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Will new FDA regulations be the death knell for medical apps?

Posted: , by Scott H.

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Will new FDA regulations be the death knell for medical apps?
Do you use a medical app on your smartphone? If so you’re in good company, as millions of people make use of the dozens of apps available on the different platforms – and that number is expected to grow to half a billion users by 2015. That growth is large enough that the U.S. Food and Drug Association is looking to regulate medical apps, and that has some people concerned.

The Washington Times – not known for its love of government regulation – published an Op/Ed piece warning of the chilling effect such regulations could have on the medical app ecosystem. Joel White’s not-so-subtly-titled piece “FDA’s assault on mobile technologies” makes the case that if the FDA chooses to regulate smartphone apps as “medical devices,” all of the innovation and vibrancy of the market may be squeezed out. In particular, White points out that the FDA takes an average of three years to approve medical devices, with an average cost of $75 million dollars. The costs of such a lengthy approval process could lead to a slowdown in medical app development, the end of free apps (as businesses pass their costs on to consumers), and the exodus of small app developers to other, non-medical fields.

That sounds pretty terrible, but luckily it turns out the FDA doesn’t want to regulate your copy of WebMD. A quick visit to the FDA’s website reveals their actual intent, including a copy of the proposed guidelines, “that outline the small number of mobile apps the agency plans to oversee”. So what type of apps does the FDA want to regulate? As luck would have it they provide examples:

  • Are used as an accessory to an FDA-regulated medical device. For example, an app could enable a health care professional to view medical images on an iPad and make a diagnosis.

  • Transform a mobile platform into a regulated medical device. For example, an app that turns a smartphone into an electrocardiography, or ECG, machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.

Will new FDA regulations be the death knell for medical apps?
 So you there you have it; the FDA doesn’t want to regulate your prescription tracker, your calorie counter, or your copy of the Merck manual that you got from your favorite app market. They want to regulate apps used by medical professionals doing things like looking at X-rays, or checking to see if you’re suffering a heart attack. The non-mobile-app versions of those tools are already regulated (and so the costs are already built in) and the FDA is trying to make sure that mobile platforms don’t become a loophole for professional medical technology companies.

We don't want to downplay the importance of the issue of industry regulation - we know it's a topic that is important to many of you. But White's article casts a very broad net, seeming to imply that all medical apps could be within the FDA's regulatory scopes, and luckily it turns out that's just not true.

If you’re of the political-activist persuasion and are concerned about how much (or how little) the FDA intends to regulate mobile apps used by medical professionals, by all means follow the source links and let your voices be heard through the appropriate channels. But for those of you who were concerned that your copy of Epocrates was going to be yanked off the market: Crisis averted.

sources: Washington Times via Textually; FDA, Proposed Guidelines

19 Comments
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posted on 08 Feb 2012, 13:19 6

1. The_Miz (Posts: 1496; Member since: 06 Apr 2011)


First. Oh look, the government looking to interfere again. How about they just stfu and leave us alone, we know how to make our own decisions and I don't need liberals telling me what apps I can and can not use.

posted on 08 Feb 2012, 14:24

4. drahmad (Posts: 478; Member since: 20 Aug 2011)


you are right miz. they have weird laws if you go to their depth. e.g. alcohol is bad for health (as a doctor i know alot) but USA has no ban on it. illicit Sex results in a lot of crimes, and other complications e.g increased risk of cervical cancer, but USA govt. does not want to ban it. and see this...

posted on 08 Feb 2012, 22:19 1

9. remixfa (Posts: 13903; Member since: 19 Dec 2008)


your absolutely right doc! as a professional, it should be your job to tell the government that they need to regulate away everything that might do us harm! booze, sex, fast food, fat, bacon, guns, personal responsibility, choice, consequence, or anything that gives us a life experience so we can be completely dependent on loving mother government to take care of all of our needs. who needs to think!!!
As a person currently going to school for meds, personal responsibility and good decision making are the choices of the individual, not the society.

posted on 09 Feb 2012, 07:52

13. drahmad (Posts: 478; Member since: 20 Aug 2011)


@ remixfa , Humans are not beasts, humans should have certain laws :-)

posted on 09 Feb 2012, 08:10

14. remixfa (Posts: 13903; Member since: 19 Dec 2008)


the only laws we need are ones PROTECTING our personal freedoms and property rights. Other than that, government needs to stay out of the way. What we dont need are laws regulating choices to what a small group of people feel are good for us. We need to be personally accountable for our actions.

posted on 09 Feb 2012, 08:50 1

15. drahmad (Posts: 478; Member since: 20 Aug 2011)


projecting personal freedoms :-) if you do something, it is automatically projected e.g.if you are using alcohol, your son will think "since dad is doing it, it shouldn't be bad" and he will grow with that thing in his mind, the way you have grown in a society where, unsolicited sex is considered good, so you think its good too :-)

posted on 09 Feb 2012, 10:54

16. remixfa (Posts: 13903; Member since: 19 Dec 2008)


my dad was an alchoholic. i drink alchohol socially, but i feel no need to drink regularly. your analogy has no merit. You think unsolicited sex is bad because you grew up in a society/family that taught you it was bad. that argument also has no merit. Morals are individual. As long as what you do does no harm to another (murder,steal,ect), you should be allowed to do it. If you wanna go shoot heroine till you die, go for it. If i wanna use MDMA and have a massive roman style orgy, then who are you to tell me I shouldnt?

Life is choice and consequence. No amount of nanny state can change that. You want to force your morality on others by making laws to curb behaviors you dont like. Who are you to judge another's life? If a person wants to make good judgements thats up to them as much as the person who wants to make bad judgements.

posted on 09 Feb 2012, 23:56

18. drahmad (Posts: 478; Member since: 20 Aug 2011)


remixfa , how many people die due to alcoholic diseases in usa every year? About 75000 ! because it is PROJECTED like I said. and that is just deaths, leave other morbidities aside. so simple.

according to your philosophy , morphine should also be available to every one and so is heroine? what do you think about this?

the point is, sometimes SOME people don't understand what they are doing. you may have control over your self, but you may transfer this habit to someone who may potentially harm himself, may be your son, may be your friend...

posted on 10 Feb 2012, 00:08 1

19. drahmad (Posts: 478; Member since: 20 Aug 2011)


and about sex, sex is not considered bad in my society, but illicit sex is... and yes it is bad. just as an example, e.g. you have a wife, you go out and have sex with a girl who has cervical cancer, then a day after you have sex with wife, YOU MAY TRANSFER THAT CANCER TO YOUR WIFE. so for you it was good, but you have ruined the life of your wife. This is just One example, there a thousand more reasons illicit sex should be banned

posted on 09 Feb 2012, 07:46 1

12. drahmad (Posts: 478; Member since: 20 Aug 2011)


lol, look at the thumbs:-D "mass mind control via media"

posted on 08 Feb 2012, 14:09

2. tbar (Posts: 34; Member since: 18 Jan 2010)


I currently have an insulin pump that has a computer app so I can download the information on blood glucose levels, insulin doese, etc. to the computer. I have to have a computer with Windows XP to do that because the FDA hasn't approved having that interface compatible with Windows 7. Never mind that the download has ABSOLUTELY NOTHING TO DO WITH THE MEDICAL FUNCTIONALITY OF THE DEVICE!!!! Absurd!!! Somebody needs to stop them now or that is a whole, useful segment of the smartphone functionality that will disappear.

posted on 08 Feb 2012, 14:14 3

3. Fallout09 (Posts: 414; Member since: 17 Oct 2011)


Miz, do you just actually read the store before you post or do you have some sort of comprehension problem?

posted on 08 Feb 2012, 14:31 3

5. The_Miz (Posts: 1496; Member since: 06 Apr 2011)


Maybe you should get an app for that. ZING!

posted on 08 Feb 2012, 14:35

6. Fallout09 (Posts: 414; Member since: 17 Oct 2011)


App for what? If I remember iPhone’s claim to fame "There's an app for that!" You seem to be one of our resident iFans.

posted on 08 Feb 2012, 15:53

7. Gawain (Posts: 353; Member since: 15 Apr 2010)


The FDA is doing this as a part of the Obamacare law. HHS has been issuing sweeping new regualations as that law gets implemented. One of the big "taxes" is on medical devices...follow the slippery slope...

posted on 08 Feb 2012, 20:21 1

8. davin8r (Posts: 45; Member since: 28 Apr 2011)


...and the Tea Pary whackos come crawling out of the woodwork. "THE FDA IS TRYING TO ENSLAVE US!!! OMG ARMAGEDDON!!!"
As the article states, they intend to only regulate programs used by medical professionals to make diagnoses and treat patients. It's no different than regulating pharmaceuticals or regulating quality of food to help reduce food-borne illness.

posted on 08 Feb 2012, 22:21

10. remixfa (Posts: 13903; Member since: 19 Dec 2008)


if the beaurocracy didnt take 3+ years at a minimum to "approve" something, and then years to "approve" each change when you upgrade it, it might not be so bad.
I love how you have to be a "tea party whacko" to question the government now. You do realize that this country was founded by people who despised government, dont you? We fought this thing called the revolutionary war to end high taxes and over regulation. yet, here we are again because u want a free ride.

posted on 08 Feb 2012, 23:50 2

11. Scott_H (Posts: 167; Member since: 28 Oct 2011)


Not to bring history into this, but actually the fight wasn't about taxes, but about taxation without representation - the colonists wanted a vote in parliament if they were going to be subject to levies. And "regulation" wasn't even a buzzword in politics then, that's a buzzword that's unique to the 20th century onward.

That said, I agree that 3 years is too much...depending on what is being approved. That 3 years figure is an average - if it's for things like approving Windows 7 over XP like the poor gentleman above, it's clearly ridiculous and a failure of government. If it's a brand new treatment for cancer that has mixed results in trials, it may not be so crazy. It's all about context.

posted on 09 Feb 2012, 10:57

17. remixfa (Posts: 13903; Member since: 19 Dec 2008)


the fight was about taxes. they wanted taxation with representation because they did not like the levies being filed against them. They thought it was unfair that the brittish were taxing the americans to fund the wars with france. They didnt want to pay the taxes, thus the fight was about taxes and not wanting them.

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