Will implantable RFID chips become mandatory under healthcare bill?

“(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) Recommendations.–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.

Subtitle D–Grants for Comprehensive Programs To Provide Education to
Nurses and Create a Pipeline to Nursing

http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200IH/html/BILLS-111hr3200IH.html

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This:

“(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.

…. does not rule out micochips. As a matter of fact, I believe it definitely includes them, as it is most certainly a technology they are pushing to facilitate ‘ease’ in obtaining patient records if nothing else … and the rest of the section is describing just that … compiling of data to determine usefulness and reliability of implantable technology.

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