Beta
×

Welcome to the Slashdot Beta site -- learn more here. Use the link in the footer or click here to return to the Classic version of Slashdot.

Thank you!

Before you choose to head back to the Classic look of the site, we'd appreciate it if you share your thoughts on the Beta; your feedback is what drives our ongoing development.

Beta is different and we value you taking the time to try it out. Please take a look at the changes we've made in Beta and  learn more about it. Thanks for reading, and for making the site better!

Should Medical Apps Be Regulated?

Soulskill posted more than 2 years ago | from the what-could-possibly-go-wrong dept.

Medicine 254

maximus1 writes "There's a tidal wave of medical-related apps coming to smartphones and tablets that will be used by doctors and patients alike. But how should the medical establishment deal with them? Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations. Obstetrician Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off. What do you think?"

cancel ×

254 comments

Sorry! There are no comments related to the filter you selected.

We no longer regulate ads and mail order products. (5, Interesting)

Kenja (541830) | more than 2 years ago | (#41071837)

So why regulate apps? You can more or less claim your snake oil does anything you want, so long as you hide a disclaimer some place that your claims have not been confirmed by the FDA. If we're going to regulate medical self help and remedies then it should be all inclusive, not limited to apps.

Re:We no longer regulate ads and mail order produc (5, Insightful)

mr1911 (1942298) | more than 2 years ago | (#41071903)

So why regulate apps?

Because regulation artificially narrows the supply, making the profits more lucrative for the incumbents. You did notice the guy pushing for regulation was a doctor already doing apps. Once he's in, regulation is good for him.

Oh, I misunderstood your question. You were looking for a good reason to regulate apps. Sorry, I can't help you there.

Re:We no longer regulate ads and mail order produc (4, Insightful)

ColdWetDog (752185) | more than 2 years ago | (#41072375)

Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.

Personally, I don't think you should regulate these. Who's going to do it? How many friggin 'lawyer' screens are you going to create (hint: more than we already have)?

Do you then regulate every 'medical' website? Most of these apps either could be duplicated by a web site or already have been.

Where, exactly, do you stop?

What happens when doctors or even medical professional societies disagree (think stroke treatment with clot busting drugs - the American Academy of Emergency Physicians and the American Neurologic Society (or whatever prof society the neurologists hang out on) disagree pretty vehemently. That's fine, it's expected but how do you 'regulate' that?

Re:We no longer regulate ads and mail order produc (3, Insightful)

jhoegl (638955) | more than 2 years ago | (#41072745)

Actually Medical apps need to be regulated because their accuracy needs to be verified.
If an app takes metrics, the metrics must be authenticated because that metric could mean life or death.
Those are the apps we are talking about here, not the calorie counters or shit where you input the info.

Re:We no longer regulate ads and mail order produc (1)

nimbius (983462) | more than 2 years ago | (#41072619)

True OP! The concept extends as well to the AMA and numerous other medical trade groups. part regulatory body, and part flow-control for doctors to prevent the possibility of lowering the price for a physician. Because if someone wrote an app to diagnose patients and select appropriate treatments, fewer people would bother scheduling an appointment and more people would start to question the US healthcare system than just the 30 million that dont get to use insurance to pay for it.

much of modern medicine is still quite trial-and-error based on a per-patient level. I think steven is playing the big-picture here. If Deep Blue can decimate every opponent on jeopardy, theres nothing preventing a smart phone from precluding his house in the hamptons 15 years.

Re:We no longer regulate ads and mail order produc (5, Insightful)

Sir_Sri (199544) | more than 2 years ago | (#41072673)

Because regulation artificially narrows the supply

And artificially strips out dangerous or faulty procedures, chemicals etc. before they experience the joys of the free market on the public who have to enjoy the burdens of what's happening. Because your medical information is *private* and letting anyone have at your private medical information without any regulation means that information could be used against you.

Because letting people take random chemicals to see if some of them cure whatever disease they have definitely isn't a good idea, but it's cheap, so we could do that.

It does however depend a lot on what apps actually do. I'm not sure you need to highly regulate the applications used by medical professionals to handle payroll or scheduling or room booking. There are custom software packages for a lot of those because all hospitals face similar problems and so on, so it makes sense then to not have to completely re-engineer your payroll system just because your hospital is not the hospital one block over. But if you're talking about tracking a patient's blood sugar and providing advice based on that tracking you're into a whole collection of privacy rules (how secure is this data? Who am I sending the data to?) and providing medical advice from something that isn't a medical professional.

Which tends to show they're talking past each other a bit. The one doctor is making an app to deal with strokes, that's almost certainly into the category of medical advice (at least potential medical advice) and tracking a lot of deeply private medical information. The other guy is helping doctors communicate information between rounds, so there are privacy implications, but he's not necessarily intending that information to ever actually see a patient.

Re:We no longer regulate ads and mail order produc (4, Insightful)

RobFrontier (550029) | more than 2 years ago | (#41071935)

If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation. This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.

Re:We no longer regulate ads and mail order produc (2)

Kenja (541830) | more than 2 years ago | (#41071963)

If a pill advertised on TV can claim to rebuild damaged joints or convert your fat into muscle (these claims have not been verified by the FDA) and in fact do nothing, an app should be able to as well. If the app can't (and it should not be able to) then neither should the sugar pills.

Re:We no longer regulate ads and mail order produc (3, Insightful)

RobFrontier (550029) | more than 2 years ago | (#41072059)

We are talking about apps in the hands of doctors potentially using them for diagnosis. There is a huge difference between that and an app in the hands of a consumer for self diagnosis (a sugar pill). The consumer can do that now with WebMD et al.

Re:We no longer regulate ads and mail order produc (0)

Anonymous Coward | more than 2 years ago | (#41072127)

Agreed, I work in medical apps. When it comes to personally identifiable information (PHI) there are already a host of HIPAA regulations. But as for FDA involvement, only if the app is used as a medical device for clinical and diagnostic purposes. For health information purposes, I say just stick with HIPAA regs and let people develop what they choose. There is SO MUCH ground to be gained to improve our healthcare system by developing information related apps alone, we can't afford to stifle innovation in this space.

Re:We no longer regulate ads and mail order produc (1)

Talderas (1212466) | more than 2 years ago | (#41072475)

HIPAA only matters if the app is storing PHI and it is being used by a covered entity. So apps targets at patients won't run afoul of HIPAA. They can keep every bit of PHI that you put into them and not have to run any special protections. It also means that if such an app were on the iPhone there's no legal issue if this data is backed up on the iCloud. Apple would not have to suddenly meet new data storage requirements to meet HIPAA standards.

Lawyers aren't covered entities either so if your personal injury attorney leaks your PHI they don't run afoul of HIPAA.

Re:We no longer regulate ads and mail order produc (5, Insightful)

Harvey Manfrenjenson (1610637) | more than 2 years ago | (#41072501)

If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation.

This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.

The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders, is available in e-book format as an "app". Is that app a medical device? What about a paper copy of the DSM-IV that I carry around in my pocket? Is that a medical device, too?

Re:We no longer regulate ads and mail order produc (1)

ArhcAngel (247594) | more than 2 years ago | (#41072631)

Using your justification all web browsers are medical devices.

Re:We no longer regulate ads and mail order produc (5, Insightful)

JackieBrown (987087) | more than 2 years ago | (#41072107)

We are on our way to regulating everything, anyways.

I can't even be astonished by new cries for regulation. It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.

Re:We no longer regulate ads and mail order produc (0)

Anonymous Coward | more than 2 years ago | (#41072573)

We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.

Me thinks you give religion WAY too much credit on how much self control it is capable of...

Re:We no longer regulate ads and mail order produc (1)

MonkeyOfRage (779297) | more than 2 years ago | (#41072203)

They're already regulated under HIPAA, and doubtless other regulations as well.

you are a peter puffer (-1)

Anonymous Coward | more than 2 years ago | (#41072225)

shut the fuck up you cock gobbling queer

Re:We no longer regulate ads and mail order produc (-1)

Anonymous Coward | more than 2 years ago | (#41072369)

All regulation ever does is add to the cost.

"the market" (1)

Anonymous Coward | more than 2 years ago | (#41071849)

"The Market" is incapable of making rational decisions

Re:"the market" (3, Insightful)

BoberFett (127537) | more than 2 years ago | (#41071929)

The market is slow to make decisions, because it relies on the input of everybody involved. That's as opposed to government bureaucracy which makes bad decisions relatively quickly and then forces those bad decisions down everyone's throat.

Re:"the market" (2)

RabidReindeer (2625839) | more than 2 years ago | (#41072007)

The market is slow to make decisions, because it relies on the input of everybody involved. That's as opposed to government bureaucracy which makes bad decisions relatively quickly and then forces those bad decisions down everyone's throat.

That's interesting. I'd always had the impression that the market resembled a stampeding herd of lemmings. Frequently making bad decisions (VHS anyone?) and forcing them down everyone's throat ("Nobody ever got fired for buying IBM!").

Re:"the market" (1)

Anonymous Coward | more than 2 years ago | (#41072165)

VHS was not a bad decision.

You see in the real world, being able to record the shows you want to watch on a three-hour VHS tape was more important to most people than having slightly better color reproduction on the short portion of the show they were able to record on a one-hour Beta tape, or not being able to record it at all because they couldn't afford a more expensive Beta deck.

But people still whine decades later because most people had a different opinion to them on the relative value of the two formats.

Re:"the market" (1)

Antipater (2053064) | more than 2 years ago | (#41072169)

The market is slow to make decisions, because it relies on the input of everybody involved. That's as opposed to government bureaucracy which makes bad decisions relatively quickly and then forces those bad decisions down everyone's throat.

I honestly can't tell if you're trolling or not.

Re:"the market" (-1)

Anonymous Coward | more than 2 years ago | (#41072263)

And we should give a fuck about that why exactly?

FDA (5, Informative)

RobFrontier (550029) | more than 2 years ago | (#41071869)

Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.

Re:FDA (1)

jimbolauski (882977) | more than 2 years ago | (#41072231)

There is very little grey area as long as the apps are seen as an extension of current methods and regulated as such. Unfortunately I have serious doubts that the FDA will take this pragmatic approach and over regulation will be their approach.

Re:FDA (1)

tgd (2822) | more than 2 years ago | (#41072357)

Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.

Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.

There are plenty of categories of medical software that already require FDA certification.

Re:FDA (1)

Man On Pink Corner (1089867) | more than 2 years ago | (#41072693)

They can try to regulate apps, but they will run smack dab full tilt into the fan blades of First Amendment law if they try.

If money is free speech, then so is code.

I think... (0)

Anonymous Coward | more than 2 years ago | (#41071875)

That the correct answer is the one that best serves patients' interests.

I'm dreaming, aren't I ?

Re:I think... (1)

tomhath (637240) | more than 2 years ago | (#41071947)

I'm dreaming, aren't I ?

Not at all, that's the goal of both doctors. The problem is that both regulating and not regulating have advantages and disadvantages.

A few dozen patient deaths caused by a buggy app and the FDA will step in.

Re:I think... (0)

Anonymous Coward | more than 2 years ago | (#41072253)

The problem is that both regulating and not regulating have advantages and disadvantages.

That kind of sensible talk isn't allowed on the internet.

Re:I think... (1)

Dunbal (464142) | more than 2 years ago | (#41072459)

A few dozen patient deaths caused by a buggy app and the FDA will step in.

Any doc who blindly trusts an app without double-checking deserves to have his license revoked. It's our job to double check files, nurses and even doses of medications because not only is it our ass on the line it could also be the patient's life. If you blindly rely on an app to think for you you might as well let the smart-phone treat your patient.

is your phone treated like a new medicine? (1)

gl4ss (559668) | more than 2 years ago | (#41071901)

no? why should the communication you're using for non-emergencies be regulated? (actually you're phone is supposedly regulated so that anyone can call 911 with it).

the apps that are just glorified pamphlets shouldn't be reviewed any different than regular pamphlets, of course, but it's not like you're going to eat the application and if it gives some wrong advice then you're as publisher on the same hook as if you produced a snake-oil pamphlet I suppose.

I don't think the paper that came with my glucose meter was regulated either, so I don't know why an app that replaces the paper should be.

Re:is your phone treated like a new medicine? (1)

Thorodin (1999352) | more than 2 years ago | (#41072025)

I think the OP is referring more to apps that providers may use. Things such as Airstrip Technologies cardio app or Eppocrates' app. Also some of the radiology vendors have their own apps. (But in fairness to them, the radiology vendors, most state that the app is not to be used for diagnostic purposes.) On a similar note, I'm sure there will come a day when we in IT are forced to be certified to work on any server\computer that contains patient data or EMR software.

In a word: yes. (4, Informative)

Samantha Wright (1324923) | more than 2 years ago | (#41071909)

Yes, they absolutely should; for the consumer, to prevent abominations like this [baltimoresun.com] . I would say that anything more interactive than a reference document or log book. For more real medical software (i.e. patient monitors or diagnostic tools), just because it's on a smartphone and not a dedicated box doesn't mean it suddenly stops being a medical tool.

Re:In a word: yes. (1)

NeutronCowboy (896098) | more than 2 years ago | (#41072087)

I don't know if that's the right approach. I'd treat it like any ol' website: if you just believe what the first site you find says about some complex medical issue, that's your own problem. I'd appreciate if the official government agencies have some guidelines on how to identify scammy apps and which apps are useful, but other than that, I'm comfortable with the idea that it's just information in a snazzy new package, and as such, cannot and should not be controlled.

That said, anything that is officially endorsed by a doctor to monitor patient data should be carefully vetted that it conforms to standard medical practices and HIPAA standards. Diagnostic tools that are also officially endorsed by doctors to help their patients identify the onset of critical side-effects should follow similar practices.

But if you decide you want to download Joe Schmoe's instant hypochondriac app, you should be able to do so. We need more ways entries for the Darwin Awards anyway.

Re:In a word: yes. (1)

Samantha Wright (1324923) | more than 2 years ago | (#41072321)

I left pure reference works out, actually. That's be analogous to your "any ol' website" statement. I don't think that expanding the Darwin Awards is a very noble ulterior motive, however. Gene Roddenberry would disapprove.

Re:In a word: yes. (0)

Anonymous Coward | more than 2 years ago | (#41072095)

No, you don't have to regulate this or anything else.
If people did their own research they could decide for themselves.

Stop letting government get in the way of stupidity, so these stupid people using anecdotal claims can be screwed for themselves.

Re:In a word: yes. (2)

Samantha Wright (1324923) | more than 2 years ago | (#41072255)

Let me get this straight—you're arguing against eliminating scammers because you want the intellectually deficient and uneducated to suffer?

Re:In a word: yes. (1)

Jammer6502 (1430197) | more than 2 years ago | (#41072213)

I'm torn. I agree issues like the one you cited are a reason to require oversight in order to protect both doctors and patients. But this is more than apps for tablets and phones, this is about regulating medical software. I may be wrong but I think medical equipment that is currently regulated is a boxed deal, hardware with embedded software, all tested as one item. If the hardware is not controlled anymore issues could arise with approving software for medical use, unless they say App X only approved to be used on an iPad... but I may be missing something, this is not my field.

Re:In a word: yes. (1)

Samantha Wright (1324923) | more than 2 years ago | (#41072529)

You're correct; the FDA gets very touchy about even the slightest modifications being made to hardware. For apps that don't know what hardware they're running on, I'm pretty sure just saying "this app has been tested on [list of phones and tablets] and has only been certified by the FDA for use on those devices" should do it.

Re:In a word: yes. (1)

TubeSteak (669689) | more than 2 years ago | (#41072295)

AcnePwner was downloaded 3,300 times at a cost of 99 cents in the Android Marketplace.
There were about 11,600 downloads of AcneApp from the iTunes store, which cost $1.99.

According to the settlement, Koby Brown and Gregory W. Pearson of DermApps are required to pay $14,294,
and Andrew N. Finkle of Acne Pwner must pay $1,700.

$2,800 sales revenue - $1,700 fine = $1,100 profit
$16,158 sales revenue - $14,294 fine = $1,864 profit

Not the most profitable fraud.
They should have gone into finance.

Re:In a word: yes. (1)

AC15 (1720178) | more than 2 years ago | (#41072341)

Yes, they absolutely should; for the consumer

I'm a consumer and I want no part of the regulatory monstrosity that you call the FDA. I advocate the peaceful solution of clearly labeling items "NOT FDA APPROVED" and letting consumers (and their doctors) choose.

Re:In a word: yes. (-1)

Anonymous Coward | more than 2 years ago | (#41072531)

There is no light way to put this.

Fuck you, fuck your ideas, fuck your ethos, and fuck your politics. Fuck everything about you.
Remove yourself from this world before you pollute it further with your memetic filth.

Re:In a word: yes. (1)

Samantha Wright (1324923) | more than 2 years ago | (#41072613)

I can imagine a world where that might be okay, but only with one condition: if something does get tested by the FDA and it's rejected, it should have to be labelled "REJECTED BY THE FDA" and not just "NOT FDA APPROVED," which is ambiguous (perhaps the sticker "NOT EVALUATED BY THE FDA" could be used too.) Wouldn't you want to know if research had been done on a given product?

To be fair, I do understand wariness around the FDA. There are a lot of very close corporate ties that have been a source of trouble in the past.

Re:In a word: yes. (0)

Anonymous Coward | more than 2 years ago | (#41072707)

> Yes, they absolutely should; for the consumer, to prevent abominations like this [baltimoresun.com].
> http://articles.baltimoresun.com/2011-09-08/business/bal-consuming-acne-app-doesnt-actually-cure-acne-sez-ftc-20110908_1_mobile-apps-acneapp-ftc-complaint

"Regulation" isn't needed for that. Simple fraud charges would suffice.

Certification (1)

mwvdlee (775178) | more than 2 years ago | (#41071943)

Why not just release new apps without any regulation, then have them voluntarily certified by a trusted party.
Then medical professionals can choose between new, as-yet-uncertified apps and ones that have been certified.

Re:Certification (1)

Anonymous Coward | more than 2 years ago | (#41072093)

But what is the trusted party? Medical Associations? Quack medicine like chiropractic, have associations which would be super willing to certify their bunk advice.

Yes and No (4, Insightful)

hsmith (818216) | more than 2 years ago | (#41071973)

"Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.

On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.

I'd be curious to see - are the big companies pushing for this? FDA approval isn't cheap OR fast. Small innovators are able to disrupt this market which has been held strongly by the giant medical firms - who can't be quick and innovate.

We have a fine line to walk between stifling innovation and regulation.

Re:Yes and No, or how is your insulin (1)

WillAffleckUW (858324) | more than 2 years ago | (#41072125)

Exactly.

It's not like if the app wrongly says you have no problem with aspirin or gives a wrong value for an insulin dosage or time for your shot that you'll die. ... or is it?

Re:Yes and No, or how is your insulin (1)

hsmith (818216) | more than 2 years ago | (#41072243)

Perhaps you had a difficult time reading: There is a big difference between recording and making recommendations.

Re:Yes and No, or how is your insulin (1)

WillAffleckUW (858324) | more than 2 years ago | (#41072339)

Perhaps you had difficulty reading.

There is a big difference between an app "communicating" between doctors and someone coding on the table because the communication failed.

Totally love some of the references being available. But diagnostic tools ... diagnose.

Re:Yes and No, or how is your insulin (1)

jklovanc (1603149) | more than 2 years ago | (#41072695)

But diagnostic tools ... diagnose.

Diagnostic tools should be regulated as they make treatment recommendations. Apps that are basically glorified note pads that happen to record personal medical data like glucose levels should not. If what they replace are regulated they should be regulated.

Re:Yes and No (2)

rcuhljr (1132713) | more than 2 years ago | (#41072235)

Having spent the last year developing an app that falls strictly into the later category (tracking) I was operating under the impression that the division you described is how things currently operate. The idea I received from our client was that as long as we did not encourage decisions or try to promote behavior we didn't have to worry about going through FDA regulation. This didn't save us from developing to the same standards as we would have for FDA submission, since the client has plans to expand the product in the future.

Re:Yes and No (1)

geekmux (1040042) | more than 2 years ago | (#41072285)

"Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.

On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.

So, in one case, you're basically calling for the regulation of what amounts to medical advice (also known today as WebMD.com), and yet, you do not find it necessary to regulate the app that tracks if you've had your meds today or not?

Seems to me an problem in the software in either situation could prove equally as deadly. Either choose to regulate them or do not, but half-assing it is simply asking for liability to come your way.

Re:Yes and No (1)

hsmith (818216) | more than 2 years ago | (#41072641)

So, you think the FDA should also regulate notepads, since - you know - people also write down when they take medications, no? Please, describe to me how logging what medications you took could prove deadly. I'd love to hear.

Hell no....I repeat, HELL NO!!! (0)

PortHaven (242123) | more than 2 years ago | (#41071983)

Someone grab the duct tape and shut this guy up.

FDA gets involved, and a $1.99 app will be $1,999. Seriously, look at MRI machines. They can cost millions of dollars. This technology is 30 years old. By now a unit should cost a mere $50,000.

In the U.S. an MRI can cost upwards of a $1,000. In India it costs $50-$100.

No we need less FDA regulation, not more.

Re:Hell no....I repeat, HELL NO!!! (1)

Skapare (16644) | more than 2 years ago | (#41072043)

I don't want a $1.99 app making guesses. That's no better than snake oil.

Re:Hell no....I repeat, HELL NO!!! (0)

Anonymous Coward | more than 2 years ago | (#41072293)

What about WebMD? And don't you still have the doctor? We aren't replacing doctors with apps...

Re:Hell no....I repeat, HELL NO!!! (0)

Anonymous Coward | more than 2 years ago | (#41072307)

I'm quite willing to take that $1.99 app and resell it to you for $1,999 if that will make you feel better.

Re:Hell no....I repeat, HELL NO!!! (1)

geekmux (1040042) | more than 2 years ago | (#41072335)

I don't want a $1.99 app making guesses. That's no better than snake oil.

I don't want stupid people running around taking medical advice from an app, but you don't see me complaining. I see it as cleansing of the gene pool. Even snake oil has its purpose among the ignorant.

Re:Hell no....I repeat, HELL NO!!! (0)

Anonymous Coward | more than 2 years ago | (#41072071)

FDA gets involved, and a $1.99 app will be $1,999. Seriously, look at MRI machines. They can cost millions of dollars. This technology is 30 years old. By now a unit should cost a mere $50,000.

In the U.S. an MRI can cost upwards of a $1,000. In India it costs $50-$100.

That would be a good point, if the FDA was the only difference between the US and India

Re:Hell no....I repeat, HELL NO!!! (0)

Anonymous Coward | more than 2 years ago | (#41072099)

In the U.S. an MRI can cost upwards of a $1,000. In India it costs $50-$100. ...assuming the power grid works.

Re:Hell no....I repeat, HELL NO!!! (0)

Anonymous Coward | more than 2 years ago | (#41072229)

Gotcha. So I guess what we do then is get that Ghost Whisperer lady to ask the people who died because of the bad apps which ones should be pulled from the market. Cool - "we'll do that" as they say on Galaxy Quest.

Re:Hell no....I repeat, HELL NO!!! (2)

Trepidity (597) | more than 2 years ago | (#41072327)

So why are MRI machines also cheaper in medical systems that are more regulated than the US's, like Scandinavia's? Could it just have something to do with the US being particularly inefficient, not the role of government per se?

Re:Hell no....I repeat, HELL NO!!! (1)

CanHasDIY (1672858) | more than 2 years ago | (#41072561)

Someone grab the duct tape and shut this guy up.

FDA gets involved, and a $1.99 app will be $1,999. Seriously, look at MRI machines. They can cost millions of dollars. This technology is 30 years old. By now a unit should cost a mere $50,000.

In the U.S. an MRI can cost upwards of a $1,000. In India it costs $50-$100.

No we need less FDA regulation, not more.

Once had to have both an MRI and a CT scan - same clinic, same expense (~$3000 each).

I called to ask why the MRI was so expensive, and they told me "Because it's new technology."

I also asked why the CT scan was so expensive - they told me "Because it's old technology."

Call it a hunch, but I doubt regulation has much to do with it.

Re:Hell no....I repeat, HELL NO!!! (1)

Sleepyhead5 (1246752) | more than 2 years ago | (#41072611)

You'd be luck to tell what anything was in an MRI scan from 20 years ago. And if you could it's because the scan took an hour.

As someone who works in MRI research, the current technology is quite new and cutting edge. Building and maintaining the machines is quick expensive.

All that said, the cost for a scan here in the states is way overly inflated. MRI scanners are generally profit leading centers in most hospitals, this is despite their large operating cost. If that doesn't tell you where your money is really going.

Hippa rules (1)

Joe_Dragon (2206452) | more than 2 years ago | (#41072005)

Hippa rules do you really want apple to have a backdoor to your medical info?

popular != quality (2)

Skapare (16644) | more than 2 years ago | (#41072031)

Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off.

I'd rather have medical professionals who are also coders looking at the source code to make such decisions, rather than the ignorant public that is too easily influenced by marketing tactics.

Re:popular != quality (0)

Anonymous Coward | more than 2 years ago | (#41072383)

> I'd rather have medical professionals who are also coders

How many of those do you think there are? Serious question. If I have a medical degree and can regularly bill 100$ for a 10 minute appointment, why would I waste my time with the tedium of coding?

[I am actually curious now to know the number of people who have both medical degrees and computer science degrees.]

fuck you stupid faggots (-1)

Anonymous Coward | more than 2 years ago | (#41072033)

you stupid faggots and your homo sex should be outlawed. you cocksuckers are fucking SICK

Not like people will die w/o regulation (2)

WillAffleckUW (858324) | more than 2 years ago | (#41072081)

It's not like an unregulated marketplace, with limited liability, will mind if a few patients die due to a coding error.

After they privatize the profit, stuff it in their kids trust funds and retirement funds, and walk away while people die.

Socializing the risk and lifetimes of pain and misery on the rest of us. ... oh. ... wait ... It is.

HATE! (-1)

Anonymous Coward | more than 2 years ago | (#41072097)

i absolutely HATE niggers, jews, faggots, mudslum camel jockeys, and commies

real apps or wrappers? (1)

vlm (69642) | more than 2 years ago | (#41072115)

app for stroke victims

What is that? A ebook, a sleazy spreadsheet app, or a MRI remote control app with special features for head scans?

Some apps are basically just an ebook. They should be regulated as much as medical book publishing (in other words, none at all).

I suppose someone could build a X-ray controller app that zaps patients. That needs a intense regulation, as much as the xray machine itself. There's a long history of killing people with buggy medical device software.

Then there's relatively sleazy stuff in the middle like making a single page spreadsheet to store data, calling it "the trendy disease tracking app" and selling it for $50 because its specifically designed for "trendy disease". Basically if a noob could recreate your "app" using google docs/drive spreadsheet in about 5 minutes and it sells for more that $1 then its a scam app. Those can just go away please.

When people's lives depend upon software... (2)

OhSoLaMeow (2536022) | more than 2 years ago | (#41072147)

.. then some government agency needs to step in and verify that said software is safe for use, whether it's an app that diagnoses a heart condition in your grannie, or a pilot who relies upon an iPad for flight manuals. It was a few years before the FAA permitted iPads to be used in the cockpit and not just because of the supposed electronic interference.

depends on the application (0)

Anonymous Coward | more than 2 years ago | (#41072175)

Looks to me like both docs have a good idea of how the app they're developing should be managed.

The doc making an app for stroke victims, presumably, is making something to either monitor their status or tell them when to take pills...actual medical stuff that should be regulated to make sure it works right every time.

The doc making an app to share information between docs, presumably, is making something that is primarily a communications tool. There are of course privilege issues to work out, but the app doesn't sound like anything that will be actually managing the patient's health. No reason to have that regulated, besides making sure it's secure enough to pass the data safely.

So my answer to this question is Yes and No. Should apps that are critical, like a stroke management app, be regulated? Of course they should. Should apps that are for all intents and purposes glorified versions of ICQ be regulated? Of course they shouldn't.

Broad brushes make for shitty paintings.

There are different kinds of medical apps (1)

hmbcarol (937668) | more than 2 years ago | (#41072181)

The story is casting too wide a net in simply saying "Medical Apps". Apps which help me record or log or communicate should not be strongly regulated (other than following HIPAA guidelines). They are no different than if I were to manually keep a journal or call the doctors office. There is nothing "new" about them other than the convenience. But apps which attempt to diagnose, analyze, or treat an illness should be regulated. Bugs or outright fraud in their capability can directly and seriously impact my health.

No studies, just crossed fingers so far. (1)

Impy the Impiuos Imp (442658) | more than 2 years ago | (#41072187)

I recommend leaving it alone. Cutting out "snake oil" is not much of an issue with professional medicine anymore.

We need to run experiments to see if delays due to full prove-outs cost more lives than does rapid development with the occasional oops.

Literally, not figuratively, billions of lives may depend on it as advancement rates deviate from where they otherwise would be over the decades, going on centuries now.

Warning labels? (1)

ndogg (158021) | more than 2 years ago | (#41072191)

I can't see why we can't go with a simple compromise, and have unapproved apps present big huge warning labels saying they hadn't been approved by the FDA, and once they do, they can put a big huge FDA logo of approval.

I know some people will, on their own risk, ignore those warnings, but I think that's something they need to realize on their own.

So, yes, I think they should be regulated, but only insofar as to allow people to make informed decisions on their risks.

Why focus on medical apps??? (1)

bobthesungeek76036 (2697689) | more than 2 years ago | (#41072259)

Why don't we regulate all apps? Look what happened with Knight Capital. Of course the FTC can call "do over" when a financial app goes bad. Kinda hard to call "do over" when something goes wrong in medicine. Will doctor's malpractice insurance premiums be affected by what software they use? The possibilities are endless......

I'm a doc... I use windows and MS Office (0)

Anonymous Coward | more than 2 years ago | (#41072273)

those aren't regulated.... maybe they should be because I use them...

Peer review is in the hall (1)

MyNameIsMike (720766) | more than 2 years ago | (#41072275)

As a family physician and tech nerd, I can say that in my experience peer review happens real quick with these types of apps. When you whip out your iPhone and a collegue sees you the conversation veers onto what apps are new and worth using, and which are utter crap. As for the content of popular apps, I don't think that even vetting by peer review would be able to eliminate all bugs. There will always be errors. But remember if used widely the axiom of a famous finn: "Given enough eyeballs all bugs are shallow." comes into play.

Fear of Competition (1)

pubwvj (1045960) | more than 2 years ago | (#41072381)

"Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations."

Of course. He's afraid of competition. Government regulation will slow that down. We wouldn't want to empower people!

The General Rule (0)

Anonymous Coward | more than 2 years ago | (#41072393)

The general rule is any software that controls something with direct access to the patient needs to be certified. Heart monitor controllers, MRI controllers, IV dosage controllers all do. Scheduling software, surgical documentation software, inventory management software does not.

>Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations.

Of course he does. It's a barrier to entry he is little effected by. I'd love to require all apps be developed by someone over 6 feet tall, because I'm over 6 feet tall.

Yes. (1)

c.r.o.c.o (123083) | more than 2 years ago | (#41072395)

Next question, I'm on a roll.

Certification (0)

Anonymous Coward | more than 2 years ago | (#41072399)

There should be no regulation of medical apps; however, it might be nice to have a certification program.

If an app is certified then you know it has been reviewed and approved by people in the medical profession. If it hasn't been reviewed then the user will have to decide whether they think the app's information or function is trustworthy based on faith or other people's reviews of the app.

really? (0)

Anonymous Coward | more than 2 years ago | (#41072411)

homeopathy is one of the things that should be regulated.

Doctors aren't smart enough for apps (1)

sandytaru (1158959) | more than 2 years ago | (#41072415)

They have enough problems getting their phones and tablets working with the legit medical apps put out by EHR companies. They don't need unregulated random medical apps floating around on top of that. (Hell, we've had doctors have trouble sending email through Outlook on a workstation. They usually make their PAs do that sort of thing for them.)

already are regulated (0)

Anonymous Coward | more than 2 years ago | (#41072423)

They are. FDA regulates lab applications and any device that touches a patient. With the lab applicants development is real slow. A lot slower than the mandates for meaningful use requirements by next year would allow. Hospitals need to be deploying electronic medical records now or lose a bunch of medicare dollars tomorrow.

Follow the liability (1)

petes_PoV (912422) | more than 2 years ago | (#41072431)

If a medical person uses an app and takes an action (or chooses not to act) on the basis of information they got from an app, who's liable for anything that goes wrong? I would expect that the medic in question would get the blame and I'd also be surprised if their professional insurance would kick in to pay for any damages that ensued.

I would also expect that any professional organisation would be advising its member to NOT use any app that had not passed some sort of approval regime. So on that basis, ignoring advice and using an unqualified device would leave the medic not only open to litigation, but without any professional support.

Question: would you be willing to fly on a plane where the pilot was using some old stuff they'd pulled off a marketplace, to fly by? The same sort of questions should be asked of medical personnel.

They are. (1)

bigattichouse (527527) | more than 2 years ago | (#41072461)

As a person coding a project going through the FDA clearance process, we have 1000+ pages that show that they *are* regulated.

Parallel question: lawsuits or not? (1)

istartedi (132515) | more than 2 years ago | (#41072465)

The question is closely tied with "Should we be able to sue the manufacturers or not?".

Do you want an "app" checking your vitals for $5 after you sign a waiver, or do you want a "certified medical device" checking your vitals for $100 and the right to sue if it misses something?

IMHO, there's room for both. Some people will delay treatment and/or not benefit from the $100 device because it costs too much. It's a cruel world, but dirt cheap screening apps that miss a few deadly diseases are actually better if everybody uses them. Yes, it's horrible to be the 0.5% that get a missed diagnosis; but when the alternative is 80% of the people not being tested, what do you do?

Another layer of complexity comes in when you consider whether the devices are more likely to give false positive or false negative readings.

I'm not sure what we should do; but I can tell you wnat NOT to do. Do not, under any circumstances give companies patents or monopolies in exchange for doing tests to certify the devices. This approach has had miserable outcomes with drugs. There is a drug combo used by pregnant women, and a gout medecine that both saw obscene price increases due to this approach. That's the worst of both worlds--the "certified" treatment is the same as the "uncertified" treatment, but at a huge price increase.

All I know is... (1)

Brewster Jennings (2642639) | more than 2 years ago | (#41072487)

When I'm using a first-aid app for instructions on performing an emergency tracheotomy, I damn well better not get a bunch of windows and flashing ad bars telling me how I can lower my power bill using one simple trick, or why Plastic Surgeons hate one mom wearing a rubber halloween mask...

Keep them away from doctors (1)

autocannon (2494106) | more than 2 years ago | (#41072491)

Hell no, do not let doctors think they can start using "apps" to handle patient data. Doctors are idiots with technology and this will just end up a nightmare of spilled/stolen data.

Now, if we're talking apps for anyone to maintain their own health data, make suggestions on possible diagnoses, or pretty much anything they want, then hell no it does not need regulation.

FDA already does (0)

Anonymous Coward | more than 2 years ago | (#41072517)

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/default.htm

Medical Applications Are Already Regulated (0)

Anonymous Coward | more than 2 years ago | (#41072537)

I'm an employee for a major developer of EHR software and hospital information systems. Our software offering runs the gamut from real-time tracking and analytics of patient biometrics to controlling the TV in their hospital suite. Medical applications are already regulated by the FDA because they meet certain criteria that qualifies them as "medical devices", which are, of course, highly regulated at different levels depending on how badly you can fuck yourself up while using them.

A medical device is defined as any tool that is used to diagnosis, treat, monitor, or prevent illness or disease. Wooden tongue depressors are a medical device and are regulated, but at a completely different and understandably lower level that, say, a defibrillator or an electrocardiograph (EKG). Medical software can be used to aid in diagnosis, treatment, monitoring, yada yada yada, so believe me, the work we do is HEAVILY regulated and the FDA makes it a point to conduct regular audits, surprise audits, and all that fun stuff. We also have entire departments devoted to hazard/incident/accident handling and all employees are required to know the system by heart and follow it to a T.

Same thing for the apps that we're developing to allow doctors to view patient records and enter orders via mobile devices. The FDA is regulating all of it because if a bug in the app generates and signs faulty orders, people could die.

For apps like WebMD though, they don't assist a licensed professional in diagnosing and treating diseases, and if a practitioner ever did use WebMD to diagnose a patient, they're probably not who you think they are. That little smartphone app that reminds you when your next flu shot is due? Don't expect the FDA to come knocking because you haven't maintained sufficient QC/QA practices or the dates get messed up or it doesn't mark your calendar in the correct color. That would be silly because the severity of incidents resulting from using those apps is very low (aside from idiots trying to perform self-surgery based on what they read on WebMD. But they're stupid and will probably harm themselves some other way). Now, if somebody makes a smartphone app that uses NFC to control your pacemaker or dialysis, the FDA will most assuredly have their hand in the process and keep a watchful eye over the developer because of the potential severity of any bugs in the code.

It's important to make the distinction between what kind of apps we're talking about, because some are already covered, and some aren't - similarly, some should be and some shouldn't be. That's my $0.02.

Regulations already exist (0)

Anonymous Coward | more than 2 years ago | (#41072637)

There is a world of difference between how the FDA views "medical" software versus software used by doctors for real diagnostic purposes. If there is patient risk involved, it's classified as a medical device and thus has to get 510(k) clearance from the FDA to be sold in the United States. Clearly, you don't need that level of regulation if you're just shuffling around patient information, so far as you are HIPAA compliant.

Intelligent Bureaucracy (1)

tobiah (308208) | more than 2 years ago | (#41072739)

I helped write code for the Plex-ID system, which among other things can identify every virus and bacteria in your spit by their genetic profile; spit in the tube, put it in the machine and wait an hour. CE (European Union) and FDA have similar requirements for a diagnostic device. But the FDA is pro-active and monitors development as it happens, where as CE takes a look at the paperwork once you are done and doesn't get in the way unless something goes wrong (in which case they come down hard, is what I hear). The upshot being that the Plex-ID has been available in Europe as a diagnostic device for the last two years, but is just coming to market in the US.
    Monitoring by the FDA did encourage code hardening; they require design documents and tests to validate those requirements. But you write your own requirements and tests, and mostly the FDA checks that the QA team (who wrote test reports, not tests) didn't change a test name on the specialized form from one release to the next. The other thing the FDA is strict about is making sure everyone's time sheet is filled out daily and accurately reports time spent on Federal grant funded projects. Another difficulty with the approach of the FDA was is making design changes as you went; every significant change risked significant delays in approval.
    Like I said CE has the same requirements, but they don't check things until it is done. So approval happens faster, requires a much smaller test team, development is more flexible and eats less time of group members. I'm sure there is a smarter way to interact with the FDA then we did, but their fundamental differences makes one a lot harder to please than the other, and produced the same product.

Depends, (1)

medv4380 (1604309) | more than 2 years ago | (#41072761)

if the app is turning your phone, or whatever, into a medical device. A random heart rate monitor app is fine unregulated, but if it's being used to monitor a patents heart rate for medical purposes then yes it must be regulated. In this case regulation is intended to give you devices that meet minimum guidelines. If it's important that a doctor know your heart rate within 20bpm but the app has a 100bpm margin of error then it's worthless as a medical device, and the regulation is to enforce the guidelines. Otherwise the doctor might think your heart is going too fast when the problem is the "app" is completely unreliable. Regulation is also for insurance purposes. Sometimes a medical device might fail, and if it results in someones death then insurance is more likely to cover it when the device that failed actually meet regulatory guidelines. Also apps that are used on an iPad by Doctors to enter medical information need to be regulated to ensure patient privacy. Everyone will be very angry if they find out that all their medical records have gone off into a private Google database to improve medical advertisements.

Hell F%&^$#g No! (1)

moeinvt (851793) | more than 2 years ago | (#41072765)

They should be subject to provisions of existing law, such as fraudulent misrepresentation of the product. For instance, I read about an app that claimed it could make your phone cure acne or something. That's no different than digital snake oil.

Creating an FDA type process for apps? Forget it.

Load More Comments
Slashdot Login

Need an Account?

Forgot your password?