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Originally posted by mamabeth
reply to post by beezzer
I have a treadmill* that also monitors by heart rate while I'm on it.
Would it also be considered a 'medical' device?
* my treadmill has not been used in a long time,it is currently in
my office collecting dust bunnies.It is also being used for storage.edit on 12-3-2012 by mamabeth because: added
Originally posted by beezzer
reply to post by OutKast Searcher
You want to make a case for reulation? Bully for you. Go for it.
But to put into a healthcare package, to hide it in a healthcare package, is disingenuous at best, and damned sneaky and crooked at worst.
Government regulation, government oversight over all means of wireless communications.
Lets hear your case for it!
Originally posted by OutKast Searcher
I'm not making a case for that...because that isn't what is being proposed.
This is just what the fear mongers are trying to sell to people dense enough to buy it.
I'm making a case for regulation of medical software...I think any logical person would want someone to regulate medical software.
Why not let the free market regulate it?
Have a bad device, a bad product? Well guess what?! The market will let that product die because people won't buy it. (Because it is a bad product)
Originally posted by OutKast Searcher
reply to post by beezzer
Why not let the free market regulate it?
And how do you propose we do that...just wait and watch where people are dying the most and then don't go to hospitals that are using that software???
The free market is concerned with profit...not safety...and healthcare isn't an industry we can just wait and let the "free market" decide which software/medical devices aren't killing people so we can make our decision.
Have a bad device, a bad product? Well guess what?! The market will let that product die because people won't buy it. (Because it is a bad product)
And how do we measure a "bad" medical device???
Exactly...we just keep a body count.
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications
Originally posted by OutKast Searcher
Originally posted by beezzer
reply to post by OutKast Searcher
You want to make a case for reulation? Bully for you. Go for it.
But to put into a healthcare package, to hide it in a healthcare package, is disingenuous at best, and damned sneaky and crooked at worst.
Government regulation, government oversight over all means of wireless communications.
Lets hear your case for it!
I'm not making a case for that...because that isn't what is being proposed.
This is just what the fear mongers are trying to sell to people dense enough to buy it.
I'm making a case for regulation of medical software...I think any logical person would want someone to regulate medical software.
The press release issued by the U.S. Food and Drug Administration (FDA), which operates under the Department of Health and Human Services (HHS), on July 19, 2011, signaled the beginning of its regulatory process, this time concerning “mobile medical apps.” The announcement made it plain that such regulation certainly fell under its jurisdiction, as if declaring it made it so: “The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery,” according to Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don’t work as intended.”
The July 19 announcement allayed concerns that the FDA was going to regulate every app somehow related to food, or drugs, or cosmetics. The press release said the agency would attempt to regulate only “a small subset of mobile medical apps that impact or may impact the performance or functionality of currently regulated medical devices.” These would include, initially at least:
Apps that are used as an accessory to a medical device already regulated by the FDA such as an app that allows a physician to make a diagnosis based on an image retrieved from a cloud by a smartphone or tablet
Apps that transform a smartphone or tablet into a regulated medical device by using attachments, sensors or other devices, such as an app that turns a smartphone, for example, into an ECG machine via sensors
Mobile medical applications are becoming increasingly popular as many Americans want to engage actively and control their own health care. Estimates indicate that the number of smartphone consumers using medical apps will grow to 500 million by 2015. This demand for mobile medical applications underscores a market-driven explosion in the use of health-information technology in ways that engage consumers, health care providers and technology vendors to enhance health care outcomes and lower health costs.
All of this innovation and growth in mobile medical applications could come to a screeching halt if the Food and Drug Administration (FDA) moves forward with its proposed regulation of mobile medical applications. The FDA continues to explore options to regulate mobile medical applications as medical devices under the Food, Drug and Cosmetic Act, particularly around adverse-event and patient-safety reporting. At this formative stage of emerging mobile medical applications, complicated and expensive new regulatory structures through the FDA would dampen prospects for future lifesaving innovations.
Not if the FDA gets involved. The average time to approve a medical device is about three years and can cost upward of $75 million. In the software market, that is a lifetime. Additionally, if mobile apps are regulated as medical devices, they will be subject to the health care reform law’s 2.3 percent medical-device tax, raising prices as taxes are passed on to consumers. Free apps may no longer be free.
Originally posted by jibeho
reply to post by OutKast Searcher
Whose going to make the money?
Not if the FDA gets involved. The average time to approve a medical device is about three years and can cost upward of $75 million. In the software market, that is a lifetime. Additionally, if mobile apps are regulated as medical devices, they will be subject to the health care reform law’s 2.3 percent medical-device tax, raising prices as taxes are passed on to consumers. Free apps may no longer be free.
www.washingtontimes.com...
Just another revenue stream added to fund this bad boy..
Originally posted by The Sword
reply to post by beezzer
More fear, dear?
I'm still not buying the boogeyman mindset regarding obamacare.
Originally posted by unityemissions
I'm not trying to defend this bill, but must say that some of the apps on the android market are messed up. I have a friend who is listening to this app that's telling her to eat 1400Kcal each day, while she is exercising for about an hour a day. She has lost a little weight, but looks horrible. I told her about yo-yo dieting, and the body entering starvation mode once you cut calories too quickly. She asserts this is quite a healthy way to lose weight. I can say nothing more, except that I hope her plan works successfully.
So how would the gov. regulate this exactly? Only way to regulate is with oversight, oversight requires the ability of those overseeing to have access to your stuff, so they can look through it and decide if your allowed to have it or not.
In short, if they can regulate what apps are on your phone, they can regulate your phone. It doesnt take a huge leep of reasoning to figure that out.
At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or "mobile medical apps."
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required.
As described in this guidance, the FDA plans to apply its regulatory oversight only to certain types of mobile apps.