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 
registries that are integrated with clinical practice guide-
lines and best practices or standards of care, including rec-
ommendations designed to minimize duplication and bur-
den on those operating or reporting to such registries, for 
the improvement 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 include 
the following: 
(1) Recommendations for a set of standards that, 
if adopted by such registries, would allow for the 
bidirectional, interoperable exchange of information 
between the electronic health records of the reporting 
clinicians and such registries. 
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(2) Recommendations on how clinical registries, 
including outcomes-based registries, may be developed 
and then used to evaluate various care models and 
methods, including improved clinical care coordina-
tion, and the impact of such models and methods on 
the management of diseases as measured by appro-
priate care parameters based on clinical practice 
guidelines and best practices (such as A1C, blood 
pressure, and cholesterol levels in the case of diabetes). 
(3) Recommendations on how such registries 
should be structured to facilitate— 
(A) the recording and reporting of post- 
market data for the purposes of monitoring safe-
ty and efficacy of FDA-approved devices and 
drugs; 
(B) the reporting of relevant clinical data to 
satisfy attestation requirements for coverage of 
prescribed devices; and 
(C) coverage with evidence development 
policies for devices under the Medicare program 
(such as improving patient access to safe and ef-
fective glucose monitoring systems). 
(4) Recommendations on how data from such 
registries may be used to inform physicians and other 
health care professionals regarding clinical practices 
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for the prevention of diseases (such as diabetes and 
the precursor conditions of diabetes) and appropriate 
methods for the dissemination of clinical practice sup-
port tools and other educational resources 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 
that may reduce the risk of chronic diseases (such as 
obesity, osteoporosis, cardiovascular disease, cancer, 
diabetes and their complications). 
(c) CONSULTATION WITH CLINICAL EXPERTS.—The 
Secretary shall consult with national medical specialty so-
cieties, patient groups, technology vendors, and developers 
and manufacturers of drugs and medical devices in the de-
velopment of such recommendations as they relate to the 
diseases that members of such societies manage and treat 
(such as with endocrinologists with respect to recommenda-
tions relating to diabetes and pre-diabetes conditions). 
(d) RULE OF CONSTRUCTION.—Nothing in this section 
may be construed as— 
(1) authorizing the Secretary of Health and 
Human Services to take any action with regard to the 
recommendations made under this section (other than 
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making such recommendations available to the public 
in the manner described in subsection (a)); 
(2) limiting or interfering with the authority of 
a health care practitioner to practice medicine or to 
prescribe or administer a drug or device to an indi-
vidual for a condition or disease; or 
(3) providing the Centers for Medicare & Med-
icaid Services with authority to limit (or to encour-
age other individuals or entities to limit) coverage 
under the Medicare program under title XVIII of the 
Social Security Act for an item or service furnished 
to an individual on account of the participation, or 
lack of participation, of the individual in a registry 
or other data collection system. 
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Union Calendar No. 514 
113TH CONGRESS 
2D SESSION 
H. R. 5214 
[Report No. 113–683] 
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. 
DECEMBER 22, 2014 
Reported with an amendment, committed to the Com-
mittee of the Whole House on the State of the Union, 
and ordered to be printed 
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