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FDA: We Can't Scale To Regulate Mobile Health Apps

samzenpus posted about 4 months ago | from the hard-work-is-hard dept.

United States 123

chicksdaddy writes Mobile health and wellness is one of the fastest growing categories of mobile apps. Already, apps exist that measure your blood pressure and take your pulse, jobs traditionally done by tried and true instruments like blood pressure cuffs and stethoscopes. If that sounds to you like the kind of thing the FDA should be vetting, don't hold your breath. A senior advisor to the U.S. Food and Drug Administration (FDA) has warned that the current process for approving medical devices couldn't possibly meet the challenge of policing mobile health and wellness apps and that, in most cases, the agency won't even try. Bakul Patel, and advisor to the FDA, said the Agency couldn't scale to police hundreds of new health and wellness apps released each month to online marketplaces like the iTunes AppStore and Google Play.

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Charge what it costs to certify (5, Insightful)

Anonymous Coward | about 4 months ago | (#47396185)

Just charge what it costs to certify that an application/ device does what it claims to do. I know it is a novel concept of fee for service, but things are far more transparent that way. If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Re:Charge what it costs to certify (1)

Jawnn (445279) | about 4 months ago | (#47396273)

If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Yeah. Look how well that's worked out for the pharmaceutical industry.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396349)

Rather than simply make a quip, would you care to show a general trend of neglect in the pharmaceutical industry? While there are instances of abuse, the over all standards for pharmaceuticals in the US for safety is far better than what one would expect from your comment. In fact the situations that have made the news of lapses in quality tend to be the exceptions that prove the rule of quality in the industry as a whole.

10 minutes to post a comment? Sigh, no, do not foster discussion /.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396455)

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396607)

I'm not sure which way that was supposed to go, but that search just shows certain diseases which research for is being neglected, not to do with the poor quality of pharmaceuticals in the US.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396629)

well general rules for pharm is pretty ridiculous....like u are allowed to toss half of your testing results out the window.....that alone is a big enough issue that the whole system needs to be evaluated.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396825)

Rather than simply make a quip, would you care to show a general trend of neglect in the pharmaceutical industry? While there are instances of abuse, the over all standards for pharmaceuticals in the US for safety is far better than what one would expect from your comment.

I beg to differ. Are you unaware of the 6+ year history of enforcement actions against the pharmaceutical giant Ranbaxy for gross violations of health and safety standards? http://www.reuters.com/article/2014/01/24/us-ranbaxy-ban-idUSBREA0N06Z20140124 [reuters.com] . And the FDA enforcements were only started after the pharma giant had been documented by private auditing firms as intentionally neglecting health and safety standards in their drug production processes. http://articles.economictimes.indiatimes.com/2013-05-28/news/39580238_1_ranbaxy-case-us-drug-regulator-paonta-sahib [indiatimes.com]

That's 3 extra years that American health was at-risk because the pharmaceutical industry was allowed to rely on non-government, private safety inspectors.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396385)

If the federal government cannot keep up, then farm it out to private firms who are then audited by the Federal Government.

Yeah. Look how well that's worked out for the pharmaceutical industry.

When you stick with US/EU manufactured pharmaceuticals, and the real US/EU pharmaceuticals distribution network, it works out really well. Most problems are with counterfeits, and some are with foreign manufacturers in developing nations. Wealthy Chinese are not paying extra for genuine US/EU meds because they are fashion statements.

Re:Charge what it costs to certify (1)

TechyImmigrant (175943) | about 4 months ago | (#47396721)

This is exactly how they do it for FIPS 140-2 cryptographic module certification. They farm it out to private certification firms.

Re:Charge what it costs to certify (1)

TheRaven64 (641858) | about 4 months ago | (#47398031)

This is exactly how they do it now for software in medical devices. Except that that 'private firms' are the manufacturers. It's ludicrous for them to claim that a certification process that basically amounts to asking the manufacturers to promise that they've tested it really well 'won't scale'.

Re:Charge what it costs to certify (-1, Flamebait)

AuMatar (183847) | about 4 months ago | (#47396323)

In other words, provide no oversight at all while an "independent" firm rubber stamps all the industry's apps for a completely legal fee which ends up going to the executives of the fake company via bonuses, then let it fold and start up a new one.

Privatized enforcement is no enforcement. If it can't be overseen by the government it needs to either be banned. You can open up the question of if it needs to be regulated at all, but providing the illusion of safety and regulation when there is none is far worse.

Re:Charge what it costs to certify (3, Insightful)

Hungus (585181) | about 4 months ago | (#47396393)

In other words, provide no oversight at all while an "independent" firm rubber stamps all the industry's apps for a completely legal fee which ends up going to the executives of the fake company via bonuses, then let it fold and start up a new one.

Privatized enforcement is no enforcement. If it can't be overseen by the government it needs to either be banned. You can open up the question of if it needs to be regulated at all, but providing the illusion of safety and regulation when there is none is far worse.

Nowhere does the OP say that, you are jumping way down an argument and not providing your work in between. How I read the OP is that private contractors do the heavy lifting and then the FDA comes back in and audits the results. If you audit one in 3, then see a group fails to catch something so you audit their entire batch, that is still substantial oversight.

I also would be willing to jump in and say the FDA is overstepping what little role it should have and might be provided by the ICC (Article I, Section 8, Clause 3) and would even be willing to say that it may only regulate the actual commerce and not the actual products, however I think the OP is a step in the right direction.

Re:Charge what it costs to certify (-1)

AuMatar (183847) | about 4 months ago | (#47396467)

Sure he does- he says a private organization. There is no way in hell a private organization would ever be legit. First off, a private organization could make more money by reducing their oversight and rubber stamping, at least in the short term. And that's all most care about. Secondly, even if they didn't drug companies could make more money by setting up sock puppet regulators so they'd eventually just do that.

Private regulation is no regulation- period.

Re:Charge what it costs to certify (1)

Hungus (585181) | about 4 months ago | (#47396527)

Actually no I did not say that. Again you are making a link that private regulation is no regulation, and even in the OP I did not say simply private regulation I said with oversight. It is really no different that hiring contractors, which is something we do frequently via the Federal Government and in private industry.

I have already given a simple example of how it could work, twice now you have simply responded with a dogmatic statement and no connecting evidence or reason.

  If you do not provide any I will have to infer three things:
1) You simply believe only the government is capable of doing the work
2) All government workers must be actual government works and not contractors
3) The government is incorruptible.

Since I know that all 3 of these are historically and factually false we will have no where left to go.

Re:Charge what it costs to certify (2, Funny)

AuMatar (183847) | about 4 months ago | (#47396563)

And I gave my reasoning. You can keep on to your infantile libertarian dreams, but a government agency is always more trustworthy than a private company- a government agency has at least some checks and balances and accountablility. A private agency has absolutely none, and is motivated solely by profits. Belief that they will actually do their job is asinine.

Private regulation is no regulation

Re:Charge what it costs to certify (1)

Hungus (585181) | about 4 months ago | (#47396625)

I am not certain why you think my ideas are Libertarian, especially given that I rate libertarians somewhere along the lines of neocons (I agree with them about 50%).

You make several comments that are absolutely falsifiable however. such as: "government agency is always more trustworthy than a private company"

I do find it interesting that you accuse me of being, or at least having, libertarian [ideas] and then go on to describe a libertarian viewpoint. Not being Libertarian, I do not agree with that viewpoint.

In any case, you have failed to make you case with me, I see that you are simply going to be dogmatic and provide neither reason nor proof. I suspect it is because we have very different qualifications for what is a "reason" and what is "proof". So how about we simply agree to disagree? You can think I am a libertarian, and I will think you are wrong. One of us will be correct.

Re:Charge what it costs to certify (1, Troll)

Rockoon (1252108) | about 4 months ago | (#47396731)

He is a full blow Statist willing to make things up to justify his Statist position, rather than form a position based on actual information.

perhaps he thinks that his Statist position is so solid that the information he is unaware of must support his position, so feels free to just make it up because hey it must be true.

Re:Charge what it costs to certify (5, Insightful)

Bing Tsher E (943915) | about 4 months ago | (#47396633)

That is completely garbage. The Underwriter's Laboratory is a private for-profit organization and does a very good job of assuring fire and electrical safety for a huge sector of industry. When something is UL listed you can be certain it meets stringent safety standards.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396637)

If you call that reasoning, may I recommend you take a course on critical thinking? Your argument is based entirely on slippery slope fallacy argument and not at all on fact.

Re:Charge what it costs to certify (1)

Anonymous Coward | about 4 months ago | (#47396697)

... but a government agency is always more trustworthy than a private company...

C'mon mods, mod that "funny"; it's one of the funniest things I've read on this site in months.

Re:Charge what it costs to certify (1)

LynnwoodRooster (966895) | about 4 months ago | (#47396879)

When you do your work, do you routinely cut corners, lie, and make stuff up just to get your next paycheck? That's what you're claiming pretty much everyone else in private industry does...

Re:Charge what it costs to certify (4, Insightful)

sycodon (149926) | about 4 months ago | (#47396997)

Because INS, "Homeland" Security (What a freaking Totalitarian sounding name), and the TSA are doing such a bang up job.

Dickheads like you are the ones shutting down Lemonade stands run by six year olds because they don't "meet regulations".

Re:Charge what it costs to certify (4, Informative)

Rockoon (1252108) | about 4 months ago | (#47396425)

Everything you said is unimportant because the FDA's purpose isnt supposed to be enforcing efficacy, only safety.

Somewhere along the way, however, some blind fool tools such as yourself got the FDA into the safety efficacy racket, and the thing that took a back seat because of it was in fact safety.


Let me quote you: "if it can't be overseen by the government it need to either be banned." Not only is this a grammatic fail, even if it was grammatically correct it would still just be a full blown blind call for complete Statism.

Re:Charge what it costs to certify (-1, Troll)

AuMatar (183847) | about 4 months ago | (#47396443)

Oh look, the Libertardians are out in full force.

Yes, the FDA is supposed to be enforcing efficacy. That's its entire point- to ensure that drugs do what they say.

Nor would regulating apps be about efficacy and not safety. If an app says you should take a certain drug and that drug has side effects, its a safety issue. If it provides a diagnosis and that's wrong, its a safety issue.

Re:Charge what it costs to certify (1, Flamebait)

Rockoon (1252108) | about 4 months ago | (#47396661)

Yes, the FDA is supposed to be enforcing efficacy. That's its entire point

"Bureau of Chemistry" was split into the "Food, Drug, and Insecticide Administration" and the "Bureau of Chemistry and Soils" in 1927, the former of which was later renamed "Food and Drug Administration"

The FDA's purpose was codified by the Pure Food and Drug Act of 1906 until the Federal Food, Drug, and Cosmetic Act of 1938 was passed.

Still at this point, the FDA's purpose was only regulating safety.

It wasnt until the Kefauver Harris Amendment of 1962 was passed that drug efficacy was considered by any federal law, Even here it wasnt until 1968 that the FDA enacted the Drug Efficacy Study Implementation that complied with the 1962 law - so the very first year that the FDA monitored efficacy was 30 years after the FFDCA, and 62 years after the PFDA.

So only 44 years of monitoring drug efficacy by the FDA, yet its original mandate has been around since 1906 and the administration has had its current name since 1927.

You've got some explaining to do: Are you being a intentionally dishonest fuck, or are you just an ignorant twat? yeah I now.. facts are hard to either know or have to defend against.

Re:Charge what it costs to certify (4, Interesting)

Rockoon (1252108) | about 4 months ago | (#47396837)

Also to add:

The Kefauver Harris Amendment was inspired by the thalidomide tragedy that caused thousands of birth defects. However, the number of birth defects it caused in America was 0 because thalidomide was not approved yet by the FDA simply on the safety mandate. Thalidomide would have passed efficacy tests because it was, in fact, effective for more that a few purposes. So effective it was for so many purposes that Germany had lifted regulations and even started selling it over the counter.

Mandating efficacy is the backwards thinking of the Statist.

not quite zero in the US (1)

publiclurker (952615) | about 4 months ago | (#47397499)

because a few proto-libertarians though that they knew better than the FDA and brought some in from abroad.

Re:Charge what it costs to certify (1)

Anonymous Coward | about 4 months ago | (#47396671)

wow "libertardians" yup, we're dealing with an intelligent and mature individual here. I believe everyone can agree you're opinion is worthless until you can make an argument without using childish insults.

Re:Charge what it costs to certify (1)

khallow (566160) | about 4 months ago | (#47396817)

Oh look, the Libertardians are out in full force.

Because only Libertardians would be concerned about a government that bans everything it doesn't control?

no. (1)

publiclurker (952615) | about 4 months ago | (#47397509)

Because libertarians like to cry like the self-entitled children they are whenever the grownups point out that they are, in fact, crying like a bunch of self-entitled children.

Re:Charge what it costs to certify (2)

Goldsmith (561202) | about 4 months ago | (#47397257)

With medical devices efficacy and safety are very closely linked. If you're providing a product that monitors blood glucose and you do a poor job of it, your customer makes incorrect medical decisions that are potentially life threatening. The closer an app gets to providing such "actionable" information, the more likely it is that it requires FDA approval.

That said, this "can't be overseen" thing is silly. The FDA doesn't have the resources to oversee ALL smartphone health apps, they don't want to, and they shouldn't. There's no debate there. If the next generation of phones include electrocardiogram electrodes or a sophisticated spectrometer, the FDA is going to regulate the health software using those tools. That's really the news coming out of that FDA statement.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396665)

And there's the Kool Aid drinking Government whore.

Fucks like you should just be shot in the street.

Re:Charge what it costs to certify (1)

khallow (566160) | about 4 months ago | (#47396779)

Privatized enforcement is no enforcement. If it can't be overseen by the government it needs to either be banned.

We have courts as back up. Relax.

Re:Charge what it costs to certify (1)

Damian J Pound (3635341) | about 4 months ago | (#47397851)

If we can't trust an app to be reliably checked for safety by a single company, then the companies should be vetted by the FDA and require that an app be tested by at least 10 of the FDA's pool of safety check companies (any others are welcome to test as well).

Not medical grade instruments ... (3, Insightful)

perpenso (1613749) | about 4 months ago | (#47396337)

I expect these new mobile devices/apps coming onto the scene will be considered some sort of novelty devices by the FDA not medical devices. Like ancient digital watches.

The info they provide will be considered more trivia or a novelty than medical info. Much like ancient digital watches that could show a pulse, novelty info, not to be used for medical purposes. Or ancient digital watches that could show pressure, novelty info, not to be used for aircraft altitude or depth when scuba diving. I actually used one for scuba diving but it was secondary to my actual depth gauge made for scuba diving. It was surprisingly close. And when driving up to the mountains it will surprisingly close to the altitude markers along the highway, assuming I calibrated. I knew my altitude at home. And when diving, I was at sea level on the beach/boat. As reasonably accurate as it was, it was still a novelty device, or a last resorts back if my actual device failed.

Re:Not medical grade instruments ... (2)

rhsanborn (773855) | about 4 months ago | (#47396695)

Unfortunately, companies like Apple are developing services to aggregate health data from things like wifi BP cuffs, scales, activity trackers, pulse oximeters, etc. And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care. So, regardless of it's novelty, it's going to be used for very real medical decisions. At the very least, there needs to be better education about the lack of oversight and the potential for wildly inaccurate data, and I don't get the feeling that's happening.

Lawsuits prevent devices from use in patient care (1)

perpenso (1613749) | about 4 months ago | (#47396991)

Unfortunately, companies like Apple are developing services to aggregate health data from things like wifi BP cuffs, scales, activity trackers, pulse oximeters, etc. And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care. So, regardless of it's novelty, it's going to be used for very real medical decisions. At the very least, there needs to be better education about the lack of oversight and the potential for wildly inaccurate data, and I don't get the feeling that's happening.

I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

Similarly I doubt Apple will be promoting its consumer oriented devices for use in patient care, well in the medical data acquisition and telemetry sense, as opposed to doctors accessing data/records via iPads. Apple will probably "prohibit" such use in its licensing agreement. Apple's pockets are way too deep and they would just make themselves a perfect target for trial lawyers if consumer grade devices were used in medical data acquisition.

Ultimately there will be mobile medical data acquisition and telemetry devices from traditional medical equipment vendors and it will be FDA approved.

Of course, maybe Apple will come out with an FDA approved model eventually, a non-consumer grade device ?

Re:Lawsuits prevent devices from use in patient ca (1)

tlhIngan (30335) | about 4 months ago | (#47397443)

I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

And that is what would regulate the market in the meantime.

The FDA doesn't want to regulate because not only is it going to be hard, but it's going to stifle what is a tremendous source of innovation that's happening.

But even better is that the industry will either self-regulate, or will call on rules after a few court cases come out. I mean, you're going to start small, like those "this app produces lightwaves that will cure acne" apps that were blocked a while ago. Small wins, but even then you'll get some traction from those who wanted to go acne-free to prom or something.

Sensors are probably regulated under some other set of rules - after all, you can buy glucosometers, blood pressure monitors, scales, and a pile of other medical devices at your local Wal-Mart. Probably under a bunch of rules stating "This product only works in conjunction with regular visits to your physician" or something.

But apps that take that data and do stuff will be an interesting field. Like those "cancer detecting" apps where you snap a mole and it tells you if it's melanoma or something. Even without regulation those things will probably fall under a court case from someone who dies from it and sues the app maker.

As far as I can tell, the FDA should regulate against obvious snake oil, but some of the other stuff, it's probably a wait-and-see approach.

Hell, Apple consulted with the FDA too - they're wondering how far they're going to allow it as well, so between Apple and Google (both of whom have their own health related ecosystems now), I think that's where the main body of regulations may come in. After all, a lawyer will go after the app developer and Apple/Google for the latter have the money.

Re:Lawsuits prevent devices from use in patient ca (1)

perpenso (1613749) | about 4 months ago | (#47397555)

I honestly doubt physicians will base medical decisions on data from non-FDA approved devices. That is an enormous opening for the trial lawyers and their malpractice lawsuits.

And that is what would regulate the market in the meantime.

That is not how the trial lawyers work. They are not defacto regulators in most cases. The are far more often just parasites and are very much like the patent trolls, just using the legal system to extort money. They will sue doctors who did receive correct data from a device and who made a medically well informed decision. They will use the fact that the device is not FDA certified to sow FUD and confuse and mislead a jury who is clueless about medicine and devices. Every once in a while they will find a gullible jury and get a payday, and insurance companies/doctors will just give them money to go away even when their suits are baseless.

Sensors are probably regulated under some other set of rules - after all, you can buy glucosometers, blood pressure monitors, scales, and a pile of other medical devices at your local Wal-Mart.

The first consumer at-home glucose monitoring device (hardware and software) that I found on walmart's website is an FDA approved device according the the FDA's website.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47396713)

Have you ever actually used FDA approved software? The one package I have seen used was only approved to run on a single operating system (NT 4; well after the date one should have probably moved on) and didn't get bug fixes. Rather than bug fixes, there were documented work arounds. It was horrible.

Re:Charge what it costs to certify (1)

aaronb1138 (2035478) | about 4 months ago | (#47396805)

The upside to a certification program, even if privatized, allows the assignment of liability which supersedes the bullshit in the EULA. The idea is to create a "seller beware" instead of "buyer beware" market and to empower the consumer in such a way as to scare off the majority heap of charlatans. Further the cost of entry of certification clears a lot of that out anyway. Certainly the spam crap apps out of China and India.

It also gives a registered address to send the legal summons and other such when someone does end up producing dangerous crap.

All of the butthurt that privatized certification is useless comes from people who don't understand how awful things would be in industries so regulated otherwise.

Re:Charge what it costs to certify (1)

Anonymous Coward | about 4 months ago | (#47397009)

Why? They've literally admitted the free market is too fast for them to manage without stiffling development. What sense does it make to demand they manage it somehow regardless? Staying out of people's hair is a good thing, not a bad one.

Re:Charge what it costs to certify (0)

Anonymous Coward | about 4 months ago | (#47397893)

The private firms would be like accountants. A problem would be the current difference of difficulty between inspecting financials and actual software. The FDA should formulate standards for the inspection, the inspectors and the inspected, so that such an inspection could actually give satisfactory and agreed upon certainty of fit to purpose in courts as well.

does it mean anything though? (1)

ed.han (444783) | about 4 months ago | (#47396199)

this does beg the question: if they're so popular without any FDA approval already, does this have any meaningful impact? i somehow doubt it.

ed

Re: does it mean anything though? (1)

Anonymous Coward | about 4 months ago | (#47396223)

Popularity isn't the issue. Lots of dangerous stuff would be remarkably popular if given a chance.

Short term pleasure, long term price.

Re: does it mean anything though? (3, Insightful)

fustakrakich (1673220) | about 4 months ago | (#47396287)

With the FDA infected with industry worms a lot of dangerous is given a chance, while less harmful substances are outright prohibited from even studying.

Re: does it mean anything though? (1)

fustakrakich (1673220) | about 4 months ago | (#47396297)

stuff

Re: does it mean anything though? (3, Insightful)

Impy the Impiuos Imp (442658) | about 4 months ago | (#47396301)

I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

Re: does it mean anything though? (0)

Anonymous Coward | about 4 months ago | (#47396435)

If that's the math, we can just say every billion that the US Congress doesn't dedicate to medical research is costing lives.

Re: does it mean anything though? (1)

Rockoon (1252108) | about 4 months ago | (#47396709)

If that's the math, we can just say every billion that the US Congress doesn't dedicate to medical research is costing lives.

Only if we know what the alternative was/is can such a claim be made.

See, the person you replied to detailed both sides of the coin (delays cost lives, rushing cost lives, compare) while you only want to look at one side with your "counter example" (lack of spending cost lives, lets not compare to anything..)

Not as many lives as delaying Thalidomide saved (0)

Anonymous Coward | about 4 months ago | (#47396757)

I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

I feel pretty confident that such a delay won't cost more lives than the FDA saved when they delayed approval for Thalidomide http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/ [fda.gov] .

For extra bonus points -- that's what prompted Congress to expand the FDA's legal mandate to ensure that drugs are both safe and effective.

Re: does it mean anything though? (0)

Anonymous Coward | about 4 months ago | (#47397025)

I'll tell you what -- all it'll take is the FDA causing the delay for one year of a decent cancer or heart disease or diabetes drug, and boom! They've cost more lives than they will have saved since 1938.

They do that literally every year.

Re: does it mean anything though? (1, Troll)

smitty_one_each (243267) | about 4 months ago | (#47396815)

One thing we know is that absence of regulation == total chaos.
Just ask a bureaucrat.
Furthermore, we know that people are stupid, and absolutely incapable of operating above caveman level without kindly bureaucrats.
In summary, ensuring Total Regulation is a basic national security requirement.

Re:does it mean anything though? (-1)

Anonymous Coward | about 4 months ago | (#47396229)

Mandatory correction for the misuse of "Begs the Question":

Begging the question
Begging the question means "assuming the conclusion", a type of circular reasoning. This is an informal fallacy where the conclusion that one is attempting to prove is included in the initial premises of an argument, often in an indirect way that conceals this fact. It does not mean to raise a question forcefully, as so many people who misuse the phrase seem to believe.

Re:does it mean anything though? (1)

I'm New Around Here (1154723) | about 4 months ago | (#47396379)

I thank you for trying to point out a mistake, but your explanation is not very enlightening. Please allow me to post a more thorough one I found.

"Another logical term widely misused by careless speakers is 'begging the question.' This is often thought to mean raising (or forcing) the question. It doesn't. To beg the question is to presuppose the conclusion in one's argument, thus to reason circularly. . . .

"I imagine that people began using the phrase improperly because 'this begs the question' seems to mean that this begs us--asks us earnestly, entreats us--to raise and consider the question.

"The actual origin of the phrase seems to come from a mistranslation of the Latin phrase the medieval logicians used to refer to an argument that assumes its own conclusion: petitio principii. This is fairly literally translated as 'assuming the starting point.' But 'petitio' also means 'begging' (whence the English word 'petition')."
(Robert M. Martin, There Are Two Errors in the the Title of This Book: A Sourcebook of Philosophical Puzzles, Paradoxes and Problems, 2nd ed. Broadview Press, 2002)

http://grammar.about.com/od/ab... [about.com]

Re:does it mean anything though? (1)

Hungus (585181) | about 4 months ago | (#47396445)

If that phraseology works for you .. fine. I tried to make it as generic as possible and actually just grabbed the Wikipedia summary and the begthequestion.info tail.

If you really want to understand it then go look at J Woods / D Walton article [springer.com] which is a nice basic intro to the subject.

Re:does it mean anything though? (0)

Anonymous Coward | about 4 months ago | (#47396387)

That is begging the question how it's like to be a virgin with 35.

Re:does it mean anything though? (1)

tr4nshum4n (2646323) | about 4 months ago | (#47397113)

That is begging the question how it's like to be a virgin with 35.

I love this!

Re:does it mean anything though? (-1)

Anonymous Coward | about 4 months ago | (#47396259)

Apologies for the pedantry but that isn't begging the question; it is raising the question. See e.g. Wikipedia: http://en.wikipedia.org/wiki/Begging_the_question

Why protect the utterly stupid? (0)

Anonymous Coward | about 4 months ago | (#47396235)

It's one thing to protect people when there's unavoidable information asymmetry. The contents of food products or the side effects of medicine are good examples of this. But is anyone really stupid enough to trust in some shitty mobile app that was free or only cost a few dollars to really be a trustworthy medical device of some sort? Seriously! Should some government agency start putting warning labels on hammers, just because somebody might be stupid enough to crush their own testes to a mush using one? For crying out loud, if somebody is stupid enough to make a blatantly stupid decision or assumption when they have information obviously available to them, no government agency should be trying to protect them from themselves and their own total and complete idiocy. That's a battle that just can't be won.

Re:Why protect the utterly stupid? (0)

Anonymous Coward | about 4 months ago | (#47396405)

It's weird how you answer your own question but don't even realize it.

FDA shouldn't even exist in the first place (3, Funny)

Anonymous Coward | about 4 months ago | (#47396247)

Nothing in the Constitution gives the federal government permission to have the FDA.

Shut it down.

Re:FDA shouldn't even exist in the first place (0)

Anonymous Coward | about 4 months ago | (#47396307)

OP is not a troll, and while I do tend to think that the FDA likely has a place under the interstate commerce clause I am willing to take the OPs position also.

The Constitution is a regulative document, not a normative document. We know it is a regulative document because of the 10th Amendment:
The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

Normative: whatever is not prohibited in the document is permitted in practice
Regulative: should include those and only those powers, departments and responsibilities that are instituted, commanded, or appointed by command or example should be the purview of the Federal Government, all else is to the States, Municipalities / People

Re:FDA shouldn't even exist in the first place (0)

andydread (758754) | about 4 months ago | (#47396451)

I have some products for you to try [google.com] Cures everything from cancer to kidney disease

Re:FDA shouldn't even exist in the first place (1, Troll)

Hungus (585181) | about 4 months ago | (#47396479)

How does the existence of radium products grant a power to the Federal Givernment? {spelling intentional). I was under the impression that we had things called laws that laid out what the government could and could not do .. but I already said that when I went into the difference between regulative and normative.

Maybe you are an ends justifies the means kind of person.. I am a deontologist.

Re:FDA shouldn't even exist in the first place (1)

andydread (758754) | about 4 months ago | (#47396601)

Re:FDA shouldn't even exist in the first place (1)

Hungus (585181) | about 4 months ago | (#47396685)

Are you certain you are responding to me in this stream? It seems more in place with another comment I made about the Interstate Commerce Clause which is Article I, Section 8, Clause 3 of the US Constitution. Regardless, it is at best a red herring.

Three laws gave Congress this power (1)

tepples (727027) | about 4 months ago | (#47396799)

How does the existence of radium products grant a power to the Federal Givernment? [sic]

I agree with you that it doesn't. But you could take the Commerce Clause, the DC Clause, or the Army Clause, and any one of those three would gave the Congress power to create the FDA. The Congress doesn't want unsafe drugs to cross state lines, be sold in Washington, or be used to treat service members.

Not a federal role is not equiv to no gov't role (1)

perpenso (1613749) | about 4 months ago | (#47396493)

I agree, pharma distribution is nationwide so federal oversight seems reasonable.

The point you address is one that is often misunderstood. When most people say the federal government should not be involved in activity X they often mean that a more local level of government should be involved. I other words a level that is (1) more knowledgable of the local environment that activity X is taking place in and (2) is more accountable to local voters.

With respect to (1) in particular, many problems have a local component. A good solution in one part of the country may be a poor solution in another. That is why many people are highly skeptical of one-size-fits-all solutions from Washington DC.

For EU readers, consider an EU based organization usurping control over some activity from your national government. That's sort of the situation with the US federal government. The US is too large and too diverse for many on-size-fits-all solutions.

OP is not a troll, and while I do tend to think that the FDA likely has a place under the interstate commerce clause I am willing to take the OPs position also.

The Constitution is a regulative document, not a normative document. We know it is a regulative document because of the 10th Amendment: The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.

Normative: whatever is not prohibited in the document is permitted in practice Regulative: should include those and only those powers, departments and responsibilities that are instituted, commanded, or appointed by command or example should be the purview of the Federal Government, all else is to the States, Municipalities / People

Re:Not a federal role is not equiv to no gov't rol (1)

Hungus (585181) | about 4 months ago | (#47396567)

Thank you for providing another viewpoint. I do appreciate other people rephrasing things within their own experience as I know my own view points are only expressed through my own lenses. Diversity helps people get past hangups they may have with my particular affectations.

Re:Not a federal role is not equiv to no gov't rol (1)

GNious (953874) | about 4 months ago | (#47397955)

For EU readers, consider an EU based organization usurping control over some activity from your national government. That's sort of the situation with the US federal government. The US is too large and too diverse for many on-size-fits-all solutions.

You mean akin to the EU effectively overturning a national ban on phthalate esters, as per earlier this year?

Re:FDA shouldn't even exist in the first place (1)

spauldo (118058) | about 4 months ago | (#47397989)

That's all very nice and all, but that's just not the way it works, or really how it's ever worked.

The federal government can pretty much do as they please, powers-wise, and leave it up to the courts to sort out. Because departments like the FDA, Agriculture, Energy, Education, etc. are in generally deemed necessary by most of the people whose opinions actually matter (i.e. not pee-ons like us), they get a pass. You could certainly challenge their constitutionality, but you'd better have a team of very good lawyers and be willing to wait a decade or so for the final decision.

Politicians, in practice, tend to treat the constitution more as a guideline or an obstacle. What really matters is how the powers of influence flow, not what some dusty old piece of eighteenth century vellum has written on it.

Don't like it? Well, you could always move to... wait, everywhere else is pretty much the same way if not worse. The moon, maybe?

Not a good enough reason (0)

Anonymous Coward | about 4 months ago | (#47396251)

So the FDA hasn't considered mandating that they vet apps and charging a yearly service fee for FDA approved apps with an FDA approved logo?
Seems to me like a no-brainer.

Re:Not a good enough reason (1)

peragrin (659227) | about 4 months ago | (#47396395)

Not yet. This was the first step in declaring the need for a much much larger budget. as every app will need to be tested and certified with qualified people and testing could take as little as 12 months.

for the FDA that is amazing.

So is an app food... (1)

Anonymous Coward | about 4 months ago | (#47396291)

... or a drug?

Why is the government involved in devices? If you want to market a device that measures BP (or whatever), great! If your customers would like some proof that it's good for the purpose, get Underwriter's Labs (or equivalent private organization for your country) to certify it.

Government neither needed nor wanted here.

Re:So is an app food... (2)

TapeCutter (624760) | about 4 months ago | (#47397475)

Why is the government involved in devices? ... get Underwriter's Labs .... to certify it.

From the WP entry on UL - "UL is one of several companies approved to perform safety testing by the US federal agency Occupational Safety and Health Administration (OSHA)". If UL started handing out certs without doing the work then their license will be pulled and they will go out of business overnight.

Very few "free markets" spontaneously arise and prosper, the government creates them with the judicious use of regulation, the most basic of these regulations is property law, the saftey cert market is simply a more recent example. This is actuacully how things should work, the government defines a fair market for the public good via regulation of property and trade, business competes to implement the new market as efficiently as possible. Neither can do it alone due to self-interest getting in the way, which is why politicians and CEO's need to be kept at arms length from each other.

vetting would be impossible regardless (0)

Anonymous Coward | about 4 months ago | (#47396369)

A given app + a given smartphone/tablet/etc + a given configuration of everything else on said device?
And really, couple minutes testing of just a pulse reading app would tell you that

Take the people (0)

Anonymous Coward | about 4 months ago | (#47396427)

Take the people who are going after 23andme.com and preventing them from providing any health data and go after/ban the obviously 'hoax/fake.

make 'em do it. (0)

AndyKron (937105) | about 4 months ago | (#47396431)

Just tell the app makers they need to go through the million dollar approval process just like everyone else.

Sports HRMS (1)

russotto (537200) | about 4 months ago | (#47396483)

You can get heart rate monitors from sporting goods stores; these aren't FDA regulated either. As long as they don't make medical claims (like being suitable to diagnose or monitor a medical condition) it's not illegal to measure pulse or blood pressure.

Re:Sports HRMS (1)

ColdWetDog (752185) | about 4 months ago | (#47396649)

What I find astounding is that the FDA doesn't even try to regulate Electronic Health Records. Large, expensive, complex programs that do monitor and help diagnose medical conditions. I'm much more leery of EHRs than random iPhone apps.

It would be a major challenge to do this, but you might actually make a difference.

Kill FDA And Its Employees (0)

Anonymous Coward | about 4 months ago | (#47396575)

Best argument for instant death in years.

Just think of the $dollar per employee value returned to the Treasury !

Just Do It.

Be Afraid (1)

tquasar (1405457) | about 4 months ago | (#47396873)

So, this info will become a part of The Health Administration's dossier? Move away from your e-gadgets....

hive mind? (1)

PopeRatzo (965947) | about 4 months ago | (#47396947)

Is this something that would respond to crowd-sourcing? I'm asking because I really don't know.

I've noticed that the reviews for apps have become much less reliable. Apple and Google have even started making it harder to break out the low-rated reviews on apps in their stores now, and there's so much manipulation of the reviews that it's impossible to fully trust them. And Apple and Google are far from blameless in this.

I wouldn't mind seeing some independent site that had sort of "wiki-reviews" of apps and medical apps might be a place to start. Let's see what some people with medical book-learnin' have to say about these things. We all know the wide range of quality of these things. This is one of those areas where anecdotal information would be pretty useful. I don't need to read peer-reviewed journal articles to know whether an app that measures and charts heart rate is useful, I just need to know if it does what it says it's doing. I've used an excellent sleep app for about a year now and I'm convinced that my experience matches what it's telling me, but I would have liked to know a little more in advance.

Having reviews on online stores was a good idea, but it's getting hopelessly corrupted. There's got to be some solution to this besides having the FDA have to chase it all down and delay the release of apps until they pass regulatory muster.

Re:hive mind? (1)

spauldo (118058) | about 4 months ago | (#47397921)

A friend of mine works in a lot of internet marketing and used to do things like search optimization and whatnot. Trust me, no matter what user-based system you set up, people will work day and night to subvert it to push their products. Any sort of review or rating system would be corrupted very quickly.

And really, user reviews aren't a good source for medical data anyway. Half the people who leave reviews think streptococci is on special at the fancy italian place downtown.

Personally, I think the FDA just needs to come up with guidelines on what an app can or can't do health-wise without going through the FDA approval process. Something that keeps track of your calories or measures how much you walk in a day should be fine. Something that keeps track of your heart rate might be acceptable with a disclaimer that it's not "medical quality" or something. Programs that interact with medical devices (pacemakers, etc.) probably should be vetted in some way.

NSA: Servers Full Monitoring Porn Site Usage (1)

l0ungeb0y (442022) | about 4 months ago | (#47396977)

Dear Mr. Obama, we're sorry to inform you that our current Data Centers are at maximum capacity storing the complete browsing history and Porn Site usage of all American Tax Payers and cannot accommodate tracking medical app usage in the iTunes or Google Play App Store. Perhaps if you could be so kind as to take a shit on and then wipe your ass with the Constitution on Fox Cable News and proclaim this a Nation of God under Martial Law, we could come to an agreeable compromise.

Thank god (1)

shaitand (626655) | about 4 months ago | (#47396999)

This is an area that needs to be free from the constraints of the FDA for awhile.

Good news (2)

jtwiegand (3533989) | about 4 months ago | (#47397055)

This is a very good sign on the whole as it shows that out-innovating the regulatory state is not only possible, but actually happening right now. Our regulatory regime is stuck in the 19th century centralized command-and-control model, and it will stay there. Better to let it fail so that a useful and effective method of necessary oversight can come to replace our gilded age government with an information age government.

Good news (0)

Anonymous Coward | about 4 months ago | (#47397355)

So why is oversight always necessary again?

Re:Good news (1)

spauldo (118058) | about 4 months ago | (#47397883)

I don't see an "information age" government happening for another twenty to thirty years, and that's probably optimistic.

Those in power tend to be older and more conservative (in general terms, not talking about politics). They're often lawyers, who are used to working on months- or years-long projects where rapid response isn't possible or (to their mind) necessary. Getting them to accept that drastic change is necessary is difficult. When they do try to implement change, there are levels upon levels of management and employees below them that resist the change and undermine it in small but cumulative ways. Add to that the fact that an "information age" government would also be a "privacy invading" government by most standards, so there would be a lot of political pressure to leave things as they are.

That said, out innovating the regulatory state has been happening for quite some time now. Just look at the patent system, for instance.

Buck Feta. (1)

buckfeta2014 (3700011) | about 4 months ago | (#47397255)

Buck Feta.

Re:Buck Feta. (1)

TechyImmigrant (175943) | about 4 months ago | (#47397317)

Buck Feta.

Yes. I suggest switching over to Wensleydale.

Good. Now go away, Big Brother. (0)

Anonymous Coward | about 4 months ago | (#47397347)

Good. Now go away, Big Brother.

In case no one has noticed... (1)

erichill (583191) | about 4 months ago | (#47397577)

Copper & magnetic bracelets and a whole bunch of other snake oil that motivated the formation of the FDA in the first place are rampant.

Sehr gut! (1)

Fred Mitchell (3717323) | about 4 months ago | (#47397585)

I am glad the FDA can't keep up with health apps. Can you imaging how much it would stifle innovation? The health monitor that comes installed with Samsung Galaxy smart phones is wonderful. It quietly monitors my daily walking and lets me know when I hit my goal. I could hope for other biomonitors too, like something that can monitor blood chemistry and the like. We can have independent bodies rate how well these things work, and also how please the current users are with them. And actually, we have a lot of that in place already. And if I choose to write a health app myself, I really don't want to be burdened with bureaucratic oversight for something that is not a life and death issue, from all the countries my apps may be used in.

When will FDA regulate Medtronic? (0)

Anonymous Coward | about 4 months ago | (#47397997)

This article seems to claim the FDA does regulating in some cases. Yet cases like the trivial to hack Medtronic insulin pumps shows that FDA certification really is not much more than a rubber stamp. We seem to have reached the point where credit card processing devices are put under more quality control testing than medical devices are. Where is the PCI DSS level of tests to prevent more Medtronic products making it easy to kill us? What has the FDA done to change it's certification process since the issues with Medtronic insulin pumps was brought to light?

It would be more honest if the FDA just admitted they aren't doing a complete job of evaluating *ANYTHING*. This misleading claim that some devices are still getting certified implies that a reasonable inspection is done. The end result is that the FDA gives the illusion of filling the gap of evaluating devices while really just putting a rubber stamp. It is time of them to step aside completely or take better crediablity for their history of incompetence.

Good. (1)

Karmashock (2415832) | about 4 months ago | (#47398019)

The FDA hinders too much medicine as is... just ask the people that actually make the medicine or the machines that save your life. They'll tell you that while the FDA means well they tend to just screw things up.

Currently they're creating several drug shortages in the US by interfering with the manufacturing process to no particular purpose.

Apps exist that measure your blood pressure? (1)

clickety6 (141178) | about 4 months ago | (#47398069)

Do they really because I've only seen apps for monitoring blood pressure readings, readings taken by an external device. How is an app supposed to measure blood pressure?

Magazine Apps For iPhone (1)

soniasingh85 (3713455) | about 4 months ago | (#47398141)

iPhones have cult status all over the globe. It is one of the most pride possessions. Publishing of magazines to such a popular device through Magazine Apps for iPhone gives an advantage to increase reach out capacity to a great extent.
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