FDA to regulate Mobile Health Apps

[Guest TankerHC]

This is interesting. I suppose they dont want anyone trying to stay healthy with the use of an app, or they intend to make money for the Government off these apps. Way to go for the FDA to kill innovation. I guess Ill eventually be removing my app that promote's walking since it gives an approximation of heart rate and calories, also tracks your walk through GPS and creates a built in map of your walk if you decide you want to upload your progress. Or my Glucose level app for keeping track of diabetes.

 

WOnder how long before banking apps are regulated, got to know how much you have in the bank, cant be having something they dont know about, or shopping apps like Amazon and Ebay by the IRS, got to make sure you pay taxes on those online purchases.

 

Might not be good for much else, but Government is very good at killing innovation. 

 

 

"As mobile platforms become more user friendly, computationally powerful, and readily 

available, innovators have begun to develop mobile apps of increasing complexity to leverage 

the portability mobile platforms can offer. Some of these new mobile apps are specifically 

targeted to assisting individuals in their own health and wellness management. Other mobile 

apps are targeted to healthcare providers as tools to improve and facilitate the delivery of patient 

care."

 

This was in 89, they then removed it unaware that that Mobile Apps would become prevalent since Mobile Phones would become prevalent. I suspect those who were unaware this might/could/would happen are still Government Bureaucrats while those who were aware this might/could/would happen are working in the tech industry. 

 

Then they brought it back, then in 2005 dropped it and now they have brought it back again. 

 

A. Mobile Platform

For purposes of this guidance, “mobile platforms” are defined as commercial off-the-shelf 

(COTS) computing platforms, with or without wireless connectivity, that are handheld in nature. 

Examples of these mobile platforms include mobile computers such as smart phones, tablet 

computers, or other portable computers. 

 

B. Mobile Application (Mobile App)

For purposes of this guidance, a mobile application or “mobile app” is defined as a software 

application that can be executed (run) on a mobile platform (i.e., a handheld commercial off-the shelf computing platform, with or without wireless connectivity), or a web-based software 

application that is tailored to a mobile platform but is executed on a server.

 

C. Mobile Medical Application (Mobile Medical App)

For purposes of this guidance, a “mobile medical app” is a mobile app that meets the definition 

of device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)4

; and 

either is intended: 

• to be used as an accessory to a regulated medical device; or

• to transform a mobile platform into a regulated medical device (My note: Note that they arent regulated yet, sounds like they definitely will be)

 

"When the intended use of 

a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, 

or prevention of disease, or is intended to affect the structure or any function of the body of man, 

the mobile app is a device."

 

Hey, cant have you keeping yourself healthy by mitigating factors that may make you sick or prevent disease by taking control of your own healthcare. Government needs to regulate that. They are here to help.

 

Need to scroll down to the nonbinding regulations. They wont be regulating your Tablet or Smartphone, they promise.

 

But any app that's specifically designed to help you manage your own healthcare, keep you from getting sick or help you stay healthy, is a device. (The app). 

 

So the FDA is now going to regulate smartphone apps, is there any place the Government cannot reach and get their hands into? (Thats a rhetorical question)

 

And dont go creating any apps that may help anyone either, in fact dont even think about it, just coming up with the specs makes you a manufacturer.

 

For purposes of this guidance, a “mobile medical app manufacturer” is any person or entity that 

manufactures mobile medical apps in accordance with the definitions of manufacturer in 21 CFR 

Parts 803, 806, 807, and 820.7

A mobile medical app manufacturer may include anyone who 

initiates specifications, designs, labels, or creates a software system or application for a regulated 

medical device in whole or from multiple software components. 

 

 

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM263366.pdf

 

 

Edited September 28, 2013 by TankerHC

[Monkeyman2500]

Big drug companies with huge ties to the gov don't want you getting healthy. It's all about the all mighty dollar.

[RED333]

Yep it is ether to make money from taxes or drugs.

[Guest Lester Weevils]

Maybe they want tax more than they want regulatory control? That thar bammycare medical device tax.

OTOH I don't see a lot of tax potential, because there doesn't seem a great deal of profit potential in the typical app. There are so many zillions of apps competing for the bucks, and at a few bucks apiece there seem to be only a few "runaway hits" which generate substantial income for even a shoestring garage biz.

Sell a big package for $500 and sell 1000 a year and maybe you can pay the rent and lights and even hire a couple of flunkies. Sell an app for a dollar, competing against a zillion other free or cheap apps-- Geeze, might as well play the lottery. Maybe better odds of a profit :)

[Guest TankerHC]

Zillions of apps could equal zillions if dollars even at a few cents an app

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[Guest Lester Weevils]

Zillions of apps could equal zillions if dollars even at a few cents an app

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Yep, for the gov if they can figger out how to tax em. But divided between a zillion developers it is still pennies.

The majority of app developers I personally "know" from mailing lists seem to live somewhere else. Good luck collecting medical device tax from those guys.

I'm not talking down the utility of apps. Mqybe it will be like the recording biz, where a statistically insignificant number of "stars" with hit records get rich and everybody else starves. And then the studio musicians (another small but more statistically significant group) make a good solid living on it but don't get rich and famous.

Perhaps the job shops are the equivalent of the studio musicians, making a good buck generating workmanlike products for xyz corp to give away to their customers, banking, commerce, etc.

Apps can be real useful. I just don't like shopping for dollar or ten dollar apps. In any niche ya have to try out a dozen or two trying to figger out if there are any that don't suck. It would be more cost effective to pay $50 or $100 for a product that does what its sposed to do and doesn't suck.

[Sam1]

They can get around this just by putting the "this not to treat, diagnose or cure any disease" disclaimer in the user agreement. Same thing the snake oil companies put on their magic pill bottles. Edited September 28, 2013 by Sam1

[Garufa]

Is the FDA going to start regulating the internet next?