La parte "incriminata" del disegno di legge HR 3200 del Governo Usa è quella che va da pagina 1192 a pagine 1199 del link di cui sopra, che qua riporto.
Qui di seguito la parte che ci riguarda del testo originale del disegno di legge:
PART 1—IN GENERAL
22 SEC. 2561. NATIONAL MEDICAL DEVICE REGISTRY.
23 (a) REGISTRY.—
1 (1) IN GENERAL.—Section 519 of the Federal
2 Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is
3 amended—
4 (A) by redesignating subsection (g) as sub
5 section (h); and
6 (B) by inserting after subsection (f) the fol
7 lowing:
8 ‘‘National Medical Device Registry
9 ‘‘(g)(1) The Secretary shall establish a national med
10 ical device registry (in this subsection referred to as the ‘reg
11 istry’) to facilitate analysis of postmarket safety and out
12 comes data on each device that—
13 ‘‘(A) is or has been used in or on a patient; and
14 ‘‘(B) is—
15 ‘‘(i) a class III device; or
16 ‘‘(ii) a class II device that is implantable,
17 life-supporting, or life-sustaining.
18 ‘‘(2) In developing the registry, the Secretary shall, in
19 consultation with the Commissioner of Food and Drugs, the
20 Administrator of the Centers for Medicare & Medicaid Serv
21 ices, the head of the Office of the National Coordinator for
22 Health Information Technology, and the Secretary of Vet
23 erans Affairs, determine the best methods for—
24 ‘‘(A) including in the registry, in a manner con
25 sistent with subsection (f), appropriate information to
1 identify each device described in paragraph (1) by
2 type, model, and serial number or other unique iden
3 tifier;
4 ‘‘(B) validating methods for analyzing patient
5 safety and outcomes data from multiple sources and
6 for linking such data with the information included
7 in the registry as described in subparagraph (A), in
8 cluding, to the extent feasible, use of—
9 ‘‘(i) data provided to the Secretary under
10 other provisions of this chapter; and
11 ‘‘(ii) information from public and private
12 sources identified under paragraph (3);
13 ‘‘(C) integrating the activities described in this
14 subsection with—
15 ‘‘(i) activities under paragraph (3) of sec
16 tion 505(k) (relating to active postmarket risk
17 identification);
18 ‘‘(ii) activities under paragraph (4) of sec
19 tion 505(k) (relating to advanced analysis of
20 drug safety data); and
21 ‘‘(iii) other postmarket device surveillance
22 activities of the Secretary authorized by this
23 chapter; and
24 ‘‘(D) providing public access to the data and
25 analysis collected or developed through the registry in
1 a manner and form that protects patient privacy and
2 proprietary information and is comprehensive, useful,
3 and not misleading to patients, physicians, and sci
4 entists.
5 ‘‘(3)(A) To facilitate analyses of postmarket safety and
6 patient outcomes for devices described in paragraph (1), the
7 Secretary shall, in collaboration with public, academic, and
8 private entities, develop methods to—
9 ‘‘(i) obtain access to disparate sources of patient
10 safety and outcomes data, including—
11 ‘‘(I) Federal health-related electronic data
12 (such as data from the Medicare program under
13 title XVIII of the Social Security Act or from the
14 health systems of the Department of Veterans Af
15fairs);
16 ‘‘(II) private sector health-related electronic
17 data (such as pharmaceutical purchase data and
18 health insurance claims data); and
19 ‘‘(III) other data as the Secretary deems
20 necessary to permit postmarket assessment of de
21vice safety and effectiveness; and
22 ‘‘(ii) link data obtained under clause (i) with in
23 formation in the registry.
24 ‘‘(B) In this paragraph, the term ‘data’ refers to infor
25mation respecting a device described in paragraph (1), in-
1 cluding claims data, patient survey data, standardized
2 analytic files that allow for the pooling and analysis of data
3 from disparate data environments, electronic health records,
4 and any other data deemed appropriate by the Secretary.
5 ‘‘(4) Not later than 36 months after the date of the
6 enactment of this subsection, the Secretary shall promulgate
7 regulations for establishment and operation of the registry
8 under paragraph (1). Such regulations—
9 ‘‘(A)(i) in the case of devices that are described
10 in paragraph (1) and sold on or after the date of the
11 enactment of this subsection, shall require manufac
12 turers of such devices to submit information to the
13 registry, including, for each such device, the type,
14 model, and serial number or, if required under sub
15 section (f), other unique device identifier; and
16 ‘‘(ii) in the case of devices that are described in
17 paragraph (1) and sold before such date, may require
18 manufacturers of such devices to submit such infor
19 mation to the registry, if deemed necessary by the
20 Secretary to protect the public health;
21 ‘‘(B) shall establish procedures—
22 ‘‘(i) to permit linkage of information sub
23 mitted pursuant to subparagraph (A) with pa
24 tient safety and outcomes data obtained under
25 paragraph (3); and
1 ‘‘(ii) to permit analyses of linked data;
2 ‘‘(C) may require device manufacturers to sub
3 mit such other information as is necessary to facili
4 tate postmarket assessments of device safety and effec
5 tiveness and notification of device risks;
6 ‘‘(D) shall establish requirements for regular and
7 timely reports to the Secretary, which shall be in
8 cluded in the registry, concerning adverse event
9 trends, adverse event patterns, incidence and preva
10 lence of adverse events, and other information the Sec
11 retary determines appropriate, which may include
12 data on comparative safety and outcomes trends; and
13 ‘‘(E) shall establish procedures to permit public
14 access to the information in the registry in a manner
15 and form that protects patient privacy and propri
16 etary information and is comprehensive, useful, and
17 not misleading to patients, physicians, and scientists.
18 ‘‘(5) To carry out this subsection, there are authorized
19 to be appropriated such sums as may be necessary for fiscal
20 years 2010 and 2011.’’.
21 (2) EFFECTIVE DATE.—The Secretary of Health
22 and Human Services shall establish and begin imple
23 mentation of the registry under section 519(g) of the
24 Federal Food, Drug, and Cosmetic Act, as added by
25 paragraph (1), by not later than the date that is 36
1 months after the date of the enactment of this Act,
2 without regard to whether or not final regulations to
3 establish and operate the registry have been promul
4 gated by such date.
5 (3) CONFORMING AMENDMENT.—Section
6 303(f)(1)(B)(ii) of the Federal Food, Drug, and Cos
7 metic Act (21 U.S.C. 333(f)(1)(B)(ii)) is amended by
8 striking ‘‘519(g)’’ and inserting ‘‘519(h)’’.
9 (b) ELECTRONIC EXCHANGE AND USE IN CERTIFIED
10 ELECTRONIC HEALTH RECORDS OF UNIQUE DEVICE IDEN
11 TIFIERS.—
12 (1) RECOMMENDATIONS.—The HIT Policy Com
13 mittee established under section 3002 of the Public
14 Health Service Act (42 U.S.C. 300jj–12) shall rec
15 ommend to the head of the Office of the National Co
16 ordinator for Health Information Technology stand
17 ards, implementation specifications, and certification
18 criteria for the electronic exchange and use in cer
19 tified electronic health records of a unique device
20 identifier for each device described in section
21 519(g)(1) of the Federal Food, Drug, and Cosmetic
22 Act, as added by subsection (a).
23 (2) STANDARDS, IMPLEMENTATION CRITERIA,
24 AND CERTIFICATION CRITERIA.—The Secretary of the
25 Health Human Services, acting through the head of
1 the Office of the National Coordinator for Health In
2 formation Technology, shall adopt standards, imple
3 mentation specifications, and certification criteria or
4 the electronic exchange and use in certified electronic
5 health records of a unique device identifier for each
6 device described in paragraph (1), if such an identi
7 fier is required by section 519(f) of the Federal Food,
8 Drug, and Cosmetic Act (21 U.S.C. 360i(f)) for the
9 device.
Fonte:
http://www.gpo.gov/fdsys/pkg/BILLS-111h ... 3200rh.pdfpag. 1192 - 1199
Un No deve salire dal profondo e spaventare quelli del Sì.
I quali si chiederanno cosa non viene apprezzato del loro ottimismo.
Ennio Flaiano