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After adding trillions to the debt on big-government policies most Americans didn't ask for and which we couldn't afford, Democratic leaders say they need more money, which they intend to take from small business, even though small businesses create the majority of new jobs.
Mitch McConnell
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I'm sounding off on this..... It's long but read it!
THE IMPLANTABLE RFID CHIP- IS IN THE HEALTHCARE BILL! once the entire population is "chipped" - they can shut you down for failure to comply with any of their crimes, sins and laws- this would cut you off from healthcare- banking- making purchases- and in a nutshell- living.
Nationa...l 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.
(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— ‘‘(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;
(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 (i) data provided to the Secretary under other provisions of this chapter; and ‘‘(ii) information from public and private sources identified under paragraph (3); ‘‘(C) integrating the activities described in this subsection with—
(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification);
(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data); and
(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; and (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.
(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—
(i) obtain access to disparate sources of patient safety and outcomes data, including—
(I) Federal health-related electronic data (such as data from the Medicare pro-gram under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs);
(II) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and
(III) other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness;
and
(ii) link data obtained under clause (i) with information in the registry.
(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.
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— ‘‘(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; and (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;
(B) shall establish procedures— ‘‘(i) to permit linkage of nformation submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and (ii) to permit analyses of linked data; (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; (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 preva-ence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; and
(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 sci-
entists.
(5) To carry out this subsection, there are author-ized to be appropriated such sums as may be necessary for fiscal years 2010 and 2011.’’.
(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.
(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)’’.
(b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE IDENTIFIERS.—
(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 Na-
tional 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).
(2) STANDARDS, IMPLEMENTATION CRITERIA, AND ERTIFICATION 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.
a “class II implantable device.” I’m trying to figure out what that means:
Btw, this doesn’t sound like a pacemaker to me) “This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The device is intended to enable access to secure patient identification and corresponding health information in humans. This guidance is issued in conjunction with a Federal Register notice announcing the classification of
implantable radiofrequency transponder system for patient identification and health information.”
Could you also help me understand: what do suppose it means on p 503 ”
medical device
 |
| COMPLETE FAILURE |
surveillance?”
Call me paranoid, but I’d like to know what is going on…. I’d feel more comfortable second guessing these things before the fact….rather than after. These are serious red flags that we need to pay careful attention to…imo.
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H–MEDICAL DEVICES
PART 880 — GENERAL HOSPITAL AND PERSONAL USE DEVICES
Sec. 880.6300
Implantable radiofrequency transponder system for patient identification and health information. And if you have a public health system then you naturally need to register the patients to eliminate abuse of the system.
§ 880.6300 21 CFR Ch. I (4–1–06 Edition)
(b) Classification. Class I (general controls).
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 54 FR 25050, June 12, 1989; 66 FR 38806, July 25, 2001]
§ 880.6300 Implantable radiofrequency transponder system for patient identification and health information.
(a) Identification. An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information.
This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.
(b) Classification. Class II (special controls). The special control is FDA’s guidance document entitled ‘‘
Class II Special Controls Guidance Document:
Implantable Radiofrequency Transponder System for Patient Identification and Health Information.’’ See § 880.1(e) for the availability of this guidance document. This device is exempt
from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations
in § 880.9.
[69 FR 71704, Dec. 10, 2004] § 880.6320 AC-powered medical examination light.
(a) Identification. An AC-powered medical examination light is an ACpowered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
((( my insert here: ahem. you will bend over……….)))
(b) Classification. Class I (general controls).
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. [45 FR 69682–69737, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, 2001]
(a) Identification. A battery-powered medical examination light is a batterypowered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
(b) Classification. Class I (general controls).
The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device also is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[45 FR 69682–69737, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]
§ 880.6375 Patient lubricant.
(a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
(b) Classification. Class I (general controls).
[45 FR 69682–69737, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001]
§ 880.6430 Liquid medication dispenser.
(a) Identification. A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.
(b) Classification. Class I (general controls).
The device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[45 FR 69682–69737, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001]
§ 880.6450 Skin pressure protectors.
(a) Identification. A skin pressure protector is a device intended for medical VerDate Aug<
Radio Frequency Implantable Device (RFID) use on humans can no longer be claimed as speculation or theory. Their use is now well documented and integrated in several planned strategies for the U.S. Department of Health and Human Services and Health Care Bills. These disturbing initiatives will see microchip implants embedded inside every American, and possibly inside every human within the next few years.
Richard Schmid has worked in radiological health for more than a decade. He has been researching RFID chips for most of his professional career and has worked extensively with RF devices in all levels of radiological medicine. He admits that his analysis of U.S. Health Care Bills and RFID documentation is alarming. “I don’t think most people understand the magnitude of what is happening with the health care legislation being imposed on Americans,” he stated.
Schmid says that RFID chips have already been implanted in thousands of people around the world, many without their knowledge. “Some of these devices are so small and scalable, that they are capable of being inserted in food, patches, medications, hypodermic needles and even inside vaccines.” A recent report from PreventDisease.com detailed how populations are being primed for nano-microchips inside vaccines.
“I used to joke with colleagues about pandemic scenarios and airborne plagues and how that would be the only way for people to submit to implantable chips….I just never thought it would come true in the exact scenario I had imagined.” Schmid said that the current situation in the Ukraine and media blackout in the west are a bad sign of things to come.
As the World Health Organization (WHO) continues to deceive the world on the current pandemic affecting the Ukraine and surrounding area, many experts well-versed in the WHO’s manipulation are calling the current reporting of Ukraine’s pandemic as one of the most deceptive in the agency’s history. Not only is the WHO refusing to release the actual number of deaths, but they also continue to delay the release of critical sequencing data for the mutated strain. The illness has infected well over one million people in the Ukraine and has spread to neighboring countries with similar infection rates. The actual number of deaths are rumoured to be much higher than those reported by the Ukraine government and the WHO.
Schmid added that people who initially refuse the device will not be able to obtain or renew essential documents like passports, driver’s licenses, med cards, and all credit/banking cards. “It’s a totally new electronic system, but they’ve been developing it for years and it will soon be integrated with all National ID cards around the world.” Schmid says the public will not be able to get back on to the grid without the RFID, something that will eventually be required from every nation.
In December 10, 2004, a document was released by the U.S. Department of Health and Human Services that detailed special controls guidance for radio frequency transponders of patient identification. The document details everything from the performance testing to the electromagnetic and resonance imaging capabilities of the device. The FDA cleared VeriChip for medical applications in the U.S. two months before the document was released.
VeriChip is the first Food and Drug Administration (FDA)-approved human-implantable radio-frequency identification (RFID) microchip. About twice the length of a grain of rice, the device is typically implanted above the triceps area of an individual’s right arm. Once scanned at the proper frequency, the VeriChip responds with a unique 16 digit number which could be then linked with information about the user held on a database for identity verification, medical records access, and used for identification by a third party.
In May 2005, the U.S. Congress passed the “Real ID” Act, which required states to issue federally approved driver’s licenses or identification (ID) cards to those who live and work in the United States. The identity cards will eventually be integrated with the RFID chips if one wants to drive, visit a federal government building, collect Social Security, access a federal government service or use the services of a private entity (such as a bank or an airline) that is required under federal law to verify customer identity. The goal is to make it nearly impossible to live without such an ID.
A Florida-based company that boasts selling the world’s first and only federally approved radio microchip for implanting in humans is now turning its development branch toward “emergency preparedness,” hoping to produce an implant that can automatically detect in its host’s bloodstream the presence of swine flu or other viruses deemed a “bio-threat.”
VeriChip Corporation currently sells a small, under-the-skin Radio Frequency Identification capsule, or RFID, that patients can opt to have implanted, containing a number computer-linked to their medical records, enabling doctors with a special reader to access the information even if the patient is unconscious or unidentified.
But VeriChip has also turned its attention to other uses for the technology, including microchips that be used to tag and log human remains after a disaster and implants the company hopes will be able to warn if their host is infected with the H1N1 swine flu virus, the H5N1 bird flu virus or other pandemic agents deemed to be a “bio-threat.”
VeriChip has also announced earlier this month additional forays into emergency preparedness through its VeriTrace system.
According to a statement, the company sold a VeriTrace system, including 1,000 RFID microchips, to Kentucky’s Green River District Health Department “for disaster preparedness and emergency management needs.”
The company explains that VeriTrace, a separate system from its virus detection or patient records technology, was created in the aftermath of Hurricane Katrina, where it was used by the Federal Disaster Mortuary Operational Response Team. The system includes the microchips, a Bluetooth handheld reader, a customized camera that receives both RFID scanned data and GPS data wirelessly and a web-based database for storing information and images captured during emergency response operations.
The microchips are implanted in human remains following a disaster or, according to one report from the Katrina catastrophe, duct-taped to bones, in order to maintain detailed records, particularly in events that result in hundreds or thousands of fatalities.
It goes without saying, of course, that this new “Med-Chip” these American’s will be forced to have put inside them will not only control their access to medical resources, but will also enable their government to know their whereabouts, spending habits, and so much more…
And for those American’s believing they will be able to escape from having these Med-Chips implanted in them they better think again, because, as they will soon discover to their horror, under the laws of their country designed to protect them against pandemics, and other such health emergencies, their president, and governments, have unlimited power and can order their citizens to do, or take, anything their officials tell them to.
The news that Novartis wants a deal with Proteus Biomedical to produce a microchip implant called “Raisin” that will text your mobile phone when it’s time to take another pill, and VeriChip’s efforts to link microchip implants to online health records, has caused two separate controversies that seem bound to collide:
some Christians believe the devices are eerily similar to the “mark of the beast” as described in the book of Revelation; while “singularity” buffs — those who look forward to the merger of humans and intelligent technology — regard it as a bold step forward in improving health.
A seriously chilling “confidential” report prepared by the US-based Russian think tank Institute for Democracy and Cooperation (IDC), and given to President Medvedev’s office this week, on the turmoil surrounding the “health care” debate currently raging in the United States claims that this “engineered controversy” is, in fact, being used as a “cover” to mask the planned microchiping of the entire American population by 2012.
According to this report, America’s propaganda corporate-government media organs have embarked this past summer on a programme of dividing its citizens along its many false fracture lines (racial/right-left/Democrat-Republican, pro gun-anti gun, etc.) over the Obama administrations plan to provide for the American people universal health care coverage.
To how far the Obama administration has already gone in their planning to put these Med-Chips in their citizens, one only need look at the curious interactions between the US government and the only company licensed in the United States (since 2004) to implant microchips in human beings called the VeriChip Corporation.
Now what is widely known about the VeriChip Corporation and their microchip we can read from one report that states:
“VeriChip is the first Food and Drug Administration (FDA)-approved human-implantable radio-frequency identification (RFID) microchip. It is marketed by VeriChip Corporation, a subsidiary of Applied Digital Solutions, and it received United States FDA approval in 2004. About twice the length of a grain of rice, the device is typically implanted above the triceps area of an individual’s right arm.[1] Once scanned at the proper frequency, the VeriChip responds with a unique 16 digit number which could be then linked with information about the user held on a database for identity verification, medical records access and other uses. The insertion procedure is performed under local anesthetic in a physician’s office. As an implanted device used for identification by a third party.”
What is NOT widely known about this VeriChip Corporation is the “new direction” they have taken since Obama has taken office, and as we can read directly from the website of their new subsidiary, VeriGreen Energy Corporation, and which says:
“In March 2009, the Company formed a new subsidiary, VeriGreen Energy Corporation, to invest in the clean and alternative energy sector. The Company is currently evaluating several opportunities and is looking to invest in companies with existing operations and infrastructure.
Following the recently signed stimulus package, which will invest nearly $79 billion in renewable energy, the Company’s investments in clean and alternative sources of energy will complement its existing healthcare initiatives.”
Now, what this IDC report says about VeriChip Corporation’s “sudden conversion” from being a maker of implantable microchips, to one of becoming a “green energy” giant lies not with them, but rather with Obama’s “Green Jobs Czar”, Van Jones, a man who is not only one of his President’s closest advisors, but is also an unashamed, and unapologetic, leftist radical and communist who is the sole determiner in who does, or doesn’t, receive billions in US taxpayer dollars already approved into law for dispersal for American’s green energy future, including an estimated $3 Billion to VeriGreen Energy Corporation.
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…
Approved by the FDA, a
class II implantable device is a “implantable radiofrequency transponder system for patient identification and health information.” The purpose of a class II device is to collect data in medical patients such as “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.”
This sort of device would be implanted in the majority of people who opt to become covered by the public health care option. With the reform of the private insurance companies, who charge outrageous rates, many people will switch their coverage to a more affordable insurance plan. This means the number of people who choose the public option will increase. This also means the number of people chipped will be plentiful as well. The adults who choose to have a chip implanted are the lucky (yes, lucky) ones in this case. Children who are “born in the United States who at the time of birth is not otherwise covered under acceptable coverage” will be qualified and placed into the CHIP or Children’s Health Insurance Program (what a convenient name). With a name like CHIP it would seem consistent to have the chip implanted into a child. Children conceived by parents who are already covered under the public option will more than likely be implanted with a chip by the consent of the parent. Eventually everyone will be implanted with a chip. And with the price and coverage of the public option being so competitive with the private companies, the private company may not survive.
I wish you success in your quest to live your life on your terms.
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