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?"
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.
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?
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.
Re:Yes, because we need government in everything (Score:3, Insightful)
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.
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.