Regulating mHealth Apps: Does it Limit Creativity?

Last year, the FDA announced plans to regulate some smart phone apps that involve medicine or health. The specific apps that would be regulated “are used as an accessory to medical device already regulated by the FDA [or] transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.” In addition, apps that suggest potential diagnoses or treatments for the person using it.

As I was perusing comment boards for various articles about this, the feelings were mixed. Some think that the FDA already has too much control. Others think it totally makes sense. A comment from someone on a Washington Post article sums up how I feel:

Yes, some software that turns a smartphone into medical use has to follow the same rules as developing a medical device — from the first moment you think about it. It’s not hard, but you had better know what you are doing because what the FDA gives you is basically the right to market the device and if you don’t follow the rules, you could end up with is a really neat program that you can’t even talk about to your customers.

I think it definitely makes sense to regulate these things. I mean, there are quack doctors out there that we don’t know about, who seem legitimate; how are we supposed to discern between a quack health app, and one that can actually be trusted? There needs to be some kind of regulation, but the question is — how much?

The issues I find with certain apps, is that if they get too advanced (such as an x-ray), people might start avoiding the doctor because they diagnose themselves. Basically, I think that without regulation, certain apps may seem awesome, but in reality, they have fatal flaws that could be just that — fatal. There shouldn’t be a chance that bad apps could possibly act as an authoritative source.

In the Washington Post article I previously referenced, Bakul Patel, a FDA adviser was interviewed. I thought he made a good point when he said:

We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. If somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.

I mean, that totally makes sense. Just because something is digital doesn’t mean it should be able to bypass requirements. A stethoscope is a stethoscope. End of story.

Overall, I agree with the regulation. If medical and health apps are going to actually be taken seriously, we should be able to see right of the bat if it can actually be trusted as a medical device. I’m not a huge fan of the government controlling everything, so there should definitely be regulation on the apps that could actually determine the health status of a person. However, the rules shouldn’t be so strict that people can’t be creative in what they create. That’s my two cents on the issue, what are your thoughts?

About the author

Katie Clark

Katie Clark

Katie Clark is originally from Colorado and currently lives in Utah with her husband and son. She writes primarily for Smart Phone Health Care, but contributes to several Health Care Scene blogs, including EMR Thoughts, EMR and EHR, and EMR and HIPAA. She enjoys learning about Health IT and mHealth, and finding ways to improve her own health along the way.


  • This is a really challenging subject. Plus, it’s made even more difficult since the FDA takes years to decide how to regulate something.

    I’m generally against any regulation by the FDA in the mobile healthcare space. The one exception is devices that really are medical devices. For example, it makes sense why an ECG monitor attached to a smartphone would need to be regulated the same as other ECG monitors.

    One problem with trying to regulate all mobile health apps is that there are tens of thousands of apps. The FDA isn’t ready for that. Plus, the FDA has more scientists than they have software people. So, they don’t have the skills to regulate software anyway.

  • I think you are totally right that it makes no sense for the FDA to even try and regulate all mobile apps. Anything that medical professionals expect to use should be regulated, but beyond that there is just too much to regulate.

    I could also see it being reasonable for anyone who wanted the FDA stamp of approval to submit their app to have the FDA approve it. The reality though, is that most of these apps don’t really need to be dissected by the FDA. That would just be a waste of time and money for everyone involved.

  • Anything used to treat, diagnosed, prevent diseases or follow up patients should be regulated.
    It is a “must” in order to maintain Telemedicine quality of care.
    One of the reasons of the slow adoptsion of IT in medicine is that is not regulated for quality of care.

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