295 
retary and others to use available electronic databases to 
create a robust surveillance system that will support active 
surveillance on important drug safety questions including 
detecting and assessing drug safety signals; monitoring 
the frequency of known adverse events; and evaluating the 
outcomes of off label uses. Such surveillance shall provide 
for adverse event surveillance using the following data 
sources: 
‘‘(A) Federal health-related electronic data 
(such as data from the Medicare program and the 
health systems of the Department of Veterans Af-
fairs). 
‘‘(B) Private sector health-related electronic 
data (such as pharmaceutical purchase data and 
health insurance claims data). 
‘‘(C) Other information as the Secretary deems 
useful to create a robust system to identify and as-
sess adverse events and potential drug safety signals 
and to evaluate the extent and outcomes of off label 
uses of drugs. 
‘‘(4) Not later than 1 year after the date of the enact-
ment of this paragraph, the Secretary, in consultation 
with experts including individuals who are recognized in 
the field of data privacy and security, shall develop meth-
ods for integrating and analyzing safety data from mul-
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tiple sources and mechanisms for obtaining access to such 
data. Such methods and mechanisms shall not compromise 
the protection of individually identifiable health informa-
tion. 
‘‘(5) Not later than 2 years after the date of the en-
actment of this paragraph, the Secretary shall have en-
tered into partnerships that will allow the analysis of avail-
able data from the various data sources using the stand-
ards and methods to identify drug safety signals and 
trends. Such analysis shall not disclose individually identi-
fiable health information when presenting such drug safe-
ty signals and trends or when responding to inquiries re-
garding such drug safety signals and trends. 
‘‘(6) Not later than 4 years after the date of the en-
actment of this paragraph, the Secretary shall report to 
the Congress on the ways in which the Secretary has used 
the surveillance system described in this subsection to 
identify specific drug safety signals and to better under-
stand the outcomes associated with drugs marketed in the 
United States. 
‘‘(7) Disclosure of individually identifiable informa-
tion is prohibited in the surveillance system described in 
this subsection. Nothing in this subsection prohibits lawful 
disclosure of such information for other purposes. 
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‘‘(8) Nothing in this subsection shall be construed as 
limiting public health activities authorized under law.’’. 
(c) AUTHORIZATION OF APPROPRIATIONS.—To carry 
out activities under the amendment made by subsection 
(b) for which funds are made available under section 736 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379h), there are authorized to be appropriated, in addition 
to such funds, $25,000,000 for each of fiscal years 2008 
through 2012. 
(d) GAO REPORT.—Not later than 18 months after 
the date of the enactment of this Act, the Comptroller 
General of the United States shall evaluate data confiden-
tiality and security issues relating to collection, trans-
mission, and maintenance of data for the surveillance sys-
tem developed pursuant to this section, and make rec-
ommendations to the Committee on Energy and Com-
merce of the House of Representatives and the Committee 
on Health, Education, Labor and Pensions of the Senate, 
and any other congressional committees of relevant juris-
diction, regarding the need for any additional legislative 
or regulatory actions to ensure confidentiality and security 
of this data or otherwise address confidentiality and secu-
rity issues to ensure the effective operation of the surveil-
lance system. 
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