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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. RECOMMENDATIONS FOR DEVELOPMENT AND 
USE OF CLINICAL DATA REGISTRIES. 
(a) IN GENERAL.—Not later than one year after the 
date of the enactment of this Act, the Secretary of Health 
and Human Services shall make recommendations for the 
development and use, when appropriate, of clinical data 
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registries that are integrated with clinical practice guide-
lines and best practices or standards of care, including 
registries designed to minimize duplication and burden on 
those operating or reporting to such registries, for the im-
provement of patient care. The Secretary shall make such 
recommendations available to the public by posting them 
on a public Website of the Department of Health and 
Human Services. 
(b) 
SPECIFIC
RECOMMENDATIONS.—Such 
rec-
ommendations, with respect to such registries, shall in-
clude the following: 
(1) Recommendations for a set of standards 
that, if adopted by such registries, would allow for 
the bidirectional, interoperable exchange of informa-
tion between the electronic health records of the re-
porting clinicians and such registries. 
(2) Recommendations on how clinical registries, 
including outcomes-based registries, may be devel-
oped and then used to evaluate various care models 
and methods, including improved clinical care co-
ordination, and the impact of such models and meth-
ods on the management of diseases as measured by 
appropriate care parameters based on clinical prac-
tice guidelines and best practices (such as A1C, 
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blood pressure, and cholesterol levels in the case of 
diabetes). 
(3) Recommendations on how such registries 
should be structured to facilitate the recording and 
reporting of post-market data for the purposes of 
monitoring safety and efficacy of FDA-approved de-
vices and drugs, reporting relevant clinical data to 
satisfy attestation requirements for coverage of pre-
scribed devices and drugs, and better defining appro-
priate clinical use in support of evidence develop-
ment for the Medicare program (such as improving 
patient access to safe and effective glucose moni-
toring systems and future glucose monitoring tech-
nologies). 
(4) Recommendations on how data from such 
registries may be used to inform physicians and 
other health care professionals regarding clinical 
practices for the prevention of diseases (such as dia-
betes and the precursor conditions of diabetes) and 
appropriate methods for the dissemination of clinical 
practice support tools and other educational re-
sources that may be derived from registry data. 
(5) Recommendations for how registries can be 
used to promote preventive health benefits such as 
screenings and the Medicare annual wellness visits 
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that may reduce the risk of chronic diseases (such 
as obesity, osteoporosis, cardiovascular disease, can-
cer, diabetes and their complications). 
(c) CONSULTATION WITH CLINICAL EXPERTS.—The 
Secretary shall consult with national medical specialty so-
cieties and with manufacturers of drugs and medical de-
vices in the development of such recommendations as they 
relate to the diseases that they (or their manufactured 
drugs or devices) manage and treat (such as with 
endocrinologists with respect to recommendations relating 
to diabetes and pre-diabetes conditions). 
Æ 
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