PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 945
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‘‘(I) for risk identification and analysis based on electronic health data, in compliance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996, and in a manner that does not disclose individually identifiable health information in violation of paragraph (4)(B); ‘‘(II) for the reporting (in a standardized form) of data on all serious adverse drug experiences (as defined in section 505–1(b)) submitted to the Secretary under paragraph (1), and those adverse events submitted by patients, providers, and drug sponsors, when appropriate; ‘‘(III) to provide for active adverse event surveillance using the following data sources, as available: ‘‘(aa) Federal health-related electronic data (such as data from the Medicare program and the health systems of the Department of Veterans Affairs); ‘‘(bb) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); and ‘‘(cc) other data as the Secretary deems necessary to create a robust system to identify adverse events and potential drug safety signals; ‘‘(IV) to identify certain trends and patterns with respect to data accessed by the system; ‘‘(V) to provide regular reports to the Secretary concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative national adverse event trends; and ‘‘(VI) to enable the program to export data in a form appropriate for further aggregation, statistical analysis, and reporting. ‘‘(ii) TIMELINESS OF REPORTING.—The procedures established under clause (i) shall ensure that such data are accessed, analyzed, and reported in a timely, routine, and systematic manner, taking into consideration the need for data completeness, coding, cleansing, and standardized analysis and transmission. ‘‘(iii) PRIVATE SECTOR RESOURCES.—To ensure the establishment of the active postmarket risk identification and analysis system under this subsection not later than 1 year after the development of the risk identification and analysis methods under subparagraph (B), as required under clause (i), the Secretary may, on a temporary or permanent basis, implement systems or products developed by private entities. ‘‘(iv) COMPLEMENTARY APPROACHES.—To the extent the active postmarket risk identification and analysis system under this subsection is not sufficient to gather data and information relevant to a priority drug safety question, the Secretary shall develop, support, and
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