Posted on 08/30/2009 12:00:38 PM PDT by flash2368
There's a pretty starling thing in the bill that 95% of Americans won't like.
The Obama Health care bill under Class II (Paragraph 1, Section B) specifically includes ‘‘(ii) a class II device that is implantable." Then on page 1004 it describes what the term "data" means in paragraph 1, section B:
14 ‘‘(B) In this paragraph, the term ‘data’ refers to in15 formation respecting a device described in paragraph (1), 16 including claims data, patient survey data, standardized 17 analytic files that allow for the pooling and analysis of 18 data from disparate data environments, electronic health 19 records, and any other data deemed appropriate by the 20 Secretary"
What exactly is a class II device that is implantable? Lets see...
You may not even know when it happens ... remember that Tetanus shot you got ...
Oh, so THAT’S what the swine flu shot is for!
OH and remember that MA is REQUIRING everyone to get a “swine flu” shot ...
Yeah but gee whiz, guys...it’s all for our own good!!
Yes “I am saved”. It’s hanging on my wall.
It’s a metaphor.
wth
Somebody on Facebook oughta get Sarah Palin on this - she needs a new column about the Chip Police or some other catchy term. Seriously.
I’m speechless.....
Well hey, if one wants "free" government health care, one should be willing to let the government chip them like an animal so they can save one money, via efficiency, with their health care "costs".
Why don’t they IMPLANT chips in WELFARE recipients????
No, in my reading, it is referring to they want an entire database of implantable stuff inside a body, like pacemakers, pins, knees, hips, etc.
It is so freaking difficult to read that bill and understand it. They made it that way so they could explain this crap off as something else.
Lets not get loony, here’s more text
``National Medical Device Registry
``(g) (1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that—
``(A) is or has been used in or on a patient; and
``(B) is—
``(i) a class III device; or
``(ii) a class II device that is implantable, life-supporting, or life-sustaining.
A database of implantable devices like pacemakers and stuff. Not implanting chips to track you.
See how insidious these evil are. First they convince you to neuter and chip your pets, then they convince you to chip your kids “for safety”, then they “have to” chip the old people, and lastly the servant cattle, that’s the rest of us. The condemnation from God is only on those who take it willingly
And if you haven't got your tetanus shot yet, you WILL be mandated to get your H1N1 flu shot whether you want it or not to make up for it.
Is this kind of stuff really in the bill no elected official want to read what they’re signing away?
What, and upset their favorite voting base?
Is this it?????
Subtitle C—National Medical
9
Device Registry
10
11 SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.
12 (a) REGISTRY.—
13 (1) IN GENERAL.—Section 519 of the Federal
14 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is
15 amended—
16 (A) by redesignating subsection (g) as sub-
17 section (h); and
18 (B) by inserting after subsection (f) the
19 following:
20 ‘‘National Medical Device Registry
21 ‘‘(g)(1) The Secretary shall establish a national med-
22 ical device registry (in this subsection referred to as the
23 ‘registry’) to facilitate analysis of postmarket safety and
24 outcomes data on each device that—
25 ‘‘(A) is or has been used in or on a patient; and
•HR 3200 IH
VerDate Nov 24 2008 01:43 Jul 15, 2009 Jkt 079200 PO 00000 Frm 01000 Fmt 6652 Sfmt 6201 E:\BILLS\H3200.IH H3200
1001
1 ‘‘(B) is—
2 ‘‘(i) a class III device; or
3 ‘‘(ii) a class II device that is implantable,
4 life-supporting, or life-sustaining.
5 ‘‘(2) In developing the registry, the Secretary shall,
6 in consultation with the Commissioner of Food and Drugs,
7 the Administrator of the Centers for Medicare & Medicaid
8 Services, the head of the Office of the National Coordi-
9 nator for Health Information Technology, and the Sec-
10 retary of Veterans Affairs, determine the best methods
11 for—
12 ‘‘(A) including in the registry, in a manner con-
13 sistent with subsection (f), appropriate information
14 to identify each device described in paragraph (1) by
15 type, model, and serial number or other unique iden-
16 tifier;
17 ‘‘(B) validating methods for analyzing patient
18 safety and outcomes data from multiple sources and
19 for linking such data with the information included
20 in the registry as described in subparagraph (A), in-
21 cluding, to the extent feasible, use of—
22 ‘‘(i) data provided to the Secretary under
23 other provisions of this chapter; and
24 ‘‘(ii) information from public and private
25 sources identified under paragraph (3);
Any lawyers out there wanna parse this bureaucrat speak?
(a) Registry-CommentsClose CommentsPermalink
(1) IN GENERAL- Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended--CommentsClose CommentsPermalink
(A) by redesignating subsection (g) as subsection (h); andCommentsClose CommentsPermalink
(B) by inserting after subsection (f) the following:CommentsClose CommentsPermalink
‘National Medical Device Registry
1
‘(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that--CommentsClose CommentsPermalink
‘(A) is or has been used in or on a patient; andCommentsClose CommentsPermalink
‘(B) is--CommentsClose CommentsPermalink
‘(i) a class III device; orCommentsClose CommentsPermalink
‘(ii) a class II device that is implantable, life-supporting, or life-sustaining.CommentsClose CommentsPermalink
‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for--CommentsClose CommentsPermalink
‘(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique identifier;CommentsClose CommentsPermalink
‘(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of--CommentsClose CommentsPermalink
‘(i) data provided to the Secretary under other provisions of this chapter; andCommentsClose CommentsPermalink
‘(ii) information from public and private sources identified under paragraph (3);CommentsClose CommentsPermalink
‘(C) integrating the activities described in this subsection with--CommentsClose CommentsPermalink ‘(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification);CommentsClose CommentsPermalink
‘(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data); andCommentsClose CommentsPermalink
‘(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; andCommentsClose CommentsPermalink
‘(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.CommentsClose CommentsPermalink
1
‘(3)(A) To facilitate analyses of postmarket safety and patient outcomes for devices described in paragraph (1), the Secretary shall, in collaboration with public, academic, and private entities, develop methods to--CommentsClose CommentsPermalink
‘(i) obtain access to disparate sources of patient safety and outcomes data, including--CommentsClose CommentsPermalink
‘(I) Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs);CommentsClose CommentsPermalink
‘(II) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); andCommentsClose CommentsPermalink
‘(III) other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness; andCommentsClose CommentsPermalink
‘(ii) link data obtained under clause (i) with information in the registry.CommentsClose CommentsPermalink
6
‘(B) In this paragraph, the term ‘data’ refers to information respecting a device described in paragraph (1), including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.CommentsClose CommentsPermalink
‘(4) Not later than 36 months after the date of the enactment of this subsection, the Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations--CommentsClose CommentsPermalink
‘(A)(i) in the case of devices that are described in paragraph (1) and sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; andCommentsClose CommentsPermalink
‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;CommentsClose CommentsPermalink
‘(B) shall establish procedures--CommentsClose CommentsPermalink
‘(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); andCommentsClose CommentsPermalink
‘(ii) to permit analyses of linked data;CommentsClose CommentsPermalink
‘(C) may require device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks;CommentsClose CommentsPermalink
‘(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; andCommentsClose CommentsPermalink
‘(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.CommentsClose CommentsPermalink
‘(5) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for fiscal years 2010 and 2011.’.CommentsClose CommentsPermalink
(2) EFFECTIVE DATE- The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.CommentsClose CommentsPermalink
(3) CONFORMING AMENDMENT- Section 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by striking ‘519(g)’ and inserting ‘519(h)’.CommentsClose CommentsPermalink
(b) Electronic Exchange and Use in Certified Electronic Health Records of Unique Device Identifiers-CommentsClose CommentsPermalink
(1) RECOMMENDATIONS- The HIT Policy Committee established under section 3002 of the Public Health Service Act (42 U.S.C. 300jj-12) shall recommend to the head of the Office of the National Coordinator for Health Information Technology standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in section 519(g)(1) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a).CommentsClose CommentsPermalink
1
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of the Health Human Services, acting through the head of the Office of the National Coordinator for Health Information Technology, shall adopt standards, implementation specifications, and certification criteria for the electronic exchange and use in certified electronic health records of a unique device identifier for each device described in paragraph (1), if such an identifier is required by section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.
Shades of Logan’s Run. Is there a provision to make soylent green out of the deceased hidden somewhere in this travesty of a bill?
A class III device and a class II device means: (i) shall be submitted in accordance with part 803 of title 21, Code of Federal Regulations (or successor regulations), unless the Secretary grants an exemption or variance from, or an alternative to, a requirement under such regulations pursuant to section 803.19 of such part, if the device involved is—
(I) a class III device;
(II) a class II device that is permanently implantable, is life supporting, or is life sustaining; or
(III) a type of device which the Secretary has, by notice published in the Federal Register or letter to the person who is the manufacturer or importer of the device, indicated should be subject to such part 803 in order to protect the public health;
The device itself doesn't make it evil. Not until its combined with willful allegiance to AC.
Oh, and the AC hasn't come to power yet. So its kinda hard to vow allegiance to him.
***Chip Police or some other catchy term***
How about COW CHIP?
(Since bovine are the only mandatory recipients now.)
That's chipped beef
I can not find the specific portion of the bill he refers too. Theree is no CLASS II cited in the document.
THis is a case where two different factual trains of thought are mushed together to make a incorrect - at the moment - train of thought.
On one hand it is reported that implantable chips have gotten smaller and smaller, and according to some sources are small enough to be administered through a needle.
Also in this bill it talks about cataloguing and setting up databases of medical devices, and from what I read, it’s not discussing implant chips, but things like pacemakers, artficial limbs, replaced joints, insulin pumps, etc.
To mix the two at this point and say this is what they are asking for in the health care bill is, IMO, incorrect. Especially since they don’t need the health care bill to inject us with tiny chips - they’d just force us to take a vaccine under the guise of an emergency. They already have separate laws for that.
The spirit of Anti Christ is always in the world, and I daresay many have pledged allegiance to him thruout history
Yeh, just call it CHiP's and get Eric Estrada to be the spokeman.
***That’s chipped beef***
LOL
Yes, and here we are beefing about the chips.
lol
Interesting.
I thought they meant pacemakers and similar “devices”. But the public deserves an explanation.
If you search the PDF file for “class II” or “class II device” NO RESULTS show up. Congress won’t even DEFINE
their own terms for the ‘ignorant peasant masses’.
I suppose they want us to look that up in the Medicare Act, or whatever other laws that would contain such definitions.
If not for the Net and independent media, we’d be royally screwed.
This is a great idea!!
Because when old folks with Alzheimer’s, who are denied health care by a government death panel, wander away from home, they can be scanned and returned to their rightful owner just like a dog or cat.
It is startling that we even have to discuss this.
What morons would even consider vague language in a Law that could be used to allow for the implantation of devices that contain various data or perform various functions?
That is exactly why this Bill is a bunch of garbage and why the American people are up in arms against it.
Now if questioned about this, Obama would simply laugh it off and say come on now its not like the government is trying to implant chips in you....
What I really think is Republicans should be standing up and informing the liberals that the control given to government in this legislation is a problem and that if they support this they need to visualize this type of control in the hands of “in their words” a radical right winger President willfully bent on the destruction of Gays and the outlaw of abortion.
Will they still report this jumbled mess then?
I don't think the technology has them quite that small yet. If they were that small the body could, most likely, remove it through normal toxin removal functions. I think you would notice a chip implant. The smallest I have heard about is about 1/64th in. x 1/4 in. That would take a pretty good sized needle. Far larger than those used for flu shots.
Besides....
I will give them permission to chip me. Yep, they can have the mortician put that chip anywhere on whats left of my body that they want. I would assume that those dozens that fall in the battle to forcibly chip me would already have their chips.
NOTE the last paragraph: implanted cerebral stimulators. Every member of Congress should be required to have thos! LOL.
United States
The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.[1] <[>The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).
[edit] Class I: General Controls Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls.
General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures.[2] (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)[2]
These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, elastic bandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the "stated/purported use" of a device, it may be necessary to obtain a Premarket Approval or 510K for the device, which is otherwise classifiable as a Class 1 device. Such devices are referred to as "reserved devices". The electrically powered arthroscope (which is really an endoscope powered electrically) is a case in point. While endoscopes are Class 1 devices, the electrically powered arthroscopes need a pre-market notification (510K) although the manual arthroscopes do not. Pre-market notified devices are marketed as "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."
[edit] Class II: General Controls with Special Controls Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices.
Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance.[2] Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user.
Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material,acupuncture needles.
[edit] Class III: General Controls and Premarket Approval A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."[3]
Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).
Though there have been anti Christ leaders, this ONE will be THE one prophesied about who will lead the world in rebellion against God.
Though chip implants now would soften peoples resistance to later, implants now, ARE NOT the mark of the beast.
If and/or when you see/hear someone telling you you MUST take this chip, in order to buy or sell, and that you MUST vow allegiance to a specific individual, and that THAT INDIVIDUAL IS GOD, then you know thats the mark of the beast.
The taking of that number will seal a persons fate. It WILL NOT be something they can be tricked into. When the person takes the mark, they will be making a willful decision, not just to accept AC, but to REJECT JESUS.
It doesn't mean people won't be pressured to accept the mark. Parents threatened to either accept the mark, and REJECT JESUS, or their child killed. or other things.
Its still willful rejection of Jesus for something else.
It will be a brutal time.
We ain't seen nothing yet.
To me, the language is such that it could be interpreted that a chip would be required if you are in the public insurance pool.
I sent the link to the article to Drudge.
This thread should be deleted before we all look like idiots. The section of the bill is about keeping a record of implanted devices.
The bill is bad enough without people making up stuff. If this gets out the folks we are trying to educate about the bill will never believe anything true we say about it.
Your very own fed ID number and probable budget line item. Balanced against your IRS data, of course.
Welcome to the American Oceania.
We are crossing a bridge too far.
THAT is fabulous!!
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