FDA Lays Out Rules for some Smartphone Health Apps.....

[MMC]

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health.

With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to high-tech heart monitors.

The FDA said Monday that the vast majority of these health care apps don't pose much of a risk to consumers if they malfunction, and will not be federally regulated. Instead, the agency will focus on a handful of apps that turn smartphones into devices, like a heart monitor, or medical attachments that plug into smartphones, like arm cuffs that measure blood pressure.

FDA officials said Monday they have already approved 75 of these "mobile medical applications," including 25 in the last year. Agency officials estimate that 500 million smartphone users worldwide will use some type of health app by 2015.

Last year the FDA approved the sale of a $199 heart monitor from AliveCor. The attachment snaps on like a smartphone case with finger electrodes that measure the users' heartbeat. Hold the device for 30 seconds and it delivers an approximate EKG reading, an essential medical test that checks for problems with the heart's electrical activity. Patients can email the reading to their doctor for analysis.....snip~

FDA lays out rules for some smartphone health apps
Associated Press – 6 hrs ago

What do you think about this tech being used with peoples health. One concern was that hackers could cause these aps to not work. How do you feel about trusting ones life with such. Knowing glitches take place. Areas crossed into where electrical devices or phones don't work? That not to say that some of this isn't a good idea.

 

[Fisher]

It is an evolution of technology. It appears that it takes the doc to interpret still so you don't have to worry about the thing misreading as much. There are already medical devices that monitor patients that they have to call into the wherever to transmit the data. It became an issue with a client of mine having a heart condition and a jail sentence too long to do on weekends. The judge didn't cut him any slack but the jail basically said screw it, we don't want you here dying on our watch after a brief stay.

 

[MMC]

It is an evolution of technology. It appears that it takes the doc to interpret still so you don't have to worry about the thing misreading as much. There are already medical devices that monitor patients that they have to call into the wherever to transmit the data. It became an issue with a client of mine having a heart condition and a jail sentence too long to do on weekends. The judge didn't cut him any slack but the jail basically said screw it, we don't want you here dying on our watch after a brief stay.

My concern would be like if one is traveling and then one hits some area where the device wont work. That could present some problems. Same with some hackers not even knowing that they did such.

 

[GottaGo]

What do you think about this tech being used with peoples health. One concern was that hackers could cause these aps to not work. How do you feel about trusting ones life with such. Knowing glitches take place. Areas crossed into where electrical devices or phones don't work? That not to say that some of this isn't a good idea.

It's interesting how much of our health we put in the hands of electronic devices. However, those devices are closely regulated and are created specifically to do their job.

To rely on a device that may or may not complete an important call at any given time, with possibly your life, well, I think I'll trust something proven to function for the specific job.

To use it for a day to day monitoring device, and have it's readings verified with a device specifically designed for the job, it's not a bad idea, but I can just see someone trusting it implicitly and then suing because it do it's job well enough.

*recall a lawsuit about the woman driving an RV, and putting it on cruise control? :lol:

 

[MMC]

It's interesting how much of our health we put in the hands of electronic devices. However, those devices are closely regulated and are created specifically to do their job.

To rely on a device that may or may not complete an important call at any given time, with possibly your life, well, I think I'll trust something proven to function for the specific job.

To use it for a day to day monitoring device, and have it's readings verified with a device specifically designed for the job, it's not a bad idea, but I can just see someone trusting it implicitly and then suing because it do it's job well enough.

*recall a lawsuit about the woman driving an RV, and putting it on cruise control? :lol:

Heya GG.

What do you think about the FDA regulating it and deciding which to not regulate?

 

[GottaGo]

Heya GG.

What do you think about the FDA regulating it and deciding which to not regulate?

Evening, MMC.

I guess it depends on the use of the device, and how strongly worded the advisories provided with it are.

I'd say if the device/app does anything other than give information, then it needs to be regulated. If it's strictly informational then it's not as vital that it be regulated, but as I said, any type of medical information gleaned from it would need to be verified with a device specifically made for the job.

 

[Fisher]

My concern would be like if one is traveling and then one hits some area where the device wont work[/B]. That could present some problems. Same with some hackers not even knowing that they did such.

Well, that would be unfortunate, but not really an issue with the device so much as cell coverage. As for hackers, I really have trouble seeing them tampering with medical software. There is no money in it for them and certainly not something that would get them any cred in hacker world. "Cool man, you killed a Grandma"--I don't thinks so.

 

[MMC]

Well, that would be unfortunate, but not really an issue with the device so much as cell coverage. As for hackers, I really have trouble seeing them tampering with medical software. There is no money in it for them and certainly not something that would get them any cred in hacker world. "Cool man, you killed a Grandma"--I don't thinks so.

Heya Fisher. :2wave: Yeah.....but the way they were talking about it. It was as if the hackers wouldn't even know they did such. Since they would be looking at something else they were doing. Hearing that I was like WTF. They don't know it, but can cause it, by tampering with stuff in a specific area or something like that. As I stated I am not that much into the knowing with computer stuff.

My first thought was if not just phones what about pacemakers.

 

[Fisher]

Heya Fisher. :2wave: Yeah.....but the way they were talking about it. It was as if the hackers wouldn't even know they did such. Since they would be looking at something else they were doing. Hearing that I was like WTF. They don't know it, but can cause it, by tampering with stuff in a specific area or something like that. As I stated I am not that much into the knowing with computer stuff.

My first thought was if not just phones what about pacemakers.

You can't defend against everything. On balance, I think it is better than worse a development for end of life issues people deal with.