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Layered deep within the bill itself, however, is an important issue that is infrequently discussed. HR 3590 dramatically changes the relationship between the U.S. government and the medical device industry.
A basic understanding of these policy shifts is critical for the practicing orthopaedic surgeon because they will, in turn, affect physician-industry relationships. This article briefly discusses five key issues regarding HR 3200 and medical devices.
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) RECOMMENDATION - 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.
LINK
Our VeriMed system, which includes our VeriChip, is designed to rapidly and accurately identify people who are unconscious, confused or unable to communicate at the time of medical treatment, for example, upon arrival at a hospital emergency room. The VeriChip is a passive RFID microchip, approximately the size of a grain of rice, which is implanted under the skin in a patient’s upper right arm under the supervision of a physician. The capsule is coated with a polymer, BioBond TM to form adherence to human tissue, thereby preventing migration in the body. Each microchip contains a unique 16-digit identification number. With that identification number, emergency room personnel or EMTs can securely obtain from our or a third party’s database the patient’s pre-approved information, including the patient’s name, primary care physician, emergency contact information, advance directives and, if the patient elects, other pertinent data, such as personal health records. We have not actively marketed the VeriMed system since early 2008.
Originally posted by H1ght3chHippie
This has nothing to do with putting RFID chips into anyones body, but it regulates that the manufacturers of devices that are meant to be implanted into human bodies ( like prostheses, artificial joints, pacemakers, etc ) have to register such devices in a central database in order to start collecting data about their safety and so on.
On top of that it says that all collected data will be accessible by the public and private research organizations to improve the safety of such devices. I am surprised that no national registry of such devices exists already, apparently there are different standards in place per state right now.
But maybe I missed the relevant part ?
Originally posted by EnochWasRight
reply to post by EnochWasRight
Educate yourself into the exact nature of rfid class iii semi-passive biobond. Your new RFID includes some amazing technologies. LINK You can even get your credit report included on the chip. So many uses on such a tiny chip. With a range of 100 meters and increasing, this chip is a wonder of NWO development.
Our VeriMed system, which includes our VeriChip, is designed to rapidly and accurately identify people who are unconscious, confused or unable to communicate at the time of medical treatment, for example, upon arrival at a hospital emergency room. The VeriChip is a passive RFID microchip, approximately the size of a grain of rice, which is implanted under the skin in a patient’s upper right arm under the supervision of a physician. The capsule is coated with a polymer, BioBond TM to form adherence to human tissue, thereby preventing migration in the body. Each microchip contains a unique 16-digit identification number. With that identification number, emergency room personnel or EMTs can securely obtain from our or a third party’s database the patient’s pre-approved information, including the patient’s name, primary care physician, emergency contact information, advance directives and, if the patient elects, other pertinent data, such as personal health records. We have not actively marketed the VeriMed system since early 2008.edit on 21-3-2013 by EnochWasRight because: (no reason given)
Originally posted by H1ght3chHippie
This has nothing to do with putting RFID chips into anyones body, but it regulates that the manufacturers of devices that are meant to be implanted into human bodies ( like prostheses, artificial joints, pacemakers, etc ) have to register such devices in a central database in order to start collecting data about their safety and so on.
On top of that it says that all collected data will be accessible by the public and private research organizations to improve the safety of such devices. I am surprised that no national registry of such devices exists already, apparently there are different standards in place per state right now.
But maybe I missed the relevant part ?
Originally posted by littled16
reply to post by EnochWasRight
And people think that the feds trying to curb our second amendment rights or an economic collapse is what will end up causing a civil war! I would say that trying to force people into allowing them to implant ANY kind of foreign device into their bodies is when the real uprising will begin! I hope they have enough space in their FEMA camps/indoctrination centers for at least half of the citizens of the US if they try it because that dog ain't gonna hunt!
Originally posted by abeverage
So what is the problem with taking this RFID other than of course the typical "Hacking?
We have been id'ing people since we could start writing this is just a digital form of it. Unless you can give me a more nefarious reasons.
Originally posted by seeker1963
reply to post by EnochWasRight
I agree with you that the technology exists. However, in one of the drafts of the Affordable Care Act, there WAS a section on the chips but in the final version, that section was not put into the current bill that was made law.....
Legally, (at this point) I am not aware of any law that requires anyone to be chipped if they do not want it! Not to say in a martial law situation that it may be forced upon people or that "illegally" people may be chipped without their knowledge.......
Agenda 21 is after all part of the globalists plan to inventory EVERYTHING, including people.
Originally posted by VaterOrlaag
reply to post by EnochWasRight
I see yet more misinformed bull#.
Nice try, using stories from a book to justify such ignorance.
Originally posted by H1ght3chHippie
This has nothing to do with putting RFID chips into anyones body, but it regulates that the manufacturers of devices that are meant to be implanted into human bodies ( like prostheses, artificial joints, pacemakers, etc ) have to register such devices in a central database in order to start collecting data about their safety and so on.
On top of that it says that all collected data will be accessible by the public and private research organizations to improve the safety of such devices. I am surprised that no national registry of such devices exists already, apparently there are different standards in place per state right now.
But maybe I missed the relevant part ?
Originally posted by RedShirt73
Originally posted by H1ght3chHippie
This has nothing to do with putting RFID chips into anyones body, but it regulates that the manufacturers of devices that are meant to be implanted into human bodies ( like prostheses, artificial joints, pacemakers, etc ) have to register such devices in a central database in order to start collecting data about their safety and so on.
On top of that it says that all collected data will be accessible by the public and private research organizations to improve the safety of such devices. I am surprised that no national registry of such devices exists already, apparently there are different standards in place per state right now.
But maybe I missed the relevant part ?
I agree with your assessment. I believe we have something similar in Canada. All medical devices used inside or outside the body have to be registered so that health care officials, the companies who make the devices and the patients are informed as to how the device works and if there are any issues with a particular device. As well this information can be easily accessed by all.
Originally posted by EnochWasRight
Originally posted by abeverage
So what is the problem with taking this RFID other than of course the typical "Hacking?
We have been id'ing people since we could start writing this is just a digital form of it. Unless you can give me a more nefarious reasons.
Other than the fact that the Bible expressly predicts this technology in Revelation 13, It is a form of control over commerce. The first step is to mandate that you purchase obamacare. The next step is the same story, second verse. We also have the coming UNESCO Carbon Tax and Trading System for the new monetary system. Do a search for UNESCO and Carbon Trading. What do you see?
UNESCO and Biosphere Reserves for Carbon Trading
Originally posted by abeverage
Originally posted by EnochWasRight
Originally posted by abeverage
So what is the problem with taking this RFID other than of course the typical "Hacking?
We have been id'ing people since we could start writing this is just a digital form of it. Unless you can give me a more nefarious reasons.
Other than the fact that the Bible expressly predicts this technology in Revelation 13, It is a form of control over commerce. The first step is to mandate that you purchase obamacare. The next step is the same story, second verse. We also have the coming UNESCO Carbon Tax and Trading System for the new monetary system. Do a search for UNESCO and Carbon Trading. What do you see?
UNESCO and Biosphere Reserves for Carbon Trading
There already are forms of control over commerce and trade it is called MONEY! I already exchange money in my hand to another hand! Now I was hoping this would have a religious slant to it because if you take the mark so what?
Religious or not I doubt there will be many who will not have to be forced to take this implant...So it will have to be forced! What if I AM FORCED TO TAKE THE MARK? Then what? I go to hell?