241 
cation criteria (and modifications, including addi-
tions, to such standards, specifications, and criteria), 
which are in accordance with the policies and prior-
ities developed by the Secretary, in consultation with 
the National Coordinator. 
‘‘(3) MULTIPLE METHODS TO TEST INTEROPER-
ABILITY STANDARDS.—For the purposes of developing 
methods to test interoperability standards for adop-
tion under section 3004, the Secretary shall ensure 
that contracts under this section allow for multiple 
methods to test such standards to account for vari-
ations in the adoption of such standards that do not 
conflict with section 3010(a). 
‘‘(c) MODIFICATIONS AND SUBSEQUENT CONTRACTS.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the National Coordinator, shall periodically 
conduct hearings to evaluate and review the stand-
ards, implementation specifications, and certification 
criteria adopted under section 3004 for purposes of 
determining if modifications, including any addi-
tions, are needed with respect to such standards, spec-
ifications, and criteria. 
‘‘(2) CONTRACT TRIGGER.—Based on the needs 
for standards, implementation specifications, and cer-
tification criteria (and modifications, including addi-
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242 
tions, to such standards, specifications, and criteria) 
under this title, as determined by the Secretary, in 
consultation with the National Coordinator, the Sec-
retary shall, as needed, enter into contracts under 
subsection (a) in addition to the initial contract. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $10,000,000 for contracts 
under subsection (a), to remain available until expended.’’. 
(4) MODIFICATIONS TO ROLE OF ONCHIT.—Sec-
tion 3001(c)(1)(A) of the Public Health Service Act 
(42 U.S.C. 300jj–11(c)(1)(A)) is amended by insert-
ing ‘‘for recommendations made before the date of the 
enactment of the 21st Century Cures Act,’’ before ‘‘re-
view and determine’’. 
(c) ADOPTION.—Section 3004 of the Public Health 
Service Act (42 U.S.C. 300jj–14) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by inserting after 
‘‘section 3001(c)’’ the following: ‘‘(or, subject to 
subsection (c), in the case of a standard, speci-
fication, or criterion recommended on or after 
the date of the enactment of the 21st Century 
Cures Act, after the date of submission of the rec-
ommendation to the Secretary under section 
3003A)’’; and 
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243 
(B) in paragraph (2)(B), by striking ‘‘and 
the HIT Standards Committee’’; 
(2) in subsection (b), by adding at the end the 
following new paragraph: 
‘‘(4) LIMITATION.—The Secretary may not adopt 
any standards, implementation specifications, or cer-
tification criteria under this subsection or subsection 
(a) that are inconsistent with or duplicative of an 
interoperability standard adopted under this section, 
in accordance with subsections (c) and (d). In the 
case of a standard, specification, or criterion that has 
been adopted under this section and is inconsistent or 
duplicative of such an interoperability standard that 
is subsequently adopted under this section, such inter-
operability standard shall supercede such other stand-
ard, specification, or criterion and such other stand-
ard, specification, or criterion shall no longer be con-
sidered adopted under this section beginning on the 
date that such interoperability standard becomes effec-
tive.’’; and 
(3) by adding at the end the following new sub-
sections: 
‘‘(c) ADOPTION OF INITIAL INTEROPERABILITY STAND-
ARDS.—Notwithstanding the previous subsections of this 
section, the following shall apply in the case of the initial 
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set of interoperability standards recommended under sec-
tion 3003A: 
‘‘(1) REVIEW OF STANDARDS.—Not later than 90 
days after the date of receipt of recommendations for 
such interoperability standards, the Secretary, in con-
sultation with the National Coordinator and rep-
resentatives of other relevant Federal agencies, shall 
jointly review such standards and shall determine 
whether or not to propose adoption of such standards. 
‘‘(2) DETERMINATION
TO
ADOPT.—If the Sec-
retary determines— 
‘‘(A) to propose adoption of such standards, 
the Secretary shall, by regulation under section 
553 of title 5, United States Code, determine 
whether or not to adopt such standards; or 
‘‘(B) not to propose adoption of such stand-
ards, the Secretary shall notify the applicable 
standards development organizations with a con-
tract under section 3003A in writing of such de-
termination and the reasons for not proposing 
the adoption of the recommendation for such 
standards. 
‘‘(3) PUBLICATION.—The Secretary shall provide 
for publication in the Federal Register of all deter-
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245 
minations made by the Secretary under paragraph 
(1). 
‘‘(4) 
APPLICATION.—Any 
standard 
adopted 
under this subsection shall be effective 12 months after 
the date of publication of the determination to adopt 
such standard. 
‘‘(d) RULES FOR ADOPTION.—In the case of a stand-
ard (including interoperability standard), implementation 
specification, or certification criteria adopted under this 
section on or after the date of the enactment of the 21st 
Century Cures Act, the following shall apply: 
‘‘(1) IN GENERAL.—Except as provided in para-
graph (2), any such standard (including interoper-
ability standard), implementation specification, or 
certification criterion shall be a standard, specifica-
tion, or criterion that has been recommended by the 
standards development organizations with which the 
Secretary has entered into a contract under section 
3003A. 
‘‘(2) SPECIAL RULE IF NO STANDARD, SPECIFICA-
TION, OR CRITERION RECOMMENDED.—If no standard 
is recommended under paragraph (1)— 
‘‘(A) in the case of interoperability stand-
ards, relating to a category described in section 
3010(b)— 
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‘‘(i) paragraph (1) shall not apply; 
and 
‘‘(ii) paragraph (4) shall apply; or 
‘‘(B) in the case of any other standard, im-
plementation specification, or certification cri-
teria, relating to a policy or priority to carry 
out this title, as determined by the Secretary, in 
consultation with the National Coordinator— 
‘‘(i) paragraph (1) shall not apply; 
and 
‘‘(ii) paragraph (4) shall apply. 
‘‘(3) EFFECTIVE DATE.—Any standard, imple-
mentation specification, or certification criterion 
adopted under this section shall be effective 12 months 
after the date of publication of the final rule to adopt 
such standard, implementation specification, or cer-
tification criterion. 
‘‘(4) ASSISTANCE TO THE SECRETARY.—In com-
plying with the requirements of this subsection, the 
Secretary shall rely on the recommendations of the 
National Committee on Vital and Health Statistics 
established under section 306(k), and shall consult 
with appropriate Federal and State agencies and pri-
vate organizations. The Secretary shall publish in the 
Federal Register any recommendation of the National 
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Committee on Vital and Health Statistics regarding 
the adoption of a standard, implementation specifica-
tion, or certification criterion under this section. Any 
standard, implementation specification, or certifi-
cation criterion adopted pursuant to this paragraph 
shall be promulgated in accordance with the rule-
making procedures of subchapter III of chapter 5 of 
title 5, United States Code.’’. 
(d) REPORTS AND NOTIFICATIONS.—Section 3010 of 
the Public Health Service Act, as added by subsection (a), 
is amended by adding at the end the following new sub-
section: 
‘‘(c) DISSEMINATION OF INFORMATION.— 
‘‘(1) INITIAL SUMMARY REPORT.—Not later than 
July 1, 2017, the Secretary, after consultation with 
relevant stakeholders, shall submit to Congress and 
provide for publication in the Federal Register and 
the posting on the Internet website of the Office of the 
National Coordinator for Health Information Tech-
nology of a report on the following: 
‘‘(A) The initial set of interoperability 
standards adopted under section 3004(c). 
‘‘(B) The strategies for achieving wide-
spread interoperability. 
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‘‘(C) An overview of the extent to which 
electronic health records and health information 
technology offered as of such date satisfy such 
initial set. 
‘‘(D) Any barriers that are preventing wide-
spread interoperability. 
‘‘(E) The plan and milestones, including 
specific steps, to achieve widespread interoper-
ability. 
‘‘(2) FOLLOWUP
DETERMINATION
AND
REPORT 
ON WIDESPREAD INTEROPERABILITY.—Not later than 
December 31, 2019, the Secretary shall provide for 
publication in the Federal Register and the posting 
on the Internet website of the Office of the National 
Coordinator for Health Information Technology of the 
following: 
‘‘(A) A determination by the Secretary 
whether the goal of widespread interoperability 
has been achieved. 
‘‘(B) A list identifying the vendors of, or 
other entities offering, qualified electronic health 
records, which categorizes such entities, with re-
spect to such records, as in compliance or not in 
compliance with the certification criteria de-
scribed in section 3001(c)(5)(B)(ii) and with the 
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requirements 
under 
clause 
(i) 
of 
section 
3001(c)(5)(C) (including with the terms of the 
attestation and other requirements under such 
clause). 
‘‘(C) Actions that may be taken by entities 
identified under subparagraph (B) as not being 
in compliance with such criteria and require-
ments in order for such entities to become in 
compliance with such criteria and requirements. 
‘‘(D) 
Penalties 
described 
in 
section 
3010A(d) to which entities, with respect to such 
qualified electronic health records, beginning 
January 1, 2019, are subject if such technology 
and entities are not in compliance with the cer-
tification 
criteria 
described 
in 
section 
3001(c)(5)(B)(ii) and with the requirements 
under clause (i) of section 3001(c)(5)(C), respec-
tively. 
‘‘(3) ONGOING PUBLICATION OF RECOMMENDA-
TIONS.—The Secretary shall provide for publication 
in the Federal Register and the posting on the Inter-
net website of the Office of the National Coordinator 
for Health Information Technology of all rec-
ommendations made under this section.’’. 
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250 
(e) CERTIFICATION AND OTHER ENFORCEMENT PROVI-
SIONS.— 
(1) CERTIFICATION OF QUALIFIED ELECTRONIC 
HEALTH RECORDS.— 
(A) IN GENERAL.—Section 3007(b) of the 
Public Health Service Act (42 U.S.C. 300jj– 
17(b)) is amended by striking ‘‘under section 
3001(c)(3) to be in compliance with’’ and all 
that follows through the period at the end and 
inserting ‘‘under section 3001(c)(3)— 
‘‘(1) for certifications made before January 1, 
2018, to be in compliance with applicable standards 
adopted under subsections (a) and (b) of section 3004; 
and 
‘‘(2) for certifications made on or after January 
1, 2018, to be in compliance with applicable stand-
ards adopted under subsections (a) and (b) of section 
3004 and to be interoperable in accordance with sec-
tion 3010, including by being in compliance with 
interoperability standards adopted under section 
3004.’’. 
(B) REQUIREMENTS OF SECRETARY.—Sec-
tion 3001(c)(5) of the Public Health Service Act 
(42 U.S.C. 300jj–11(c)(5)) is amended— 
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(i) by amending subparagraph (B) of 
such section to read as follows: 
‘‘(B) 
CERTIFICATION
CRITERIA
DE-
SCRIBED.—In this title, the term ‘certification 
criteria’ means, with respect to qualified elec-
tronic health records— 
‘‘(i) for certifications made before Jan-
uary 1, 2018, criteria to establish that the 
records meet standards and implementation 
specifications adopted under subsections (a) 
and (b) of section 3004 for qualified elec-
tronic health records; and 
‘‘(ii) for certifications made on or after 
January 1, 2018, criteria described in 
clause (i) and criteria to establish that the 
records are interoperable, in accordance 
with section 3010, including by being in 
compliance with interoperability standards 
adopted under section 3004.’’; and 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(C) ENFORCEMENT; DECERTIFICATIONS.— 
‘‘(i) REQUIREMENTS.—Under any pro-
gram kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
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any vendor of or other entity offering quali-
fied electronic health records seeking a cer-
tification of such records under such pro-
gram on or after January 1, 2018, shall, as 
a condition of certification (and mainte-
nance of certification) of such a record 
under such program— 
‘‘(I) provide to the Secretary an 
attestation— 
‘‘(aa) that the entity, unless 
for a legitimate purpose specified 
by the Secretary, has not taken 
any action, including through 
any financial, administrative, or 
technological barrier, which the 
entity knows or should know (as 
defined in section 1128A(i)(7) of 
the Social Security Act), is to 
limit or restrict the exchange of 
information or to prevent or 
disincentivize widespread inter-
operability between any providers 
using such records or other health 
information technology in connec-
tion with such record; 
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‘‘(bb) on the pricing informa-
tion described in clause (v) for 
purposes of the portal created 
under paragraph (9); that such 
information will be available on a 
public Web site of such entity and 
in marketing materials, commu-
nications statements, and other 
assertions of such entity related to 
such record; and that the entity 
will voluntarily provide such in-
formation to customers prior to 
providing any qualified electronic 
health records or related product 
or service (including subsequent 
updates, add-ons, or additional 
products or services to be provided 
during the course of an on-going 
contract), prospective customers 
(such as persons who request or 
receive a quotation, estimate, or 
other similar marketing or pro-
motional material), and other 
persons who request such informa-
tion; 
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‘‘(cc) that the software with 
respect to such records have pub-
lished application programming 
interfaces 
for 
medical 
records 
data, search and indexing, seman-
tic harmonization and vocabulary 
translation, and user interface ap-
plications; 
‘‘(dd) that the entity has suc-
cessfully tested the use of the 
record in the type of setting in 
which it would be marketed; 
‘‘(ee) the entity has in place 
implementation 
guidelines 
for 
such record that support inter-
operability, consistent with sec-
tion 3010; and 
‘‘(ff) that the entity has in 
place data sharing programs or 
capabilities based on common 
data elements through application 
programming interfaces without 
the requirement for vendor-specific 
interfaces; 
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‘‘(II) publish application pro-
gramming interfaces and associated 
documentation, with respect to such 
records, for medical records data, 
search and indexing, semantic harmo-
nization and vocabulary translation, 
and user interface applications; and 
‘‘(III) demonstrate to the satisfac-
tion of the Secretary that data from 
such records are able to be exchanged 
through the use of application pro-
gramming interfaces and used in a 
manner that allows for exchange and 
everyday use, as authorized under ap-
plicable law, of such records. 
‘‘(ii) DECERTIFICATION.—Under any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
beginning January 1, 2019, any qualified 
electronic health records that do not satisfy 
the certification criteria described in section 
3001(c)(5)(B)(ii) or with respect to which 
the vendor or other entity described in 
clause (i) does not satisfy the requirements 
under such clause (or is determined to be in 
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violation of the terms of the attestation or 
other requirements under such clause) shall 
no longer be considered as certified under 
such program. 
‘‘(iii) 
ANNUAL
PUBLICATION.—For 
2019 and each subsequent year, the Sec-
retary shall post on the public Internet 
website of the Department of Health and 
Human Services a list of any vendors of or 
other entities offering qualified electronic 
health records with respect to which certifi-
cation has been withdrawn under clause (ii) 
during such year. 
‘‘(iv) PERIODIC
REVIEW.—The Sec-
retary shall periodically review and confirm 
that vendors of and other entities offering 
qualified electronic health records have pub-
licly published application programming 
interfaces and associated documentation as 
required by clause (i)(II) for purposes of 
certification and maintaining certification 
under any program kept or recognized 
under subparagraph (A). 
‘‘(v) PRICING INFORMATION.—For pur-
poses of clause (i)(I)(bb), the pricing infor-
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mation described in this clause, with respect 
to a vendor of or other entity offering a 
qualified electronic health record, is the fol-
lowing: 
‘‘(I) Additional types of costs or 
fees (whether fixed, recurring, trans-
action based, or otherwise) imposed by 
the entity (or any third-party from 
whom the entity purchases, licenses, or 
obtains any technology, products, or 
services in connection with the quali-
fied electronic health record) to pur-
chase, license, implement, maintain, 
upgrade, use, or otherwise enable and 
support the use of capabilities to which 
such record is to be certified under this 
section; or in connection with any data 
generated in the course of using any 
capability to which the record is to be 
so certified. 
‘‘(II) Limitations, whether by 
contract or otherwise, on the use of any 
capability to which the record is to be 
certified under this section for any 
purpose within the scope of the record’s 
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certification; or in connection with any 
data generated in the course of using 
any capability to which the record is 
to be certified under this section. 
‘‘(III) 
Limitations, 
including 
technical or practical limitations of 
technology or its capabilities, that 
could prevent or impair the successful 
implementation, 
configuration, 
customization, maintenance, support, 
or use of any capabilities to which the 
record is to be certified under this sec-
tion; or that could prevent or limit the 
use, exchange, or portability of any 
data generated in the course of using 
any capability to which the record is 
to be so certified.’’. 
(2) 
ADDITIONAL
ENFORCEMENT
PROVISIONS 
UNDER THE PUBLIC HEALTH SERVICE ACT.—Subtitle 
A of title XXX of the Public Health Service Act (42 
U.S.C. 300jj–11 et seq.), as amended by subsections 
(a)(1) and (d), is further amended by adding at the 
end the following new section: 
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‘‘SEC. 3010A. ENFORCEMENT MECHANISMS. 
‘‘(a) INSPECTOR GENERAL AUTHORITY.—The Inspec-
tor General of the Department of Health and Human Serv-
ices shall have the authority to investigate claims of— 
‘‘(1) vendors of, or other entities offering, quali-
fied electronic health records— 
‘‘(A) being in violation of an attestation 
made under section 3001(c)(5)(C)(i)(I), with re-
spect to the use of such records by a health care 
provider under a specified meaningful use incen-
tive program; and 
‘‘(B) having engaged in information block-
ing (as defined in subsection (f)), unless for a le-
gitimate purpose specified by the Secretary, with 
respect to the use of such records by a health care 
provider under such a program; 
‘‘(2) health care providers, with respect to the use 
of such records under a specified meaningful use in-
centive program, having, unless for a legitimate pur-
pose specified by the Secretary, engaged in informa-
tion blocking (as so defined); 
‘‘(3) health information system providers de-
scribed in subsection (b) having engaged in informa-
tion blocking (as so defined), unless for a legitimate 
purpose specified by the Secretary, with respect to the 
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PDP sponsor to select under subpara-
graph (D) in the case that the bene-
ficiary is identified as an at-risk bene-
ficiary for prescription drug abuse as 
described in clause (iii)(I); 
‘‘(V) an explanation of the mean-
ing and consequences of the identifica-
tion of the beneficiary as potentially 
being an at-risk beneficiary for pre-
scription drug abuse, including an ex-
planation of the drug management 
program established by the PDP spon-
sor pursuant to subparagraph (A); 
‘‘(VI) clear instructions that ex-
plain how the beneficiary can contact 
the PDP sponsor in order to submit to 
the PDP sponsor the preferences de-
scribed in subclause (IV) and any 
other communications relating to the 
drug management program for at-risk 
beneficiaries established by the PDP 
sponsor; and 
‘‘(VII) contact information for 
other organizations that can provide 
the beneficiary with assistance regard-
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