H.R.3200 - National Human Identification System!
Author: Barbara H. Peterson
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WASHINGTON - November 21, 2009 - Move over, NAIS, here comes NHIS – a National Human Identification System under the FDA. And you thought a tracking system was just for livestock. Well, you are right. To the ruling oligarchy, we the people are just that – livestock to be herded, tracked, culled, and medicated.
Take a look at the following section of HR 3200, which can be found in entirety here. My comments are bolded.
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H.R.3200
Subtitle C—Food and Drug Administration
(This section of HR 3200 specifically sets up the NHIS, or National Human Identification System under the FDA.)
PART 1—IN GENERAL
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
(Notice the word “or” in the following. This means that the device is either implantable, life-supporting, or life sustaining. It can be neither life-supporting or life sustaining, just implantable.)
(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—
(Each device will have a unique identifier. Since the devices are implanted in humans, each human will most likely be registered with that device number.)
(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
(Through this implantable device, surveilled activities will be monitored)
(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—
(Here is the data that will be collected – all health related information, including insurance information, pharmaceutical purchases, health insurance claims, and anything else the Secretary deems necessary, including Medicare and information from the Dept. of Veteran’s Affairs, as well as privately owned health care facilities and pharmacies.)
(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
(Links the data collected with registry information.)
(ii) link data obtained under clause (i) with information in the registry.
(This section sets up the registry files, and allows for the pooling and analysis of the information gleened.)
(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—
(Notice that this is done under the guise of protecting the public health, and the requirement to submit each device’s unique identifyer to the registry is addressed here.)
(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—
(Permits linkage of retrieved information to patients in registry.)
(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); and
(Permits analyses of linked data.)
(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;
(Items included in the registry that are pooled and analyzed include adverse event trends, patterns, and any other information the Secretary deems appropriate. Timely reports to be given to the Secretary concerning data analysis.)
(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.
(Sums to be appropriated to institute the registry. From whom? Taxpayers. We will be paying for our own NHIS system.)
(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 36t 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)’’.
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).
(The information retrieved by the devices will be exchanged and used in electronic health records Health Information Technology – HIT.)
(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,8 Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the device.
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Welcome to the future where everything we do is tracked, analyzed, and used to formulate actuarial tables for insurance companies, food suppliers, medical establishments, pharmaceutical companies, and any private corporation or government entity that the Secretary deems appropriate for public health and safety. And all under the oh so competent hands of the Food and Drug Administration. Feel like a piece of meat? I sure do. All of our movements, purchases, and health statistics, including vaccination records, tracked under the FDA just like a herd of cows.
First NAIS, then NHIS. After all, we are are just another species of animal, right? Just another warm-blooded mammal led around on a leash, herded into corrals and tamed. WRONG! It is time to stand up on our hind legs and fight this takeover by the New World Order oligarchs. It is time to just say NO!
