WE ARE NOT TAKING THE MARK OF THE BEAST!!! Page 1004 of the new law (dictating the timing of this chip), reads, and I quote: “Not later than 36 months after the date of the enactment” 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 post-market 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.” 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.” 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! “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.”
Posted on: Wed, 25 Jun 2014 20:01:58 +0000
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