***(Update - April 3, 2012) - Please see my note in the comments below. The proposed health bill embedded here is an older version of the House health care bill (HR 3200). Obamacare (HR 3590) DOES NOT contain the microchip provision that was in the older version.
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As I read page 1014 of H.R. 3590, it certainly seems like this health care reform bill includes a provision that discusses the potential for RFID implantable microchips. You can read the bill at this link. This provision speaks on the analysis of postmarket safety and outcomes data on various medical devices, including Class II devices.
The FDA has established standards for an implantable radiofrequency transponder systems (a/k/a RFID chips) that are Class II compliant (see above embedded document or on the FDA page). However, these RFID chips will have patient identification and health information. While the bill does not require mandatory RFID microchip implantation, it does establish an initial framework where the scope could be expanded with future legislation and regulation. For further information on one type of chip like this, see Microchip Implant Links All Medical Records, Credit History and Social Security Identification Numbers.
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H.R. 3590 amends Section 519 of the Food, Drug and Cosmetic Act (21 U.S.C .360i). Here is the applicable language from H.R. 3590 (page 1,014):
(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...
3(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.
******
As I read page 1014 of H.R. 3590, it certainly seems like this health care reform bill includes a provision that discusses the potential for RFID implantable microchips. You can read the bill at this link. This provision speaks on the analysis of postmarket safety and outcomes data on various medical devices, including Class II devices.
The FDA has established standards for an implantable radiofrequency transponder systems (a/k/a RFID chips) that are Class II compliant (see above embedded document or on the FDA page). However, these RFID chips will have patient identification and health information. While the bill does not require mandatory RFID microchip implantation, it does establish an initial framework where the scope could be expanded with future legislation and regulation. For further information on one type of chip like this, see Microchip Implant Links All Medical Records, Credit History and Social Security Identification Numbers.
###
H.R. 3590 amends Section 519 of the Food, Drug and Cosmetic Act (21 U.S.C .360i). Here is the applicable language from H.R. 3590 (page 1,014):
(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...
3(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.
2 comments:
i don't see it in the bill http://www.opencongress.org/bill/111-h3590/text .... wheres the real prove guy?
You are correct. It's not in the final bill text. When I originally posted this article on March 24, 2010, I was reviewing an older version of the House bill (http://web.archive.org/web/20100320074148/http://budget.house.gov/doc-library/FY2010/03.15.2010_reconciliation2010.PDF) that DID include these provisions.
These microchip provisions were NOT in the final bill that was signed by Obama.
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