Required RFID implanted chip
Sec. 2521, Pg. 1000 – The government will establish a National Medical Device Registry. What does a National Medical Device Registry mean?
National Medical Device Registry from H.R. 3200 [Healthcare Bill], pages 1001-1008:
(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; ‘‘(B)and is— ‘‘(i) a class III device; or ‘‘(ii) a class II device that is implantable, life-supporting, or life-sustaining.”
Then on page 1004 it describes what the term “data” means in paragraph 1,
‘‘(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”
From H.R. 3200 on Thomas.gov
PART 1–IN GENERAL
SEC. 2561. NATIONAL MEDICAL DEVICE 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
`(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.