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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?"
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.
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.
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The market is slow to make decisions, because it relies on the input of everybody involved. That's as opposed to government bureaucracy which makes bad decisions relatively quickly and then forces those bad decisions down everyone's throat.
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.
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.
The market is slow to make decisions, because it relies on the input of everybody involved. That's as opposed to government bureaucracy which makes bad decisions relatively quickly and then forces those bad decisions down everyone's throat.
That's interesting. I'd always had the impression that the market resembled a stampeding herd of lemmings. Frequently making bad decisions (VHS anyone?) and forcing them down everyone's throat ("Nobody ever got fired for buying IBM!").
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.
.. 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.
So why are MRI machines also cheaper in medical systems that are more regulated than the US's, like Scandinavia's? Could it just have something to do with the US being particularly inefficient, not the role of government per se?
10 PRINT CHR$(205.5+RND(1)); : GOTO 10
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!
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?
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.
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.
> 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"
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.
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."
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.
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.
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
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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.
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