SPJ
04-03-2012, 04:19 PM
Anyone else notice this in the health care 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 sub17
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 med22
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 Coordi9
nator for Health Information Technology, and the Sec10
retary of Veterans Affairs, determine the best methods
11 for—
12 ‘‘(A) including in the registry, in a manner con13
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 iden16
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), in21
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 sec4
tion 505(k) (relating to active postmarket risk
5 identification);
6 ‘‘(ii) activities under paragraph (4) of sec7
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, aca21
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-
1 gram under title XVIII of the Social Secu2
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 as10
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 in15
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 promul23
gate regulations for establishment and operation of the
24 registry under paragraph (1)
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 sub17
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 med22
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
VerDate Nov 24 2008 01:43 Jul 15, 2009 Jkt 079200 PO 00000 Frm 01000 Fmt 6652 Sfmt 6201 E:\BILLS\H3200.IH H3200 jlentini on DSKJ8SOYB1PROD with
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 Coordi9
nator for Health Information Technology, and the Sec10
retary of Veterans Affairs, determine the best methods
11 for—
12 ‘‘(A) including in the registry, in a manner con13
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 iden16
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), in21
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);
VerDate Nov 24 2008 01:43 Jul 15, 2009 Jkt 079200 PO 00000 Frm 01001 Fmt 6652 Sfmt 6201 E:\BILLS\H3200.IH H3200 jlentini on DSKJ8SOYB1PROD with
1 ‘‘(C) integrating the activities described in this
2 subsection with—
3 ‘‘(i) activities under paragraph (3) of sec4
tion 505(k) (relating to active postmarket risk
5 identification);
6 ‘‘(ii) activities under paragraph (4) of sec7
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, aca21
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-
1 gram under title XVIII of the Social Secu2
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 as10
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 in15
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 promul23
gate regulations for establishment and operation of the
24 registry under paragraph (1)