Sec. 1123. Data on natural history of diseases
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It is the sense of the Congress that studies on the natural history of diseases can help to facilitate and expedite the development of medical products for such diseases. Part A of title II of the Public Health Service Act ( 42 U.S.C. 202 et seq. ) is amended by adding at the end the following: The Secretary may, for the purposes described in subsection (b)— participate in public-private partnerships engaged in one or more activities specified in subsection (c); and award grants to patient advocacy groups or other organizations determined appropriate by the Secretary.
The purposes described in this subsection are to establish or facilitate the collection, maintenance, analysis, and interpretation of data regarding the natural history of diseases, with a particular focus on rare diseases. The activities of public-private partnerships in which the Secretary may participate for purposes of this section include— cooperating with other entities that sponsor or maintain disease registries, including disease registries and disease registry platforms for rare diseases; developing or enhancing a secure information technology system that— has the capacity to support data needs across a wide range of disease studies; is easily modified as knowledge is gained during such studies; and is capable of handling increasing amounts of data as more studies are carried out; and providing advice to clinical researchers, patient advocacy groups, and other entities with respect to— the design and conduct of disease studies; the modification of any such ongoing studies; and addressing associated patient privacy issues.
Data relating to the natural history of diseases obtained, aggregated, or otherwise maintained by a public-private partnership in which the Secretary participates under subsection
(a)shall be made available, consistent with otherwise applicable Federal and State privacy laws, to the public (including patient advocacy groups, researchers, and drug developers) to help to facilitate and expedite medical product development programs. Notwithstanding subsection (d), nothing in this section authorizes the disclosure of any information that is a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code. There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020. .
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Sec. 1123
Data on natural history of diseases
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