H.R. 3200 section 2521, Pg. 1001, paragraph 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— ‘‘is or has been used in or on a patient; ‘‘and is— ‘‘a class III device; or ‘‘a class II device that is implantable, life-supporting, or life-sustaining.”
What exactly is a class II device that is implantable? As you saw earlier, it is the device approved by the FDA in 2004.
Federal Food, Drug, and Cosmetic Act:
http://www.fda.gov/downloads/MedicalDev ... ionandGuid…
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.”
Going back to what we just looked at, the creation of the national medical device registry in section 2521, page 1002 line 5:
“In developing the registry, the secretary shall…”
And the law continues on with a laundry list of items that the secretary must do in the process of creating this registry. In this laundry list of items to do, Line 17, subparagraph 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)”
Going back to subparagraph A [right above subparagraph B], it says: “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;” Don’t be confused by the intentional obfuscation and skillful wording, This law first creates the national device registry and then immediately list all the task the secretary of health and human services will have do in the process of creating this registry.
The very first two items in the list mandates that the secretary first gives a unique identification to each of the items listed in paragraph 1 which is:
‘‘a class III device; or ‘‘a class II device that is implantable.”
Then, the very next thing the secretary is to do is to create the process by which “patient safety and outcomes data from multiple sources”, which is electronic medical records, that are linked to these newly and uniquely identified items from paragraph 1 which are the class III and class II implantable devices.
Class III devises are items such as breast implants, pacemakers, heart valves, etc. A Class II device that is implantable is, as you seen from the FDA, an implantable radio frequency transponder, RFID chip. From breast implants, to pacemakers, to RFID chips which one is the only possible one that can used for the stated purpose in section B which is, “for linking such data with the information included in the registry”? As we know from subsection A, the information in the registry is the name of a device. In plain speak, we are in a clear way being told that our electronic medical records are going to be linked to a class II implantable device! Continuing a few lines down in this same section, section B subsection ii on still on page 1002, the “patient safety and outcomes data from multiple sources”, that is to be linked is clearly spelled out as electronic medical records. It reads: “link data obtained under clause (i) with information in the registry”. Information in the registry is, as we know from subparagraph A, the name of the device. So what is the data obtained under clause i? Back up a few lines to clause i It reads: “obtain access to disparate sources of patient safety and outcomes data, including Federal health-related electronic data”. Again, from breast implants, to pacemakers, to RFID chips which one is the only possible one that can used for the stated purpose in section B? That stated purpose is “for linking such data” and the such data is electronic medical records. What we already have already seen in just the creation of this registry, is the device that will serve as the link, which is an RFID microchip that is categorized as a Class II implantable device, as well as what it will be the link for which is your electronic medical records.
In case the law wasn’t clear enough on that point, still in the laundry list of things to do a few more lines down on the next page, page 1005
“The Secretary to protect the public health; shall establish procedures to permit linkage of information submitted pursuant to subparagraph (A, remember subparagraph A is the class 2 implantable device reference) with patient safety and outcomes data obtained under paragraph (3, which is electronic medical records); and to permit analyses of linked data;” Continuing on to page 1007, in the STANDARDS, IMPLEMENTATION CRITERIA, AND CERTIFICATION CRITERIA section, the secretary of health and human services is given full power to intact all mandates from the laundry list of to-do items in the creation process of the registry as well as dictate how the devises listed in the National Medical Device Registry are to be used and implemented. “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 (National Medical Device Registry), 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.” Now on Page 503, section E Lines 13-17 and I quote: “encourage, as appropriate, the development and use of clinical registries and the development of clinical effectiveness research data networks from electronic health records, post marketing drug and medical device surveillance efforts”. Let me say that again, medical device surveillance efforts! Now lets look at section 163 of HR3200, which gives the government a direct electronic access to your bank account which will work in conjunction with an implanted chip. Page 58 Lines 5 through 15 reads:
(D) enable the real-time (or near real time) determination of an individual’s financial responsibility at the point of service and, to the extent possible, prior to service, including whether the individual is eligible for a specific service with a specific physician at a specific facility, which may include utilization of a machine-readable health plan beneficiary identity detection card; (E) enable, where feasible, near real-time adjudication of claims. What does this mean? It means that the government will give everybody a health ID card that contains a machine readable device (magnetic strip or RFID chip) similar to a credit card. Embedded in this chip or strip is your Health Identification Number. When you visit a medical provider, the medical claims will be processed while you are still in the office. The medical providers will be paid in real time. The portion that you owe will be deducted from your bank account, in real time, according to HR 3200. Notice here in this part which is at the beginning of 2000 plus pages of the law, it is carefully worded “which may include utilization of a machine-readable health plan beneficiary identity detection card”. Here we are told that it may be a card. As you have already seen, deeper in the law [Sec. 2521 Pg. 1000] what this “may” utilize is clearly spelled out as a “class II device that is implantable”. We can only speculate at this point why the law is set up this way. Most likely this section was written to account for the gap in time from when the process of chipping begins to when everyone has received a chip. A means of starting with a card for the sake of expedience while the process of chipping citizenry plays out.
Posted: Wed Mar 20, 2013 8:53 am