainly dangers lurking in app stores when it comes to mobile health, not all of these apps should be avoided. “Wearable medical devices can be used to collect prescription data and deliver it to remote clinicians. This data is reliable because it is generated under controlled conditions and considered to be very beneficial, ”explains Fernando.

But that doesn’t mean you have to print out your FitBit data to bring it to your next doctor’s appointment, Fernando explains. “While data can be very useful, it can also be less reliable, perhaps more error-prone and less reliable. The trust aspect of data and how clinicians can actually use that data is still under scrutiny, and there is much discussion about how it should be regulated to generate greater trust.

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The biggest pushback against FDA mHealth regulations comes, unsurprisingly, from tech companies. Together, Microsoft, McKesson, Siemens, Dell, and Intel spent more than $ 20 million on lobbying efforts in 2012. These tech companies fear delaying advancements on wearable devices and medical mobile apps because the involvement of the FDA could hamper release dates in the future. As Politico points out, that means Apple can authorize an mHealth app in the App Store that connects to a diabetic user’s blood glucose meter to monitor their blood sugar. And it didn’t stop in 2012, in 2014 Apple spent $ 1.2 million lobbying against FDA regulations, while Intel spent an additional $ 1.5 million on lobbying efforts.

What to look for in mhealth apps?

This means that consumers need to be aware of what they are downloading to their mobile devices or what they attach to their wrists. Without intervention from the FDA, it could mean that you are getting wrong data or inaccurate medical advice. However, there are a few things that you can look for to help you make an informed decision when downloading an mhealth app or purchasing a smart device that promises certain medical benefits.

“You want to make sure they comply with applicable regulations and regulatory guidelines. And you want to make sure that the developers of these technologies have gone through the process to make sure that they have correctly identified the regulations and standards that apply to their product and whether they have received third-party testing on their product ” , explains Fernando.

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For Charles Settles, who has written extensively on the subject of health information technology, it’s not just about reviewing the guidelines and practices of an app maker. Personally, he wouldn’t even use an app that didn’t put him in direct contact with his doctor in his home country. “I would also be wary of any app without the 510 (k) approval, but that kind of information is hard to find and even harder for the average consumer to understand. “

While our technology has certainly brought major advancements in healthcare including affordable 3D printed prosthetics, electronic health records, and even telemedicine, that certainly doesn’t mean you have to trust every app or device. mHealth. Without FDA regulation, it’s important to make sure apps you download don’t misrepresent your health and consult your doctor before relying on data from an mHealth app or portable device.


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