Pub. L. 111-148, tit. X, subtit. F, sec. 10602
CLARIFICATIONS TO PATIENT-CENTERED OUTCOMES RESEARCH.
SEC. 10602. CLARIFICATIONS TO PATIENT-CENTERED OUTCOMES RESEARCH. Section 1181 of the Social Security Act (as added by section 6301) is amended—(1) in subsection (d)(2)(B)—(A) in clause (ii)(IV)—(i) by inserting “, as described in subparagraph (A)(ii),” after “original research”; and(ii) by inserting “, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate” after “publication”; and(B) by amending clause (iv) to read as follows:“(iv) Subsequent use of the data.—The Institute shall not allow the subsequent use of data from original research in work-for-hire contracts with individuals, entities, or instrumentalities that have a financial interest in the results, unless approved under a data use agreement with the Institute.”;(2) in subsection (d)(8)(A)(iv), by striking “not be construed as mandates for” and inserting “do not include”; and(3) in subsection (f)(1)(C), by amending clause (ii) to read as follows:“(ii) 7 members representing physicians and providers, including 4 members representing physicians (at least 1 of whom is a surgeon), 1 nurse, 1 State-licensed integrative health care practitioner, and 1 representative of a hospital.”.124 STAT. 1006