THis can be found on page 1013 starting on the bottom of page 1013  Of H.R. 4872 of Obamacare.

        Subtitle C—National Medical Device Registry

SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.

(a) REGISTRY.—

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1014 (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 sub- section (h); and

(B) by inserting after subsection (f) the following:

‘‘National Medical Device Registry ‘‘(g)(1) The Secretary shall establish a national med- ical 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 Coordi- nator for Health Information Technology, and the Sec- retary of Veterans Affairs, determine the best methods for—

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1015 ‘‘(A) including in the registry, in a manner con-

sistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique iden- tifier;

‘‘(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), in- cluding, 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 sec-

tion 505(k) (relating to active postmarket risk identification);

‘‘(ii) activities under paragraph (4) of sec- tion 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

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1016 ‘‘(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, aca- demic, and private entities, develop methods to—

‘‘(i) obtain access to disparate sources of patient safety and outcomes data, including—

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‘‘(I) Federal health-related electronic data (such as data from the Medicare pro- gram under title XVIII of the Social Secu- rity 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 as- sessment of device safety and effectiveness; and

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1017 1 ‘‘(ii) link data obtained under clause (i)

2 with information in the registry. 3 ‘‘(B) In this paragraph, the term ‘data’ refers to in- 4 formation respecting a device described in paragraph (1), 5 including claims data, patient survey data, standardized 6 analytic files that allow for the pooling and analysis of 7 data from disparate data environments, electronic health 8 records, and any other data deemed appropriate by the 9 Secretary.

10 ‘‘(4) Not later than 36 months after the date of the 11 enactment of this subsection, the Secretary shall promul- 12 gate regulations for establishment and operation of the 13 registry under paragraph (1). Such regulations—

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‘‘(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 manufac- turers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under sub- section (f), other unique device identifier; and

‘‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may re- quire manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;

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1018 ‘‘(B) shall establish procedures—

‘‘(i) to permit linkage of information sub- mitted pursuant to subparagraph (A) with pa- tient safety and outcomes data obtained under paragraph (3); and

‘‘(ii) to permit analyses of linked data; ‘‘(C) may require device manufacturers to sub- mit such other information as is necessary to facili- tate postmarket assessments of device safety and ef-

fectiveness 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 preva- lence 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 propri- etary information and is comprehensive, useful, and not misleading to patients, physicians, and sci- entists.

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1019 ‘‘(5) To carry out this subsection, there are author-

ized 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 en- actment 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 amend- ed 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 Na- tional Coordinator for Health Information Tech- nology standards, implementation specifications, and

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1020 1 certification criteria for the electronic exchange and

2 use in certified electronic health records of a unique 3 device identifier for each device described in section 4 519(g)(1) of the Federal Food, Drug, and Cosmetic 5 Act, as added by subsection (a).

6 (2) STANDARDS, IMPLEMENTATION CRITERIA, 7 AND CERTIFICATION CRITERIA.—The Secretary of 8 the Health Human Services, acting through the 9 head of the Office of the National Coordinator for

10 Health Information Technology, shall adopt stand- 11 ards, implementation specifications, and certification 12 criteria for the electronic exchange and use in cer- 13 tified electronic health records of a unique device 14 identifier for each device described in paragraph (1), 15 if such an identifier is required by section 519(f) of 16 the Federal Food, Drug, and Cosmetic Act (21 17 U.S.C. 360i(f)) for the device.

18 Subtitle D—Grants for Comprehen- 19 sive Programs To Provide Edu- 20 cation to Nurses and Create a 21 Pipeline to Nursing

22 SEC. 2531. ESTABLISHMENT OF GRANT PROGRAM. 23 (a) PURPOSES.—It is the purpose of this section to 24 authorize grants to—

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