I 

114TH CONGRESS 

2D SESSION H. R. 4805 

To amend the Health Information Technology for Economic and Clinical 

Health Act to provide that information held by health care clearinghouses 

is subject to privacy protections that are equivalent to the protections 

that apply to information held by other types of covered entities under 

the HIPAA Privacy Rule, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 17, 2016 

Mrs. MCMORRIS RODGERS (for herself and Mr. BYRNE) introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To amend the Health Information Technology for Economic 

and Clinical Health Act to provide that information held 

by health care clearinghouses is subject to privacy protections that are equivalent to the protections that apply 

to information held by other types of covered entities 

under the HIPAA Privacy Rule, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Ensuring Patient Ac3 cess to Healthcare Records Act of 2016’’. 

4 SEC. 2. FINDINGS. 

5 The Congress finds as follows: 

6 (1) The Health Insurance Portability and Ac7 countability Act of 1996 (‘‘HIPAA’’), through cer8 tain of its implementing regulations known as the 

9 Privacy Rule, protects the health information of en10 rollees of health plans and other individuals (in this 

11 section referred to as ‘‘protected health informa12 tion’’). 

13 (2) The HIPAA Privacy Rule applies to pro14 tected health information held by health care pro15 viders, plans, and clearinghouses, which are known 

16 as ‘‘covered entities’’. Such Rule also applies to ven17 dors that perform certain functions for covered enti18 ties and thereby come into possession of protected 

19 health information. The HIPAA Privacy Rule refers 

20 to these vendors as ‘‘business associates’’. 

21 (3) The HIPAA Privacy Rule applies both to 

22 the internal use of protected health information by 

23 covered entities and their business associates and to 

24 the disclosure of such information to other parties. 

25 (4) Covered entities and their business associ26 ates are subject to substantial civil and criminal penVerDate Sep 11 2014 19:38 Mar 21, 2016 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H4805.IH H4805

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1 alties if they use or disclose protected health infor2 mation in violation of the HIPAA Privacy Rule. 

3 (5) Clearinghouses play a unique, central role 

4 in the health care system, interacting with both 

5 health care providers and plans. Clearinghouses con6 vert information from providers into claims-proc7 essing standard electronic formats and then submit 

8 the claims to the plans and finally send providers 

9 the plan payments. 

10 (6) Claims and other data held by clearing11 houses could be analyzed longitudinally and geo12 graphically, providing powerful analytical tools that 

13 could benefit the overall health care system and fa14 cilitate medical innovation in the 21st Century. 

15 (7) Clearinghouses are unable to unlock the 

16 benefits of such claims and other data because the 

17 HIPAA Privacy Rule assigns clearinghouses a dual 

18 role. Such clearinghouses are not only covered enti19 ties, but are also business associates. The latter role 

20 substantially restricts the ability of clearinghouses to 

21 analyze claims data. 

22 (8) Clearinghouses should not be considered 

23 business associates and should instead have the 

24 same ability to use and disclose health-related data 

25 as other types of covered entities. 


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1 (9) Eliminating the business-associate role of 

2 clearinghouses would not affect the applicability of 

3 the civil and criminal penalties that enforce the 

4 HIPAA Privacy Rule. Clearinghouses would con5 tinue to be subject to such penalties in their role as 

6 covered entities. 

7 (10) In addition to the uses of health-related in8 formation that the HIPAA Privacy Rule currently 

9 authorizes for covered entities, there are several par10 ticular analytical uses that should be authorized spe11 cifically for clearinghouses because of the unique 

12 benefits that would result from authorizing those 

13 uses. Although these particular new analytical uses 

14 should be authorized for clearinghouses, the disclo15 sure of health information pursuant to these uses 

16 should be subject to the protection principles cur17 rently underlying the HIPAA Privacy Rule, includ18 ing enforcement principles. 

19 SEC. 3. TREATMENT OF CERTAIN HIPAA-RELATED ACTIVI20 TIES OF HEALTH CARE CLEARINGHOUSES. 

21 (a) IN GENERAL.—Subtitle D of the Health Informa22 tion Technology for Economic and Clinical Health Act (42 

23 U.S.C. 17921 et seq.) is amended by adding at the end 

24 the following: 


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1 ‘‘PART 5—HEALTH CARE CLEARINGHOUSES; ANA2 LYTICAL FUNCTIONS TOWARD IMPROVING 

3 THE HEALTH CARE SYSTEM 

4 ‘‘SEC. 13451. AUTHORITY REGARDING ANALYTICAL FUNC5 TIONS TOWARD IMPROVING THE HEALTH 

6 CARE SYSTEM. 

7 ‘‘(a) IN GENERAL.—With respect to the use and dis8 closure of protected health information, the Secretary— 

9 ‘‘(1) shall not consider health care clearing10 houses to be business associates under this subtitle, 

11 part C of title XI of the Social Security Act, or the 

12 regulations promulgated pursuant to section 264(c) 

13 of the Health Insurance Portability and Account14 ability Act of 1996 for purposes of carrying out ac15 tivities described in section 1171(2) of the Social Se16 curity Act and subsections (b) and (c) of this sec17 tion; and 

18 ‘‘(2) shall consider such clearinghouses to be 

19 covered entities under such provisions of law for 

20 such purposes. 

21 ‘‘(b) CERTAIN FUNCTIONS.—The functions that may 

22 be carried out by a health care clearinghouse pursuant to 

23 subsection (a) include the following: 

24 ‘‘(1) Promptly upon the request of individuals, 

25 providing such individuals with access to their pro26 tected health information as permitted by section 


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1 164.502(a)(1)(i) of title 45, Code of Federal Regula2 tions. In carrying out the previous sentence, the 

3 clearinghouse may charge such an individual a fee, 

4 not to exceed the fair market value, for preparing 

5 the record of such information involved. 

6 ‘‘(2) Promptly upon the request of individuals, 

7 providing such individuals with access to their pro8 tected health information as required by section 

9 164.502(a)(2)(i) of title 45, Code of Federal Regula10 tions. In carrying out the previous sentence, the 

11 clearinghouse may charge such an individual a fee, 

12 not to exceed the fair market value, for preparing 

13 the record of such information involved. 

14 ‘‘(3) With respect to the access of patients to 

15 experimental treatments and diagnostics, notifying 

16 patients that they may be appropriate candidates as 

17 subjects in clinical research, and conducting research 

18 to identify such patients, pursuant to the pre19 paratory-research provisions of section 164.512(i) of 

20 title 45, Code of Federal Regulations, and pursuant 

21 to the regulations referred to in paragraph (1) of 

22 this subsection. 

23 ‘‘(4) Making public health disclosures author24 ized by sections 164.512(b) or 164.514(e) of title 

25 45, Code of Federal Regulations, including notifying 


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1 manufacturers of drugs or devices about adverse 

2 events related to their products pursuant to such 

3 section 164.512(b). 

4 ‘‘(5) Research as authorized by sections 

5 164.512(i) or 164.514(e) of title 45, Code of Federal 

6 Regulations. 

7 ‘‘(6) Consistent with the applicable require8 ments of section 164.514 of title 45, Code of Fed9 eral Regulations, creating de-identified health infor10 mation or a limited data set. 

11 ‘‘(c) ADDITIONAL FUNCTIONS.— 

12 ‘‘(1) IN GENERAL.—In addition to the functions 

13 that may be carried out by a health care clearing14 house pursuant to subsection (a), such a clearing15 house may, subject only to the privacy protections 

16 under paragraph (2), aggregate, use, and disclose 

17 data the clearinghouse possesses in order to carry 

18 out the following functions: 

19 ‘‘(A) Prepare reports, analyses, and pres20 entations on the quality and costs of health care 

21 services, including in specific geographic areas, 

22 in order to assist individuals select health care 

23 services and providers. 

24 ‘‘(B) Prepare reports, analyses, and pres25 entations of health-services outcomes data, inVerDate Sep 11 2014 00:33 Mar 19, 2016 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H4805.IH H4805

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1 cluding presentations addressing outcomes of 

2 various types of approaches to a particular dis3 ease, disorder, or other adverse health condi4 tion. 

5 ‘‘(C) Prepare reports, analyses, and pres6 entations of epidemiological data to assist deci7 sionmaking in development programs for new 

8 treatments or diagnostics. 

9 ‘‘(D) Prepare reports, analyses, and pres10 entations on costs and charges for health care 

11 products and services. 

12 ‘‘(E) Upon the request of a covered entity, 

13 prepare reports, analyses, and presentations 

14 that benchmark the operations of such covered 

15 entity against the operations of one or more 

16 other covered entities that have elected to par17 ticipate in such benchmarking. 

18 ‘‘(2) PRIVACY.—A health care clearinghouse 

19 may carry out the functions described in paragraph 

20 (1) without obtaining any authorizations under sec21 tion 164.508 of title 45, Code of Federal Regula22 tions. For purposes of such paragraph, with respect 

23 to any report, analysis, or presentation provided by 

24 the clearinghouse to a third party, such report, anal25 ysis, or presentation— 


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1 ‘‘(A) shall include only de-identified data; 

2 or 

3 ‘‘(B) if containing protected health infor4 mation, shall include such data that is— 

5 ‘‘(i) subject to a qualifying data use 

6 agreement (as defined in subsection (i)); or 

7 ‘‘(ii) provided to the Food and Drug 

8 Administration for purposes authorized by 

9 law for such Administration, subject to 

10 protected health information being dis11 closed to such Administration only to the 

12 extent necessary for such purposes. 

13 ‘‘(d) RELEVANT INFORMATION.—In the case of a 

14 health care clearinghouse, the authority under subsections 

15 (a) through (c) includes applicability with respect to pro16 tected health information collected from other covered en17 tities and includes applicability with respect to the aggre18 gation of such information between covered entities. 

19 ‘‘(e) COMPREHENSIVE RECORDS PER REQUEST OF

20 INDIVIDUAL.—For purposes of subsection (b)(2), when a 

21 health care clearinghouse receives a request from an indi22 vidual for the protected health information of the indi23 vidual, the clearinghouse shall provide to the individual a 

24 comprehensive record of such information (across health 

25 care providers and health plans), unless the clearinghouse 


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1 determines in its discretion that providing a comprehen2 sive record is not technologically feasible. In preparing 

3 such record for the individual, the clearinghouse may, with 

4 the permission of the individual, purchase the protected 

5 health care information of the individual from one or more 

6 other health care clearinghouses (and the cost of such pur7 chase may be included in the fee charged to the indi8 vidual). 

9 ‘‘(f) SITUATIONS NOT INVOLVING DIRECT INTER10 ACTION WITH INDIVIDUALS.—Sections 164.400 through 

11 164.414, sections 164.520 through 164.528, and 164.530 

12 of title 45, Code of Federal Regulations, apply to a clear13 inghouse to the extent that it has current contact informa14 tion pursuant to direct interaction with the individual. In 

15 the case of each other individual, the clearinghouse shall 

16 carry out its functions under this subtitle, part C of title 

17 XI of the Social Security Act, and the regulations promul18 gated pursuant to section 264(c) of the Health Insurance 

19 Portability and Accountability Act of 1996 as if the clear20 inghouse were a business associate. The individuals to 

21 whom the preceding sentence applies includes individuals 

22 with respect to whom the sole clearinghouse function is 

23 to process or facilitate the processing of nonstandard data 

24 elements of health information into standard data ele25 ments. 


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1 ‘‘(g) TRANSITION.—With respect to agreements en2 tered into by a health care clearinghouse before the effec3 tive date of this section, a provision of an agreement that 

4 conflicts with this section shall not have any legal force 

5 or effect. The preceding sentence may not be construed 

6 as affecting any provision of an agreement that does not 

7 conflict with this section. A health care clearinghouse shall 

8 provide notice of this subsection to each entity with which 

9 the clearinghouse has an agreement that is affected by this 

10 subsection. 

11 ‘‘(h) ENFORCEMENT.—Section 13410(a)(2) applies 

12 to this part in the same manner as such section applies 

13 to parts 1 and 2. 

14 ‘‘(i) DEFINITIONS.—For purposes of this part: 

15 ‘‘(1) The term ‘de-identified’, with respect to 

16 health information, means such information that is 

17 not individually identifiable as determined in accord18 ance with the standards under section 164.514(b) of 

19 title 45, Code of Federal Regulations. 

20 ‘‘(2) The term ‘health care clearinghouse’ has 

21 the meaning given such term in section 1171 of the 

22 Social Security Act. 

23 ‘‘(3) The term ‘individual’, with respect to pro24 tected health information, has the meaning that apVerDate Sep 11 2014 00:33 Mar 19, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H4805.IH H4805

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1 plies under section 160.103 of title 45, Code of Fed2 eral Regulations. 

3 ‘‘(4) The term ‘qualifying data use agreement’ 

4 means an agreement that establishes the permitted 

5 uses and disclosures of protected health information 

6 by the recipient for one or more functions described 

7 in subsection (c)(1) and restricts the use and disclo8 sure of the information by the recipient in the same 

9 manner as applies under paragraphs (e)(4)(ii)(B) 

10 and (e)(4)(ii)(C) (1)–(4) of section 164.514 of title 

11 45, Code of Federal Regulations, but without regard 

12 to the references to limited data sets. 

13 ‘‘(j) RELATION TO OTHER LAWS.—Section 13421 

14 applies to this part in the same manner as such section 

15 applies to parts 1 and 2, except to the extent that such 

16 section concerns section 1178(a)(2)(B) of the Social Secu17 rity Act.’’. 

18 (b) REGULATIONS.—Not later than the expiration of 

19 the 90-day period beginning on the date of the enactment 

20 of this Act, the Secretary of Health and Human Services 

21 shall promulgate regulations to carry out the amendment 

22 made by subsection (a). 

23 (c) CONFORMING AMENDMENT.—Section 1171(2) of 

24 the Social Security Act (42 U.S.C. 1320d(2)) is amended 

25 by inserting before the period the following: ‘‘, or that carVerDate Sep 11 2014 00:33 Mar 19, 2016 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H4805.IH H4805

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1 ries out such processing function and in addition any of 

2 the functions authorized in section 13451 of the Health 

3 Information Technology for Economic and Clinical Health 

4 Act’’. 

Æ 


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