FDA: We Can't Scale To Regulate Mobile Health Apps 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.
Charge what it costs to certify (Score:5, Insightful)
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.
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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.
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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.
You can 'beg to differ" all you want to, but you made my point for me with "FDA enforcements were only started after the pharma giant had been documented by private auditing firms".
In fact, I am well aware of that case and it was the specific case I had in mind when I mentioned the exception that proves the rule.
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This is exactly how they do it for FIPS 140-2 cryptographic module certification. They farm it out to private certification firms.
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Re:Charge what it costs to certify (Score:4, Insightful)
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.
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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 a
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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
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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 viewpoi
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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 (Score:5, Insightful)
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.
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One counter example does not equal "complete garbage".
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... 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.
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Re:Charge what it costs to certify (Score:5, Insightful)
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".
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Saying government is better at regulating is WAAAY different from advocating regulating everything. Would a child's lemonade stand be better regulated privately?
And how do the mentioned agencies relate to regulation?
Complete nonsense, F- try again.
Re:Charge what it costs to certify (Score:5, Informative)
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.
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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
Re:Charge what it costs to certify (Score:5, Interesting)
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.
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Mandating efficacy is the best defense against snake oil sales. Fear of lawsuits polices safety.
The only way to prove a drug safe is to have people use it for years, and see how many die or incur damage. It us better to take the health risk on effective medicine, instead of on snake oil, yes?
Personally, I think all new medicine should be on limited release for 10 years, only for those not helped by existing medicine. That limits exposure and effectively operates as phase 4 trial. But why take the risk if it
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Mandating efficacy is the best defense against snake oil sales.
Yep, thats why there was a big "snake oil" market until 1968 when efficacy was finally monitored by government .... oh, wait... "snake oils" pretty much disappeared half a century previous to that? How can that be?
So no, mandating efficacy is NOT the best defense against snake oil sales after all. If anything, mandating efficacy pushes "snake oils" underground or into adjacent markets such as "dietary supplements" where again the FDA does not ensure potency, purity or biologic activity of the ingredients
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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.
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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?
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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
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Efficacy and safety are often the same thing. If you have cancer and I tell you I have a miracle cure that only cost half as much as proper medical procedures and you decide to take it, you will die of cancer. If I tell you I have a miracle diet pill that lets you eat as much as you like, you will get fat.
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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.
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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 ... (Score:4, Insightful)
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.
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Lawsuits prevent devices from use in patient care (Score:2)
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 m
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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.
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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 g
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Why do you assume a doctor will be using this data?
Because the post I responded to said "And, physicians and regulators are already looking at ways to integrate that information into a broader plan of care." :-)
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It also gives a registered address to send the legal summons and other such when
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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.
does it mean anything though? (Score:2)
ed
Re: does it mean anything though? (Score:1)
Popularity isn't the issue. Lots of dangerous stuff would be remarkably popular if given a chance.
Short term pleasure, long term price.
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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.
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stuff
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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.
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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..)
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It's a good point, but the problem is to recognize the good one amongst all the bad ones. A bad one slipping through could cost even more lives.
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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.
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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]
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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.
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That is begging the question how it's like to be a virgin with 35.
I love this!
FDA shouldn't even exist in the first place (Score:3, Funny)
Nothing in the Constitution gives the federal government permission to have the FDA.
Shut it down.
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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.
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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 (Score:2)
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 (Score:2)
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
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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.
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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?
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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 go
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The Moon is a Harsh Mistress.
I agree with your description of the situation as accurate, I however do not agree the situation is uncorrectable or right however.
Back to being AC again, but I am the one you were replying too.
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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... (Score:1)
... 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.
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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
Sports HRMS (Score:2)
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.
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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.
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Be Afraid (Score:1)
hive mind? (Score:2)
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
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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 j
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So the system is inherently flawed.
I can't believe there's no way to design a more robust system of review that isn't prone to corruption. Maybe the FDA is that system, but it's an expensive and inefficien
NSA: Servers Full Monitoring Porn Site Usage (Score:2)
Thank god (Score:2)
Good news (Score:2)
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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
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In case no one has noticed... (Score:2)
Sehr gut! (Score:1)
Good. (Score:2)
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? (Score:2)
Magazine Apps For iPhone (Score:1)
ITT: (Score:2)
Good! (Score:1)
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Buck Feta.
Yes. I suggest switching over to Wensleydale.