Steve Jobs is a hero in our household, my husband prides himself on the fact that his business is 100 percent Apple. We are those annoying people who don’t remember how we lived before the invention of the iPhone (more sanely, perhaps?). The thing about mobile apps is that I know there are some amazing programs out there that would make my life easier but I just haven’t found them yet. I need someone to make me a list of must-have apps for each of my interests, hobbies and life in general.
If you are one of those people who manages to have an app for everything, each time you discover an indespensible program you simply log on to the Apple store from your mobile phone, pay 99 cents or so and bam!, your new technological purchase downloads itself right before your eyes. But what if some of your app purchases required prior approval such as a prescription from a primary care provider? Should healthcare providers be responsible for doling out medical apps to the general public? If so, which apps deserve to be FDA regulated requiring a prescription?
I first learned that some mobile apps require a prescription when blogging a review of AliveCor’s heart monitor, an app capable of recording an ECG anytime, anywhere from the iPhone. A prescription is required before AliveCor allows the app to be downloaded. But why is it such a big deal to perform your own ECG analysis? Does this really need to be FDA regulated?
Yes, there is the obvious point that if someone is experiencing chest pains, chooses to run their own ECG analysis via mobile app and the rhythm strip indicates an ST segment myocardial infarction (AKA “The Big One”), the layperson may not be able to interpret their results and not realize they are having a massive heart attack. Good point. However, anyone can currently visit Amazon.com, throw down two thousand dollars and purchase an ECG machine for themselves. I’m sure many people aren’t paying a few thousand bucks to own their own ECG machines (who has that kind of closet space?) but the point is the do-it-yourself ECG analysis hasn’t been regulated in the past.
The FDA is currently perfecting guidelines regarding regulation of mobile apps. They must determine what makes an app wellness focused vs a truly medical app, clarify the difference between apps that diagnose vs monitor disease and establish the risk of different kinds of app to individuals. Based on these classifications, the FDA plans to develop guidelines indicating which apps will require a prescription before download. Last week, in congressional hearings on the issue, physician groups and tech companies had their chance to offer opinions with app developers ultimately seeking to keep control of their products.
Mobile apps have an uncertain future in medicine. It seems that medical app technology could become the new pharmaceutical industry. Similarly to regulations surrounding pharmaceutical companies, the FDA’s classifications will affect more than just prescribers. FDA regulation promises to have indications for app developers such as strict marketing guidelines. Like drug manufaturers, when medical apps become prescription regulated, mobile app manufacturers will feel pressure to form relationships with healthcare providers encouraging app prescription writing. After all, if mobile medical apps become highly regulated, they will only be profitable if you prescribe them.
The last thing the world of medicine needs during this highly legalized, monitored and regulated era is app prescribing responsibility. Sure, if a patient wants me to check out their most recently recorded at-home ECG I am happy to do so. But, don’t hold me responsible as the prescriber if I didn’t happen to be awake at 3am on a Sunday morning when a patient decided it was a good time for a DIY cardiac assessment. Mandating prescription status of most medical apps is unnecessary. Allow individuals to decide which self-gathered information they would like to share with medical providers elevating personal responsibility above government regulation.
Nurse practitioners, physicians and physician assistants should not be required to have “App” listed among allowed prescribing schedules on their DEA license.
Do you think mobile apps should be FDA regulated? If so, to what extent? As a nurse practitioner, do you plan to incorporate mobile app prescribing into your practice?
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