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Implants by Legislation

Analysis of The National Medical Registry Device aka (RFID Chip) in Several Bills & Health Care Reform - (known as Obamacare)
September 8, 2012 at 8:13pm
 
To: General Public & The American People

Say NO! to an enforced - National Medical Registry Device aka Class II and Class III Device (RFID Chip) in the Health Care Reform and In various Bills Presented in Congress (also known as Obamacare)                               

The National Medical Registry - Class II and Class III Devices, also known as (Unique Device Identification System). Presented in Several Bills of Government, such as H.R 3962 and H.R 3200 also know as Obamacare. 

As Government established by LAW that all Americans must have Healthcare, what is not being addressed as to the many who are concerned, is that such care comes with the use of a device that will be IMPLEMENTED in a RFID Chip, also described as a Class II and Class III Device. Such, will allow access to all our Financial, Medical, Immigration Status, Crime and all other information needed as The Secretary of State, seems fit. 

HERE IS A COPY OF THE BILL:: H.R.3962 - Affordable Health Care for America Act

(Introduced in House - NOT PASSED)

SEC. 2571. NATIONAL MEDICAL DEVICE REGISTRY.(a) Registry (1) IN GENERAL- Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended(A) by re-designating subsection (g) as subsection (h); and(B) by inserting after subsection (f) the following:National Medical Device Registry(g)(1)(A) The Secretary shall establish a national medical device registry (in this subsection referred to as the `registry') to facilitate analysis of postmarked safety and outcomes data on each covered device.(B) In this subsection, the term `covered device'--(i) shall include each class III device; and(ii) may include, as the Secretary determines appropriate and specifies in regulation, a class II device that is life-supporting or life-sustaining.(C) Notwithstanding sub paragraph (B)(i), the Secretary may by order exempt a class III device from the provisions of this subsection if the Secretary concludes that inclusion of information on the device in the registry will not provide useful information on safety or effectiveness.(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 Administrator of the Agency for Healthcare Research and Quality, 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 covered device 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 sub paragraph (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 (so as to avoid duplication) with--(i) activities under paragraph (3) of section 505(k) (relating to active postmarked risk identification);(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data);(iii) other postmarked device surveillance activities of the Secretary authorized by this chapter; and(iv) registries carried out by or for the Agency for Healthcare Research and Quality; 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 postmarked safety and patient outcomes for covered devices, 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 program 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 postmarked 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 covered device,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) The Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations--(A)(i) in the case of covered devices that are 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 covered devices that are 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 information submitted pursuant to sub paragraph (A) with patient safety and outcomes data obtained under paragraph (3); and(ii) to permit analyses of linked data;(C) may require covered device manufacturers to submit such other information as is necessary to facilitate postmarked 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 prevalence 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 scientists.(5)(A) The Secretary shall promulgate final regulations under paragraph (4) not later than 36 months after the date of the enactment of this subsection.(B) Before issuing the notice of proposed rule-making preceding the final regulations described in sub paragraph (A), the Secretary shall hold a public hearing before an advisory committee on the issue of which class II devices to include in the definition of covered devices.(C) The Secretary shall include in any regulation under this subsection an explanation demonstrating that the requirements of such regulation--(i) do not duplicate other Federal requirements; and(ii) do not impose an undue burden on device manufacturers.(6) With respect to any entity that submits or is required to submit a safety report or other information in connection with the safety of a device under this section (and any release by the Secretary of that report or information), such report or information shall not be construed to reflect necessarily a conclusion by the entity or the Secretary that the report or information constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or otherwise caused or contributed to a death, serious injury, or serious illness. Such an entity need not admit, and may deny, that the report or information submitted by the entity constitutes an admission that the product involved malfunctioned, caused or contributed to an adverse experience, or caused or contributed to a death, serious injury, or serious illness.(7) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for each of fiscal years 2011 and 2012.'.(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 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 covered device (as defined under section 519(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)).(2) STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA- The Secretary of Health and 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 covered device referred to 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.(c) Unique Device Identification System- The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue proposed regulations to implement section 519(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)) not later than 6 months after the date of the enactment of this Act.
This is what Wikipedia has to say about trying to get this implant system in place.  [Notice there is no mention of these implanted devices being operated with cell phones. No one will be aware of that!]

The Affordable Health Care for America Act (or HR 3962)[1] was a bill that was crafted by the United States House of Representatives in October 29th of 2009. It never became law as originally drafted. At the encouragement of the Obama administration, the 111th Congress devoted much of its time to enacting reform of the United States' health care system. Known as the "House bill", HR 3962 was the House of Representatives' chief legislative proposal during the health reform debate.
On December 24, 2009, the Senate passed an alternative health care bill, the Patient Protection and Affordable Care Act (H.R. 3590).[2] In 2010, the House abandoned its reform bill in favor of amending the Senate bill (via the reconciliation process) in the form of the Health Care and Education Reconciliation Act of 2010.
Under the H.R. 3962 Section 2571, Pg. 1501-1510, you will find - The National Medical Registry.
As you read it you will see the use of a Class II and Class III Device, which is the tool or your can say strategy, by which this National Medical Registry Device will function, as you will now see in the Bill. Description of such devices, can be found by the Federal Drug Administration (FDA) who are responsible for approving such devices.

What does a  National Medical Device Registry mean?
 
National Medical Device Registry from H.R. 3200 [Healthcare Bill], pages 1001-1008: (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; ”(B)and is- ”(i) a class III device; or  ”(ii) a class II device that is implantable, life-supporting, or  life-sustaining.”
 
Then on page 1004 it describes what the term “data” means in paragraph 1,section B:”(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.
 
“What exactly is a class II device that is implantable?  It is NOT worn outside your body! It will contain every item of information collected by the fusion centers. It is also programmable - it can be updated.
Information on whether you are on a blacklist or not, implant you have in your body, which radio stations you are hooked up to, which satellites are used to strike you, RFID and tracking information, body frequencies, all your body frequencies, so anyone who can read this chip can torture you. This is the gateway to Electronic Slavery. [Note:  If you have a high pitched tuning sound in your left ear, you are connected to a radio station! They record your brain activity 24 hrs. a day!]
 
Approved by the FDA, a class II implantable device is an “implantable radio frequency 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.”
 
See it for yourself:
 
https://www.fda.gov/downloads/MedicalDevices/.pdf
 
This new law – when fully implemented – provides the framework for making the United States the first nation in the world to require each and every one of its citizens to have implanted in them a radio-frequency identification (RFID) microchip for the purpose of controlling who is, or isn’t, allowed medical care in their country. Don’t believe it?
 
Look it up yourself. Healthcare Bill H.R. 3200: http://waysandmeans.house.gov/media/pdf/111/AAHCA09001xml.pdf
 
Pages 1001-1008 “National Medical Device Registry” section.Page  1006 “to be enacted within 36 months upon passage”
 
Page 503 “. medical  device surveillance“
 
Why would the government use the word “surveillance” when referring to citizens? 
 
THIS IS THE BASIS OF PHONE STALKING, PEOPLE CONNECTING YOUR MEDICAL SURVEILLANCE IMPLANTS.  The definition of “surveillance” is the monitoring of the behavior, activities, or other changing information, usually of people and often in a secret manner. The root of the word [French] means to “watch over.” In theory, the intent to streamline healthcare and to eliminate fraud via “health chips” seems right.