EBOOKS Y LIBROS TRADICIONALES A TU ALCANCE EN AMAZON - TODOS LOS EBOOKS SON GRATIS AL SUSCRIBIRTE A KINDLE UNLIMITED

Saturday, February 11, 2012

La propuesta de una marca de IMPLANTE EN LA PIEL de los humanos como parte de la reforma de salud americana es real

La propuesta de una marca de IMPLANTE EN LA PIEL de los humanos como parte de la reforma de salud americana es real tal y como se expone en el “America's Affordable Health Choices Act of 2009” y debe ser efectiva en 2013.

Si usted va a la sección donde dice:

National Medical Device Registry  (Instrumento de Registro Medico Nacional)  H.R.3200 - America's Affordable Health Choices Act of 2009

Allí encontrará lo siguiente:

H.R.3200

America's Affordable Health Choices Act of 2009 (Introduced in House - IH)

 

`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.

___________________________________________

¿A qué se refieren cuando hablan de un “device” Clase II y Clase III?

Vea:  en (punto) wikipedia (punto)org/wiki/Medical_device

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. The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).

Class I: General controls

Class I devices are subject to the least regulatory control. Class I devices are subject to "General Controls" as are Class II and Class III devices.  General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

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 existing methods are available to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. A few Class II devices are exempt from the premarket notification. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.

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 usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury  Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.

Medical devices incorporating RFID

In 2004, the FDA authorized marketing of two different types of medical devices that incorporate radio-frequency identification, or RFID. The first type is the SurgiChip tag, an external surgical marker that is intended to minimize the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries. The tag consists of a label with passive transponder, along with a printer, an encoder and a RFID reader. The tag is labeled and encoded with the patient's name and the details of the planned surgery, and then placed in the patient's chart. On the day of surgery, the adhesive-backed tag is placed on the patient's body near the surgical site. In the operating room the tag is scanned and the information is verified with the patient's chart. Just before surgery, the tag is removed and placed back in the chart.

The second type of RFID medical device is the implantable radiofrequency transponder system for patient identification and health information. One example of this type of medical device is the VeriChip, which includes a passive implanted transponder, inserter and scanner. The chip stores a unique electronic identification code that can be used to access patient identification and corresponding health information in a database. The chip itself does not store health information or a patient's name.

 Practical and information security considerations


Companies developing RFID-containing medical devices must consider product development issues common to other medical devices that come into contact with the body, are implanted in the body, or use computer software. For example, as part of product development, a company must implement controls and conduct testing on issues such as product performance, sterility, adverse tissue reactions, migration of the implanted transponder, electromagnetic interference, and software validation.

Medical devices that use RFID technology to store, access, and/or transfer patient information also raise significant issues regarding information security. The FDA defines "information security" as the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. At its core, this means ensuring the privacy of patient information.

Four components of information security

The FDA has recommended that a company's specifications for implantable RFID-containing medical devices address the following four components of information security: confidentiality, integrity, availability and accountability (CIAA).
·                    Confidentiality means data and information are disclosed only to authorized persons, entities and processes at authorized times and in the authorized manner. This ensures that no unauthorized users have access to the information.
·                    Integrity means data and information are accurate and complete, and the accuracy and completeness are preserved. This ensures that the information is correct and has not been improperly modified.
·                    Availability means data, information and information systems are accessible and usable on a timely basis in the required manner. This ensures that the information will be available when needed.
·                    Accountability is the application of identification and authentication to ensure that the prescribed access process is followed by an authorized user.
Although the FDA made these recommendations in the context of implantable RFID-containing medical devices, these principles are relevant to all uses of RFID in connection with pharmaceuticals and medical devices.

Fuente:

1) opencongress (PUNT0) org/bill/111-h3200/show

2) thomas (PUNTO) loc (PUNTO) gov/cgi-bin/query/z?c111:h3200:

3) thomas (PUNTO) loc (PUNTO) gov/cgi-bin/query/F?c111:1:./temp/~c111jpv5EB:e1188186:


4) en (punto) wikipedia (punto)org/wiki/Medical_device

Conclusión:
Los gobiernos están usando el tema de la salud para ir imponiendo sus “adelantos tecnológicos” sobre los humanos lo que les da lugar para ir adelantando sus planes de ir sellando a los humanos como mercancía de compra-venta e ir experimentando sus sistemas de control social por medio de tecnología de rastreo microchip-computadora-satélite. ¿Será esta la tecnología que luego convertirán en la manera para comprar y vender de la que habla la Biblia cuyo número de identificación es 666?

“Y hacía que a todos, pequeños y grandes, ricos y pobres, libres y esclavos, se les pusiese una marca en la mano derecha, o en la frente; y que ninguno pudiese comprar ni vender, sino el que tuviese la marca o el nombre de la bestia, o el número de su nombre. Aquí hay sabiduría. El que tiene entendimiento, cuente el número de la bestia, pues es número de hombre. Y su número es seiscientos sesenta y seis.” (Apocalipsis 13:16-18)
 

  ¿Estará la elite de adinerados e influyentes del mundo detrás de todo esto para ir adelantando su plan de control global del Nuevo Orden Mundial?

¿Qué significado tiene todo esto? Que tanto Estados Unidos, Europa, Francia, Rusia, y las demás potencias del mundo SON MERAS MARIONETAS DE UN MISMO SISTEMA DE CONSPIRADORES.

NOTA: No importa que digan que implantaran un microchip en los humanos, o que luego digan que no lo harán. Simplemente, cuando lo traten de imponer o lo hagan de forma compulsoria ¡RECHÁZALOS!  Vale más lo eterno que los sufrimientos que se pasen en esta tierra.  Ahora mismo se anuncia que la sección del microchip (RFID) no ha sido aprobada, sino simplemente contemplada como una posibilidad.  Hemos estudiado el documento publicado por el gobierno y habla claramente sobre los microchip sobre la piel de los humanos, sin embargo, hay ciertas estrategias que están usando para “retractarse” o suavizar el contenido de lo qua ya anunciaron o tienen intenciones de implantar. Ahora hablan de la aprobación de “partes” del Obamacare, y afirman que no se incluye el microchip. Sin embargo, ya la gente le vio las uñas al gato.