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FDA Will Regulate Some Apps As Medical Devices

Soulskill posted about 7 months ago | from the software-is-hardware dept.

Medicine 130

chicksdaddy writes "In an important move, the U.S. Food & Drug Administration (FDA) has released final guidance to mobile application developers that are creating medical applications to run on mobile devices. Some applications, it said, will be treated with the same scrutiny as traditional medical devices. The agency said on Monday that, while it doesn't see the need to vet 'the majority of mobile apps,' because they pose 'minimal risk to consumers,' it will exercise oversight of mobile medical applications that are accessories to regulated medical devices, or that transform a mobile device into a regulated medical device. In those cases, the FDA said that mobile applications will be assessed 'using the same regulatory standards and risk-based approach that the agency applies to other medical device.' The line between a mere 'app' and a 'medical device' is fuzzy. The FDA said it will look to the 'intended use of a mobile app' when determining whether it meets the definition of a medical 'device.' The Agency may study the labeling or advertising claims used to market it, or statements by the device maker and its representatives. In general, '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 it is intended to affect the structure of any function of the body of man, the mobile app is a device.'"

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130 comments

Woohoo! (0, Troll)

geek (5680) | about 7 months ago | (#44940623)

Nanny State to the rescue! Did someone appoint Bloomberg to the FDA?

Re:Woohoo! (0, Flamebait)

Anonymous Coward | about 7 months ago | (#44940665)

why don't you move to Somalia, you jack off.

Re:Woohoo! (0)

Tablizer (95088) | about 7 months ago | (#44940773)

EnronCare in Somalia is what libertarians get. If they need a medical loan, then they have the Bank of Madoff to help out.

Re:Woohoo! (4, Funny)

CajunArson (465943) | about 7 months ago | (#44940923)

You know what else they don't have in Somalia?

1. Patent trolls.
2. DMCA.
3. Central Government Spying.

So if you are in any way against any of those things then you want America to be exactly like Somalia. Thank you for playing the deluded Straw Man game!

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44942079)

Cant stand this type of Argument, it is just like the people who would use the dont like America in Iraq then leave patriotism nonsense.

People can express their rightful discontent of Government overreach or hindrance of progress etc without having to be resorted to told go to Somalia. A better place of comparison is go to Hong Kong,

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44942105)

That is silliness. I think we all know that Somalia is not defined by it's lack of DMCA.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44943711)

Okay, I'm usually very pro-nanny state. However, there is a valid point (not necessarily the one made above) that FDA regulatory hurdles- especially in drug trials- severely cripple the state of the art. They make it unprofitable to pursue cures (rather than ammerlioratives) for rare diseases, or even for HIV, and lead a lot of science like drug trials to be conducted overseas in places where ethical oversight may be more lax. The FDA really does need some very mindful deregulation, and I say this as a hardcore liberal.

Re: Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44943741)

Big pharm, and the big device makers, like things just the way they are. They have skilled Regulatory Affairs departments, and the highly regulated environment keeps out upstarts.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44941181)

Why don't you move to the liberal paradise of Detroit?

captcha: welfare (how apt)

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44941573)

why don't you move to Somalia, you jack off.

Why don't you post your real name and address so we can all know who you
are, mister big talker ?

Re:Woohoo! (4, Insightful)

ColdWetDog (752185) | about 7 months ago | (#44940691)

So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

That's what this is about. The FDA neither has the time nor energy to look at every stupid 'medical' app in the store. They're only going to deal with ones that have an interaction to hardware that can cause problems or if the app is really, egregariously touting some medical benefit that it can't possibly provide.

Re:Woohoo! (4, Insightful)

geek (5680) | about 7 months ago | (#44940751)

So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

Why the fuck would you use a mobile app to control an IV pump? That's like running a production database for a fortune 500 company off of Arch Linux.

You don't use something that isn't stable to run something as important and life critical as an IV pump. Nor would any hospital do so and any individual that tried would simply be a victim of natural selection.

Re:Woohoo! (3, Insightful)

bill_mcgonigle (4333) | about 7 months ago | (#44940857)

Why would you put a poorly-tested embedded bluetooth stack in a pacemaker that crashes under fuzzing? Crazy, right?

If it's anything like it was when I was in medical software, the FDA is more concerned with process than specifics of implementation. If you're practicing good software development and QA methodologies and you can impress your ISO9001 auditor, then the FDA won't be too tough. Then again, "those were the days", so maybe somebody can update this - last time I flew to FDA for a development seminar was the first time I got wanded by TSA.

Re:Woohoo! (3, Insightful)

Artraze (600366) | about 7 months ago | (#44941109)

These days they have ISO 13485 [wikipedia.org]. It's a lot like ISO 9001, but drops the more marketing continual improvement and customer feedback and adds additional requirement for creation of requirements, something more-or-less non existent in 9001.

So theoretically, 13485 would require you to recognize risks (e.g. fuzzing) and add mitigation (e.g. not crashing) to your requirements, which would then be tested and all the in a similar matter to 9001. I'd say that as a result it's about as good as can really be expected. The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.

For completeness it's worth mentioning that when it comes to diagnostic software (I believe this started in the last couple years) they also require clinical trials to verify effectiveness somewhat like they do for medicine. Therefore if you write an application that, say, helps determine if someone is concussed (the case which started diagnostic software, IIRC) then you actually have to collect data for concussed and non-concussed people (verified by traditional means) and prove that it can provide a meaningful diagnosis.

Re:Woohoo! (1)

TapeCutter (624760) | about 7 months ago | (#44942899)

The only real other steps would be for the FDA to bring in experts to verify the considered risks and possibly verify the testing, which starts to become unrealistic.

Yes, in many cases the only 'experts' are the people who wrote the code. All you can really do is minimise risks by erecting procedural walls and testers between the experts, the accountants, and the patients. Sure it slows things down, bumps up costs, and is still not 'failsafe'. But that's the price of working under the motto "first do no harm".

Aside from that, in most western nations if your software does kill or injure someone, your 'principle engineer' better be able to demonstrate due diligence such as adherence to government mandated standards, ie: adherence to the law. If not he will find himself charged with the local equivalent of "negligent homicide". Why do people think there was so much fuss over Y2K? Why would an insurer not cancel a public liability policy if the insured was not Y2K "compliant", who would the coroner hold responsible if there was an accident? Y2K was not a "beat up", it was proof that software engineers can and do act like real engineers when risks are identified.

To the rest of the world a software engineer that ignores mandated standards is just as criminally reckless as the (veteran) Italian train driver who recently crashed his passenger train into a concrete embankment because he took a bend at twice the posted speed.

Re:Woohoo! (2)

khb (266593) | about 7 months ago | (#44940921)

A wide variety of medical devices currently use Windows (often XP) to provide the client interface. Most Doctors have smart phones, so getting the buggy, unreliable, insecure Windows box out of the picture may appeal to some ... and leveraging the technology that the staff already have is not unreasonable (yes, there's some OTHER computer actually monitoring the flow. But setting the rates? Receiving alerts? ... why not use the smartphone?).

As to whether the FDA does a good or bad job (or a bit of both), it neither seems odd that some people would want to leverage the control (think Cochlear implant devices and programming adjustments) that folks already have, to manage their devices (durable, not just hospital based). Nor, if one accepts that the FDA has a role of any sort, why they should not be involved JUST because something is a software app as opposed to the software running in the otherwise regulated device.

Re:Woohoo! (1)

K. S. Kyosuke (729550) | about 7 months ago | (#44941103)

A wide variety of medical devices currently use Windows (often XP) to provide the client interface.

I hope that the Feds on Drugs Administration has thoroughly tested those Windows as well. I can't imagine a medical device having anything COTS-related that wouldn't be isolated in some safe way that would make testing the front-end at least less important, if not completely meaningless. You don't prevent Therac-25-like incidents by vetting an XP client that controls everything, you prevent them by minimizing the implementation into a single-purpose controller with bulletproof interface to the XP client. Likewise, I can't see how a cell phone or tablet could even communicate with a trustworthy medical device without either 1) the cell phone having an simple but reliable add-on port hardware to connect to the device, or 2) the device having a common wireless communication equipment such as WiFi or BT. The former makes it a non-app (as in, not a downloadable file, but a physical device with a SW client, and therefore a medical device in the old sense), the latter would be extremely braindead given the complexity of the WiFi and BT stuff, and the potential bugs therein.

Re:Woohoo! (1)

TapeCutter (624760) | about 7 months ago | (#44943323)

People see a windows front end and conclude it's running the entire ICU with an excel spread sheet. You'd think on Slashdot there would be less ignorance of the subject, ironically it's one of the few places I hear the meme repeated ad-nauseam.

Re:Woohoo! (2)

TapeCutter (624760) | about 7 months ago | (#44943243)

My mum is in her late 70's and has a $6k hearing aid that is tuned on a PC. The FDA don't want to prevent people tuning their hearing aid with their mobile phone, they want to ensure they can't accidentally blast their brains out with a 130db screech in the pitch of a 6yo girl. They will also want to look at the hearing aid to ensure it can't be used as an audio torture device in the first place.

It's well known that principles are expensive. The majority of the $6k for the device and software represents the cost compliance with the "first do no harm" principle that has been central to western medical practice for over 2000yrs, money well spent IMHO.

Pre-emptive "free market" retort: Hearing aids and the software that interacts with them are tested, certified, and sold as a standalone "system". Everyone is "free" to play in that "market", although individuals and groups have varying degrees of influence on how the market works, they are not "free" to dictate the rules of trade that constitute the market itself, that's the role of government.

Re:Woohoo! (4, Insightful)

reebmmm (939463) | about 7 months ago | (#44940949)

Why the fuck would you use a mobile app to control an IV pump?

The point is really two-fold. First, we already regulate medical devices like infusion pumps and radiology information systems. Under the proposed regime, one does not simply avoid regulatory scrutiny and obligations by offloading them to an app.

Second, if a app makes claims to do things things that would ordinarily be regulated, you don't escape the regulatory regime simply by saying, I'm just an iPhone app.

Both prongs make some sense if you accept the basic assumption that FDA regulation of devices makes sense at all.

Re:Woohoo! (0)

roman_mir (125474) | about 7 months ago | (#44941305)

Of-course you are correct in that last statement. There should be no FDA in the first place, government is not authorised to run that agency (and do 99% of all other things that government does either).

Re:Woohoo! (2)

Kalriath (849904) | about 7 months ago | (#44942387)

Oh get off. The stated goal of the agency (to prevent companies and individuals selling products which are patently unsafe, causing harm to consumers, or making medical claims which are patently false) is a necessary one, otherwise scumbags would be (taking it to the extreme) selling cyanide pills and claiming they cure cancer.

Whether the agency is living up the goal they claim, or acting in a corrupt fashion is another story entirely.

Re:Woohoo! (0)

roman_mir (125474) | about 7 months ago | (#44943287)

No, I don't care if the goal is at all good or noble, it is beside the point. The point is that this goal cannot be given as a mandate to any type of government, and it was not in fact given as a mandate to the USA gov't (in fact it is unconstitutional for USA gov't to do this).

The point is that in the name of such a goal the government gets ability to destroy individual freedoms, which it does. Government cannot be given such powers, these powers should not be concentrated in the hands of any type of legal authority. This is not a power that anybody should have at all.

If the market sees a need to have a rating agency that rates products and services against any type of a standard then there will be a number of agencies competing for the market share of that industry and the customers can then decide to trust a particular rating brand or not based on their past performance and in fact there cannot be any regulations of any such rating agency by any level of gov't either, or it will become a monopoly that will again, serve to the detriment of the society rather than to its advantage.

Re: Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44943785)

The Underwriters Laboratory fills a similar role to the FDA and does it while being a private nongovernmental entity. Government does NOT need a central role in the regulating, beyond providing a legal framework (the court system) which is well established and enshrined in the Constitution.

Piggybacking? (0)

Anonymous Coward | about 7 months ago | (#44941701)

While writing or proofreading, didn't it at some point become apparent that your post answers an altogether different question than the one the parent is asking?

Key Point (1)

rshol (746340) | about 7 months ago | (#44941733)

you don't escape the regulatory regime

Exactly. Ever. And that is the root of the problem.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44940987)

Arch Linux is not stable enough to run anything

Re:Woohoo! (1)

Urza9814 (883915) | about 7 months ago | (#44943389)

I run Arch on my desktop and laptops and it requires *orders of magnitude* less maintenance than the Mandriva system it replaced...not that that's saying much. Of course Mandriva still beat Ubuntu -- I could never manage to get an Ubuntu system fully working in the first place! (granted, the last time I tried was probably six years ago when it was a fairly new distro...)

Re:Woohoo! (3, Insightful)

icebike (68054) | about 7 months ago | (#44941043)

You don't use something that isn't stable to run something as important and life critical as an IV pump. Nor would any hospital do so and any individual that tried would simply be a victim of natural selection.

From your mouth to God's Ears.

But just in case someone was thinking of doing this the FDA is going to step in and set guidelines.
Why: Because people are re-purposing cellphones for all sorts of stuff, most of it not well thought out.

You can find examples which contain unvetted information on the Google Play store. Some of this might find its way into actual use in the field, because in all too many cases doctors and computers live in two different worlds, and may come to trust something that looks approximately right, only to find out its horribly wrong in some places:

Examples (with no allegations of incorrectness or danger, simply to show examples that already exist):
https://play.google.com/store/apps/details?id=com.shahlab.anesthesiologist [google.com]
https://play.google.com/store/apps/details?id=net.klier.blutdruck [google.com]
https://play.google.com/store/apps/details?id=com.qxmd.calculate [google.com]
https://play.google.com/store/apps/details?id=com.mobisystems.msdict.embedded.wireless.mcgrawhill.ivdh [google.com]
https://play.google.com/store/apps/details?id=com.sekos.dosagecalc [google.com]

So yeah you might thing such doesn't exist, and these might be harmess infomation apps, but who's to know when nobody is watching.
And with NFC built into every phone these days, who's to say someone won't find another use for it?

Re: Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44941373)

A lot of those examples are more akin to books. AFAIK there is not a similar review process for that scenario at least.

I think people should only be afraid of over reach. When I think of over reach I am more concerned with things like the kickstarter eeg projects.

Apps that actually can injure someone due to malfunction IS different than someone being stupid and trusting questionable information.

which is quite the point. why use rhino horn? (1)

raymorris (2726007) | about 7 months ago | (#44941097)

That's exactly when the FDA should step in, and when they have, historically. It doesn't make any sense to try to cure diabetes with lizard tails. If you sell lizard tails as a diabetes cure, the FDA may come knocking. If you sell a magnet hat as brain cancer protection, the FDA may want to talk to you. If you sell a strobe light app as a cure for emphysema, same thing.

Really this is just another case of "on a computer doesn't change anything". If you sell a "cure" for a disease, the FDA may want to have a look.

Re:which is quite the point. why use rhino horn? (0)

Anonymous Coward | about 7 months ago | (#44941601)

This is so ironic it's funny.

http://en.wikipedia.org/wiki/Exenatide [wikipedia.org]

From the article: "medication approved in April 2005 for the treatment of diabetes mellitus type 2....Exenatide is a synthetic version of exendin-4, a hormone found in the saliva of the Gila monster..."

So, lizard spit IS a treatment for diabetes.

Re:Woohoo! (1)

mspohr (589790) | about 7 months ago | (#44941147)

I agree that the software should be stable and tested (and that is the purpose of these regulations).
As to "why use a mobile app to control an IV pump"... let me count the ways.
Use your imagination.
- patient is in isolation... don't touch the pump
- nurse can monitor and control a lot of pumps from one application
- the application can check for problems with the pump
- the application can check for drug interactions
- the application can check for drug overdoses
- the application can check lab values and recommend changes in dosage
--- these are just a few off the top of my head...

It's not hard if you have a little imagination.

Re:Woohoo! (1)

jklovanc (1603149) | about 7 months ago | (#44941189)

How about the following?
1. An app that interfaces with a glucose reader that calculates what dose of insulin and when to administer but miscalculates and over/under prescribes.
2. An app that displays ECGs for cardiologists but mis-displays and life threatening illnesses are missed.
3. A portable ECG that mis-records? I used to work at a company that uses puck sized ECGs with USB interfaces.
4. An app that interfaces with a blood pressure cuff and attempts to diagnose high blood pressure.

A smart phone makes a great display and data recorder and they can get into areas where mistakes can cause death or disability.

Re:Woohoo! (1)

mjr167 (2477430) | about 7 months ago | (#44941283)

By your logic we should never do anything because it is not safe.

The world is moving on and us kids will happily get off your lawn and take our new mobile shinies with us. We are moving into a world where the data gets shot through the air and my device fits in my pocket. You can bitch about it or you can help us make it work. The IV pump you mention CAN accept its inputs from mobile apps. But between the app and the IV pump should be something that is going to validate the inputs coming from the app. And the IV pump is going to perform the same validations that it currently performs against the nurse fiddling with the knobs/buttons/whatever manually.

Yes it's not safe because it gets shot through the air, but smart software engineers will build in fail saves and checks and security. Oh noes! We will have to test and validate our code! The horror!

Re:Woohoo! (1)

geek (5680) | about 7 months ago | (#44941375)

You're young and apparently stupid. There is a name for people like you, "Organ donors"

Re:Woohoo! (1)

Luciano Moretti (2887109) | about 7 months ago | (#44941627)

What would probably happen is the actual logic and safeties would be written in an embedded board on the IV pump, and then the app would be a remote display app, with a touchscreen interface allowing you to adjust settings within predefined limits.

I used to work in medical imaging, and people floated the idea of display apps on iPads for doctors to view images, but the display quality wasn't good enough for medical diagnosis. Even our monitors on our equipment had a disclaimer that they weren't for medical diagnosis: usually that was offloaded onto a dedicated workstation with a super-high resolution monitor (usually grayscale)

Other potential uses would be remote display of ECG/Vitals, but then you have to make sure that alarms come across your network correctly to the device, and that data isn't delayed or incorrectly displayed (which could cause misdiagnosis).

That said, when I left about a year ago we were still selling a device that had Windows 95 on it.

Re:Woohoo! (3, Interesting)

Alternate Interior (725192) | about 7 months ago | (#44941677)

Speaking as a Diabetic- yes I do.

I wear an infusion pump already. And a continuous monitor. They're plastic screens and buttons I clip to my belt. They have to be easily accessible because there is so much variance day-to-day.

Having everything talk via ANT or BT or something. Having one controller for it all. It'd be wonderful. I think your point is that it's too dangerous to put all that burden on a single piece of commodity hardware. And that's a valid point, in theory. But in reality, if I can replace the pump UI and CGM UI with a phone **that I'm already carrying** I end up with a whole lot fewer widgets to keep track of. Also, by virtue of commoditization, I could replace the software stack infinitely easier than a purpose-built controller, Dangerous? Sure. But understand the position we're in now:

  1. Taking too much insulin is deadly.
  2. It's easy to take too much insulin.
  3. Since 2009, pumps and CGMs have been available in much of the world which automatically stop delivering insulin when your blood sugar is low.
  4. The FDA has not allowed this technology in the United States.

I don't care if it's dangerous or voids the warranty or puts the FDA boogey-man on me. If a development like this occurs in the future and the FDA impedes it, I would like the opportunity to get it. Running on an open stack, even a quasi-open stack, is the only viable way for that to happen. And for today, smartphones are the best way to make that happen.

Re:Woohoo! (1)

c (8461) | about 7 months ago | (#44941775)

Why the fuck would you use a mobile app to control an IV pump?

An IV pump, probably not. In fact, you'd be silly to run hospital gear with a phone.

A personal device like an insulin pump... yep, I could see it. They've already got pumps that wirelessly communicate with glucometers, and a user interface written on a mobile has to be less confusing than the nests of modal menus on a pump.

Re:Woohoo! (1, Interesting)

cayenne8 (626475) | about 7 months ago | (#44940771)

I'm guessing it is also a nice move to allow more tax revenue to be gathered due to be being categorized as a medical device....another nice little by product of obamacare (the increased taxation of medical devices).

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44941325)

The beauty of conspiracy theory is facts don't kill it, only make it stronger.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44940813)

So you want an app that's controlling an IV pump to be written to the same standards as your average fart app?

That's what this is about. The FDA neither has the time nor energy to look at every stupid 'medical' app in the store. They're only going to deal with ones that have an interaction to hardware that can cause problems or if the app is really, egregariously touting some medical benefit that it can't possibly provide.

But the government can't possibly do anything right! Surely we are better off just letting our corporate fart-app overlords have final say over what we are allowed to use as a medical device, instead.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44941609)

The idiot bastards at the FDA don't have any authority to regulate any app.

Re:Woohoo! (1)

Jack Quack (1352327) | about 7 months ago | (#44942345)

Here are two examples of how an app on it's own can pose significant risk to a patient, if the app is intended to make a diagnosis.

1) a medical professional prescribes an intervention that is influenced by the app's diagnosis. If the diagnosis is inaccurate, the prescribed intervention may be very harmful to the patient.

2) If the diagnosis leads to a treatment that is incorrect, the patient may be delayed from receiving the best treatment for that particular case, and this delay may be very harmful to the patient.

Re:Woohoo! (1)

TapeCutter (624760) | about 7 months ago | (#44942565)

Agree, just the fact the FDA have announced they are looking at them will deter some quacks from peddling their brand of crazy as an app. Also the FDA is used as a global standard, it's one of the few admirable institutions within your health system. You guys should reinvent it as a UN agency so that you're not the only ones paying for it.

Re:Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44940755)

I saw him on CNN on July 4th saying that this date reminds us of all the freedoms we enjoy as Americans.
What a turd.

Re:Woohoo! (1)

Artraze (600366) | about 7 months ago | (#44940939)

The important fine print omitted by the summary (and very nearly the article; way to push the important information to the last third ya damn flamebaiters masquerading as journalists) is that they targeting apps

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 it is intended to affect the structure of any function of the body of man

Now, we'll have to see how it plays out, to be sure. Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible. However, they generally allow anything with sufficient (and reasonable) disclaimers (e.g. for research purposes only) so I'm not too concerned yet.

So while I loathe nanny state type policies and don't like everything that the FDA does, I view stuff like this to actually be rather important. Basically, think of it as a proactive enforcement of truth in advertising (vs reactive which requires a lawsuit). If I say my app diagnoses X, the FDA wants to make sure it actually does that. Coupled with the ability for the developer to avoid that by saying 'this is not approved to actually do anything' it makes for a valuable tool for consumer choice.

Re:Woohoo! (1)

skids (119237) | about 7 months ago | (#44941139)

a free/cheap pulse monitor simply impossible

I don't think phones need to be attached to anything to do that, but that's beside the point, as how I read the document things such as this heart rate monitor [f-droid.org]

...might be considered a device that needs to register, but might not, and what makes the difference is entirely how it is marketed, that is what claims are made of it. In which case small demo apps like this might be able to just get away with disclaimers that state "for demo purposes only." Which, without some level of QA, is pretty much all you should be using them for.

Re:Woohoo! (1)

SonnyDog09 (1500475) | about 7 months ago | (#44942973)

Right. But since being overweight has just been re-classified as a disease, any app that lets you track you weight can be interpreted as being one that is involved in the "treatment or prevention of disease." Don't you think they won't.

The other thing I like about this is that they have a scheme for registering and tracking these devices. See http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm [fda.gov] for details.

This is the Globally Unique Device Identifier (GUDID), which they are pronouncing "Good ID". Who says that the government can't market its stuff.

Re:Woohoo! (1)

Urza9814 (883915) | about 7 months ago | (#44943441)

Certainly I think that their interest in targeting apps that interface with medial devices is a little disconcerting because it would make, say, a free/cheap pulse monitor simply impossible.

Every treadmill I've ever seen includes a heart rate monitor. Usually when I try to use them I get readings of 0...or 500...or some other equally absurd number. Clearly things like heart rate monitors are not very strictly regulated.

Re:Woohoo! (1)

Dahamma (304068) | about 7 months ago | (#44941543)

Totally! We all agree that the FDA is one of the most ridiculous, intrusive examples of a nanny state imaginable.

Signed,
- Monsanto, Pfizer, GlaxoSmithKline, Philip Morris, Tyson, and 100s of other companies fined for marketing and selling tainted, dangerous, or untested products to consumers

Biggest story on slashdot (0)

Anonymous Coward | about 7 months ago | (#44941613)

And only 55 comments? Something tells me you guys just don't get it.

Nobody has addressed the real issue (1)

Anonymous Coward | about 7 months ago | (#44941681)

The FDA is protecting traditional medical device manufacturers an their exorbitant, overpriced tech to prevent vastly cheaper apps from disrupting the high cost of health care and allowing the average person to monitor their health at home for pennies a day.

Re:Woohoo! (3, Insightful)

mcgrew (92797) | about 7 months ago | (#44942269)

Nanny State to the rescue!

Bullshit, regulating medical devices isn't being nanny-state, outlawing marijuana is. I, for one am damned glad that the FDA had to approve the device they inserted surgically into my eyeball. I'm damned glad that drugs are regulated, so I won't underdose or overdose on a needed medicine because a supplier is incompetent or dishonest.

Do you scream "nanny state" when the cops go after armed robbers? Did you scream Nanny State when they jailed Madoff?

Sorry, kid, but your comment is just brain-dead stupid. Read a little history, look up "patent medicine" and "snake oil". Read Upton Sinclair's The Jungle (public domain, it's at gutenberg).

Re: Woohoo! (0)

Anonymous Coward | about 7 months ago | (#44943819)

It's rather telling that your scare-examples all reach waaaay back go the early 20th century.

Here come the disclaimers (2)

rolfwind (528248) | about 7 months ago | (#44940713)

Stating the app is only for entertainment/educational purposes only.

Re:Here come the disclaimers (1)

Zumbs (1241138) | about 7 months ago | (#44941131)

App developers can do that, but it would effectively cut their app off from being used by doctors and nurses. Why? Because if an error happens and the doctor/nurse used such an app, the doctor/nurse would be liable. And it would most likely also significantly reduce the price they could ask for the app.

Will this really protect the consumer (1)

oDDmON oUT (231200) | about 7 months ago | (#44940775)

Or just be another black hole that taxpayer dollars funnel into?
[Think medical device fraud via Medicare/Medicaid that is STILL rampant]

Re:Will this really protect the consumer (1)

alen (225700) | about 7 months ago | (#44941011)

part of the ruling says that companies have to disclose where they get their data from. if they are lifting data from copyrighted works they will have to admit it and get sued

HIPPA (0)

globaljustin (574257) | about 7 months ago | (#44941299)

Will this really protect the consumer?

it could...

ex: iphone app for diabetics...you test your blood on a dongle conncted to the phone and the data gets sent via internet to your doctor's office or to a parent

if you don't check or your blood sugar goes below a set limit the system sends txt message reminders to you/your parents/your doctor

this data is covered by HIPPA [wikipedia.org]

HIPPA has privacy rights built in, but I've also read it has some back doors for doctors to share info w/ big pharma

it's not perfect but it's *definitely* HIPPA data...which gives the user more protection and removes the obligation to show damages in a civil case against a hacker

Re:HIPPA (0)

Anonymous Coward | about 7 months ago | (#44942089)

How in the fuck do you link to HIPAA and still manage to spell it wrong 4 times? Are you a moron?

obv. u knew what i meant (1)

globaljustin (574257) | about 7 months ago | (#44943333)

you still got the point so i don't care

do you have any thoughts on the subject to contribute or are you just trolling?

Correct response. (0)

Anonymous Coward | about 7 months ago | (#44940787)

Just as certain applications for other specific fields may need to pass testing and scrutiny before being available for general use (flying and the FAA comes to mind), so it is reasonable for the FDA to step in here.

And tax them accordingly? (3, Informative)

PseudoCoder (1642383) | about 7 months ago | (#44940887)

Would they then be subject to the O-care medical device tax? Let's not forget what it was all about to begin with.

http://www.youtube.com/watch?v=r2Kevz_9lsw

http://www.youtube.com/watch?v=BLiexzoAq7E

Re:And tax them accordingly? (1)

hrvatska (790627) | about 7 months ago | (#44941295)

Doesn't it depend on whether the apps are considered to be something that is purchased at retail by the general consumer? Things like mechanical and powered wheelchairs, portable oxygen concentrators, glucose monitors and personal heart rate monitors are not taxed. NMR and x-ray machines are taxed.

Re:And tax them accordingly? (1)

DigiShaman (671371) | about 7 months ago | (#44943681)

More than likely, yes! They would be subjected to the tax among other filing fees and what not. Effectively it should shut the app down. However, what if these apps were open sourced? Would the feds shut them down and go after anyone torrenting the source code?

An Android app got my wife pregnant!! (0)

Anonymous Coward | about 7 months ago | (#44940903)

How many software applications can say that?!

"My Days"

Helps track ovulation cycles to aid (or prevent) pregnancy.

Also helps track when the horrible PMS monster will emerge.

same here, with help from margaritas (1)

raymorris (2726007) | about 7 months ago | (#44941163)

Same here. Margaritas also played a key role.
Had I been smarter, I would have made my own fertility app that said "its time" whenever _I_ wanted to have some romance .

FDA scrutiny still gets Windows BSOD on devices... (1)

PseudoCoder (1642383) | about 7 months ago | (#44941001)

Witnessed this myself at the birth ward when my wife gave birth last month. Took a photo of a health monitor BSOD while giggling in the hallway, but haven't posted it anywhere. Isn't there a website where you can post BSOD's in funny places?

Re:FDA scrutiny still gets Windows BSOD on devices (1)

idontgno (624372) | about 7 months ago | (#44941117)

The Daily WTF. [thedailywtf.com]

Their Error'd [thedailywtf.com] series is chock full'o this kind of failage.

The only risk is that someone's already submitted a screenie of any given inappopriate BSOD, but the only way to know is to try. Or read it through first.

Re:FDA scrutiny still gets Windows BSOD on devices (1)

captaindomon (870655) | about 7 months ago | (#44942531)

This may sound silly, but it is also very important to report the issue to the device manufacturer, if you can. The FDA sets very strict rules on how companies have to handle feedback they receive from you, so your feedback will be taken very seriously. IANAL etc.

Apple TOS Covers this already (2)

BetaDays (2355424) | about 7 months ago | (#44941019)

I think Apple's terms of service says it all and that all medical apps need tossed out since they would break the tos of the device. Or am I missing something. http://www.apple.com/legal/sla/docs/iOS7.pdf [apple.com]

7.5 YOU FURTHER ACKNOWLEDGE THAT THE iOS SOFTWARE AND SERVICES ARE NOT INTENDED OR SUITABLE FOR USE IN SITUATIONS OR ENVIRONMENTS WHERE THE FAILURE OR TIME DELAYS OF, OR ERRORS OR INACCURACIES IN, THE CONTENT, DATA OR INFORMATION PROVIDED BY THE iOS SOFTWARE OR SERVICES COULD LEAD TO DEATH, PERSONAL INJURY, OR SEVERE PHYSICAL OR ENVIRONMENTAL DAMAGE, INCLUDING WITHOUT LIMITATION THE OPERATION OF NUCLEAR FACILITIES, AIRCRAFT NAVIGATION OR COMMUNICATION SYSTEMS, AIR TRAFFIC CONTROL, LIFE SUPPORT OR WEAPONS SYSTEMS.

Re:Apple TOS Covers this already (1)

mjr167 (2477430) | about 7 months ago | (#44941161)

Don't ALL OS TOS say that? I'm pretty sure windows says that and they do use it in nuke plants...

This is pretty standard for the silicon already.. (1)

Ellis D. Tripp (755736) | about 7 months ago | (#44941331)

FWIW, most of the electronic components IN a phone are also sold with a disclaimer like that. Typical example here:

http://www.analog.com/en/content/analog_devices_terms_and_conditions/fca.html [analog.com]

Use in Life Support and Other Critical Applications

Products sold by Analog Devices are not designed, intended or approved for use in life support, implantable medical devices, transportation, nuclear, safety or other equipment where malfunction of the Product can reasonably be expected to result in personal injury, death, severe property damage or severe environmental harm. Buyer uses or sells Products for use in such critical applications at Buyer's own risk and agrees to defend, indemnify and hold harmless Analog Devices from any and all damages, claims, suits or expenses resulting from such use.

I'm pretty sure that any smartphone app-based system isn't exactly going to be a critical care/life support type of device, though.

Re:Apple TOS Covers this already (1)

frog_strat (852055) | about 7 months ago | (#44941367)

I wonder if this is just waiving liability or does it mean they would refuse to approve the app ?
Medical software can have 3 types of use:
-records display (display of data)
-diagnostic (take your temperature)
-therapeutic (shock your heart or cut tissue)
You see many companies jumping up and down, claiming to want in the medical space, but they usually are talking about records display only.

Can the FDA regulate free software? (0)

Anonymous Coward | about 7 months ago | (#44941215)

So what if I create a free software app that serves some medical purpose? Am I required to get FDA approval first? What if I refuse and the FDA tries to initiate an enforcement action against me and forces me to stop distributing it? How have the courts been ruling on free software as a free speech issue?

Re:Can the FDA regulate free software? (1)

trevmar (188523) | about 7 months ago | (#44941413)

You need to differentiate between apps distributed in the USA and those elsewhere in the world. FDA only has control over the US of A. They will claim control (and to the best of my knowledge they have control) over the distribution of free-software (described by this final guidance) within the USA.

Re:Can the FDA regulate free software? (0)

Anonymous Coward | about 7 months ago | (#44941559)

So what if I create a free software app that serves some medical purpose? Am I required to get FDA approval first? What if I refuse and the FDA tries to initiate an enforcement action against me and forces me to stop distributing it? How have the courts been ruling on free software as a free speech issue?

You can make your app, but unless you get FDA approval your options for marketing said app will be limited (you can't claim it cures any medical conditions). Also no doctor will touch for nontrivial uses as they'd be exposing themselves to malpractice liability if they trusted your app and as a result failed to treat someone's condition, or made their condition worse.

Blood glucose monitoring? (0)

Anonymous Coward | about 7 months ago | (#44941237)

I have a blood glucose meter that works fine all by itself (for a one day reading), if you plug it in to an iDevice you can get all of the readings, graphs, reports, etc.

Should that app be regulated? I think it is today, but does it need to be? It is only a convenience, it does not control anything or provide recommendations or diagnosis.

I'd like to get the raw data to build my own plots, the vendor response is that the FDA will not let them do that, the best they can export is a pdf.

I need the government out of my business. I don't see how this regulation helps.

Re:Blood glucose monitoring? (1)

trevmar (188523) | about 7 months ago | (#44941427)

That app will most definitely be subject to regulation. I speak from personal knowledge :(

Re:Blood glucose monitoring? (1)

vux984 (928602) | about 7 months ago | (#44942501)

I'd like to get the raw data to build my own plots, the vendor response is that the FDA will not let them do that, the best they can export is a pdf.

The vendor is lying.

So what if... (1)

Kazoo the Clown (644526) | about 7 months ago | (#44941747)

What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?

Generally no... (0)

Anonymous Coward | about 7 months ago | (#44943055)

To answer your question, no. Unless you go around trying to sell those products by claiming that they have a medical benefit or control life saving devices without evidence to that effect.

Re:So what if... (1)

drinkypoo (153816) | about 7 months ago | (#44944195)

What if I open source my DIY ultrasound code? Or my STL files of the 3D printed parts? Should I be expecting a gag order?

Source code != App. STL != part. They say they will control apps. Not your problem.

WebMD (0)

Anonymous Coward | about 7 months ago | (#44941889)

Smart phones have browsers, and browsers can go to WebMD which people use for self "diagnosis", thus every smartphone is a medical device? And if it is an app that turns it into a medical device, if I write such an app for the Iphone does apple now have to submit all their Iphones to be regulated by this because it could potentially become a medical device?

"Biofeedback" software (1)

deadlydiscs (1505207) | about 7 months ago | (#44941985)

Comes to mind.... http://en.wikipedia.org/wiki/Biofeedback [wikipedia.org]

Re:"Biofeedback" software (1)

deadlydiscs (1505207) | about 7 months ago | (#44942099)

... and I suppose the FDA potentially could have been challenged and/or lobbied to have better testing & controls around things like this by the insurance industry (who pay for the treatments). Increased regulation typically comes re-actively from our government as a result of people screwing up, or getting screwed.

Would this apply to an Australian? (0)

Anonymous Coward | about 7 months ago | (#44943125)

I have a CPR Assistant app in the google play store: https://play.google.com/store/apps/details?id=com.chewsta.cprassist

Would these proposed regulations apply to me as an Australian, even though my app is in an American owned store?

Re:Would this apply to an Australian? (1)

melstav (174456) | about 7 months ago | (#44944505)

The fact that Google Play is run by an American company is not the issue.

Whether or not your app is available to be downloaded in the US is. Because you're importing your app into the US to be used by Americans.

But that's a side issue. EVEN BY AUSTRALIA'S STANDARDS your app likely qualifies as a medical device [tga.gov.au]. If you're not already registered with the Ministry of Health as a medical device manufacturer, I would highly recommend contacting someone to confirm with them whether your app should be regulated under Australian law, and whether you're breaking the law by distributing it (or allowing it to be distributed) in Australia without registration.

And then do the same thing with every other country your app is downloadable in. Because every country's regulations may be somewhat different.

Overreach? (1)

llamahunter (830343) | about 7 months ago | (#44944265)

I can certainly understand wanting to qualify a mobile app that controls an insulin pump or something like that (Appendix C), but Appendix B indicates the FDA intends to regulate applications that "are intended for individuals to log, record, track, evaluate, or make decisions or behavioral suggestions related to developing or maintaining general fitness, health or wellness" such as meal logs, calorie counters, exercise activity, brain games, etc. Sounds like you can kiss a whole bunch of useful apps goodbye as they get regulated out of existence.

Re:Overreach? (0)

Anonymous Coward | about 7 months ago | (#44944535)

BINGO. The FDA should not be allowed to regulate apps. Once they get their hands on this, they will set technological innovation back a century or more. The government is very good at destroying things, such as building bombs and invading countries. Protecting public health and promoting innovation in the medical field? Not so much.

Software is not special just because it's mobile. (3, Interesting)

melstav (174456) | about 7 months ago | (#44944383)

DISCLAIMER: I am, (among other hats) a software developer for a medical device manufacturer in the United States.

Seriously, people. The FDA's stance has *ALWAYS* been that if something has a medical purpose or is an accessory to a medical device, then it *IS* a medical device, even with software. See: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices [fda.gov], dated 2005.

For the purposes of this document, we refer to devices that contain one or more software components, parts, or accessories, or are composed solely of software as “software devices,” including:

  • firmware and other means for software-based control of medical devices
  • stand-alone software applications
  • software intended for installation in general-purpose computers
  • dedicated hardware/software medical devices.
  • accessories to medical devices when those accessories contain or are composed of software.

This guidance applies to software devices regardless of the means by which the software is delivered to the end user, whether factory-installed, installed by a third-party vendor, or field-installed or -upgraded.

So, yes, apps with a medical purpose are medical devices, just like any other piece of software.

Which means they *ARE* subject to the "Obamacare Tax" -- Which is *NOT* a "sales tax" to be paid by the consumer. It's an "income tax" to be paid by the manufacturer / developer.

This also means that if your app is categorized as a medical device, you (the developer) have to register with the FDA as a device manufacturer, which costs a couple thousand dollars a year, and means that every few years, the FDA sends someone out to review your quality control system, which includes your testing methodologies, what complaints you've received and how you've handled them, how you document your development process, etc.

AND what your software does determines what kind of medical device the FDA calls it. And the kind of medical device determines whether you are required to get the FDA's permission before you distribute it. (even if you distribute it for free) And yes, applying for that permission costs money, whether it's approved or not.

And, by the way: Each country makes its own rules about what makes a medical device and what you're required to do to be able to legally distribute it in that country. And in most countries that includes software.

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