FDA To Scrutinize Mobile Medical Apps 142
mikejuk writes "It looks like 'first do no harm' is coming to an app near you. The US Food and Drug Administration (FDA) is seeking input on its proposed oversight of some health-related mobile phone apps. It is almost too easy to create an app that aims to help people detect or manage some condition or other — but should programmers play the role of doctor even in seemingly harmless areas?"
Yes, because we need government in everything (Score:1, Troll)
because if there is a word 'health' in it, that's it, you are not your own person, you are property of your government and even when there is cancer treatment that can help you, created by a guy back in 1976, you can't have that treatment because the government says so [burzynskimovie.com] and you can't choose to exercise your freedoms, you are not your own person.
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As for all of the other 'Alternative / natural / homeopathic a
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Those images are major diagnostic tools. They need to be stored securely, both against loss and theft, and displayed accurately so nobody misses anything or sees something that isn't there.
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There's a lot more to a PACS than "just" a DB of images. For example, a lot of times radiology has their own registration system, so you have two different patient identities you have to correlate, possibly through an MPI. You also want to make sure that relevant medical history or notes are available to the doc reading the film. And then at the end of the day, you may want to package the film and the read up into a clinical document and ship it off to an XDS or some other document system.
If any of that g
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But wait, it's not yourself (Score:1)
There's a difference when you go beyond yourself to serving others.
And as serving others is what the app market is about, I don't see a reason for you, or anybody else to have an unrestricted freedom to do what you want unto others in this regard.
You'll have to find another set of circumstances if you want to be convincing that there's something outrageous going on.
Re:Yes, because we need government in everything (Score:4, Insightful)
Protecting me from snake oil salesmen (like your Burzynski [quackwatch.org] quack [scienceblogs.com]) who have the one true cure for cancer is exactly why I want the government involved in health. You shouldn't be able to make shit up and pass it off as medicine, and you bet I want someone looking over real science before something goes to market where it can do real damage either if it is dangerous or if it just doesn't work and prevents people from getting real treatment. Could this lead to a a legitimate treatment being overlooked due to those big bad close minded doctors who just can't see the brilliance of (insert probable pseudoscience but possible real treatment here)? Maybe. But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.
And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line? You really want them running amok?
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But it's better than the alternative, and it is much more likely that they'll be preventing lots of bad treatments rather than suppressing a few good ones.
you got any statistics to back that up? Because Milton Freedman's analysis of their incentive structure showed the opposite to be the case -- their built-in bias is against approval.
And it's funny that the people always bashing the FDA (usually because their favorite quackery didn't get approval) are always the same ones hating on the pharma companies. Uh, hello, who the hell do you think is keeping those guys in line?
Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.
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you got any statistics to back that up?
Look at how many so-called alternative medicines turn out to be just quackery, and how many turn out to be vindicated. There is a heavy skew toward bad ones.
Pharma companies are unsung heroes of our time. They separate us from the misery of the natural world. Natural life if brutish, painful and short.
Hey, I love living free of polio, measles, mumps, rotovirus, ect. courtesy of the pharmaceutical sector. I like that there's all kinds of helpful medications for things that were once a death sentence developed by the drug companies. I'm not trying to say they're this big evil cabal or anything like a lot of conspiracy nutters make them out to be, ju
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Now if they would just protect us from the very expensive and occasionally deadly snake oil that comes out of big pharma. Or from the gray area cases where the prescription "drug" turns out to be a fantastically expensive minor variation on a cheap generic dietary supplement.
Meanwhile, in the midst of the food contamination scares, the FDA was busy raising the approved levels of the contaminants and seizing e-cigs in defiance of a federal judge rather than helping to solve an actual problem.
So, there's the
Bad examples. You're not helping... (Score:2)
Having never heard of Dr. Burzynski, I took the liberty of reviewing your posted links.
None of the posted information in the links discusses the therapy *or* the evidence, it only discusses the physician and in an uncomfortably bad light. They take the evidence of his credibility and dismiss it out of hand.
For instance, the 2nd link points out that he is an MD and a PHD. Rather than take the obvious stance of "this is a trained scientist, perhaps we should examine his claims", they state this:
"First, he rea
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We protect the stupid, because we are all stupid in our own way. I highly doubt that many of the people on Slashdot are qualified to assess medical treatments and those who claim to do so are mostly choosing their own authority (one of which could be the FDA).
I, for one, welcome institutions like the FDA because it is comforting to know that there is an independent organization that evaluates the claims of medical devices and treatments. It may not be a perfect institution, but it is fully accountable to
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We protect the stupid
- those who 'protect the stupid', are using this argument in exactly the same way as the 'think of the children' and 'terrorist' and 'pedophiles' so called arguments are used. What do you think, government is better at handling your money than you are yourself? Really? Seriously? Is that why SS is such a disaster? If government was better than you are at handling your money, the SS program would have been an actual fund, rather than being an income transfer program, with the fund being managed as an inves
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We protect the stupid
- those who 'protect the stupid', are using this argument in exactly the same way as the 'think of the children' and 'terrorist' and 'pedophiles' so called arguments are used.
No, no it's not. I know there's no chance in hell of convincing you of that, but I'm going to try any way. When people profess "beware of terrorists," they themselves are giving in to fear. When people say "think of the children," they're giving in to fear. When people say "we're protecting the stupid," finally, they're fighting fear. Why? Because fear makes EVERYONE stupid. You, me, the guy down the block, Stephen Hawking, EVERYONE. When you're afraid, you'll do anything that might almost sort of work to h
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Because fear makes EVERYONE stupid.
Interesting. I wonder how you can speak for everyone in the present as well as everyone in the future and be 100% correct. Such an amazing ability must be useful.
Health issues make everyone afraid
Can you prove this?
Because when you're gravely ill, you're facing death, and that's scary, either because you don't know what's on the other side, or because you don't like being weak, or relying on others, or some other reason.
I doubt that everyone is afraid. I'm sure that there's people who simply don't care.
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Sure you are. If you want to drink urine or eat peach pits for your cancer you're free to go ahead and do that. What you're not free to do is call yourself a doctor and tell other people with cancer that drinking urine and eating peach pits will cure them.
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Re:Why protect the stupid? (Score:4, Insightful)
First of all, without the FDA, he doesn't have to say it's his urine. He'll claim it's "insert some scientific description", Without the FDA he might be charging $16,000 per treatment - which is what just one of my cancer drugs cost. When MY life is on the line, and I'm not in a position to tell what's going to help and what's snake-oil, I WANT THE FDA TO OVERLOOK HIS RESEARCH. I'm a software guy, I can't be an expert on drugs, especially cancer drugs.
That doesn't guarantee that my cancer won't kill me, it doesn't even mean his product won't kill me. But it does mean that people have been able to check his research and I'll have good idea of the risks involved in taking it and potential benefits.
You call me stupid to rely on a doctor. All medicine is empirical. We are a long way from understanding the physiology of the human body. Deal with it. Doctors make mistakes, so get yourself a doctor you trust, one who oozes competence, who enjoys his job, who is willing to give you the time to discuss all the issues involved. But be aware he is relying on medical research also, and without the FDA he wouldn't have any real data about the drugs he's about to pump into you.
When YOU have a life threatening disease, then you can decide whether you want factual data behind the drugs you are taking, or whether you want to go with whatever the drug maker claims. As for me, I'm damn glad there is an FDA.
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This. No one can be an expert on everything. A lot of people aren't scientifically literate enough to understand why, say, homeopathy is wrong, let alone the medical value of a questionable treatment that actually has an active ingredient, and even people who are scientifically literate can still get fooled if they're in something outside their area of knowledge. In my field (agriculture) I can usually tell a good claim from a questionable one, but once I go into drugs & medicine, although I conside
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This. No one can be an expert on everything.
Agreed, with above and also everything else you wrote. However: government should provide only a rating agency, not a sales preventative agency. In other words, government should be able to say, "Bob's chiropractic care is worse than a placebo". Government should not be able to say, "Bob can no longer practice chiropractic." There's a world of difference.
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Yeah, I think pretty much the same way, applying it also to how things can be sold and marketed. If, for example, someone really believes in homeopathy, well that's their right to treat themselves with it, be their ailment a cold or cancer (although you'd really hope they have access to complete information before doing so). And if someone wants to sell them what they need for it, they should be allowed too. However, they should not be allowed to call it medicine, nor should they be allowed to mention an
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Why can't more people think like you? I completely agree with government agencies rating products and services, mandating truth in labeling. If that food contains rat droppings, then yes I want to know. But maybe I enjoy rat droppings now and then. Government as an equalizing force between parties, yes. Government acting as my nanny, no.
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That's exactly right. Only, if you are not in a position to tell what the treatment is, why are you taking it? There is a simple solution to this problem that does not require the FDA: don't take it! If instead of trusting the government to decide what's good for you, you only deci
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Rating agencies, eh? I'm sure the drug companies won't try to bribe them, or get their employees into those agencies, or just plain buy the agencies (as they will be commercial entities). You really think this is better than the FDA?
How do I prove a doctor isn't a quack? Give him a medical test? Rely on the reports of others? That won't work - nobody starting out would have any reports so nobody would go to them so they won't get any reports.
And you expect me to know what treatment I'm taking. How? Y
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I think this is at least as good as the FDA. The FDA is bribed all the time, as evidenced by the amount of dangerous crap they let through.
The difference is not that a rating agency would be better than the FDA, but that you would be able to make your own definition of "better"
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I keep repeating this, but you left wingers just don't seem to get the point: everything the government does, it does at the point of a gun. The entire debate is exclusively about coercion. You believe you have the right to decide what's good for me and then to enforce it with violence. You think this is all right and proper. I, on the other hand, see little difference between you and the terrorists who blow up planes trying to impose their values upon us. My point of view is that coercion and violence are never acceptable except to stop coercion and violence by others. All other arguments naturally flow from this.
Damn fucking right I have the right to do so. I don't give a fuck what you think, because those quacks peddling death in a pill ARE using coercion and violence. It's called "Take my pill or you are going to die. I guarantee this pill will let you live. Nothing else can save you." And that's what their sales pitches boil down to. They're using coercion, and don't want to give people the opportunity to test those claims, because those claims will be proven false. And ratings agencies won't help that for shit,
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".. because those quacks peddling death in a pill ARE using coercion and violence. It's called "Take my pill or you are going to die. I guarantee this pill will let you live. Nothing else can save you." And that's what their sales pitches boil down to."
Are you talking about the conventional practicioners or the alternative ones?
"The Triumph of New-Age Medicine"
http://www.theatlantic.com/magazine/archive/2011/07/the-triumph-of-new-age-medicine/8554/ [theatlantic.com]
"Medicine has long decried acupuncture, homeopathy, and the
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left wingers
Anyone who disagrees must be a left winger.
I, on the other hand, see little difference between you and the terrorists who blow up planes trying to impose their values upon us.
The average person imposes their values upon other people all the time. Laws against murder, violence, etc. They're really just saying, "I don't like this particular behavior. Therefore, I think that it should be banned."
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With commercial entities doing the work, the worst that can happen is you get smeared in the media.
They can't raid you armed to the teeth like the feds can.
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Not surprising. Anyone can put together a compound with homology to a biologically active substance and do a quick short term test to see if it has an effect. But it takes a lot of money to see if it isn't screwing up something in the long term. I'm not saying that the FDA is perfect; given that they are generally have more stuff to look over than resources to look over it all, no doubt they make mistakes. But I don't see how it is an argument against them that they increase costs. Making sure things w
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[Draft guidelines] specifies the following two categories of mobile medical apps:
a: those used as an accessory to medical device already regulated by the FDA. (For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. (For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.
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I'd rather my doctor not use apps with his approved devices that are unregulated. Although, I'm sure the free-market would sort it all out.
I'd rather the FDA regulate the use of the combination of the app and the attachment in the case of (b). And require a standard of testing for the combination of app on tablet and attachment together. The tablet or app itself shouldn't need to be regulated or certified as an individual unit.
But (I suppose) a consequence of this, would be workers would have to use sp
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We have the highest drug costs and highest hospital and physician prices of any country in the world. We end up paying twice as much as any other developed country for lower quality and access to health care.
All other developed countries have strong regulation of health care prices and this gives them lower costs and better access to health services. Government regulation works.
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The proper role of government here would be to regulate prices and access in a similar manner a
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The proper role of government here would be to regulate prices and access in a similar manner as the other 21 "developed" countries. This would give us lower prices, higher quality and better access.
We call it "Medicare." Parts of it (like Diagnosis Related Group-based reimbursement) are remarkably similar to the Netherlands' Diagnosis Treatment Combinations (DBCs).
It's been around for awhile; I wonder why no one deciding the future of healthcare has heard of it.
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You want your drugs and doctors to be low cost. How about your treatment quality? Want that to be low also?
Want to go back to the 19th century where only the rich could afford good treatment? Doctors figured out a long time ago that people will pay lots of money for good medical treatment. So most good doctors treated the rich and became rich themselves.
That's what happens without government involvement. If you doubt my words, go to a country where the government isn't involved in health-care, and see
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back in 19 century economy moved from agricultural to urban/manufacturing, and mid-19 century was the time when first health insurance (critical illness insurance actually) was created at costs that were extremely competitive. Up to 1965 in US the cost of private health insurance and medical treatments were actually extremely affordable, people were paying for most of it out of pocket.
I left a comment with data long ago on this [slashdot.org]. To reiterate:
Here is a good primer on this [eh.net], the article comes to erroneous con
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A long treatise that does not to address the point - low cost equates to low quality treatment.
Why? High cost has only a vague correlation to high quality.
Healthcare is expensive because government makes it so. There are huge swathes of costs which could be eliminated before doctors have to start giving you sugar pills instead of real medicine to cut their prices.
Frankly, I'm thoroughly sick of the worship of medicine when so much of it is barely beyond the level of witch-doctoring. The real breakthroughs in medicine will come from engineering, not feeding people random chemicals to see what happens.
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I would rather not have government involved in anything that has to do with business, including medical business.
No regulation at all, then?
I like my costs low, my drugs cheap, my doctors competing with each other based on price and efficiency, maybe I am the only one, in which case it's a non-starter here.
And I'm sure many people don't like monopolies or businesses cooperating with one another in order to gain more profit.
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No regulation at all, then?
- obviously, there should be no government regulations at all in any business and there should be no subsidies or any bail outs to any business or person, and there must be no income taxes, corporate taxes or payroll taxes, no taxes on work.
And I'm sure many people don't like monopolies or businesses cooperating with one another in order to gain more profit.
if people don't like it, they should stop their governments from creating them [mises.org], which is what government's real role in economy is - creating and maintaining monopolies, because that's where the real money for governments are.
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if people don't like it, they should stop their governments from creating them [mises.org], which is what government's real role in economy is - creating and maintaining monopolies, because that's where the real money for governments are.
Sometimes monopolies can happen because of government intervention. But not always. And there can be monopolies and businesses that cooperate with one another (in order to maximize their profit) without any regulation at all, as far as I know (though it would depend on the circumstances).
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Actual competition is a constant dynamic process, which is only stopped by government intervention. Monopoly forms when some business gets preferential treatment from government (patents, franchises, subsidies, special tax provisions, etc.)
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It's possible for monopolies to exist without government intervention. Perhaps the business in question is a risky endeavor that no one but a select few wish to take up. Perhaps very few people have the money to provide competition towards an already established business. Perhaps the majority help create a monopoly themselves by not shopping elsewhere enough (for whatever reason, and this would doom the minority).
And without regulation, how would anyone stop companies that cooperate with one another (which
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It's possible for monopolies to exist without government intervention.
- without gov't intervention no monopoly can exist, and if there is some dominant business, it's domination is totally temporary.
. Perhaps the business in question is a risky endeavor that no one but a select few wish to take up.
- what does that even mean? Every business is a risky endeavor that only very few are willing to take up. Case in point is private space launches, what can be more risky and time/resource consuming that that? Well, there are things, but this is definitely one of them:
http://www.space.com/11298-spacex-rocket-private-spaceflight-falcon9.html [space.com]
http://copenhagensuborbitals.com/ [copenhagen...bitals.com]
http:// [virgingalactic.com]
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- without gov't intervention no monopoly can exist
How so? It's logically impossible?
- what does that even mean?
Businesses far more risky than others could easily end up as monopolies.
- nobody wants to share their pie with somebody else, who may or may not succeed being a competitor.
It's easily possible if it would help maximize their profits. They know that if they do something that will attract customers (but still increase costs), the others will probably follow (if they have good business sense and do not want to lose customers). It would be a pointless thing to do if your intention was to maximize profits.
Businesses know that it's better to have as much market penetration as possible
I doubt that. Otherwise, why would there ever have been companies that c
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How so? It's logically impossible?
- it's physically impossible, as there are always new people being born, new people come to the market with new ideas, new stuff gets invented, old stuff becomes old, ideas and fashions change, technologies change, there is always movement. You are thinking about the world in weird way, the way I thought of it when i was 4, and I thought that everything around me was stable and was that way forever and will stay that way forever.
Even governments fall and countries fall, I was born in USSR, that country doe
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- it's physically impossible
It's either impossible or it isn't. I see no reason why it would be logically impossible (as unlikely as it may be).
as there are always new people being born, new people come to the market with new ideas, new stuff gets invented, old stuff becomes old, ideas and fashions change, technologies change, there is always movement.
Which could take quite a while.
You are thinking about the world in weird way, the way I thought of it when i was 4, and I thought that everything around me was stable and was that way forever and will stay that way forever.
I don't recall saying that (nor do I see what age has to do with anything).
- they do not end up as monopolies
I'm talking about businesses that are incredibly hard to start up (unless you have a lot of money). Competing with an established business is quite difficult (and the chances of someone trying to do so when it is incredibly risky lessen even more).
you lower the price a little here and there, you have more customers
Only if the ones you were previously coope
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It's either impossible or it isn't. I see no reason why it would be logically impossible (as unlikely as it may be).
- it's physically impossible, because it never happened. There is no monopoly and there was no monopoly that had its status in a free market, all monopolies are creations of government.
Is it logically possible? As in, is it theoretically possible to have a monopoly? Yes. If the combination of factors is such, that one company satisfies all customers at all times with the price/value combination for the product that there is just no way for a competitor to form because there is no space for more sales and t
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- it's physically impossible, because it never happened.
So it's impossible because it hasn't happened yet? What? I also don't see any reason that it's "physically" (whatever that means in this context) impossible. But, then again, I think debating over something like this is rather pointless.
- when one person cannot start a business without lots of money, he needs to convince investors that he can make money starting that business, and if he convinces them, they'll provide the capital, this is not necessarily rocket science, it's called a business plan.
Someone could already have lots of money (enough to start it). Or drive out small businesses. Once they are established, competition may become difficult.
- there are no absolutes, and they are not necessary to have mostly free markets.
There are no absolutes? Well, that may be true, but getting rid of all regulations would get rid of all regulations.
And I
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So it's impossible because it hasn't happened yet? What?
- I gave an example of how it is theoretically possible, but it's very unlikely, given that it never happened, so it's improbable, as good as physically impossible.
Someone could already have lots of money (enough to start it). Or drive out small businesses. Once they are established, competition may become difficult.
- so what? So what that it is difficult? You are ignoring the examples I gave earlier of very difficult things that private businesses are doing - launching rockets to space with useful cargo.
(so people would be able to better understand its advantages and disadvantages far more easily and believably). I think it should be tested.
- USA 19 century was such a market, it's in the past for USA, but in Asia that's sort of what some countries have there. Even China has a freer market th
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- I gave an example of how it is theoretically possible, but it's very unlikely, given that it never happened, so it's improbable, as good as physically impossible.
I believe that the right words should be used for the right situations. If it's not impossible, but just unlikely, then just say that. But, really, there's technically no way that I see to know that it's unlikely, either.
- USA 19 century was such a market, it's in the past for USA, but in Asia that's sort of what some countries have there. Even China has a freer market than any Western economy, and its wealth is increasing as its production capacity is growing.
But all of them have (or had) at least some regulation, correct? I was referring to a place where absolutely no regulation exists at all. That would be the way to truly test this theory.
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In USA in 19 century most of the industries had no regulations, the government was very tiny, involved only with the largest tycoons, that's why in 19 century USA switched from being an agriculture based society, that owed huge debts to the largest manufacturer of cheap, high quality consumer goods, while driving innovation by allowing the people to come over from around the world and start their own businesses in the freest (at the time), society in the world.
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Sounds like you could use someone to protect you. If you want to take "antineoplastons" you're welcome to do so (they seem to be found in urine). Governments regulate people who give you medical advice and prescribe treatment.
I do like how your "evidence" prominently includes a Dr Oz endorsement though.
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I guess you're a little fuzzy on what evidence is. An interview with a guy about social security isn't. Neither is your own personal rant about your country's (admittedly broken) medical system. And no, getting a treatment approved for a phase I, II or III trial isn't really evidence it works either. Nor is it evidence the treatment is safe, contrary to your assertion.
The FDA regulates what treatments can be recommend and/or provided by health professionals or others giving medical advice. in order for one
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There is plenty of evidence [slashdot.org] in my comments showing that FDA is not only ineffective at figuring out efficacy, but it is criminally effective at pushing for the dangerous drugs to be sold, when there is evidence that those drugs are in fact dangerous, and FDA does not regulate chemicals that are not immediately acutely dangerous, like fructose.
However in that very comment there is also evidence of how FDA 'approval' provides a company with a monopoly to sell a drug, which pushes the prices up by many orders
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Oh, you're giving me evidence to support your conspiracy theory! Wonderful. Just bypassing the issue of the craziness of your main example, hey?
And no, it's not my country.
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Conspiracy?
The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. Thatâ(TM)s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nationâ(TM)s bloated annual health-care tab would swell by more than $4 billion. [washingtonpost.com]
What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost â" about
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You're very determined to avoid the issue of whether Burzynski is a fraud hey?
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Maybe you should have read the thread.
I said earlier [slashdot.org] that to me it does not matter whether this guy is a fraud or not. If his treatment is harmless, then there the rest of it, the efficacy of it should be left up to the market to decide, not to a fraudulent government monopoly.
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Where's the evidence his treatment is harmless? Don't forget to include the harm of people seeking his treatment and not getting or not being able to pay for an actual treatment that does work.
Come on, pony up some evidence instead of just spewing meaningless rhetoric.
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Gotta keep that pharmaceutical lobby going.
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You know I sort of agree on this. Let the libertarians and "alternative medicine" kooks get their non-FDA approved medicine. Bring a little Darwin back into our idiot-safe modern world >:-)
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Whatever you want to call it, get rid of government monopolies on drugs and there will be more drugs. Many of them will not help you, many of them will help you, and the market will sort it out. The way it's done now is ridiculous, apparently you are not your own person, you are property of your government, which decides for you what is it that you need and are allowed or not.
Played a roll (Score:3)
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Bad Summary (Score:5, Insightful)
It isn't planning to oversee all health apps - just those medical apps that could present a risk to patients if the apps don’t work as intended.
It specifies the following two categories of mobile medical apps:
a: those used as an accessory to medical device already regulated by the FDA.
(For example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet)
b: transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices.
(For example, an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack).
The FDA wants interested parties including software creators to comment on its proposals during the next 90-days.
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I can see that being a good idea in some cases, like monitoring for heart attacks, but I'm worried that the definitions will be too broad. As a private individual, it seems like I should be able to hook up a smartphone to a sensor and install an app that, say, monitors my sleep patterns. Maybe I'm "self-treating" some sort of sleep disorder; but maybe I'm just curious; or maybe I'm collecting data for an art installation based around my sleeping patterns. Either way it doesn't really seem like it should be
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Either way it doesn't really seem like it should be the government's business to regulate it, unless it's actually being sold as a medical product.
They're not. They are going after real 'medical devices'. If you claim that your device is not intended to cure or diagnose disease then you get a free pass. Just don't try to sell it with advertising suggesting that it's a real medical device.
computers and health care (Score:2)
Now is probably a bad time to point out to the FDA that the last time they tried regulating this, it was because the computer diagnostic program didn't have a license to practice medicine. They ignored the fact that the program was better at diagnosing medical conditions than the doctors that asked for its removal.
I fail to see how giving people the resources to diagnose their own problems is a public health concern, any more than providing people with information about how to fix their own cars. Yes, some
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There's a significant amount of researching and testing that has to be done before you're allowed to advertise something as having a medical use. With good reason, while a pillow might really treat certain types of sleep apnea you would have to do the trials necessary to back it up.
I'm guessing that the issue wasn't solely about not having a license to practice medicine. Personally, I'd rather have somebody that's been trained working on me than some random quack. I have had a lot of luck with complementary
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Thanks for the non sequitur. I don't deny that doctors make mistakes (and bear in mind that back pain is notoriously difficult to diagnose), but the debate was that "the [computer] program was better at diagnosing medical conditions than the doctors", to which your story adds no information. I'm pretty sure that a computer program could have helped provide a list of possibilities for your condition, but ultimately it was a good doctor who got you sorted.
It's also interesting to note the intuition of the
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Posting about personal responsibility... anonymously...
I'd make a joke, but I think you covered it.
"for entertainment purposes only" (Score:2)
If you use it for a real medical issue and hurt yourself, its your own damned fault.
I can see an 'app czar' coming soon :(
could they go after the 'one secret to trim belly' (Score:5, Insightful)
could they go after the '1 secret to trim belly fat' or 'dermatologists hate this woman' ads first?
those are out and out fraud, but more than that, im sick of looking at them.
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I was curious what kind of woo was behind the belly fat ads so I followed the link until it wanted to charge for a PDF, then went and found the document on the pirate bay. Once you cut through all the crap, basically the secret is "exercise."
The shape of things to come (Score:2)
Medical apps are just one step in a trend that will redo the way we manage health.
Health care is broken in the US. The problem is that the system is so unbelievably entrenched that it's impossible to dislodge. Health insurance companies that make billions, safety rules that require half a billion investment to test a drug, physicians' inability to make exceptions... everything is frozen in bureaucracy that will not change.
Any entrenched fixed system will eventually be overtaken by smaller innovative solutio
wrong question (Score:2)
As a programmer, not only am I not interested in doing that, but I'm not qualified either, and no user would have reason to trust me even if I did it. So the answer (in my case) is obviously no.
But that's irrelevant anyway, because someone already mentioned the FDA. The question is now, "Should government use force to prevent people from using programs written by people who play doctor?"
You might think that answer is just as clear
FDA's Incestuous relationship with corporations .. (Score:2)
leads me to conclude that some corporation wants the FDA to eliminate competition to some of its medical apps. After this plays out, and we see which corporation is still peddling medical apps, we'll know who paid the FDA to go after the others.
It's such a common problem these days. Every government agency is headed by a former corporate CEO or lawyer, and when their term expires they return to the corporate world, being replaced by the CEO they replace. This goes on unchecked because Congressmen and
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Indeed, they're hoping to come out of this with the best of both worlds. They want to sell devices using commodity iPad / iPhone hardware, greatly lowering their costs compared to the low-production-run custom stuff that medical devices have typically been, but they still want to sell them in these "certified" packages w/ software for high medical-device prices without any commodity competition.
FDA to stamp out innovation (Score:2)
now, easy for gaxosmithkline to afford but not for a two person indie shop. The large companies haven't innovated at all in the mobile market, almost all top apps in the Appe Medical App Store are from small shops
bravo FDA for destroying the innovators in the market reducing health care costs.
Tht's stupid (Score:2)
but should programmers play the role of doctor even in seemingly harmless areas?
That's a stupid generalization. A doctor can hire a programmer to create an app but a that still does not make the programmer a doctor.
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Although.. what IS a doctor (MD), really?
A person who has spent the better part of a decade cramming as many (hopefully correct and up-to-date) facts into his head and relating them all to each other in such a way that they will have quick access to the important ones for each patient he is presented with.
In other words, an MD is a medical database in organic form! One that has to be built from scratch on each new piece of hardware running it. (and one whose pruning algorithm is a little aggressive....)
Fr
As long as they don't claim to be diagnosing: NO (Score:2)
We don't need government involvement in apps, websites or other sources that are simply informative in purpose. If you getting close to medical advice the creators should just tell you: this is not medical advice, if in doubt contact your doctor, do not use for diagnosis etc. If people are stupid and use it for it, why not, some believe and practice lot of old wive tales about medical things, some even believe in homeopathy, faith healing etc., government involvement over those things is simply encroaching
FDA is a bleeding pustule (Score:2)
Everything at all related to food and drugs is FUCKED UP IN THE U.S.A.. The FDA is one of the major causes of this. They feed on our own money and drop their excrement on us.
Improve the physical and economic health of America by doing whatever you can to take those motherfuckers down.
This is why healthcare costs so much (Score:2)
In every other industry there is an acknowledged trade off between quality and cost.
This at least the low-hanging fruit to become cheap and affordable.
But not in the healthcare industry. There, you just mention the world quality and it must be done. Driving up the cost and preventing people from getting cheaper affordable treatment.
No, we're talking about someone hacking you up to do brain surgery at low cost. But the low-hanging fruit.
I've been on the same thyroid medication for years. Yet I always hav
Red herring (Score:2)
No, obviously no one other than a doctor should play the role of doctor. But this is a red herring. We're not talking about medical apps that claim to be equivalent to doctors. No one is practicing medicine without a license here.
It should be obvious to anyone that an app can be written by someone who does not have a medical degree or any relevant experience. Now, if these apps were claiming to be written by doctors or to
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