239 
‘‘(2) DETERMINATION TO ADOPT.—If the Sec-
retary determines— 
‘‘(A) to propose adoption of such stand-
ards, the Secretary shall, by regulation under 
section 553 of title 5, United States Code, de-
termine whether or not to adopt such stand-
ards; or 
‘‘(B) not to propose adoption of such 
standards, the Secretary shall notify the Na-
tional Coordinator and the standards develop-
ment organizations under section 3003A in 
writing of such determination and the reasons 
for not proposing the adoption of the rec-
ommendation for such standards. 
‘‘(3) PUBLICATION.—The Secretary shall pro-
vide for publication in the Federal Register of all de-
terminations made by the Secretary under para-
graph (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. 
‘‘(c) RULES FOR ADOPTION.—In the case of a stand-
ard (including interoperability standard), implementation 
specification, or certification criteria adopted under this 
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240 
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 criteria 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, SPECI-
FICATION, 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)— 
‘‘(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— 
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241 
‘‘(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 specifica-
tion, or certification criteria. 
‘‘(4) ASSISTANCE
TO
THE
SECRETARY.—In 
complying with the requirements of this subsection, 
the Secretary shall rely on the recommendations of 
the National Committee on Vital and Health Statis-
tics established under section 306(k), and shall con-
sult with appropriate Federal and State agencies 
and private organizations. The Secretary shall pub-
lish in the Federal Register any recommendation of 
the National Committee on Vital and Health Statis-
tics regarding the adoption of a standard implemen-
tation specification, or certification criterion under 
this section. Any standard, implementation specifica-
tion, or certification criterion adopted pursuant to 
this paragraph shall be promulgated in accordance 
with the rulemaking procedures of subchapter III of 
chapter 5 of title 5, United States Code.’’. 
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242 
(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 
Technology 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. 
‘‘(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 
widespread interoperability. 
‘‘(E) The plan and milestones, including 
specific steps, to achieve widespread interoper-
ability. 
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‘‘(2) FOLLOW-UP DETERMINATION AND REPORT 
ON
WIDESPREAD
INTEROPERABILITY.—Not later 
than December 31, 2019, the Secretary shall provide 
for publication in the Federal Register and the post-
ing on the Internet website of the Office of the Na-
tional Coordinator for Health Information Tech-
nology 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 respect to such records, as in compliance 
or not in compliance with the certification cri-
teria described in section 3001(c)(5)(B)(ii) and 
with the requirements under clause (i) of sec-
tion 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. 
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‘‘(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), re-
spectively. 
‘‘(3) ONGOING PUBLICATION OF RECOMMENDA-
TIONS.—The Secretary shall provide for publication 
in the Federal Register and the posting on the 
Internet website of the Office of the National Coor-
dinator for Health Information Technology of all 
recommendations made under this section.’’. 
(e) CERTIFICATION
AND
OTHER
ENFORCEMENT 
PROVISIONS.— 
(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)— 
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‘‘(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 sec-
tion 3004 and to be interoperable in accordance with 
section 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— 
(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 
January 1, 2018, criteria to establish that 
the records meet standards and implemen-
tation specifications adopted under sub-
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sections (a) and (b) of section 3004 for 
qualified electronic 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 accord-
ance with section 3010, including by being 
in compliance with interoperability stand-
ards adopted under section 3004.’’; and 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(C) 
ENFORCEMENT; 
DECERTIFICATIONS.— 
‘‘(i) 
REQUIREMENTS.—Under 
any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
any vendor of or other entity offering 
qualified electronic health records seeking 
a certification of such records under such 
program on or after January 1, 2018, 
shall, as a condition of certification (and 
maintenance of certification) of such a 
record under such program— 
‘‘(I) provide to the Secretary an 
attestation— 
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‘‘(aa) that the entity, unless 
for a legitimate purpose specified 
by the Secretary, has not taken 
any action, including through any 
financial, administrative, or tech-
nological barrier, which the entity 
knows or should know (as defined 
in section 1128A(i)(7) of the So-
cial Security Act), is to limit or 
restrict the exchange of informa-
tion 
or 
to 
prevent 
or 
disincentivize widespread inter-
operability between any providers 
using such records or other 
health information technology in 
connection with such record; 
‘‘(bb) on the pricing infor-
mation 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, com-
munications 
statements, 
and 
other assertions of such entity re-
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lated to such record, and that the 
entity will voluntarily provide 
such information to customers 
prior to providing any qualified 
electronic health records or re-
lated product or service (includ-
ing subsequent updates, add-ons, 
or additional products or services 
to be provided during the course 
of an on-going contract), prospec-
tive customers (such as persons 
who 
request 
or 
receive 
a 
quotation, 
estimate, 
or 
other 
similar marketing or promotional 
material), and other persons who 
request such information; 
‘‘(cc) that the software with 
respect to such records have pub-
lished application programming 
interfaces for medical records 
data, search and indexing, se-
mantic harmonization and vocab-
ulary translation, and user inter-
face applications; 
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249 
‘‘(dd) that the entity has 
successfully 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 applica-
tion 
programming 
interfaces 
without the requirement for ven-
dor-specific interfaces; 
‘‘(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 satis-
faction of the Secretary that data 
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250 
from such records is able to be ex-
changed through the use of applica-
tion programming interfaces and used 
in a manner that allows for exchange 
and everyday use, as authorized under 
applicable law, of such record. 
‘‘(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 sat-
isfy 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 require-
ments under such clause (or is determined 
to be in violation of the terms of the attes-
tation 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 
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(3) eligible originating sites should be expanded 
beyond those originating sites described in section 
1834(m)(4)(C) of the Social Security Act (42 U.S.C. 
1395m(m)(4)(C)); and 
(4) any expansion of telehealth services under 
the Medicare program should— 
(A) recognize that telemedicine is the deliv-
ery of safe, effective, quality health care serv-
ices, by a health care provider, using technology 
as the mode of care delivery; 
(B) meet or exceed the conditions of cov-
erage and payment with respect to the Medicare 
program under title XVIII unless specifically 
address in subsequent statute, of such Act if 
the service were furnished in person, including 
standards of care; and 
(C) involve clinically appropriate means to 
furnish such services. 
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