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1 such sums as may be necessary for each of the fiscal years
2 2011 through 2014.’’.
3 (b) EFFECTIVE DATE.—The Secretary of Health and
4 Human Services shall begin awarding grants under section
5 399Z–1 of the Public Health Service Act, as added by sub-
6 section (b), not later than July 1, 2010, without regard
7 to whether or not final regulations have been issued under
8 section 399Z–1(h) of such Act
9 Subtitle C—National Medical
10 Device Registry
11 SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.

12 (a) REGISTRY.—
13 (1) IN GENERAL.—Section 519 of the Federal
14 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is
15 amended—
16 (A) by redesignating subsection (g) as sub-
17 section (h); and
18 (B) by inserting after subsection (f) the
19 following:
20 ‘‘National Medical Device Registry
21 ‘‘(g)(1) The Secretary shall establish a national med-
22 ical device registry (in this subsection referred to as the
23 ‘registry’) to facilitate analysis of postmarket safety and
24 outcomes data on each device that—
25 ‘‘(A) is or has been used in or on a patient; and

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1 ‘‘(B) is—
2 ‘‘(i) a class III device; or
3 ‘‘(ii) a class II device that is implantable,
4 life-supporting, or life-sustaining.
5 ‘‘(2) In developing the registry, the Secretary shall,
6 in consultation with the Commissioner of Food and Drugs,
7 the Administrator of the Centers for Medicare & Medicaid
8 Services, the head of the Office of the National Coordi-
9 nator for Health Information Technology, and the Sec-
10 retary of Veterans Affairs, determine the best methods
11 for—
12 ‘‘(A) including in the registry, in a manner con-
13 sistent with subsection (f), appropriate information
14 to identify each device described in paragraph (1) by
15 type, model, and serial number or other unique iden-
16 tifier;
17 ‘‘(B) validating methods for analyzing patient
18 safety and outcomes data from multiple sources and
19 for linking such data with the information included
20 in the registry as described in subparagraph (A), in-
21 cluding, to the extent feasible, use of—
22 ‘‘(i) data provided to the Secretary under
23 other provisions of this chapter; and
24 ‘‘(ii) information from public and private
25 sources identified under paragraph (3);

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1 ‘‘(C) integrating the activities described in this
2 subsection with—
3 ‘‘(i) activities under paragraph (3) of sec-
4 tion 505(k) (relating to active postmarket risk
5 identification);
6 ‘‘(ii) activities under paragraph (4) of sec-
7 tion 505(k) (relating to advanced analysis of
8 drug safety data); and
9 ‘‘(iii) other postmarket device surveillance
10 activities of the Secretary authorized by this
11 chapter; and
12 ‘‘(D) providing public access to the data and
13 analysis collected or developed through the registry
14 in a manner and form that protects patient privacy
15 and proprietary information and is comprehensive,
16 useful, and not misleading to patients, physicians,
17 and scientists.
18 ‘‘(3)(A) To facilitate analyses of postmarket safety
19 and patient outcomes for devices described in paragraph
20 (1), the Secretary shall, in collaboration with public, aca-
21 demic, and private entities, develop methods to—
22 ‘‘(i) obtain access to disparate sources of
23 patient safety and outcomes data, including—
24 ‘‘(I) Federal health-related electronic
25 data (such as data from the Medicare pro-

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1 gram under title XVIII of the Social Secu-
2 rity Act or from the health systems of the
3 Department of Veterans Affairs);
4 ‘‘(II) private sector health-related
5 electronic data (such as pharmaceutical
6 purchase data and health insurance claims
7 data); and
8 ‘‘(III) other data as the Secretary
9 deems necessary to permit postmarket as-
10 sessment of device safety and effectiveness;
11 and
12 ‘‘(ii) link data obtained under clause (i)
13 with information in the registry.
14 ‘‘(B) In this paragraph, the term ‘data’ refers to in-
15 formation respecting a device described in paragraph (1),
16 including claims data, patient survey data, standardized
17 analytic files that allow for the pooling and analysis of
18 data from disparate data environments, electronic health
19 records, and any other data deemed appropriate by the
20 Secretary.
21 ‘‘(4) Not later than 36 months after the date of the
22 enactment of this subsection, the Secretary shall promul-
23 gate regulations for establishment and operation of the
24 registry under paragraph (1). Such regulations—

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1 ‘‘(A)(i) in the case of devices that are described
2 in paragraph (1) and sold on or after the date of the
3 enactment of this subsection, shall require manufac-
4 turers of such devices to submit information to the
5 registry, including, for each such device, the type,
6 model, and serial number or, if required under sub-
7 section (f), other unique device identifier; and
8 ‘‘(ii) in the case of devices that are described in
9 paragraph (1) and sold before such date, may re-
10 quire manufacturers of such devices to submit such
11 information to the registry, if deemed necessary by
12 the Secretary to protect the public health;
13 ‘‘(B) shall establish procedures—
14 ‘‘(i) to permit linkage of information sub-
15 mitted pursuant to subparagraph (A) with pa-
16 tient safety and outcomes data obtained under
17 paragraph (3); and
18 ‘‘(ii) to permit analyses of linked data;
19 ‘‘(C) may require device manufacturers to sub-
20 mit such other information as is necessary to facili-
21 tate postmarket assessments of device safety and ef-
22 fectiveness and notification of device risks;
23 ‘‘(D) shall establish requirements for regular
24 and timely reports to the Secretary, which shall be
25 included in the registry, concerning adverse event

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1 trends, adverse event patterns, incidence and preva-
2 lence of adverse events, and other information the
3 Secretary determines appropriate, which may include
4 data on comparative safety and outcomes trends;
5 and
6 ‘‘(E) shall establish procedures to permit public
7 access to the information in the registry in a manner
8 and form that protects patient privacy and propri-
9 etary information and is comprehensive, useful, and
10 not misleading to patients, physicians, and sci-
11 entists.
12 ‘‘(5) To carry out this subsection, there are author-
13 ized to be appropriated such sums as may be necessary
14 for fiscal years 2010 and 2011.’’.
15 (2) EFFECTIVE DATE.—The Secretary of
16 Health and Human Services shall establish and
17 begin implementation of the registry under section
18 519(g) of the Federal Food, Drug, and Cosmetic
19 Act, as added by paragraph (1), by not later than
20 the date that is 36 months after the date of the en-
21 actment of this Act, without regard to whether or
22 not final regulations to establish and operate the
23 registry have been promulgated by such date.
24 (3) CONFORMING AMENDMENT.—Section

25 303(f)(1)(B)(ii) of the Federal Food, Drug, and

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1 Cosmetic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amend-
2 ed by striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
3 (b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED
4 ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE
5 IDENTIFIERS.—
6 (1) RECOMMENDATIONS.—The HIT Policy
7 Committee established under section 3002 of the
8 Public Health Service Act (42 U.S.C. 300jj–12)
9 shall recommend to the head of the Office of the Na-
10 tional Coordinator for Health Information Tech-
11 nology standards, implementation specifications, and
12 certification criteria for the electronic exchange and
13 use in certified electronic health records of a unique
14 device identifier for each device described in section
15 519(g)(1) of the Federal Food, Drug, and Cosmetic
16 Act, as added by subsection (a).
17 (2) STANDARDS, IMPLEMENTATION CRITERIA,

18 AND CERTIFICATION CRITERIA.—The Secretary of

19 the Health Human Services, acting through the
20 head of the Office of the National Coordinator for
21 Health Information Technology, shall adopt stand-
22 ards, implementation specifications, and certification
23 criteria for the electronic exchange and use in cer-
24 tified electronic health records of a unique device
25 identifier for each device described in paragraph (1),

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1008
1 if such an identifier is required by section 519(f) of
2 the Federal Food, Drug, and Cosmetic Act (21
3 U.S.C. 360i(f)) for the device.
4 Subtitle D—Grants for Comprehen-
5 sive Programs to Provide Edu-
6 cation to Nurses and Create a
7 Pipeline to Nursing
8 SEC. 2531. ESTABLISHMENT OF GRANT PROGRAM.

9 (a) PURPOSES.—It is the purpose of this section to

10 authorize grants to—
11 (1) address the projected shortage of nurses by
12 funding comprehensive programs to create a career
13 ladder to nursing (including Certified Nurse Assist-
14 ants, Licensed Practical Nurses, Licensed Vocational
15 Nurses, and Registered Nurses) for incumbent ancil-
16 lary health care workers;
17 (2) increase the capacity for educating nurses
18 by increasing both nurse faculty and clinical oppor-
19 tunities through collaborative programs between
20 staff nurse organizations, health care providers, and
21 accredited schools of nursing; and
22 (3) provide training programs through edu-
23 cation and training organizations jointly adminis-
24 tered by health care providers and health care labor
25 organizations or other organizations representing

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