The RFID Chip

Here’s some further information on the Radio Frequency ID Chip.  According to the bill’s language, the RFID chip language begins on page 1,000 of the Affordable Health Care Act:

“National Medical Device Registry”

(1)The Secretary shall establish a national medical device 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

a.       (i) a class II device; or

b.      (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 date 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(l) (relating to active postmakret 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 enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.”

The bill goes on to say, on page 1006:

“(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. 300 jj-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).”

So, the RFID Chip Implant is not specifically mentioned in the Health Care Bill.  However, it is an actual medical device used to record information that is implanted under a patient’s skin.  It qualifies as one of the medical devices.

The danger here isn’t that the bill doesn’t mention this chip implant specifically, but that the Supreme Court ruling, and various other regulations within the Health Care Act, could eventually be construed as authority for the government to mandate that everyone have this implant.  The chip itself is not a figment of someone’s imagination; it exists.   The language of this bill – in various places - is just porous enough to allow the government to make such a mandate a reality.

A government that could require every citizen to purchase health care insurance, whether they want it or can afford it, can certainly authorize everyone to have this chip implanted.  Remember:  we didn’t think that Obamacare would pass the Constitutional test in the Supreme Court, but it did.  Thanks to SCOTUS, the federal government can now force us to purchase anything (or pay a fine for not doing so).

Although advocates of Obamacare would dismiss reports of the RFID Chip Implant as conspiratorial scare stories, this thing is a reality and something to be extremely concerned about in the future.  Right now, the language may only imply tracking of, say, a pacemaker.  We’ve seen what an overreaching government can do, however, and it’s certainly not beyond this administration’s capacity, at any time, to mandate this particular device for everyone.  Justification could be as simple as determining that it's necessary in case of an automobile accident.

SCOTUS and the language of the Obamacare bill have simply paved the way for such an implementation.  Be scared.  Be very, very scared.  We’ve already seen that, with this president, anything is possible and likely.