cluding presentations addressing outcomes of 
various types of approaches to a particular dis-
ease, disorder, or other adverse health condi-
tion. 
‘‘(C) Prepare reports, analyses, and pres-
entations of epidemiological data to assist deci-
sionmaking in development programs for new 
treatments or diagnostics. 
‘‘(D) Prepare reports, analyses, and pres-
entations on costs and charges for health care 
products and services. 
‘‘(E) Upon the request of a covered entity, 
prepare reports, analyses, and presentations 
that benchmark the operations of such covered 
entity against the operations of one or more 
other covered entities that have elected to par-
ticipate in such benchmarking. 
‘‘(2) PRIVACY.—A health care clearinghouse 
may carry out the functions described in paragraph 
(1) without obtaining any authorizations under sec-
tion 164.508 of title 45, Code of Federal Regula-
tions. For purposes of such paragraph, with respect 
to any report, analysis, or presentation provided by 
the clearinghouse to a third party, such report, anal-
ysis, or presentation— 
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‘‘(A) shall include only de-identified data; 
or 
‘‘(B) if containing protected health infor-
mation, shall include such data that is— 
‘‘(i) subject to a qualifying data use 
agreement (as defined in subsection (i)); or 
‘‘(ii) provided to the Food and Drug 
Administration for purposes authorized by 
law for such Administration, subject to 
protected health information being dis-
closed to such Administration only to the 
extent necessary for such purposes. 
‘‘(d) RELEVANT INFORMATION.—In the case of a 
health care clearinghouse, the authority under subsections 
(a) through (c) includes applicability with respect to pro-
tected health information collected from other covered en-
tities and includes applicability with respect to the aggre-
gation of such information between covered entities. 
‘‘(e) COMPREHENSIVE RECORDS PER REQUEST OF 
INDIVIDUAL.—For purposes of subsection (b)(2), when a 
health care clearinghouse receives a request from an indi-
vidual for the protected health information of the indi-
vidual, the clearinghouse shall provide to the individual a 
comprehensive record of such information (across health 
care providers and health plans), unless the clearinghouse 
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determines in its discretion that providing a comprehen-
sive record is not technologically feasible. In preparing 
such record for the individual, the clearinghouse may, with 
the permission of the individual, purchase the protected 
health care information of the individual from one or more 
other health care clearinghouses (and the cost of such pur-
chase may be included in the fee charged to the indi-
vidual). 
‘‘(f) SITUATIONS NOT INVOLVING DIRECT INTER-
ACTION WITH INDIVIDUALS.—Sections 164.400 through 
164.414, sections 164.520 through 164.528, and 164.530 
of title 45, Code of Federal Regulations, apply to a clear-
inghouse to the extent that it has current contact informa-
tion pursuant to direct interaction with the individual. In 
the case of each other individual, the clearinghouse shall 
carry out its functions under this subtitle, part C of title 
XI of the Social Security Act, and the regulations promul-
gated pursuant to section 264(c) of the Health Insurance 
Portability and Accountability Act of 1996 as if the clear-
inghouse were a business associate. The individuals to 
whom the preceding sentence applies includes individuals 
with respect to whom the sole clearinghouse function is 
to process or facilitate the processing of nonstandard data 
elements of health information into standard data ele-
ments. 
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‘‘(g) TRANSITION.—With respect to agreements en-
tered into by a health care clearinghouse before the effec-
tive date of this section, a provision of an agreement that 
conflicts with this section shall not have any legal force 
or effect. The preceding sentence may not be construed 
as affecting any provision of an agreement that does not 
conflict with this section. A health care clearinghouse shall 
provide notice of this subsection to each entity with which 
the clearinghouse has an agreement that is affected by this 
subsection. 
‘‘(h) ENFORCEMENT.—Section 13410(a)(2) applies 
to this part in the same manner as such section applies 
to parts 1 and 2. 
‘‘(i) DEFINITIONS.—For purposes of this part: 
‘‘(1) The term ‘de-identified’, with respect to 
health information, means such information that is 
not individually identifiable as determined in accord-
ance with the standards under section 164.514(b) of 
title 45, Code of Federal Regulations. 
‘‘(2) The term ‘health care clearinghouse’ has 
the meaning given such term in section 1171 of the 
Social Security Act. 
‘‘(3) The term ‘individual’, with respect to pro-
tected health information, has the meaning that ap-
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plies under section 160.103 of title 45, Code of Fed-
eral Regulations. 
‘‘(4) The term ‘qualifying data use agreement’ 
means an agreement that establishes the permitted 
uses and disclosures of protected health information 
by the recipient for one or more functions described 
in subsection (c)(1) and restricts the use and disclo-
sure of the information by the recipient in the same 
manner as applies under paragraphs (e)(4)(ii)(B) 
and (e)(4)(ii)(C) (1)–(4) of section 164.514 of title 
45, Code of Federal Regulations, but without regard 
to the references to limited data sets. 
‘‘(j) RELATION TO OTHER LAWS.—Section 13421 
applies to this part in the same manner as such section 
applies to parts 1 and 2, except to the extent that such 
section concerns section 1178(a)(2)(B) of the Social Secu-
rity Act.’’. 
(b) REGULATIONS.—Not later than the expiration of 
the 90-day period beginning on the date of the enactment 
of this Act, the Secretary of Health and Human Services 
shall promulgate regulations to carry out the amendment 
made by subsection (a). 
(c) CONFORMING AMENDMENT.—Section 1171(2) of 
the Social Security Act (42 U.S.C. 1320d(2)) is amended 
by inserting before the period the following: ‘‘, or that car-
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ries out such processing function and in addition any of 
the functions authorized in section 13451 of the Health 
Information Technology for Economic and Clinical Health 
Act’’. 
Æ 
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