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US Health Care Bill (PDF) in a “non-discussed” section titled: Subtitle C-11 Sec. 2521— National Medical Device Registry, and which states its purpose as…….. He quotes that part of the law and then goes on to say: "In “real world speak”, according to this report, 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 microchip for the purpose of controlling who is, or isn’t, allowed medical care in their country".

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Welcome to Skeptics! Please reference who you are quoting. I think you are trying to repeat this claim, but it isn't clear. –  Oddthinking Sep 14 '12 at 2:24

1 Answer 1

Well, this comes down to dismissing paranoid claims as to what the language actually says... I did a search for 2521 in the text of the bill, and didn't come up with anything remotely resembling this claim. What I did find was:

Sec. 2521. Comprehensive programs to provide education to nurses and create a pipeline to nursing.

I searched for the words "National Medical Device Registry' and came up with this (I'd start being suspicious if they can't even get the part they are paranoid about right):

SEC. 2561. 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 redesignating subsection (g) as subsection (h); and

       (B) by inserting after subsection (f) the following: '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.

            ‘(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 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 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 information 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 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) To carry out this subsection, there are authorized 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 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).

      (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.

First of all, I don't see how this is "non-discussed" when it is available for all people with internet access...

All this legal language really says is that medical devices that we already use (things like pacemakers, blood analysis machines, etc.) will be kept track of for purposes of taxation and safety. This is really a continuation of an already existing bit of FDA law, with the addition of allowing the government to track and tax devices at the manufacturing level.

There is no mention of making the insertion of devices mandatory, nor is there any mention of tracking the patients who may even have the type of devices that are inserted into them (such as pacemakers, insulin pumps, etc.) outside of standard medical practice. And there is zero mention of anything like an RFID.

The absence of evidence in this case is indeed evidence of absence, and it seems Snopes agrees with my search of the actual bill.

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Can someone clean this up? I need to go to bed and get rested for work. I have no idea what is causing the code reaction from my paste directly from the bill... –  Larian LeQuella Sep 14 '12 at 2:36
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I fixed it; the issue was spacing before blockquoted lines. I had to add several spaces to the start of the top two lines. Sorry about changing some wording but I had to change 6+ chars for the edit to be valid. –  William Grobman Sep 14 '12 at 3:53
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Thank you very much. –  Larian LeQuella Sep 14 '12 at 10:25
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Thank you for always contributing such well written and researched answers. I'm glad I could help. –  William Grobman Sep 14 '12 at 15:07
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@sabertabatabaeeyazdi you seem to be missing the entire debunking. There is no provision to place RFID chips in the body. That's the point, it's a paranoid delusion. –  Larian LeQuella Mar 23 '13 at 3:10

protected by Community Mar 2 '13 at 4:24

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