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Know how many idiots would think they have good b.p. when they don't because of a faulty app?
Originally posted by thov420
Doesn't say anywhere that it's going to be regulating all computers/smartphones etc.
Originally posted by muse7
I will believe some Sacha Faal before I believe Breitbart
talk about a fear mongering right wing nut job.
Originally posted by thov420
reply to post by beezzer
It doesn't demand anything.
It says in the guidance itself its only recommendations and suggestions at this point.
Originally posted by timidgal
reply to post by beezzer
Far be it for me to take away from the potential gravity of this situation, but I would be remiss if I didn't point out that this guidance was never part of ObamaCare, otherwise know as the Patient Protection and Accountability Act which comprised of the enrolled bill H.R. 3590 or P.L 111-142 passed by both the House and Senate on 3/23/2010 and later amended by the Health Care and Reconciliation Act, H.R. 4872 or P.L. 111-152. Neither law addressed the FDA's oversight or rights of guidance on mobile medical devices.
Originally posted by beezzer
Originally posted by timidgal
reply to post by beezzer
Far be it for me to take away from the potential gravity of this situation, but I would be remiss if I didn't point out that this guidance was never part of ObamaCare, otherwise know as the Patient Protection and Accountability Act which comprised of the enrolled bill H.R. 3590 or P.L 111-142 passed by both the House and Senate on 3/23/2010 and later amended by the Health Care and Reconciliation Act, H.R. 4872 or P.L. 111-152. Neither law addressed the FDA's oversight or rights of guidance on mobile medical devices.
Yet they are using Obamacare as an umbrella for draconiam measures such as this.
Your post has value though.
Will try to find a definitive link.
beez
ETA; I know it is difficult to prove a negative, but have you read through the bill to insure that measures like this are not in it?edit on 13-3-2012 by beezzer because: (no reason given)
Originally posted by beezzer
Will be back in a bit after digesting it.
Nawww, LE is in it for the hate, not the information gained. Of course he does all his homework and knows everything. That's why he can sit in judgement.
Originally posted by timidgal
reply to post by LErickson
Let's be fair to Beezer. Our country is in a state of confusion with all of these new rules, which the authors don't even initially understand themselves. That's why there's guidance and interim final rules followed by final rules which are later amended being thrown at us left and right.
The fact that this particular guidance wasn't part of the PPACA text doesn't negate some of the valid concerns presented by some within the thread, including Beezer him/herself.
Timidgal
Originally posted by The Sword
And you're overly paranoid, along with everyone else that's running around with their heads missing.
A government that cannot regulate its' own debt cannot effectively regulate the people, despite the fears of those same people.
Originally posted by beezzer
From here.
In another outrageous power-grab, FDA says your own stem cells are drugs—and stem cell therapy is interstate commerce because it affects the bottom line of FDA-approved drugs in other states!...
Originally posted by timidgal
reply to post by beezzer
Far be it for me to take away from the potential gravity some feel has been created by this guidance, but I would be remiss if I didn't point out that this particular guidance was never part of ObamaCare, otherwise know as the Patient Protection and Accountability Act, which comprised of the enrolled bill H.R. 3590 or P.L 111-142 passed by both the House and Senate on 3/23/2010 and later amended by the Health Care and Reconciliation Act, H.R. 4872 or P.L. 111-152. Neither law addressed the FDA's oversight or rights of guidance on mobile medical devices.
The draft guidance cited and issued on 7/21/2011 can be found here and was issued separate and non-related to ObamaCare.
This guidance has to do with controlling the display of personal medical information, controlling it's intended use by the manufacturer or the energy source of the mobile device (i.e. potential exposure to radiation)' ensuring that the mobile device has been transformed from a legimate medical device (the functions and specifications of which have always had the oversight of the FDA) and negating the possibility of creating false alarms or new personal data by use of the mobile devices.
Whereas each person is entitled to review the guidance text and decide for him/herself its intended purpose, it was not a part of PPACA. I had the unfortunate job of dissecting and interpreting the 1,000's of pages of PPACA text after it was released at 4:00 pm on 3/23/2010 and the myriad of summaries from the various governing bodies that followed.
edit on 3/13/2012 by timidgal because: (no reason given)