I 

114TH CONGRESS 

1ST SESSION H. R. 2549 

To amend the HITECH Act with respect to accessing, sharing, and using 

health data for research purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 21, 2015 

Mrs. MCMORRIS RODGERS introduced the following bill; which was referred 

to the Committee on Energy and Commerce 

A BILL 

To amend the HITECH Act with respect to accessing, 

sharing, and using health data for research purposes. 

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

3 SECTION 1. ACCESSING, SHARING, AND USING HEALTH 

4 DATA FOR RESEARCH PURPOSES. 

5 (a) IN GENERAL.—The HITECH Act (title XIII of 

6 division A of Public Law 111–5) is amended by adding 

7 at the end of subtitle D of such Act (42 U.S.C. 17921 

8 et seq.) the following: 


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1 ‘‘PART 4—ACCESSING, SHARING, AND USING 

2 HEALTH DATA FOR RESEARCH PURPOSES 

3 ‘‘SEC. 13441. REFERENCES. 

4 ‘‘In this part: 

5 ‘‘(a) THE RULE.—References to ‘the Rule’ refer to 

6 part 160 or part 164, as appropriate, of title 45, Code 

7 of Federal Regulations (or any successor regulation). 

8 ‘‘(b) PART 164.—References to a specified section of 

9 ‘part 164’, refer to such specified section of part 164 of 

10 title 45, Code of Federal Regulations (or any successor 

11 section). 

12 ‘‘SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART 

13 OF HEALTH CARE OPERATIONS. 

14 ‘‘(a) IN GENERAL.—Subject to subsection (b), the 

15 Secretary shall revise or clarify the rule to allow the use 

16 and disclosure of protected health information by a cov17 ered entity for research purposes, including studies whose 

18 purpose is to obtain generalizable knowledge, to be treated 

19 as the use and disclosure of such information for health 

20 care operations described in subparagraph (1) of the defi21 nition of health care operations in section 164.501 of part 

22 164. 

23 ‘‘(b) MODIFICATIONS TO RULES FOR DISCLOSURES

24 FOR HEALTH CARE OPERATIONS.—In applying section 

25 164.506 of part 164 to the disclosure of protected health 

26 information described in subsection (a)— 


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1 ‘‘(1) the Secretary shall revise or clarify the 

2 Rule so that the disclosure may be made by the cov3 ered entity to only— 

4 ‘‘(A) another covered entity for health care 

5 operations (as defined in such section 164.501 

6 of part 164); 

7 ‘‘(B) a business associate that has entered 

8 into a contract under section 164.504(e) of part 

9 164 with a disclosing covered entity to perform 

10 health care operations; or 

11 ‘‘(C) a business associate that has entered 

12 into a contract under section 164.504(e) of part 

13 164 for the purpose of data aggregation (as de14 fined in such section 164.501 of part 164); and 

15 ‘‘(2) the Secretary shall further revise or clarify 

16 the Rule so that the limitation specified by section 

17 164.506(c)(4) of part 164 does not apply to disclo18 sures that are described by subsection (a). 

19 ‘‘(c) RULE OF CONSTRUCTION.—This section shall 

20 not be construed as prohibiting or restricting a use or dis21 closure of protected health information for research pur22 poses that is otherwise permitted under part 164. 


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1 ‘‘SEC. 13443. TREATING DISCLOSURES OF PROTECTED 

2 HEALTH INFORMATION FOR RESEARCH SIMI3 LARLY TO DISCLOSURES OF SUCH INFORMA4 TION FOR PUBLIC HEALTH PURPOSES. 

5 ‘‘(a) REMUNERATION.—The Secretary shall revise or 

6 clarify the Rule so that disclosures of protected health in7 formation for research purposes are not subject to the lim8 itation on remuneration described in section 

9 164.502(a)(5)(ii)(B)(2)(ii) of part 164. 

10 ‘‘(b) PERMITTED USES AND DISCLOSURES.—The 

11 Secretary shall revise or clarify the Rule so that research 

12 activities, including comparative research activities, re13 lated to the quality, safety, or effectiveness of a product 

14 or activity that is regulated by the Food and Drug Admin15 istration are included as public health activities for pur16 poses of which a covered entity may disclose protected 

17 health information to a person described in section 

18 164.512(b)(1)(iii) of part 164. 

19 ‘‘SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED 

20 HEALTH INFORMATION BY RESEARCHERS. 

21 ‘‘The Secretary shall revise or clarify the Rule so that 

22 subparagraph (B) of section 164.512(i)(1)(ii) of part 164 

23 (prohibiting the removal of protected health information 

24 by a researcher) shall not prohibit remote access to health 

25 information by a researcher so long as— 


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1 ‘‘(1) appropriate security and privacy safe2 guards are maintained by the covered entity and the 

3 researcher; and 

4 ‘‘(2) the protected health information is not 

5 copied or otherwise retained by the researcher. 

6 ‘‘SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE 

7 AND DISCLOSURE OF PROTECTED HEALTH 

8 INFORMATION FOR RESEARCH PURPOSES. 

9 ‘‘(a) IN GENERAL.—The Secretary shall revise or 

10 clarify the Rule to specify that an authorization for the 

11 use or disclosure of protected health information, with re12 spect to an individual, for future research purposes shall 

13 be deemed to contain a sufficient description of the pur14 pose of the use or disclosure if the authorization— 

15 ‘‘(1) sufficiently describes the purposes such 

16 that it would be reasonable for the individual to ex17 pect that the protected health information could be 

18 used or disclosed for such future research; 

19 ‘‘(2) either— 

20 ‘‘(A) states that the authorization will ex21 pire on a particular date or on the occurrence 

22 of a particular event; or 

23 ‘‘(B) states that the authorization will re24 main valid unless and until it is revoked by the 

25 individual; and 


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1 ‘‘(3) provides instruction to the individual on 

2 how to revoke such authorization at any time. 

3 ‘‘(b) REVOCATION OF AUTHORIZATION.—The Sec4 retary shall revise or clarify the Rule to specify that, if 

5 an individual revokes an authorization for future research 

6 purposes such as is described by subsection (a), the cov7 ered entity may not make any further uses or disclosures 

8 based on that authorization, except, as provided in para9 graph (b)(5) of section 164.508 of part 164, to the extent 

10 that the covered entity has taken action in reliance on the 

11 authorization.’’. 

12 (b) REVISION OF REGULATIONS.—Not later than 12 

13 months after the date of the enactment of this Act, the 

14 Secretary of Health and Human Services shall revise and 

15 clarify the provisions of title 45, Code of Federal Regula16 tions, for consistency with part 4 of subtitle D of the 

17 HITECH Act, as added by subsection (a). 

Æ 


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