Slashdot Mirror
FDA: We Can't Scale To Regulate Mobile Health Apps
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.
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.
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
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.
Nothing in the Constitution gives the federal government permission to have the FDA.
Shut it down.
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.
... 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.
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.
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 who are going after 23andme.com and preventing them from providing any health data and go after/ban the obviously 'hoax/fake.
Just tell the app makers they need to go through the million dollar approval process just like everyone else.
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.
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
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.
Bad Panda! No Bamboo for you! In matters of importance ACs will not be responded to. Want to say something critical,OK
Best argument for instant death in years.
Just think of the $dollar per employee value returned to the Treasury !
Just Do It.
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/.
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.
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.
So, this info will become a part of The Health Administration's dossier? Move away from your e-gadgets....
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.
You are welcome on my lawn.
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.
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 ?
This is an area that needs to be free from the constraints of the FDA for awhile.
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.
Buck Feta.
Buck Feta. You know what to do.
Good. Now go away, Big Brother.
So why is oversight always necessary again?
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.
because a few proto-libertarians though that they knew better than the FDA and brought some in from abroad.
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.
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.
Copper & magnetic bracelets and a whole bunch of other snake oil that motivated the formation of the FDA in the first place are rampant.
Credo sim. - I think I am.
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.
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?
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.
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.
I've decided to stop wasting my time responding to AC trolls/sockpuppets... so if you want a response from me... login.
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?
----------------------------------- My Other Sig Is Hilarious -----------------------------------
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.
www.flipbookmaker.co
ITT: libertardian circlejerk
Snowden and Manning are heroes.
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.
Some people never met their local government then. I've never met a more wretched hive of ignorance and corruption since I left Mos Eisely.
It would be just one more thing the "pay to play" FDA has no business being involved in.
Why do you assume a doctor will be using this data?
From what I can tell, patients will be using this to avoid going to the doctor. The doctor is inconvenient, can cost money, takes a lot of time (hours waiting in the waiting room), etc., so an app that says "you're fine!" means I don't have to take a day off work, don't have to spend it waiting with 16 others coughing up lungs and germs and disease, pay whatever co-pay or deductible and make an insurance claim.
In fact, the primary use of health sensors so far is quantifying one's health - how many calories have I burned so far today, how far have I run/walked/biked/hiked/etc so far, what my heart rate is, etc.
The FDA came down hard on people that claimed "a special wavelength of light cures acne" and the apps therein. But why does that app exist? I mean, there are plenty of acne medications on the shelf, OTC and prescription. The app was easier, cheaper, and avoided a doctor's visit. And that's what's really going to happen.
A doctor might be alerted by oddities in a patient's readings, but they aren't going to rely on it anymore than "can you come in and we need to run a full diagnostic on you". The sensors may detect say, heart arrhythmia or potential diabetes, but it would be very stupid for the doctor to rely on those alerts and not perform tests themselves to verify the condition.
It certainly won't replace a doctor's periodic tests - it may help fill in the gaps between visits, what doctor and hospital will want to rely on tests and diagnoses by apps? Especially when you can do the tests again "to be sure" and run up the insurance bill?
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." :-)
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.
Some people never met their local government then. I've never met a more wretched hive of ignorance and corruption since I left Mos Eisely.
Apparently you never visited the Tatooine planetary government.