I 

113TH CONGRESS 

2D SESSION H. R. 5214 

To require the Secretary of Health and Human Services to provide for 

recommendations for the development and use of clinical data registries 

for the improvement of patient care. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 28, 2014 

Mr. OLSON introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To require the Secretary of Health and Human Services 

to provide for recommendations for the development and 

use of clinical data registries for the improvement of 

patient care. 

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

3 SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND 

4 USE OF CLINICAL DATA REGISTRIES. 

5 (a) IN GENERAL.—Not later than one year after the 

6 date of the enactment of this Act, the Secretary of Health 

7 and Human Services shall make recommendations for the 

8 development and use, when appropriate, of clinical data 


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1 registries that are integrated with clinical practice guide2 lines and best practices or standards of care, including 

3 registries designed to minimize duplication and burden on 

4 those operating or reporting to such registries, for the im5 provement of patient care. The Secretary shall make such 

6 recommendations available to the public by posting them 

7 on a public Website of the Department of Health and 

8 Human Services. 

9 (b) SPECIFIC RECOMMENDATIONS.—Such rec10 ommendations, with respect to such registries, shall in11 clude the following: 

12 (1) Recommendations for a set of standards 

13 that, if adopted by such registries, would allow for 

14 the bidirectional, interoperable exchange of informa15 tion between the electronic health records of the re16 porting clinicians and such registries. 

17 (2) Recommendations on how clinical registries, 

18 including outcomes-based registries, may be devel19 oped and then used to evaluate various care models 

20 and methods, including improved clinical care co21 ordination, and the impact of such models and meth22 ods on the management of diseases as measured by 

23 appropriate care parameters based on clinical prac24 tice guidelines and best practices (such as A1C, 


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1 blood pressure, and cholesterol levels in the case of 

2 diabetes). 

3 (3) Recommendations on how such registries 

4 should be structured to facilitate the recording and 

5 reporting of post-market data for the purposes of 

6 monitoring safety and efficacy of FDA-approved de7 vices and drugs, reporting relevant clinical data to 

8 satisfy attestation requirements for coverage of pre9 scribed devices and drugs, and better defining appro10 priate clinical use in support of evidence develop11 ment for the Medicare program (such as improving 

12 patient access to safe and effective glucose moni13 toring systems and future glucose monitoring tech14 nologies). 

15 (4) Recommendations on how data from such 

16 registries may be used to inform physicians and 

17 other health care professionals regarding clinical 

18 practices for the prevention of diseases (such as dia19 betes and the precursor conditions of diabetes) and 

20 appropriate methods for the dissemination of clinical 

21 practice support tools and other educational re22 sources that may be derived from registry data. 

23 (5) Recommendations for how registries can be 

24 used to promote preventive health benefits such as 

25 screenings and the Medicare annual wellness visits 


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1 that may reduce the risk of chronic diseases (such 

2 as obesity, osteoporosis, cardiovascular disease, can3 cer, diabetes and their complications). 

4 (c) CONSULTATION WITH CLINICAL EXPERTS.—The 

5 Secretary shall consult with national medical specialty so6 cieties and with manufacturers of drugs and medical de7 vices in the development of such recommendations as they 

8 relate to the diseases that they (or their manufactured 

9 drugs or devices) manage and treat (such as with 

10 endocrinologists with respect to recommendations relating 

11 to diabetes and pre-diabetes conditions). 

Æ 


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