Page:United States Statutes at Large Volume 121.djvu/969

 121 STAT. 948

‘‘(III) Experience with, and expertise on, the development of drug safety and effectiveness research using electronic population data. ‘‘(IV) An understanding of drug development or risk/benefit balancing in a clinical setting. ‘‘(V) Other expertise which the Secretary deems necessary to fulfill the activities under this paragraph. ‘‘(G) CONTRACT REQUIREMENTS.—Each contract with a qualified entity under subparagraph (F)(i) shall contain the following requirements: ‘‘(i) ENSURING PRIVACY.—The qualified entity shall ensure that the entity will not use data under this subsection in a manner that— ‘‘(I) violates the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996; ‘‘(II) violates sections 552 or 552a of title 5, United States Code, with regard to the privacy of individually-identifiable beneficiary health information; or ‘‘(III) discloses individually identifiable health information when presenting drug safety signals and trends or when responding to inquiries regarding drug safety signals and trends. Nothing in this clause prohibits lawful disclosure for other purposes. ‘‘(ii) COMPONENT OF ANOTHER ORGANIZATION.—If a qualified entity is a component of another organization— ‘‘(I) the qualified entity shall establish appropriate security measures to maintain the confidentiality and privacy of such data; and ‘‘(II) the entity shall not make an unauthorized disclosure of such data to the other components of the organization in breach of such confidentiality and privacy requirement. ‘‘(iii) TERMINATION OR NONRENEWAL.—If a contract with a qualified entity under this subparagraph is terminated or not renewed, the following requirements shall apply: ‘‘(I) CONFIDENTIALITY AND PRIVACY PROTECTIONS.—The entity shall continue to comply with the confidentiality and privacy requirements under this paragraph with respect to all data disclosed to the entity. ‘‘(II) DISPOSITION OF DATA.—The entity shall return any data disclosed to such entity under this subsection to which it would not otherwise have access or, if returning the data is not practicable, destroy the data. ‘‘(H) COMPETITIVE PROCEDURES.—The Secretary shall use competitive procedures (as defined in section 4(5) of the Federal Procurement Policy Act) to enter into contracts under subparagraph (G). ‘‘(I) REVIEW OF CONTRACT IN THE EVENT OF A MERGER OR ACQUISITION.—The Secretary shall review the contract

dkrause on GSDDPC44 with PUBLAW

Applicability.

VerDate Aug 31 2005

13:52 Jan 23, 2009

PUBLIC LAW 110–85—SEPT. 27, 2007

Jkt 059194

PO 00001

Frm 00946

Fmt 6580

Sfmt 6581

M:\STATUTES\2007\59194PT1.001

APPS10

PsN: 59194PT1

�