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Should Medical Apps Be Regulated?
maximus1 writes "There's a tidal wave of medical-related apps coming to smartphones and tablets that will be used by doctors and patients alike. But how should the medical establishment deal with them? Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations. Obstetrician Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off. What do you think?"
So why regulate apps? You can more or less claim your snake oil does anything you want, so long as you hide a disclaimer some place that your claims have not been confirmed by the FDA. If we're going to regulate medical self help and remedies then it should be all inclusive, not limited to apps.
"Have you ever thought about just turning off the TV, sitting down with your kids, and hitting them?"
"The Market" is incapable of making rational decisions
Speaking as someone who works as a mobility specialist in the medical products industry, the FDA already issues guidance in this area. It won't be long before the guidance turns into regulation.
That the correct answer is the one that best serves patients' interests.
I'm dreaming, aren't I ?
no? why should the communication you're using for non-emergencies be regulated? (actually you're phone is supposedly regulated so that anyone can call 911 with it).
the apps that are just glorified pamphlets shouldn't be reviewed any different than regular pamphlets, of course, but it's not like you're going to eat the application and if it gives some wrong advice then you're as publisher on the same hook as if you produced a snake-oil pamphlet I suppose.
I don't think the paper that came with my glucose meter was regulated either, so I don't know why an app that replaces the paper should be.
world was created 5 seconds before this post as it is.
So why regulate apps?
Because regulation artificially narrows the supply, making the profits more lucrative for the incumbents. You did notice the guy pushing for regulation was a doctor already doing apps. Once he's in, regulation is good for him.
Oh, I misunderstood your question. You were looking for a good reason to regulate apps. Sorry, I can't help you there.
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Yes, they absolutely should; for the consumer, to prevent abominations like this. I would say that anything more interactive than a reference document or log book. For more real medical software (i.e. patient monitors or diagnostic tools), just because it's on a smartphone and not a dedicated box doesn't mean it suddenly stops being a medical tool.
Bio questions? Ask me to start a Q&A journal. Computer analogies available for most topics!
If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation. This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.
Why not just release new apps without any regulation, then have them voluntarily certified by a trusted party.
Then medical professionals can choose between new, as-yet-uncertified apps and ones that have been certified.
Slashdot social media options: AIM, ICQ, Yahoo, Jabber and Mobile Text. Why no MySpace?
If a pill advertised on TV can claim to rebuild damaged joints or convert your fat into muscle (these claims have not been verified by the FDA) and in fact do nothing, an app should be able to as well. If the app can't (and it should not be able to) then neither should the sugar pills.
"Have you ever thought about just turning off the TV, sitting down with your kids, and hitting them?"
"Medical Apps" is a broad range of things. Apps that make medical decisions for you certainly should be. Are they making a diagnosis? Telling you treatment? Yes.
On the other hand, Apps that help you track things (Say your glucose levels) or tracks your prescriptions - don't need that added cost / regulation.
I'd be curious to see - are the big companies pushing for this? FDA approval isn't cheap OR fast. Small innovators are able to disrupt this market which has been held strongly by the giant medical firms - who can't be quick and innovate.
We have a fine line to walk between stifling innovation and regulation.
Someone grab the duct tape and shut this guy up.
FDA gets involved, and a $1.99 app will be $1,999. Seriously, look at MRI machines. They can cost millions of dollars. This technology is 30 years old. By now a unit should cost a mere $50,000.
In the U.S. an MRI can cost upwards of a $1,000. In India it costs $50-$100.
No we need less FDA regulation, not more.
Hippa rules do you really want apple to have a backdoor to your medical info?
Kurian Thott, developer of an app called iRounds that helps communication between doctors, thinks they should be released quickly and the market should decide which take off.
I'd rather have medical professionals who are also coders looking at the source code to make such decisions, rather than the ignorant public that is too easily influenced by marketing tactics.
now we need to go OSS in diesel cars
We are talking about apps in the hands of doctors potentially using them for diagnosis. There is a huge difference between that and an app in the hands of a consumer for self diagnosis (a sugar pill). The consumer can do that now with WebMD et al.
It's not like an unregulated marketplace, with limited liability, will mind if a few patients die due to a coding error.
After they privatize the profit, stuff it in their kids trust funds and retirement funds, and walk away while people die.
Socializing the risk and lifetimes of pain and misery on the rest of us. ... oh. ... wait ... It is.
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We are on our way to regulating everything, anyways.
I can't even be astonished by new cries for regulation. It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.
app for stroke victims
What is that? A ebook, a sleazy spreadsheet app, or a MRI remote control app with special features for head scans?
Some apps are basically just an ebook. They should be regulated as much as medical book publishing (in other words, none at all).
I suppose someone could build a X-ray controller app that zaps patients. That needs a intense regulation, as much as the xray machine itself. There's a long history of killing people with buggy medical device software.
Then there's relatively sleazy stuff in the middle like making a single page spreadsheet to store data, calling it "the trendy disease tracking app" and selling it for $50 because its specifically designed for "trendy disease". Basically if a noob could recreate your "app" using google docs/drive spreadsheet in about 5 minutes and it sells for more that $1 then its a scam app. Those can just go away please.
"Science flies us to the moon. Religion flies us into buildings." - Victor Stenger
Exactly.
It's not like if the app wrongly says you have no problem with aspirin or gives a wrong value for an insulin dosage or time for your shot that you'll die. ... or is it?
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Agreed, I work in medical apps. When it comes to personally identifiable information (PHI) there are already a host of HIPAA regulations. But as for FDA involvement, only if the app is used as a medical device for clinical and diagnostic purposes. For health information purposes, I say just stick with HIPAA regs and let people develop what they choose. There is SO MUCH ground to be gained to improve our healthcare system by developing information related apps alone, we can't afford to stifle innovation in this space.
.. then some government agency needs to step in and verify that said software is safe for use, whether it's an app that diagnoses a heart condition in your grannie, or a pilot who relies upon an iPad for flight manuals. It was a few years before the FAA permitted iPads to be used in the cockpit and not just because of the supposed electronic interference.
They can take my LifeAlert pendant when they pry it from my cold dead fingers.
Looks to me like both docs have a good idea of how the app they're developing should be managed.
The doc making an app for stroke victims, presumably, is making something to either monitor their status or tell them when to take pills...actual medical stuff that should be regulated to make sure it works right every time.
The doc making an app to share information between docs, presumably, is making something that is primarily a communications tool. There are of course privilege issues to work out, but the app doesn't sound like anything that will be actually managing the patient's health. No reason to have that regulated, besides making sure it's secure enough to pass the data safely.
So my answer to this question is Yes and No. Should apps that are critical, like a stroke management app, be regulated? Of course they should. Should apps that are for all intents and purposes glorified versions of ICQ be regulated? Of course they shouldn't.
Broad brushes make for shitty paintings.
The story is casting too wide a net in simply saying "Medical Apps". Apps which help me record or log or communicate should not be strongly regulated (other than following HIPAA guidelines). They are no different than if I were to manually keep a journal or call the doctors office. There is nothing "new" about them other than the convenience. But apps which attempt to diagnose, analyze, or treat an illness should be regulated. Bugs or outright fraud in their capability can directly and seriously impact my health.
I recommend leaving it alone. Cutting out "snake oil" is not much of an issue with professional medicine anymore.
We need to run experiments to see if delays due to full prove-outs cost more lives than does rapid development with the occasional oops.
Literally, not figuratively, billions of lives may depend on it as advancement rates deviate from where they otherwise would be over the decades, going on centuries now.
(-1: Post disagrees with my already-settled worldview) is not a valid mod option.
I can't see why we can't go with a simple compromise, and have unapproved apps present big huge warning labels saying they hadn't been approved by the FDA, and once they do, they can put a big huge FDA logo of approval.
I know some people will, on their own risk, ignore those warnings, but I think that's something they need to realize on their own.
So, yes, I think they should be regulated, but only insofar as to allow people to make informed decisions on their risks.
// file: mice.h
#include "frickin_lasers.h"
They're already regulated under HIPAA, and doubtless other regulations as well.
Perhaps you had a difficult time reading: There is a big difference between recording and making recommendations.
Why don't we regulate all apps? Look what happened with Knight Capital. Of course the FTC can call "do over" when a financial app goes bad. Kinda hard to call "do over" when something goes wrong in medicine. Will doctor's malpractice insurance premiums be affected by what software they use? The possibilities are endless......
Karma: Bad
those aren't regulated.... maybe they should be because I use them...
As a family physician and tech nerd, I can say that in my experience peer review happens real quick with these types of apps. When you whip out your iPhone and a collegue sees you the conversation veers onto what apps are new and worth using, and which are utter crap. As for the content of popular apps, I don't think that even vetting by peer review would be able to eliminate all bugs. There will always be errors. But remember if used widely the axiom of a famous finn: "Given enough eyeballs all bugs are shallow." comes into play.
Perhaps you had difficulty reading.
There is a big difference between an app "communicating" between doctors and someone coding on the table because the communication failed.
Totally love some of the references being available. But diagnostic tools ... diagnose.
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Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.
Personally, I don't think you should regulate these. Who's going to do it? How many friggin 'lawyer' screens are you going to create (hint: more than we already have)?
Do you then regulate every 'medical' website? Most of these apps either could be duplicated by a web site or already have been.
Where, exactly, do you stop?
What happens when doctors or even medical professional societies disagree (think stroke treatment with clot busting drugs - the American Academy of Emergency Physicians and the American Neurologic Society (or whatever prof society the neurologists hang out on) disagree pretty vehemently. That's fine, it's expected but how do you 'regulate' that?
Faster! Faster! Faster would be better!
"Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations."
Of course. He's afraid of competition. Government regulation will slow that down. We wouldn't want to empower people!
The general rule is any software that controls something with direct access to the patient needs to be certified. Heart monitor controllers, MRI controllers, IV dosage controllers all do. Scheduling software, surgical documentation software, inventory management software does not.
>Neurologist Steven Levine, currently working on an app for stroke victims, thinks they should be treated like new medicines: developed using scientific peer review and subject to regulation by the government or professional associations.
Of course he does. It's a barrier to entry he is little effected by. I'd love to require all apps be developed by someone over 6 feet tall, because I'm over 6 feet tall.
Next question, I'm on a roll.
There should be no regulation of medical apps; however, it might be nice to have a certification program.
If an app is certified then you know it has been reviewed and approved by people in the medical profession. If it hasn't been reviewed then the user will have to decide whether they think the app's information or function is trustworthy based on faith or other people's reviews of the app.
homeopathy is one of the things that should be regulated.
They have enough problems getting their phones and tablets working with the legit medical apps put out by EHR companies. They don't need unregulated random medical apps floating around on top of that. (Hell, we've had doctors have trouble sending email through Outlook on a workstation. They usually make their PAs do that sort of thing for them.)
Occasionally living proof of the Ballmer peak.
They are. FDA regulates lab applications and any device that touches a patient. With the lab applicants development is real slow. A lot slower than the mandates for meaningful use requirements by next year would allow. Hospitals need to be deploying electronic medical records now or lose a bunch of medicare dollars tomorrow.
If a medical person uses an app and takes an action (or chooses not to act) on the basis of information they got from an app, who's liable for anything that goes wrong? I would expect that the medic in question would get the blame and I'd also be surprised if their professional insurance would kick in to pay for any damages that ensued.
I would also expect that any professional organisation would be advising its member to NOT use any app that had not passed some sort of approval regime. So on that basis, ignoring advice and using an unqualified device would leave the medic not only open to litigation, but without any professional support.
Question: would you be willing to fly on a plane where the pilot was using some old stuff they'd pulled off a marketplace, to fly by? The same sort of questions should be asked of medical personnel.
politicians are like babies' nappies: they should both be changed regularly and for the same reasons
As a person coding a project going through the FDA clearance process, we have 1000+ pages that show that they *are* regulated.
meh
The question is closely tied with "Should we be able to sue the manufacturers or not?".
Do you want an "app" checking your vitals for $5 after you sign a waiver, or do you want a "certified medical device" checking your vitals for $100 and the right to sue if it misses something?
IMHO, there's room for both. Some people will delay treatment and/or not benefit from the $100 device because it costs too much. It's a cruel world, but dirt cheap screening apps that miss a few deadly diseases are actually better if everybody uses them. Yes, it's horrible to be the 0.5% that get a missed diagnosis; but when the alternative is 80% of the people not being tested, what do you do?
Another layer of complexity comes in when you consider whether the devices are more likely to give false positive or false negative readings.
I'm not sure what we should do; but I can tell you wnat NOT to do. Do not, under any circumstances give companies patents or monopolies in exchange for doing tests to certify the devices. This approach has had miserable outcomes with drugs. There is a drug combo used by pregnant women, and a gout medecine that both saw obscene price increases due to this approach. That's the worst of both worlds--the "certified" treatment is the same as the "uncertified" treatment, but at a huge price increase.
For all intensive purposes, "whom" is no longer a word. That begs the question, "who cares"?
HIPAA only matters if the app is storing PHI and it is being used by a covered entity. So apps targets at patients won't run afoul of HIPAA. They can keep every bit of PHI that you put into them and not have to run any special protections. It also means that if such an app were on the iPhone there's no legal issue if this data is backed up on the iCloud. Apple would not have to suddenly meet new data storage requirements to meet HIPAA standards.
Lawyers aren't covered entities either so if your personal injury attorney leaks your PHI they don't run afoul of HIPAA.
"Lack of speed can be overcome. In the worst case by patience." --Znork
When I'm using a first-aid app for instructions on performing an emergency tracheotomy, I damn well better not get a bunch of windows and flashing ad bars telling me how I can lower my power bill using one simple trick, or why Plastic Surgeons hate one mom wearing a rubber halloween mask...
Hell no, do not let doctors think they can start using "apps" to handle patient data. Doctors are idiots with technology and this will just end up a nightmare of spilled/stolen data.
Now, if we're talking apps for anyone to maintain their own health data, make suggestions on possible diagnoses, or pretty much anything they want, then hell no it does not need regulation.
If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation.
This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.
The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders, is available in e-book format as an "app". Is that app a medical device? What about a paper copy of the DSM-IV that I carry around in my pocket? Is that a medical device, too?
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/MedicalDeviceDataSystems/default.htm
I'm an employee for a major developer of EHR software and hospital information systems. Our software offering runs the gamut from real-time tracking and analytics of patient biometrics to controlling the TV in their hospital suite. Medical applications are already regulated by the FDA because they meet certain criteria that qualifies them as "medical devices", which are, of course, highly regulated at different levels depending on how badly you can fuck yourself up while using them.
A medical device is defined as any tool that is used to diagnosis, treat, monitor, or prevent illness or disease. Wooden tongue depressors are a medical device and are regulated, but at a completely different and understandably lower level that, say, a defibrillator or an electrocardiograph (EKG). Medical software can be used to aid in diagnosis, treatment, monitoring, yada yada yada, so believe me, the work we do is HEAVILY regulated and the FDA makes it a point to conduct regular audits, surprise audits, and all that fun stuff. We also have entire departments devoted to hazard/incident/accident handling and all employees are required to know the system by heart and follow it to a T.
Same thing for the apps that we're developing to allow doctors to view patient records and enter orders via mobile devices. The FDA is regulating all of it because if a bug in the app generates and signs faulty orders, people could die.
For apps like WebMD though, they don't assist a licensed professional in diagnosing and treating diseases, and if a practitioner ever did use WebMD to diagnose a patient, they're probably not who you think they are. That little smartphone app that reminds you when your next flu shot is due? Don't expect the FDA to come knocking because you haven't maintained sufficient QC/QA practices or the dates get messed up or it doesn't mark your calendar in the correct color. That would be silly because the severity of incidents resulting from using those apps is very low (aside from idiots trying to perform self-surgery based on what they read on WebMD. But they're stupid and will probably harm themselves some other way). Now, if somebody makes a smartphone app that uses NFC to control your pacemaker or dialysis, the FDA will most assuredly have their hand in the process and keep a watchful eye over the developer because of the potential severity of any bugs in the code.
It's important to make the distinction between what kind of apps we're talking about, because some are already covered, and some aren't - similarly, some should be and some shouldn't be. That's my $0.02.
We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.
Me thinks you give religion WAY too much credit on how much self control it is capable of...
True OP! The concept extends as well to the AMA and numerous other medical trade groups. part regulatory body, and part flow-control for doctors to prevent the possibility of lowering the price for a physician. Because if someone wrote an app to diagnose patients and select appropriate treatments, fewer people would bother scheduling an appointment and more people would start to question the US healthcare system than just the 30 million that dont get to use insurance to pay for it.
much of modern medicine is still quite trial-and-error based on a per-patient level. I think steven is playing the big-picture here. If Deep Blue can decimate every opponent on jeopardy, theres nothing preventing a smart phone from precluding his house in the hamptons 15 years.
Good people go to bed earlier.
Using your justification all web browsers are medical devices.
"A person is smart. People are dumb, panicky dangerous animals and you know it." - K
There is a world of difference between how the FDA views "medical" software versus software used by doctors for real diagnostic purposes. If there is patient risk involved, it's classified as a medical device and thus has to get 510(k) clearance from the FDA to be sold in the United States. Clearly, you don't need that level of regulation if you're just shuffling around patient information, so far as you are HIPAA compliant.
Because regulation artificially narrows the supply
And artificially strips out dangerous or faulty procedures, chemicals etc. before they experience the joys of the free market on the public who have to enjoy the burdens of what's happening. Because your medical information is *private* and letting anyone have at your private medical information without any regulation means that information could be used against you.
Because letting people take random chemicals to see if some of them cure whatever disease they have definitely isn't a good idea, but it's cheap, so we could do that.
It does however depend a lot on what apps actually do. I'm not sure you need to highly regulate the applications used by medical professionals to handle payroll or scheduling or room booking. There are custom software packages for a lot of those because all hospitals face similar problems and so on, so it makes sense then to not have to completely re-engineer your payroll system just because your hospital is not the hospital one block over. But if you're talking about tracking a patient's blood sugar and providing advice based on that tracking you're into a whole collection of privacy rules (how secure is this data? Who am I sending the data to?) and providing medical advice from something that isn't a medical professional.
Which tends to show they're talking past each other a bit. The one doctor is making an app to deal with strokes, that's almost certainly into the category of medical advice (at least potential medical advice) and tracking a lot of deeply private medical information. The other guy is helping doctors communicate information between rounds, so there are privacy implications, but he's not necessarily intending that information to ever actually see a patient.
But diagnostic tools ... diagnose.
Diagnostic tools should be regulated as they make treatment recommendations. Apps that are basically glorified note pads that happen to record personal medical data like glucose levels should not. If what they replace are regulated they should be regulated.
I helped write code for the Plex-ID system, which among other things can identify every virus and bacteria in your spit by their genetic profile; spit in the tube, put it in the machine and wait an hour. CE (European Union) and FDA have similar requirements for a diagnostic device. But the FDA is pro-active and monitors development as it happens, where as CE takes a look at the paperwork once you are done and doesn't get in the way unless something goes wrong (in which case they come down hard, is what I hear). The upshot being that the Plex-ID has been available in Europe as a diagnostic device for the last two years, but is just coming to market in the US.
Monitoring by the FDA did encourage code hardening; they require design documents and tests to validate those requirements. But you write your own requirements and tests, and mostly the FDA checks that the QA team (who wrote test reports, not tests) didn't change a test name on the specialized form from one release to the next. The other thing the FDA is strict about is making sure everyone's time sheet is filled out daily and accurately reports time spent on Federal grant funded projects. Another difficulty with the approach of the FDA was is making design changes as you went; every significant change risked significant delays in approval.
Like I said CE has the same requirements, but they don't check things until it is done. So approval happens faster, requires a much smaller test team, development is more flexible and eats less time of group members. I'm sure there is a smarter way to interact with the FDA then we did, but their fundamental differences makes one a lot harder to please than the other, and produced the same product.
"The ability to delude yourself may be an important survival tool" - Jane Wagner -
Actually Medical apps need to be regulated because their accuracy needs to be verified.
If an app takes metrics, the metrics must be authenticated because that metric could mean life or death.
Those are the apps we are talking about here, not the calorie counters or shit where you input the info.
if the app is turning your phone, or whatever, into a medical device. A random heart rate monitor app is fine unregulated, but if it's being used to monitor a patents heart rate for medical purposes then yes it must be regulated. In this case regulation is intended to give you devices that meet minimum guidelines. If it's important that a doctor know your heart rate within 20bpm but the app has a 100bpm margin of error then it's worthless as a medical device, and the regulation is to enforce the guidelines. Otherwise the doctor might think your heart is going too fast when the problem is the "app" is completely unreliable. Regulation is also for insurance purposes. Sometimes a medical device might fail, and if it results in someones death then insurance is more likely to cover it when the device that failed actually meet regulatory guidelines. Also apps that are used on an iPad by Doctors to enter medical information need to be regulated to ensure patient privacy. Everyone will be very angry if they find out that all their medical records have gone off into a private Google database to improve medical advertisements.
They should be subject to provisions of existing law, such as fraudulent misrepresentation of the product. For instance, I read about an app that claimed it could make your phone cure acne or something. That's no different than digital snake oil.
Creating an FDA type process for apps? Forget it.
The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders
DSM-IV is not medical but political.
Captcha: outcast.
Doctors, with the exception of high-volume neurosurgeons and orthopedic surgeons, don't have houses in the Hamptons unless they live there year-round. Most family physicians would love to break $200k.
Simple.
* Dispencing controlled substances directly into a patient = medical device.
* Helping doctors or patients in any other way = cheap-ass app.
That includes devices that provide sensors like heart rate, blood pressure, core temperative, etc .... those are apps.
> Uh, the other guy who DIDN'T think that regulations were needed was - also a doctor.
Well saying that one person or groups recomendation is self-interested doesn't make any specific claim about every member of the group or profession. It can be self interested, and still not supported by everyone who would benefit. (this is what always perplexes me about people who simplify down to "why should they be against welfare, they recieve it, they would lose out if it went away".... yes... but that doesn't mean that they think its a good policy... totally different issue)
> Personally, I don't think you should regulate these. Who's going to do it? How many friggin 'lawyer'
> screens are you going to create (hint: more than we already have)?
I MOSTLY agree. However, I do think there could be a few sensible ones... mostly having to do with claims. I do think it quite valid to say... you can make any software you want, but you have to comply with regs X, Y, and Z if you want to claim that results in positive medical outcomes.
So, if I write a program that helps you track what you eat, set targets for calories, nutrients etc.... fine. If I want to claim it "helps you track your consumption" or "helps organize your attempts to lose weight" fine.... but.... to claim that it "helps you lose weight" is a specific claim on the outcome... and I think its reasonable to put some requirements on such a claim.
Frankly, thats all I would want to see. Otheriwse, its too stifiling, people own their devices, I would hate to see them not able to run apps or people writting apps just for themselves for fear of releasing them to others.
"I opened my eyes, and everything went dark again"
Just add a fitting punishment for life-threatening failures. Like the CEO of the affected company must sit in a vat of spiders (imported from Australia), until he promises to fix the problem.
I am John Hurt.
Meanwhile the worshippers of Mammon complain that they aren't given free reign.
At least the government doesn't try to sell us an imaginary god.
Getting together and making rules is fine. The problem with religion is all the fraud and deceit regarding an afterlife and supernatural beings.
Regulation is necessary on a good many things.
However, the degree of regulation must be carefully weighed.
In any industry, adding regulation means:
1. Higher cost to the consumer
2. More boredom of paperwork for employees, so often lowered standards
3. More bureaucrats and other unimaginative people in power
If we regulate anything, we should make our rules short and clear and the approval process fast and supportive of industry, or we shoot ourselves in the foot.
Futurist Traditionalism
If apps make claims to have a certain medical benefit, and do not provide that benefit, then of course there is a good reason to regulate. Medicine isn't all about markets. I'd say the litmus test ought to be - if the app fills a similar role to medicine - it is a part of a patient's treatment plan with medically significant impact - then it needs to be regulated. If the app is purely for convenience, entertainment, or education - then there is no need.
Patients have been self-diagnosing for as long as doctors have existed. I'm guilty of it myself, and won't usually see a doctor unless I think the doctor will actually be able to do something. (no point in seeing a doctor for a runny nose, it's probably just allergies or a cold... if it's allergies the doctor can't do anything other than give me the antihistamines I'm already taking, and if it's a cold, no self-respecting doctor will give me anti-virals for something my body can heal on its own in a few days).
Regulating apps like this isn't about flow control... it's about accountability. "Doctor, this app on my iPhone says that I have pneumonia, I need antibiotics!" would be a best case scenario... more likely people will assume that the app is telling them the truth and will self-medicate on that basis. At best, this means you're taking some cough medicine when you don't need it, and you'll heal on your own anyway. At worst... I don't really want to think about a worst-case scenario with somebody with no medical training self-diagnosing and self-treating. People have been doing that for years with WebMD, and they were using "common wisdom" for centuries before that.
Given that stupid people *will* take what these kinds of apps say as gospel, they need to be regulated to make sure they're giving reliable information.
Now, when it comes to a glorified calendar app, like one I've seen mentioned here already, (iRounds), I don't think it should be regulated. It's not dispensing any medical advice or diagnosis, it's simply providing a platform to facilitate the doctor's scheduling and communication.
And most normal people would love to break $100k...
Any app that claims to either itself be a cure/treatment, or which directly interfaces with a system that is (or is already subject to regulation), gets regulated. So a "game" that claims to treat dementia, or an app that interfaces with a medical records system needs to be regulated, or an app that connects to a pacemaker for diagnostics, would need regulation.
Anything that simply offers medical information or rudimentary "advice" is fine. So a WebMD-type app would need no regulation, although it could still cause liability if it's wrong to the point of causing physical harm.
Basically, replace "app" with "book" and see if it makes sense.
"This book contains a list of diseases, cross-indexed by symptom. It does not need to be regulated."
"This book contains the complete medical history of everyone who has ever visited this hospital. It should be subject to basic regulation regarding patient privacy."
"This book allows the doctor to control an implanted medical device. It should be strictly regulated, including stringent testing and controlled distribution."
Ideology *is* a religion, or at least it is for the masses. The sociopaths preaching the holy writ of Party platforms are just using it as a tool.
When is software a device?
That means the FDA could drop a big hammer on any one of these already available apps which fall into these criteria as they've failed to put out a IND or NDA (innovative new drug / new drug application).
Will they? Probably not unless an adverse event (someone gets hurt) or politics force them into it (or both). The FDA is way under strength to meet their mandate.
I don't know why the US can't accept "on license" and "off license" variants of things like restaurants, medicine, etc.? As a customer of an off-license product, you're basically saying: The regulatory agency hasn't approved this and I don't care. If M.D.s want to put their malpractice insurance to the test and use off license apps, let them.
This anger, while amusing, is just so very confusing. Do you have such a visceral reaction to the fact that non-medical drugs get by with putting an * and a disclaimer in their add in tiny print that your first reaction is hatred? Why?
At least the government doesn't try to sell us an imaginary god.
No, it doesn't. However, it tries to sell us a whole other pile of imaginary bullshit.
Getting together and making rules is fine.
Do I start singing the Schoolhouse Rock theme here?
The problem with religion is all the fraud and deceit regarding an afterlife and supernatural beings.
True. However the problem with government is all the fraud and deceit regarding trillions of dollars and slaughtering people and destroying lives.
People taking advice from medical (and "medical") websites are pretty similar, internet is the ultimate app after all. But in a sense, all mass media give medical advice, sometimes just ads disguised as them. Should be all regulated? If so, what you do with other countries websites and/or media? In any case, you end in doing media control without control on your side (and that includes promoted medical advice to push products from paying companies, is not like that never happened in a way or another).
Instead of banning, giving some sort of seal of approval to good apps/websites/etc by some central authority to show that it was somewhat checked for accuracy could at least give a hint that something may be correct. Still have the potential of abuses, but at least don't limit people to picking other alternatives if they want.
there should be 'Official Approved Scientific Based' process.
You don't have to get it, but getting it means you have been vetted by the proper specialists.
Medical apps are far to wide of a area to classify them all. O I need scientific vetting for my app the emails my Dr.? no.
Should I get one that's giving me, or my Dr, advice on my medical condition? IN many case, yes.
The Kruger Dunning explains most post on
If the app is connected to a clinical information system, or is used to control medical devices, then the app should be subjected to the same controls that those systems or devices are subject to. The reasoning for this should be self evident. A heart-lung machine in an operating theatre needs to pass some pretty rigourous standards, and that should include any device or software that will feed it information or control.
If it's just a tool for the doc to use him or herself, or the patient to use him or herself, then buyer beware.
Thanx,
John
When the going gets weird, The weird turn pro.
- Hunter S. Thompson
"Personally, I don't think you should regulate these."
See, this is a really tricky topic because almost unlike any other category, people's lives are at stake. I know it's fun to joke about "snake oil" (see posts above) but "old school legit doctors" are pretty good, so an app they use could directly affect a patient's life. Remember, this was "Medical Apps", not just "communication between people who happen to be doctors". So I'd want a review of a "Medical App" because so help me if it includes "advice to the doctor" I'd want *someone* looking at it.
My first Journal Entry ever, in 8 years! http://slashdot.org/journal/365947/aphelion-scifi-fantasy-horror-poetry-webzine
Sounds like someone has invested in the "medical professional" mythology. This is a fairy tale, along the lines of the Easter Bunny. Doctors kill roughly 195,000 people every year in the US due to preventable medical mistakes. Yes, you can Google that.
Regulation is for strict control of economics, to make sure doctors and the various companies in the medical industry keep getting paid no matter how many people they harm. Regulation is one of the things that is driving costs up as it creates a false perception of a safe industry and dramatically limits competition. Ever wonder why there are almost no small companies in the medical industry? Or why as soon as there is a viable marketplace for small companies -- apps -- why suddenly there is a rush to for more "regulation"?
Stop for a minute and ask yourself the question -- What do consumers get out of regulation? It isn't safety. It isn't privacy. All it is is less choice and higher prices. The medical industry today depends on lots of people getting sick and lots of people staying sick. Regulation makes sure that these two things happen. A better word for it might be "strangulation".
There are already regulations out there, it's called HIPAA. The last thing you want is an app that stores patient data on a public ftp server with no security. How would that happen, pretty easily actually. All it would take is a Doctor purchasing an app that supports FTP uploading/downloading. Then said doc goes to Google, types in free FTP services, thinking that everything on the web is secure and puts that server into his new app and the app of his nurses so they can bring the "almighty cloud" into their practice.
Most normal people don't have $200K in student loans to repay.
Any insufficiently advanced magic is indistinguishable from technology.
It is a very sorry world we are creating. We push aside religion for being too invasive and controlling and then ask the government to be even more invasive and controlling than the religion could ever hope to be.
Nobody expects, er, remembers the Spanish Inquisition!
The "government" is the electorate, and the electorate's demand for regulation is in response to the unregulated's history of abusive practices.
What relevance is the number 195,000? It's meaningless unless you can compare it to the percent of deaths from preventable medical mistakes in other countries.
We hope your rules and wisdom choke you / Now we are one in everlasting peace
What do consumers get out of regulation? It isn't safety. It isn't privacy.
As someone who has had to deal with HIPAA and FISMA regulations, I can attest firsthand that these regulations do give patients privacy with regards to your medical information.
And if you think the FDA isn't keeping medicine safe, I suggest you start buying it from alternate sources. Like strange men selling medicine out of their trunk in the Walmart parking lot. That is the "free market" at work!
"But this one goes to 11!"
If the app causes harm to somebody and there appears to be obvious negligence, e.g. advised the incorrect drug. All professionals need to worry about this whether in person or in an app.
Critical apps need to be regulated. Less critical apps might be controlled by requiring some highly regulated insurance policies that pay out if an app causes harm or loss.
For example an app that somehow informed you that your caloric intake was a bit high today would need very little in the way of assurances as failure or in accuracy would not cause great harm. But an app that failed to warn a diabetic that his blood sugar was low could easily be fatal in nature. It could even be fatal to people other than the diabetic. For example a crane operator suddenly going into shock from low blood sugar could easily kill many others.
the app requires that the smart phone be injected through any orifice into the users' body.
In a regulated world, you generally have to show that a product is safe and/or effective *before* release.
So if Apple has a category for "medical" apps, they could require some form of certification before they could be published.
At that point there's no need (or less need anyhow) for fines, because the snake-oil never makes it to market.
I might have to look up 21 CFR but I'm going to avoid it for a while if at all possible....
Are you trying to say that web sites like this stroke risk score are illegal?
"intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals" is one hella broad category. Frankly, I just can't see the FDA wanting to touch this area with a 10 meter colonoscope.
Faster! Faster! Faster would be better!
Of course they should! Otherwise people will be doing things without permission! Why would you not want "medical apps" to cost $500 and take five years to gain approval? and why stop with medical apps? Surely everything would benefit from proper "oversight"! We can't have people choosing for themselves as if they know what's best for them.
Warning: this article may contain humor, sarcasm, parody, and perhaps even irony. Read at your own risk.
...Doctors WILL use apps. Don't think one (even the gov't) can just say "no" and expect them to comply. I have fought this fight, and it is mostly a losing battle. It would take real teeth to make something happen.
That said, the title is a little misleading. Anyone can use an app, but it had better be compliant with HIPAA and ARRA regulations. (Which mostly consist of following an intentionally undefined 'industry standard' for treatment of patient information. In practice this is generally agreed to mean no unencrypted transmission, format, or storage of PHI.) So, there already is regulation concerning what Doctors can do with what apps.
The question is: Do they know it? Or should the onus be on the *developer* to certify that whatever they've come up with is sufficient that a physican can trust whatever data it manipulates or uses?
Physicians are already regulated (by the State, by HHS for Medicare, by DEA.) So why shouldn't we require the same of the companies which supply software intended for their use?
Because desperate people who can't afford the good stuff care not making an informed decision.
const int one = 65536; (Silvermoon, Texture.cs)
SJW, n: "Someone I don't like, and by the way I'm a fuckwit" - AC
I would doubt it. That site is just measuring your risk of a stroke, it's not determining if you are currently having one.
And they can't pay those off at $100k a year?
Give me a break. Do what the rest of us do and live below your means. At $100k/year, any responsible person could have $200k of student loan debt paid off in well-under 10 years and still have a nice lifestyle.
Required reading for internet skeptics
You mean, you'd rather have a free-for-all abuse and exploitation based on your "free market" religion, instead of science-based regulation agreed upon by the consent of the electorate. Yup. The gubbermint is out to get you. Obviously
Ubi solitudinem faciunt, pacem appellant.
An imaginary god like 'security'?
Said the guy who's mom didn't take Thalidomide.
There are two types of people in the world: Those who crave closure
How about "certified". Don't block apps, but those that have passed verification get a rubber stamp of approval. Or even certify smaller snippets of information. Let the user decide if they want to trust information that isn't certifiably correct.
No, it doesn't. However, it tries to sell us a whole other pile of imaginary bullshit.
If they are, then you have a problem with your government, and need to work to change it.
Which is your right, if you can convince enough people with legitimate arguments, that the government is based on BS, that should be rectified.
Any government that impeded it would be justly opposed.
The problem comes from the people who want to make things suit their dogma, and no, they don't listen to any other argument. You can especially tell they're taking things on faith when they rely on arguments to authority, such as the Founding Fathers.
That's certainly a case of turning government into religion.
And that's terrible.
Also terrible is the people whose solution seems to be embracing the law of the Jungle in some sort of paranoid anti-government ideology.
Actually Medical apps need to be regulated because their accuracy needs to be verified. If an app takes metrics, the metrics must be authenticated because that metric could mean life or death. Those are the apps we are talking about here, not the calorie counters or shit where you input the info.
Actually, Medical advice needs to be regulated because your friends and relatives' accuracy needs to be verified.
If a family member takes your temperature, it must be authenticated because that measurement could mean life or death.
Those are the people we are talking about here, not the Weight Watchers or self help books.
Yup. The gubbermint is out to get you. Obviously
Ask Assange; ask anyone that gets frisked by the TSA, ask anyone that gets flagged as a terrorist if the "gubbermint" is out to get them.
Suppose normal people make 50K and the doctor makes 150K. If the doctor lives on the normal person salary and pays off loans with the rest then his loan is paid off inside of 3 years. After that he's got clear sailing for decades of income-earning potential.
then they'll be liable to be sued out of existance if anything goes wrong.
Who's going to use an uncertified app if they haven't audited every line of code?
The problem with things like medical apps is false negatives -- things the apps miss but a doctor should be able to discover. Except you don't go to the doctor because your app says "all clear."
Of course regulation can only go so far. Just as doctors themselves aren't always perfect and sometimes miss or even mis-diagnose issues, so will these apps no matter how tightly controlled they are.
But there's a huge difference between apps that have actual thought and medical knowledge (and UI design to prevent users from getting bad results due to bad input) put into them compared to apps that just give you some arbitrary "diagnosis" based on whatever informal medical buzzword happens to sell the best that year.
Cause lets face it, the majority of people are gullible and stupid when it comes to things they don't understand, and very few of us understand medicine and biology to any great extent. Obtaining a medical license wouldn't be nearly as expensive or take nearly as long if most of it could be (accurately) summed up as common knowledge.
What happens when doctors or even medical professional societies disagree (think stroke treatment with clot busting drugs - the American Academy of Emergency Physicians and the American Neurologic Society (or whatever prof society the neurologists hang out on) disagree pretty vehemently.
I haven't followed the discussion, but as a person who received a thrombolytic treatment for a stroke, I think the issue is complicacting factors. It's supposed to be given within 3 hours, and I got mine at just a few minutes before, as they will not administer it here without a brain MRI showing the clot, as ischemic and aneurysm present the same. And when I was in recovery, all the others were ancient people who were on hundreds of medications prior to the stroke, as opposed to an athletic 30-something with no previous health issues and zero risk factors. Perhaps they should look at tPA as linked to age, or other factors to determine why there is a better recovery with it, but also higher mortality.
Learn to love Alaska
Actually Medical apps need to be regulated because their accuracy needs to be verified.
Accuracy of what? Acne is a medical condition, treatable by dermitologists. What screening has ProActive gone through, and have Jessica Simpson's and Katty Perry's celebrity endorsements been evaluated by a doctor?
Obesity is a medical problem. Have the Ab wave circle's claims been evaluated by a panel of doctors?
A fancy pedometer or alarm clock (take your medicine, eat right, exercise reminders) is much much less of a treatment than many many things we allow today with no regulations.
Those are the apps we are talking about here, not the calorie counters or shit where you input the info.
Oh, so you've seen the ap? I've looked for the one by the doctor mentioned, and couldn't find anything about the actual app. I'm just about as well versed in stroke as a family doctor (having had one at a young age), and I wanted to see what the app did or said about it. but I couldn't find anything. Since you make statements about the content, please enlighten us how you came by that information.
Learn to love Alaska
Obviously if it is a direct translation of a document no. If it is an app being used for clinical diagnostics (e.g. measuring something) then yes it's a medical device. The situation you are inferring is obviously not the case. Again there is guidance already out there from the FDA on this issue. Read it. Or attend this: Medical Device Mobile Apps: What Needs FDA Approval An FDAnews Virtual Conference Thursday, Aug. 30, 2012 10:00 a.m. – 4:00 p.m. EDT http://www.fdanews.com/conference/detail?eventId=3193&hittrk=12809LT&utm_source=MagnetMail&utm_medium=email&utm_term=mmarkiew@wlgore.com&utm_content=L12830%20-%2012809LT%20-%208/9/12%20-%20DV/MBDV/MDV/RDD/RDV/MD&utm_campaign=Medical%20Device%20App%20Development%20%E2%80%94%20What%20Needs%20FDA%20Approval%20and%20What%20Doesn't%20%20
Looks like it's designed to use the output for "prevention of disease" by identifying risk factors for addressing them.
Learn to love Alaska
I would refer back then to what the FDA considers an app. I'm not referring to documentation, but something that is performing an action (e.g a measurement). The FDA will ultimately be the arbiter, so if you are in the medical device industry (as I am) you would be wise to accept that guidance and consult with your legal and compliance teams. Ask Pfizer exactly how much the government likes coming after violators.
Those deaths have absolutely nothing to do with regulation. A doctor accidentally injecting you with the wrong drug or screwing up a surgery has nothing to do with regulation. It's called medical errors (note the word error as in it shouldn't happen) and it is the number you're referring to.
The deaths you probably wanted to mention, but are too stupid to realize the difference regarding, are due to "faulty" medicines or devices. That you can tie to regulations or their failures as that is what regulations should prevent. This also wouldn't include deaths due to side-effects if those side-effects are known, I'd take a 10% chance of liver failure if it means I don't die of a heart attack in the next 10 minutes baring other options. That has nothing specifically to do with doctors except in the sense that doctors are probably involved with making them.
Of course, as someone else pointed out if not for regulation there'd be million or tens of millions who died from snake oil medicines of all kinds. There's a reason the FDA was formed and back then there's wasn't an ocean of Chinese companies willing to Fedex poisons to anyone with a mailing address.
In summary, you're an utter moron who doesn't even understand your own argument.
You fantasize that you are going to get some sort of enlightened government, because THAT is the statism religion. You believe that some bunch of good and noble ones are going to work in the government to care for us and protect us from the rotten ones?
This is the delusion!
Did you ever stop to think, while wallowing in self-interest masqerading as idealism, that the people in government are just like you? They are self-convinced enlightened folk, who believe they are doing good with the gun of government, while completely unable to admit to themselves that they are selfish animals as well.
We all are!
There is no one enlightened!
That is why anyone who claims that government regulation can achieve a noble result is fooling themselves. You bleat on about "science-based regulation" well where is it? Is it in the SWAT teams that are busting the little farmers who sell a gallon of unpasteurized milk to their neighbor? Is it in the tonnes of paraquat dumped on Amazon rainforests?
The empirical fact is that government destroys everything it touches. Look at what is happening right now! Why aren't the bankers who have committed high crimes being indicted!?!?!?
Government does not work. Perhaps we need it minimally--to do one thing and one thing only. Punish crime.
Selling an "app" that falsely diagnoses an illness leading to trouble is one of two things: 1. a mistake and someone can be held liable for it in civil court; 2. criminal fraud and negligence which someone can be tried for in court.
Pray tell why do we need anything more? The "free market" is NOT a license to commit fraud, despite what Marxist propaganda has been shoved down your throat in government funded school. The free-market would have put out of business the criminal banksters in 2008. But why are they still in business? The GOVERNMENT!!!
Just because you use hysterical phrases like "free-for-all abuse", doesn't mean that remotely describes reality ... if you have an irrational phobia of unregulated people then you should deal with that at a psychologist.
By the same logic that would regulate apps, numerous web-based tools for patients to help themselves should also be regulated. And with that, books for patients that also use an algorithmic approach to the same kind of self diagnosis. For example the American Academy of Family Practice has an excellent set of symptom based self-checks that you can find here: http://familydoctor.org/familydoctor/en/health-tools/search-by-symptom.html These kind of self-help algorithms are a significantly better approach than just googling your complaint. For example if you are 20 year old with heartburn, this algorithm will likely get you to the advice of trying an antacid. If you are 55 and having the big one, it will most likely tell you to call 911. However if you do a search, google gives you a helpful list of related searches - all of which are quite deadly and none of which are the most common cause of chest pain - which might work fine for the 55 year old, but not the 20 year old.
I'm an ER doctor and I deal with 20-somethings with cyberchondria on a regular basis. Once I pull them back from the abyss of thinking their chest pain is due to their aorta ripping in two, I suggest a better way to seek out information is to go to trusted sites that provides better information in easily approachable ways. FamilyDoctor.org, Mayo Clinic, Medline Plus, UpToDate (the free patient part), hell even wiki-fucking-pedia gives you more balanced information.
The problem is that medicine (and medical informatics) is growing too fast to effectively regulate apps. If you regulate apps but don't regulate google, the benefits of regulation are far outweighed by the risks. I would rather have an app or web content from AAFP guide someone's decisions about health care than having them go to message boards and get information from people who may be several french fries short of a happy meal or who are themselves snake-oil salesmen.
If information is out there, regulating the way that professionals provide that information but not how kooks and idiots and charlatans provide it is a recipe for disaster.
HIPAA has never fined anyone for loose handling of medical records. The only fines so far have been for not releasing a record when required to do so. Or at least that statement was true last time I investigated, as I was a HIPAA expert (but not consultant, as HIPAA needed almost no IT changes to any organization, just a few minor process changes, and evil lying consultants made billions off HIPAA.
Learn to love Alaska
"medical professional" mythology
I'm canadian, I have a somewhat different experience with medical professionals than americans have.
What do consumers get out of regulation? It isn't safety. It isn't privacy.
Around here it is both of those things, and much less privacy concerns because regulation means even if your private medical information gets out it cannot be used by your employer. Just because *your* regulations are terrible doesn't mean they have to be.
Given that stupid people *will* take what these kinds of apps say as gospel, they need to be regulated to make sure they're giving reliable information.
How is this any different than people's reaction to the bullcrap ads that pharmaceutical companies run on TV?
'The tyrant will always find pretext for his tyranny.' - Aesop's Fables
By the same logic that would regulate apps, numerous web-based tools for patients to help themselves should also be regulated.
Sure, as they should be. As i say somewhere above, I'm canadian. In canada chiropractors aren't allowed to present a professional opinion about vaccines because it is considered outside their expertise. That basically applies to any writing they do, web or otherwise,. Algorithms are a bit more complicated to regulate but the premise is there.
I know a lot of doctors around here (at the university I'm at, we have a teaching hospital) find that the web has done more harm than good, patients are convinced their problem must be the serious but rare case, and can't possibly be the common and not serious thing and get all upset when you tell them it's in fact not cancer or a heart attack. Granted the ones who look up symptoms and think 'hmm maybe I should just go to a doctor' aren't done any harm by it and they don't necessarily open their mouths and say they couldn't diagnose themselves.
addendum
The medical industry today depends on lots of people getting sick and lots of people staying sick.
That's not true at all. The *US* medical industry depends on people getting and staying sick. Civilized countries do not have this problem to nearly the same degree because their industries are government owned and operated with rewards for making people healthy, not making money.
A government owned and operated industry is in effect the most extreme form of regulation possible, and is demonstrably appropriate for healthcare.
No need to ask. My years at a pacemaker/implantable defibrillator company working on the design and testing of medical devices taught me more than I ever wanted to know about the FDA. As for your guidance I simply implied it was a tad heavy handed. I agree that if an app is being marketed to medical professionals the vendor should cross their T's and dot their I's.
"A person is smart. People are dumb, panicky dangerous animals and you know it." - K
If you think it's such a good deal, apply to med school and go. Nobody's stopping you. The truth is that it's a long and painful investment for a future that is very uncertain right now.
Doctors aren't normal people. They're not uniformly brilliant; there are plenty of relative clods who can memorize the necessary facts to get in and get through, but even those are pretty damned sharp by general standards. So people who go into medicine in the US have other options, and if you make medicine too much less attractive you'll only succeed in giving us crappier doctors.
Posted using HTTP over TCP/IP. Oh the irony.
"I know I will be modded down for this": where's the option '-1, Asking for it'?
So why regulate apps? You can more or less claim your snake oil does anything you want, so long as you hide a disclaimer some place that your claims have not been confirmed by the FDA. If we're going to regulate medical self help and remedies then it should be all inclusive, not limited to apps.
OK, having looked around on the responses, I think there is a need for a bit of a balancing viewpoint in favour of regulation.
Perhaps we really should regulate not just apps, but also advertising and a lot of other things. And it isn't really a question of "should we" since most of these things are already regulated to some extent in most industrialised countries, it is just a question about how much. Far too many charlatans get away with far too much far too easily, IMO.
As far as I can see, it doesn't necessarily imply giving monopoly status to a narrow group of experts - there are already regulatory bodies that supervise advertising (at least in Europe) and one could adjust their powers, strengthen the penalties imposed etc.
We, as consumers, can do something about too; we could for example be louder about "naming and shaming" things we find unacceptable.
And artificially strips out dangerous or faulty procedures, chemicals etc. before they experience the joys of the free market on the public who have to enjoy the burdens of what's happening.
** citation needed
If there was a DSM app where you input a list of symtpoms and it spits out a possible diagnosis, the FDA would consider it is a medical device and it would be subject to FDA regulations. If it is just a reference which relies exlusively on the judgement of the physician then it would not.
The FDA is pretty strict about these things, which is one of the main reasons why medical information systems are so far behind the rest of the IT world.
any regs need to be separated into a few different parts to allow for innovation but also catch stuff "not fit for purpose"
1 The code itself how tightly was this coded and does it prevent corruption of the data? rate this 1- 10 with 1 being should not crash (but will recover safely if it does) to 10 being Will not crash unless there is a hardware failure and is as RealTime as the platform allows
2 How reliable is the data it is using? 1 would be Wikipedia (with minor edits) 10 is Chapter and Verse from the DSMVItr level
3 General Fitness for Purpose 1 is "home test" 10 is Major Lab would back the results
then the FDA needs to sign off on these aps according to the level of Possible Harm (so iSurgeon would need to have all 9s and 10s)
Any person using FTFY or editing my postings agrees to a US$50.00 charge
I don't think I really want to touch specific applications - especially if it's just a computerized version of a paper survey, but by the letter of the law: are most of these apps illegal? Yes. There are massive areas which even involve prescription only products which are technically illegal - many products have a monograph somewhere in 21 CFR, and products outside of that monograph are produced/sold in prescription strengths. However, especially with historical products, these products are continually made, sold, and used (with great effect by the doctor/dentist). The FDA doesn't have the manpower to meet its mandate. So, instead of blasting the nutraceuticals off the shelf, they focus their energy on real drugs which have major risk/benefit considerations.
In short - are most medical apps going to be technically illegal? Yes. Are most medical apps going to be subjected to FDA regulation? Not likely anytime soon. Is it a grey area? No, but most people will pretend that it is.
Taking on exorbitant student loans does not mean that society owes you a living. If you are artificially restricting supply of services to boost income, this runs contrary to the interest of the public and should be stopped.
Because regulation artificially narrows the supply, making the profits more lucrative for the incumbents.
Bullshit. I'm damned glad that my CrystaLens had to be approed by the FDA. Regulations ensure that a medical device is effective, that you get the correct amount of the drug you were prescribed, and that the drug is effective, and that its downsides are listed. Drugs aren't expensive because of regulations, they're expensive because you have little choice whether or not to take them and they cost a lot to develop. I don't want to go back to the days of snake oil salesmen. I want my treatments to be scientifically tested for safety and effectiveness.
As to medical apps, it would depend on the app. I think most apps would be fine unregulated, but an app that (for instance) told a diabetic when to take her insulin probably should be.
Free Martian Whores!
No.
I object to power without constructive purpose. --Spock
These kinds of apps could lower the cost of medicine. It's NOT like the quality of what you overpay for today is much better.
But apps on a mobile device? You can go to a million web sites and be given information that is frankly crap, and it is your choice if you want to believe it unquestioningly. So why not a mobile app? I can see the argument that it should be regulated when a mobile device is used for actual measurement that will influence treatment (such as http://www.americandiabetes.com/living-diabetes/diabetes-supplies-articles/horizon-alternative-glucose-monitoring-methods-under), but otherwise I think we have become way too paternalistic in our approach....
Someone raised HIPPA compliance - that is MY obligation. So do we really need to regulate an app that facilitates communications between doctors covering patients? I am the one in violation if I email protected info using standard email... We don't insist that the email providers show HIPPA compliance. Likewise, if I use a communications app and I did not check to see if it is HIPPA compliant, that should be MY problem - and then the market will insure that those apps fail...
Someone mentioned iSurgeon. If iSurgeon adds the ability to use it to plot incisions or such and they suggest those plottings are accurate and should be used for surgical purposes, then yes, it should be regulated. But as it is, it's just a reference tool no different than pointing at a picture in a magazine and saying "Make me look like that". Most the Medical apps are nothing more than reference tools. And it's up to the doctor (and their malpractice attorney) to decide if their reference is accurate/comprehensive enough to be used by them or not in their practice.
Talk is cheap and easy, AC.
Both of the doctors mentioned are developing apps for medical use. The one for regulation is developing an assistive app for patients of a specific condition, the other is developing a communication app for doctors. It makes some sense to regulate the first one, at least to the extent of preventing harm, the second is unlikely to do anything that would warrant regulation.