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FDA To Scrutinize Mobile Medical Apps
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?"
Nope, never played a roll, but I have baked them.
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.
I like microcars
Protecting me from snake oil salesmen (like your Burzynski quack) 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?
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.
Oh, and just so I don't wander off into total snark ville - The FDA is really just looking for comments on things that either are used directly by a medical provider to view images or is attached to a medical device (like a glucometer). Makes perfect sense although why the FDA is so wound up about PACS (Picture Archival and Communication System - just a glorified version of a image viewer and database) is beyond me, but that's the FDA for you.
As for all of the other 'Alternative / natural / homeopathic apps - so long as they state they are not designed to diagnose or cure disease then they're fine.
Faster! Faster! Faster would be better!
[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.
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.
I don't read your sig. Why are you reading mine?
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 the law as well as public ire when things do go wrong. But most of all it uses rational methods in order to test medical claims.
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.
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.
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."
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.
I use to write medical applications and instruments years ago, and one of the most expensive things was testing the work, and running it past lawyers -- who tested the work one more time with a different team.
And my products were generally known as being good, accurate, and scientifically tested. ...
And then I would see competitors put out similar works that was not tested, and often times inaccurate. And much cheaper. Hell, one of my competitors put a disclaimer and lawyerly notice with the same guys I had been working with and I asked them if it was a conflict of interest...my guys said that if they were involved, they couldn't talk about it because of client lawyer priv...but then came back and said they could talk about it because they never heard from the guy. And yet, people thought his work was as scientifically tested and rigorous mine.
In my case, I was doing mostly psychological work...I was careful about my clients. I only licensed my software to legitimate psychologists or MDs with the appropriate background. My competitors didn't care...schools would try to buy my work to test kids to see if they were psychos or needed kicked out...and wants software that could take the place of a trained professional (where as I actually took out a few automations that would have been easier to diagnose, BUT it made it easier for people that had no right to diagnose, nor actually understood the ramification of doing this...I wanted the diagnosis to come from a licensed psychologist).
The whole point is, there is too much unregulated work in this world. Too many people that think they are experts, just because they have a book with equations and knowledge of programming. Too many people that are willing to put their name on a product for a percentage of the sales without ever looking at it. I spend the money on making certain things were right -- and it cut into my profit A LOT -- but it was the right thing to do. Everything I hear from this law is that it will actually make the law a little more uniform and a lot of stuff that we had to guess at is now concrete and no guessing needed. It will be actually cheaper to do this than what I paid before...the only people complaining are those that took shortcuts and didn't really care about your health.
(and sadly, these days I have the credentials to do the work...and yet I do no programming any more).