While there are certainly dangers lurking in app stores when it comes to mHealth, not all of these apps should be avoided. "Medical wearables can be used to gather data under prescription and provide it to remote clinicians. That data is trusted, as it is generated under controlled conditions and seen as highly beneficial," says Fernando.
But that doesn't mean you should print out your FitBit data to bring into your next doctor's appointment, says Fernando. "While the data can be very useful, it can also be less reliable, perhaps more prone to error and not as trusted. The trust aspect of data and how clinicians can actually use this data is still under a lot of scrutiny and there is a lot of discussion happening around how it should be regulated to generate greater trust."
The biggest pushback against FDA regulation of mhealth comes from, not surprisingly, tech companies. Combined, Microsoft, McKesson, Siemens, Dell and Intel spent over $20 million in lobbying efforts in 2012. These tech companies are concerned about delaying progress on wearables and medical mobile apps, since involving the FDA could hamper release dates in the future. As Politico points out, this means that Apple can allow an mHealth app into the App Store that connects with a diabetic user's 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 another $1.5 million on lobbying efforts.
What to look for in mhealth apps?
This means that consumers need to become aware of what they are downloading onto their mobile devices, or what they are strapping to their wrists. Without FDA intervention, it might mean you are getting faulty data or inaccurate medical advice. There are some things you can look for, however, to help make an informed decision when downloading an mhealth app or buying a connected device that promises certain medical benefits.
"You want make sure they comply with current regulations and regulatory guidance. And you want to make sure that the developers of these technologies have gone through the process of making sure they have correctly identified what regulations and standards apply to their product and if they have received third-party testing on their product," says Fernando.
For Charles Settles, who has written numerous articles on the topic of health IT, it's more than simply reviewing an app maker's guidelines and practices. He personally wouldn't even use an app that didn't connect him directly with his doctor in his home state. "I also would be wary of any app without 510(k) approval, but that sort of information is hard to find and even more difficult to understand for the average consumer."
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