285 
demonstrate a commitment to 
transparency and accountability; 
‘‘(bb) protects against con-
flicts of interest through a com-
prehensive set of policies that ad-
dress potential conflicts of inter-
est, ethics, disclosure, and report-
ing requirements; 
‘‘(cc) provides monthly ac-
counting on the use of funds pro-
vided under such agreement; and 
‘‘(dd) provides on a quarterly 
basis, 
reports 
regarding 
the 
progress made toward meeting the 
identified needs set forth in the 
agreement. 
‘‘(v) SUPPLEMENT
NOT
SUPPLANT.— 
Activities carried out under this subpara-
graph shall supplement, and not supplant, 
other activities carried out under this sec-
tion. 
‘‘(vi) NO
ESTABLISHMENT
OF
ENTI-
TY.—To prevent unnecessary duplication 
and target resources effectively, nothing in 
this subparagraph shall be construed to au-
286 
thorize the Secretary to establish within the 
Department of Health and Human Services 
an entity for the purposes of carrying out 
this subparagraph. 
‘‘(vii) 
TRANSPARENCY
AND
OVER-
SIGHT.—Upon request, the Secretary shall 
provide to Congress the information pro-
vided 
to 
the 
Secretary 
under 
clause 
(iv)(V)(dd). 
‘‘(viii) INDEPENDENT
EVALUATION.— 
Not later than 4 years after the date of en-
actment of the 21st Century Cures Act, the 
Comptroller General of the United States 
shall conduct an independent evaluation, 
and submit to the Secretary and the appro-
priate committees of Congress a report, con-
cerning the activities conducted under this 
subparagraph. Such report shall include 
recommendations with respect to any agree-
ment or activities carried out pursuant to 
this subparagraph. 
‘‘(ix) 
SUNSET.—This 
subparagraph 
shall have no force or effect after September 
30, 2022.’’.
287 
SEC. 3085. STREAMLINING PROJECT BIOSHIELD PROCURE-
MENT. 
Section 319F–2(c) of the Public Health Service Act (42 
U.S.C. 247d–6b(c)) is amended— 
(1) in paragraph (4)(A)(ii), by striking ‘‘make a 
recommendation under paragraph (6) that the special 
reserve fund as defined in subsection (h) be made 
available for the procurement of such countermeasure’’ 
and inserting ‘‘and subject to the availability of ap-
propriations, make available the special reserve fund 
as defined in subsection (h) for procurement of such 
countermeasure, as applicable’’; 
(2) in paragraph (6)— 
(A) by striking subparagraphs (A), (B), and 
(E); 
(B) by redesignating subparagraphs (C) 
and (D) as subparagraphs (A) and (B), respec-
tively; 
(C) by amending subparagraph (A), as so 
redesignated, to read as follows: 
‘‘(A) NOTICE
TO
APPROPRIATE
CONGRES-
SIONAL COMMITTEES.—The Secretary shall no-
tify the Committee on Appropriations and the 
Committee on Health, Education, Labor, and 
Pensions of the Senate and the Committee on 
Appropriations and the Committee on Energy
288 
and Commerce of the House of Representatives of 
each decision to make available the special re-
serve fund as defined in subsection (h) for pro-
curement of a security countermeasure, includ-
ing, where available, the number of, the nature 
of, and other information concerning potential 
suppliers of such countermeasure, and whether 
other potential suppliers of the same or similar 
countermeasures were considered and rejected for 
procurement under this section and the reasons 
for each such rejection.’’; and 
(D) in the heading, by striking ‘‘REC-
OMMENDATION
FOR
PRESIDENT’S
APPROVAL’’ 
and inserting ‘‘RECOMMENDATIONS
FOR
PRO-
CUREMENT’’; and 
(3) in paragraph (7)— 
(A) by striking subparagraphs (A) and (B) 
and inserting the following: 
‘‘(A) PAYMENTS
FROM
SPECIAL
RESERVE 
FUND.—The special reserve fund as defined in 
subsection (h) shall be available for payments 
made by the Secretary to a vendor for procure-
ment of a security countermeasure in accordance 
with the provisions of this paragraph.’’; and
289 
(B) by redesignating subparagraph (C) as 
subparagraph (B). 
SEC. 3086. ENCOURAGING TREATMENTS FOR AGENTS THAT 
PRESENT A NATIONAL SECURITY THREAT. 
Subchapter E of chapter V of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 
by inserting after section 565 the following: 
‘‘SEC. 565A. PRIORITY REVIEW TO ENCOURAGE TREAT-
MENTS FOR AGENTS THAT PRESENT NA-
TIONAL SECURITY THREATS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) HUMAN
DRUG
APPLICATION.—The term 
‘human drug application’ has the meaning given such 
term in section 735(1). 
‘‘(2) PRIORITY REVIEW.—The term ‘priority re-
view’, with respect to a human drug application, 
means review and action by the Secretary on such 
application not later than 6 months after receipt by 
the Secretary of such application, as described in the 
Manual of Policies and Procedures in the Food and 
Drug Administration and goals identified in the let-
ters described in section 101(b) of the Food and Drug 
Administration Safety and Innovation Act. 
‘‘(3) PRIORITY
REVIEW
VOUCHER.—The term 
‘priority review voucher’ means a voucher issued by
290 
the Secretary to the sponsor of a material threat med-
ical countermeasure application that entitles the hold-
er of such voucher to priority review of a single 
human drug application submitted under section 
505(b)(1) or section 351(a) of the Public Health Serv-
ice Act after the date of approval of the material 
threat medical countermeasure application. 
‘‘(4) MATERIAL
THREAT
MEDICAL
COUNTER-
MEASURE APPLICATION.—The term ‘material threat 
medical countermeasure application’ means an appli-
cation that— 
‘‘(A) is a human drug application for a 
drug intended for use— 
‘‘(i) to prevent, or treat harm from a 
biological, chemical, radiological, or nuclear 
agent identified as a material threat under 
section 319F–2(c)(2)(A)(ii) of the Public 
Health Service Act; or 
‘‘(ii) to mitigate, prevent, or treat 
harm from a condition that may result in 
adverse health consequences or death and 
may be caused by administering a drug, or 
biological product against such agent; and 
‘‘(B) the Secretary determines eligible for 
priority review;
291 
‘‘(C) is approved after the date of enactment 
of the 21st Century Cures Act; and 
‘‘(D) is for a human drug, no active ingre-
dient (including any ester or salt of the active 
ingredient) of which has been approved in any 
other application under section 505(b)(1) or sec-
tion 351(a) of the Public Health Service Act. 
‘‘(b) PRIORITY REVIEW VOUCHER.— 
‘‘(1) IN GENERAL.—The Secretary shall award a 
priority review voucher to the sponsor of a material 
threat medical countermeasure application upon ap-
proval by the Secretary of such material threat med-
ical countermeasure application. 
‘‘(2) TRANSFERABILITY.—The sponsor of a mate-
rial threat medical countermeasure application that 
receives a priority review voucher under this section 
may transfer (including by sale) the entitlement to 
such voucher to a sponsor of a human drug for which 
an application under section 505(b)(1) or section 
351(a) of the Public Health Service Act will be sub-
mitted after the date of the approval of the material 
threat medical countermeasure application. There is 
no limit on the number of times a priority review 
voucher may be transferred before such voucher is 
used.
292 
‘‘(3) NOTIFICATION.— 
‘‘(A) IN
GENERAL.—The sponsor of a 
human drug application shall notify the Sec-
retary not later than 90 calendar days prior to 
submission of the human drug application that 
is the subject of a priority review voucher of an 
intent to submit the human drug application, 
including the date on which the sponsor intends 
to submit the application. Such notification 
shall be a legally binding commitment to pay for 
the user fee to be assessed in accordance with this 
section. 
‘‘(B) TRANSFER AFTER NOTICE.—The spon-
sor of a human drug application that provides 
notification of the intent of such sponsor to use 
the voucher for the human drug application 
under subparagraph (A) may transfer the vouch-
er after such notification is provided, if such 
sponsor has not yet submitted the human drug 
application described in the notification. 
‘‘(c) PRIORITY REVIEW USER FEE.— 
‘‘(1) IN GENERAL.—The Secretary shall establish 
a user fee program under which a sponsor of a 
human drug application that is the subject of a pri-
ority review voucher shall pay to the Secretary a fee
293 
determined under paragraph (2). Such fee shall be in 
addition to any fee required to be submitted by the 
sponsor under chapter VII. 
‘‘(2) FEE AMOUNT.—The amount of the priority 
review user fee shall be determined each fiscal year by 
the Secretary and based on the average cost incurred 
by the agency in the review of a human drug applica-
tion subject to priority review in the previous fiscal 
year. 
‘‘(3) ANNUAL FEE SETTING.—The Secretary shall 
establish, before the beginning of each fiscal year be-
ginning after September 30, 2016, for that fiscal year, 
the amount of the priority review user fee. 
‘‘(4) PAYMENT.— 
‘‘(A) IN
GENERAL.—The priority review 
user fee required by this subsection shall be due 
upon the submission of a human drug applica-
tion under section 505(b)(1) or section 351(a) of 
the Public Health Service Act for which the pri-
ority review voucher is used. 
‘‘(B) COMPLETE APPLICATION.—An appli-
cation described under subparagraph (A) for 
which the sponsor requests the use of a priority 
review voucher shall be considered incomplete if 
the fee required by this subsection and all other
294 
applicable user fees are not paid in accordance 
with the Secretary’s procedures for paying such 
fees. 
‘‘(C) NO
WAIVERS, EXEMPTIONS, REDUC-
TIONS, OR REFUNDS.—The Secretary may not 
grant a waiver, exemption, reduction, or refund 
of any fees due and payable under this section. 
‘‘(5) OFFSETTING COLLECTIONS.—Fees collected 
pursuant to this subsection for any fiscal year— 
‘‘(A) shall be deposited and credited as off-
setting collections to the account providing ap-
propriations to the Food and Drug Administra-
tion; and 
‘‘(6) shall not be collected for any fiscal year ex-
cept to the extent provided in advance in appropria-
tion Acts. 
‘‘(d) NOTICE OF ISSUANCE OF VOUCHER AND AP-
PROVAL OF PRODUCTS UNDER VOUCHER.—The Secretary 
shall publish a notice in the Federal Register and on the 
Internet website of the Food and Drug Administration not 
later than 30 calendar days after the occurrence of each of 
the following: 
‘‘(1) The Secretary issues a priority review 
voucher under this section.
295 
‘‘(2) The Secretary approves a drug pursuant to 
an application submitted under section 505(b) of this 
Act or section 351(a) of the Public Health Service Act 
for which the sponsor of the application used a pri-
ority review voucher issued under this section. 
‘‘(e) ELIGIBILITY FOR OTHER PROGRAMS.—Nothing 
in this section precludes a sponsor who seeks a priority re-
view voucher under this section from participating in any 
other incentive program, including under this Act, except 
that no sponsor of a material threat medical counter-
measure application may receive more than one priority 
review voucher issued under any section of this Act with 
respect to such drug. 
‘‘(f) RELATION TO OTHER PROVISIONS.—The provi-
sions of this section shall supplement, not supplant, any 
other provisions of this Act or the Public Health Service 
Act that encourage the development of medical counter-
measures. 
‘‘(g) SUNSET.—The Secretary may not award any pri-
ority review vouchers under subsection (b) after October 1, 
2023.’’.
296 
SEC. 3087. PAPERWORK REDUCTION ACT WAIVER DURING A 
PUBLIC HEALTH EMERGENCY. 
Section 319 of the Public Health Service Act (42 
U.S.C. 247d) is amended by adding at the end the fol-
lowing: 
‘‘(f) DETERMINATION WITH RESPECT TO PAPERWORK 
REDUCTION ACT WAIVER DURING
A PUBLIC HEALTH 
EMERGENCY.— 
‘‘(1) DETERMINATION.—If the Secretary deter-
mines, after consultation with such public health offi-
cials as may be necessary, that— 
‘‘(A)(i) the criteria set forth for a public 
health emergency under paragraph (1) or (2) of 
subsection (a) has been met; or 
‘‘(ii) a disease or disorder, including a 
novel and emerging public health threat, is sig-
nificantly likely to become a public health emer-
gency; and 
‘‘(B) the circumstances of such public health 
emergency, or potential for such significantly 
likely public health emergency, including the spe-
cific preparation for and response to such public 
health emergency or threat, necessitate a waiver 
from the requirements of subchapter I of chapter 
35 of title 44, United States Code (commonly re-
ferred to as the Paperwork Reduction Act),
297 
then the requirements of such subchapter I with re-
spect to voluntary collection of information shall not 
be applicable during the immediate investigation of, 
and response to, such public health emergency during 
the period of such public health emergency or the pe-
riod of time necessary to determine if a disease or dis-
order, including a novel and emerging public health 
threat, will become a public health emergency as pro-
vided for in this paragraph. The requirements of such 
subchapter I with respect to voluntary collection of 
information shall not be applicable during the imme-
diate postresponse review regarding such public health 
emergency if such immediate postresponse review does 
not exceed a reasonable length of time. 
‘‘(2) TRANSPARENCY.—If the Secretary deter-
mines that a waiver is necessary under paragraph 
(1), the Secretary shall promptly post on the Internet 
website of the Department of Health and Human 
Services a brief justification for such waiver, the an-
ticipated period of time such waiver will be in effect, 
and the agencies and offices within the Department of 
Health and Human Services to which such waiver 
shall apply, and update such information posted on 
the Internet website of the Department of Health and 
Human Services, as applicable.
298 
‘‘(3) EFFECTIVENESS OF WAIVER.—Any waiver 
under this subsection shall take effect on the date on 
which the Secretary posts information on the Internet 
website as provided for in this subsection. 
‘‘(4) TERMINATION
OF
WAIVER.—Upon deter-
mining that the circumstances necessitating a waiver 
under paragraph (1) no longer exist, the Secretary 
shall promptly update the Internet website of the De-
partment of Health and Human Services to reflect the 
termination of such waiver. 
‘‘(5) LIMITATIONS.— 
‘‘(A) PERIOD OF WAIVER.—The period of a 
waiver under paragraph (1) shall not exceed the 
period of time for the related public health emer-
gency, including a public health emergency de-
clared pursuant to subsection (a), and any im-
mediate postresponse review regarding the public 
health emergency consistent with the require-
ments of this subsection. 
‘‘(B) SUBSEQUENT COMPLIANCE.—An ini-
tiative subject to a waiver under paragraph (1) 
that is ongoing after the date on which the waiv-
er expires, shall be subject to the requirements of 
subchapter I of chapter 35 of title 44, United 
States Code, and the Secretary shall ensure that
299 
compliance with such requirements occurs in as 
timely a manner as possible based on the appli-
cable circumstances, but not to exceed 30 cal-
endar days after the expiration of the applicable 
waiver.’’. 
SEC. 3088. CLARIFYING FOOD AND DRUG ADMINISTRATION 
EMERGENCY USE AUTHORIZATION. 
(a) AUTHORIZATION FOR MEDICAL PRODUCTS FOR 
USE IN EMERGENCIES.—Section 564 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360bbb–3) is amend-
ed— 
(1) in subsection (a)(2)— 
(A) in subparagraph (A)— 
(i) by striking ‘‘or 515’’ and inserting 
‘‘512, or 515’’; and 
(ii) by inserting ‘‘or conditionally ap-
proved under section 571 of this Act’’ after 
‘‘Public Health Service Act’’; and 
(B) in subparagraph (B), by inserting 
‘‘conditionally approved under section 571,’’ 
after ‘‘approved,’’ each place the term appears; 
(2) in subsection (b)(4), by striking the second 
comma after ‘‘determination’’;
300 
(3) in subsection (e)(3)(B), by striking ‘‘section 
503(b)’’ and inserting ‘‘subsection (b) or (f) of section 
503 or under section 504’’; 
(4) in subsection (f)(2)— 
(A) by inserting ‘‘, or an animal to which,’’ 
after ‘‘to a patient to whom’’; and 
(B) by inserting ‘‘or by the veterinarian 
caring for such animal, as applicable’’ after ‘‘at-
tending physician’’; 
(5) in subsection (g)(1), by inserting ‘‘condi-
tional approval under section 571,’’ after ‘‘approval,’’; 
(6) in subsection (h)(1), by striking ‘‘or section 
520(g)’’and inserting ‘‘512(j), or 520(g)’’; and 
(7) in subsection (k), by striking ‘‘section 
520(g),’’and inserting ‘‘512(j), or 520(g)’’. 
(b) NEW ANIMAL DRUGS.—Section 512(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360b(a)(1)) is amended— 
(1) in subparagraph (B), by striking ‘‘or’’ at the 
end; 
(2) in subparagraph (C), by striking the period 
and inserting ‘‘; or’’; and 
(3) by inserting after subparagraph (C) the fol-
lowing:
301 
‘‘(D) there is in effect an authorization pursuant 
to section 564 with respect to such use or intended use 
of such drug, and such drug, its labeling, and such 
use conform to any conditions of such authorization.’’. 
(c) EMERGENCY USE OF MEDICAL PRODUCTS.—Sec-
tion 564A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3a) is amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘, con-
ditionally approved under section 571,’’ after ‘‘chap-
ter’’; and 
(2) in subsection (d), by striking ‘‘sections 503(b) 
and 520(e)’’ and inserting ‘‘subsections (b) and (f) of 
section 503, section 504, and section 520(e)’’. 
(d) PRODUCTS HELD FOR EMERGENCY USE.—Section 
564B(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bbb–3b(2)) is amended— 
(1) in subparagraph (A)— 
(A) by inserting ‘‘or conditionally approved 
under section 571 of this Act’’ after ‘‘Public 
Health Service Act’’; and 
(B) by striking ‘‘or 515’’ and inserting 
‘‘512, or 515’’; and 
(2) in subparagraph (B), by striking ‘‘or 520’’ 
and inserting ‘‘512, or 520’’.
302 
Subtitle I—Vaccine Access, 
Certainty, and Innovation 
SEC. 3091. PREDICTABLE REVIEW TIMELINES OF VACCINES 
BY THE ADVISORY COMMITTEE ON IMMUNIZA-
TION PRACTICES. 
(a) CONSIDERATION OF NEW VACCINES.—Upon the li-
censure of any vaccine or any new indication for a vaccine, 
the Advisory Committee on Immunization Practices (in this 
section referred to as the ‘‘Advisory Committee’’) shall, as 
appropriate, consider the use of the vaccine at its next regu-
larly scheduled meeting. 
(b) ADDITIONAL INFORMATION.—If the Advisory Com-
mittee does not make a recommendation with respect to the 
use of a vaccine at the Advisory Committee’s first regularly 
scheduled meeting after the licensure of the vaccine or any 
new indication for the vaccine, the Advisory Committee 
shall provide an update on the status of such committee’s 
review. 
(c) CONSIDERATION FOR BREAKTHROUGH THERAPIES 
AND FOR POTENTIAL USE DURING PUBLIC HEALTH EMER-
GENCY.—The Advisory Committee shall make recommenda-
tions with respect to the use of certain vaccines in a timely 
manner, as appropriate, including vaccines that— 
(1) are designated as a breakthrough therapy 
under section 506 of the Federal Food, Drug, and
303 
Cosmetic Act (21 U.S.C. 356) and licensed under sec-
tion 351 of the Public Health Service Act (42 U.S.C. 
262); or 
(2) could be used in a public health emergency. 
(d) DEFINITION.—In this section, the terms ‘‘Advisory 
Committee on Immunization Practices’’ and ‘‘Advisory 
Committee’’ mean the Advisory Committee on Immuniza-
tion Practices established by the Secretary pursuant to sec-
tion 222 of the Public Health Service Act (42 U.S.C. 217a), 
acting through the Director of the Centers for Disease Con-
trol and Prevention.’’. 
SEC. 3092. REVIEW OF PROCESSES AND CONSISTENCY OF 
ADVISORY COMMITTEE ON IMMUNIZATION 
PRACTICES RECOMMENDATIONS. 
(a) REVIEW.—The Director of the Centers for Disease 
Control and Prevention shall conduct a review of the proc-
esses used by the Advisory Committee on Immunization 
Practices in formulating and issuing recommendations per-
taining to vaccines, including with respect to consistency. 
(b) CONSIDERATIONS.—The review under subsection 
(a) shall include an assessment of— 
(1) the criteria used to evaluate new and existing 
vaccines, including the identification of any areas for 
which flexibility in evaluating such criteria is nec-
essary and the reason for such flexibility;
304 
(2) the Grading of Recommendations, Assess-
ment, Development, and Evaluation (GRADE) ap-
proach to the review and analysis of scientific and 
economic data, including the scientific basis for such 
approach; and 
(3) the extent to which the processes used by the 
work groups of the Advisory Committee on Immuni-
zation Practices are consistent among such groups, 
including the identification of reasons for any vari-
ation. 
(c) STAKEHOLDERS.—In carrying out the review 
under subsection (a), the Director of the Centers for Disease 
Control and Prevention shall solicit input from vaccine 
stakeholders. 
(d) REPORT.—Not later than 18 months after the date 
of enactment of this Act, the Director of the Centers for Dis-
ease Control and Prevention shall submit to the appropriate 
committees of the Congress, and make publicly available, 
a report on the results of the review under subsection (a), 
including any recommendations on improving the consist-
ency of the processes described in such subsection. 
(e) DEFINITION.—In this section, the term ‘‘Advisory 
Committee on Immunization Practices’’ means the Advi-
sory Committee on Immunization Practices established by 
the Secretary of Health and Human Services pursuant to
305 
section 222 of the Public Health Service Act (42 U.S.C. 
217a), acting through the Director of the Centers for Disease 
Control and Prevention. 
SEC. 3093. ENCOURAGING VACCINE INNOVATION. 
(a) VACCINE MEETINGS.—The Director of the Centers 
for Disease Control and Prevention shall ensure that appro-
priate staff within the relevant centers and divisions of the 
Office of Infectious Diseases, and others, as appropriate, co-
ordinate with respect to the public health needs, epidemi-
ology, and program planning and implementation consid-
erations related to immunization, including with regard to 
meetings with stakeholders related to such topics. 
(b) REPORT ON VACCINE INNOVATION.— 
(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sec-
tion as the ‘‘Secretary’’), in collaboration with appro-
priate agencies or offices within the Department of 
Health and Human Services, including the National 
Institutes of Health, the Centers for Disease Control 
and Prevention, the Food and Drug Administration, 
and the Biomedical Advanced Research and Develop-
ment Authority, shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the
306 
House of Representatives, and post publicly on the 
Internet website of the Department of Health and 
Human Services, a report on ways to promote inno-
vation in the development of vaccines that minimize 
the burden of infectious disease. 
(2) CONTENTS.—The report described in para-
graph (1) shall review the current status of vaccine 
development and, as appropriate— 
(A) consider the optimal process to deter-
mine which vaccines would be beneficial to pub-
lic health and how information on such vaccines 
is disseminated to key stakeholders; 
(B) examine and identify whether obstacles 
exist that inhibit the development of beneficial 
vaccines; and 
(C) make recommendations about how best 
to remove any obstacles identified under sub-
paragraph (B) in order to promote and 
incentivize vaccine innovation and development. 
(3) CONSULTATION.—In preparing the report 
under this subsection, the Secretary may consult 
with— 
(A) representatives of relevant Federal agen-
cies and departments, including the Department
307 
of Defense and the Department of Veterans Af-
fairs; 
(B) academic researchers; 
(C) developers and manufacturers of vac-
cines; 
(D) medical and public health practitioners; 
(E) representatives of patient, policy, and 
advocacy organizations; and 
(F) representatives of other entities, as the 
Secretary determines appropriate. 
(c) UPDATES RELATED
TO MATERNAL IMMUNIZA-
TION.— 
(1) ADDITIONAL VACCINES.—Section 2114(e) of 
the Public Health Service Act (42 U.S.C. 300aa– 
14(e)) is amended by adding at the end the following: 
‘‘(3) VACCINES
RECOMMENDED
FOR
USE
IN 
PREGNANT WOMEN.—The Secretary shall revise the 
Vaccine Injury Table included in subsection (a), 
through the process described in subsection (c), to in-
clude vaccines recommended by the Centers for Dis-
ease Control and Prevention for routine administra-
tion in pregnant women and the information de-
scribed in subparagraphs (B) and (C) of paragraph 
(2) with respect to such vaccines.’’.
308 
(2) PETITION
CONTENT.—Section 2111 of the 
Public Health Service Act (42 U.S.C. 300aa–11) is 
amended by adding at the end the following: 
‘‘(f) MATERNAL IMMUNIZATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of law, for purposes of this subtitle, both a 
woman who received a covered vaccine while pregnant 
and any child who was in utero at the time such 
woman received the vaccine shall be considered per-
sons to whom the covered vaccine was administered 
and persons who received the covered vaccine. 
‘‘(2) DEFINITION.—As used in this subsection, 
the term ‘child’ shall have the meaning given that 
term by subsections (a) and (b) of section 8 of title 
1, United States Code, except that, for purposes of 
this subsection, such section 8 shall be applied as if 
the term ‘include’ in subsection (a) of such section 
were replaced with the term ‘mean’.’’. 
(3) PETITIONERS.—Section 2111(b)(2) of the 
Public Health Service Act (42 U.S.C. 300aa–11(b)(2)) 
is amended by adding ‘‘A covered vaccine adminis-
tered to a pregnant woman shall constitute more than 
one administration, one to the mother and one to each 
child (as such term is defined in subsection (f)(2))
309 
who was in utero at the time such woman was ad-
ministered the vaccine.’’ at the end. 
Subtitle J—Technical Corrections 
SEC. 3101. TECHNICAL CORRECTIONS. 
(a) FFDCA.— 
(1) REFERENCES.—Except as otherwise expressly 
provided, whenever in this subsection an amendment 
is expressed in terms of an amendment to a section 
or other provision, the reference shall be considered to 
be made to that section or other provision of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.). 
(2) AMENDMENTS.— 
(A) PROHIBITED ACTS.—Section 301(r) (21 
U.S.C. 331(r)) is amended by inserting ‘‘, drug,’’ 
after ‘‘device’’ each place the term appears. 
(B) NEW DRUGS.—Section 505 (21 U.S.C. 
355) is amended— 
(i) in subsection (d), in the last sen-
tence, by striking ‘‘premarket approval’’ 
and inserting ‘‘marketing approval’’; and 
(ii) in subsection (q)(5)(A), by striking 
‘‘subsection (b)(2) or (j) of the Act or 
351(k)’’ and inserting ‘‘subsection (b)(2) or 
(j) of this section or section 351(k)’’.
310 
(C) RISK
EVALUATION
AND
MITIGATION 
STRATEGIES.—Section 505–1(h)(21 U.S.C. 355– 
1(h)) is amended— 
(i) in paragraph (2)(A)(iii)— 
(I) in the clause heading, by strik-
ing ‘‘LABEL’’ and inserting ‘‘LABEL-
ING’’; 
(II) by striking ‘‘label’’ each place 
the term appears and inserting ‘‘label-
ing’’; and 
(III) by striking ‘‘sponsor’’ and 
inserting ‘‘responsible person’’; and 
(ii) in paragraph (8), by striking ‘‘and 
(7).’’ and inserting ‘‘and (7)’’. 
(D) PEDIATRIC
STUDY
PLANS.—Section 
505B (21 U.S.C. 355c) is amended— 
(i) in subsection (e)— 
(I) in paragraph (2)— 
(aa) in subparagraph (A), by 
inserting ‘‘study’’ after ‘‘initial 
pediatric’’ each place the term ap-
pears; and 
(bb) in subparagraph (B), in 
the subparagraph heading, by 
striking ‘‘INITIAL PLAN’’ and in-
311 
serting 
‘‘INITIAL
PEDIATRIC 
STUDY PLAN’’; 
(II) in paragraph (5), in the 
paragraph 
heading, 
by 
inserting 
‘‘AGREED
INITIAL
PEDIATRIC
STUDY’’ 
before ‘‘PLAN’’; and 
(III) in paragraph (6), by strik-
ing ‘‘agreed initial pediatric plan’’ 
and inserting ‘‘agreed initial pediatric 
study plan’’; and 
(ii) in subsection (f)(1), by inserting 
‘‘and any significant amendments to such 
plans,’’ after ‘‘agreed initial pediatric study 
plans,’’. 
(E) DISCONTINUANCE OR INTERRUPTION IN 
THE PRODUCTION OF LIVE-SAVING DRUGS.—Sec-
tion 506C (21 U.S.C. 356c) is amended— 
(i) in subsection (c), by striking ‘‘dis-
continuation’’ and inserting ‘‘discontinu-
ance’’; and 
(ii) in subsection (g)(1), by striking 
‘‘section 505(j) that could help’’ and insert-
ing ‘‘section 505(j), that could help’’.
312 
(F) ANNUAL REPORTING ON DRUG SHORT-
AGES.—Section 506C–1(a) (21 U.S.C. 331(a)) is 
amended, in the matter before paragraph (1)— 
(i) by striking ‘‘Not later than the end 
of calendar year 2013, and not later than 
the end of each calendar year thereafter,’’ 
and inserting ‘‘Not later than March 31 of 
each calendar year,’’; and 
(ii) by inserting ‘‘, with respect to the 
preceding calendar year,’’ after ‘‘a report’’. 
(G) 
DRUG
SHORTAGE
LIST.—Section 
506E(b)(3)(E) (21 U.S.C. 356e(b)(3)(E)) is 
amended by striking ‘‘discontinuation’’ and in-
serting ‘‘discontinuance’’. 
(H) INSPECTIONS OF ESTABLISHMENTS.— 
Section 510(h) (21 U.S.C. 360(h)) is amended— 
(i) in paragraph (4), in the matter 
preceding subparagraph (A), by striking 
‘‘establishing the risk-based scheduled’’ and 
inserting ‘‘establishing a risk-based sched-
ule’’; and 
(ii) in paragraph (6)— 
(I) in subparagraph (A), by strik-
ing ‘‘fiscal’’ and inserting ‘‘calendar’’ 
each place the term appears; and
313 
(II) in subparagraph (B), by 
striking ‘‘an active ingredient of a 
drug, a finished drug product, or an 
excipient of a drug’’ and inserting ‘‘an 
active ingredient of a drug or a fin-
ished drug product’’. 
(I) CLASSIFICATION OF DEVICES INTENDED 
FOR
HUMAN
USE.—Section 513(f)(2)(A) (21 
U.S.C. 360c(f)(2)(A)) is amended— 
(i) in clause (i), by striking ‘‘within 
30 days’’; and 
(ii) in clause (iv), by striking ‘‘low- 
moderate’’ and inserting ‘‘low to moderate’’. 
(J) 
PREMARKET
APPROVAL.—Section 
515(a)(1) (21 U.S.C. 360e(a)(1)) is amended by 
striking ‘‘subject to a an order’’ and inserting 
‘‘subject to an order’’. 
(K) PROGRAM TO IMPROVE THE DEVICE RE-
CALL SYSTEM.—Section 518A (21 U.S.C. 360h– 
1) is amended— 
(i) by striking subsection (c); and 
(ii) by redesignating subsection (d) as 
subsection (c). 
(L) UNIQUE DEVICE IDENTIFIER.—Section 
519(f) (21 U.S.C. 360i(f)) is amended by strik-
314 
ing ‘‘and life sustaining’’ and inserting ‘‘or life 
sustaining’’. 
(M) PRIORITY
REVIEW
TO
ENCOURAGE 
TREATMENTS FOR TROPICAL DISEASES.—Section 
524(c)(4)(A) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360n(c)(4)(A)) is amended 
by striking ‘‘Services Act’’ and inserting ‘‘Serv-
ice Act’’. 
(N) PRIORITY REVIEW FOR QUALIFIED IN-
FECTIOUS
DISEASE
PRODUCTS.—Section 524A 
(21 U.S.C. 360n–1) is amended— 
(i) by striking ‘‘If the Secretary’’ and 
inserting the following: 
‘‘(a) IN GENERAL.—If the Secretary’’; 
(ii) by striking ‘‘any’’ and inserting 
‘‘the first’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(b) CONSTRUCTION.—Nothing in this section shall 
prohibit the Secretary from giving priority review to a 
human drug application or efficacy supplement submitted 
for approval under section 505(b) that otherwise meets the 
criteria for the Secretary to grant priority review.’’. 
(O) CONSULTATION
WITH
EXTERNAL
EX-
PERTS ON RARE DISEASES, TARGETED THERA-
315 
PIES, 
AND
GENETIC
TARGETING
OF
TREAT-
MENTS.—Section 
569(a)(2)(A) 
(21 
U.S.C. 
360bbb–8(a)(2)(A)) is amended, in the first sen-
tence, by striking ‘‘subsection (c)’’ and inserting 
‘‘subsection (b)’’. 
(P) 
OPTIMIZING
GLOBAL
CLINICAL 
TRIALS.—Section 569A(c) (21 U.S.C. 360bbb– 
8a(c)) is amended by inserting ‘‘or under the 
Public Health Service Act’’ after ‘‘this Act’’. 
(Q) USE OF CLINICAL INVESTIGATION DATA 
FROM OUTSIDE THE UNITED STATES.—Section 
569B (21 U.S.C. 360bbb–8b) is amended by 
striking ‘‘drug or device’’ and inserting ‘‘drug, 
biological product, or device’’ each place the term 
appears. 
(R) MEDICAL GASES DEFINITIONS.—Section 
575(1)(H) (21 U.S.C. 360ddd(1)(H)) is amend-
ed— 
(i) by inserting ‘‘for a new drug’’ after 
‘‘any period of exclusivity’’; and 
(ii) by inserting ‘‘or any period of ex-
clusivity for a new animal drug under sec-
tion 512(c)(2)(F),’’ after ‘‘section 505A,’’.
316 
(S) REGULATION OF MEDICAL GASES.—Sec-
tion 576(a) (21 U.S.C. 360ddd–1(a)) is amend-
ed— 
(i) in the matter preceding subpara-
graph (A) of paragraph (1), by inserting 
‘‘who seeks to initially introduce or deliver 
for introduction a designated medical gas 
into interstate commerce’’ after ‘‘any per-
son’’; and 
(ii) in paragraph (3)— 
(I) in subparagraph (A)— 
(aa) in clause (i)(VIII), by 
inserting ‘‘for a new drug’’ after 
‘‘any period of exclusivity’’; and 
(bb) in clause (ii), in the 
matter preceding subclause (I), by 
inserting ‘‘the’’ before ‘‘final use’’; 
and 
(II) in subparagraph (B)— 
(aa) in clause (i), by insert-
ing ‘‘for a new drug’’ after ‘‘any 
period of exclusivity’’; and 
(bb) in clause (ii), by insert-
ing a comma after ‘‘drug prod-
uct’’.
317 
(T) INAPPLICABILITY
OF
DRUG
FEES
TO 
DESIGNATED MEDICAL GASES.—Section 577 (21 
U.S.C. 360ddd–2) is amended by inserting ‘‘or 
740(a)’’ after ‘‘section 736(a)’’. 
(U) CONFLICTS
OF
INTEREST.—Section 
712(e)(1)(B) (21 U.S.C. 379d–1(e)(1)(B)) is 
amended by striking ‘‘services’’ and inserting 
‘‘service’’. 
(V) AUTHORITY TO ASSESS AND USE BIO-
SIMILAR
BIOLOGICAL
PRODUCT
FEES.—Section 
744H(a) (21 U.S.C. 379j–52(a)) is amended— 
(i) in paragraph (1)(A)(v), by striking 
‘‘Biosimilars User Fee Act of 2012’’ and in-
serting ‘‘Biosimilar User Fee Act of 2012’’; 
and 
(ii) in paragraph (2)(B), by striking 
‘‘Biosimilars User Fee Act of 2012’’ and in-
serting ‘‘Biosimilar User Fee Act of 2012’’. 
(W) REGISTRATION
OF
COMMERCIAL
IM-
PORTERS.— 
(i) AMENDMENT.—Section 801(s)(2) 
(21 U.S.C. 381(s)(2)) is amended by adding 
at the end the following: 
‘‘(D) EFFECTIVE DATE.—In establishing the 
effective date of the regulations under subpara-
318 
graph (A), the Secretary shall, in consultation 
with the Secretary of Homeland Security acting 
through U.S. Customs and Border Protection, as 
determined appropriate by the Secretary of 
Health and Human Services, provide a reason-
able period of time for an importer of a drug to 
comply with good importer practices, taking into 
account differences among importers and types 
of imports, including based on the level of risk 
posed by the imported product.’’. 
(ii) CONFORMING
AMENDMENT.—Sec-
tion 714 of the Food and Drug Administra-
tion Safety and Innovation Act (Public 
Law 112–144; 126 Stat. 1074) is amended 
by striking subsection (d). 
(X) RECOGNITION
OF
FOREIGN
GOVERN-
MENT
INSPECTIONS.—Section 
809(a)(2) 
(21 
U.S.C. 384e(a)(2)) is amended by striking ‘‘con-
duction’’ and inserting ‘‘conducting’’. 
(b) FDASIA.— 
(1) FINDINGS RELATING TO DRUG APPROVAL.— 
Section 901(a)(1)(A) of the Food and Drug Adminis-
tration Safety and Innovation Act (Public Law 112– 
144; 21 U.S.C. 356 note) is amended by striking ‘‘se-
319 
rious and life-threatening diseases’’ and inserting ‘‘se-
rious or life-threatening diseases’’. 
(2) REPORTING OF INCLUSION OF DEMOGRAPHIC 
SUBGROUPS.—Section 907 of the Food and Drug Ad-
ministration Safety and Innovation Act (Public Law 
112–144; 126 Stat. 1092, 1093) is amended— 
(A) in the section heading, by striking 
‘‘BIOLOGICS’’ in the heading and inserting 
‘‘BIOLOGICAL PRODUCTS’’; and 
(B) in subsection (a)(2)(B), by striking 
‘‘applications for new drug applications’’ and 
inserting ‘‘new drug applications’’. 
(3) COMBATING PRESCRIPTION DRUG ABUSE.— 
Section 1122 of the Food and Drug Administration 
Safety and Innovation Act (Public Law 112–144; 126 
Stat. 1112, 1113) is amended— 
(A) in subsection (a)(2), by striking 
‘‘dependance’’ and inserting ‘‘dependence’’; and 
(B) in subsection (c), by striking ‘‘promul-
gate’’ and inserting ‘‘issue’’. 
SEC. 3102. COMPLETED STUDIES. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed— 
(1) in section 505(k)(5) (21 U.S.C. 355(k)(5))—
320 
(A) in subparagraph (A), by inserting 
‘‘and’’ after the semicolon; 
(B) by striking subparagraph (B); and 
(C) by redesignating subparagraph (C) as 
subparagraph (B); 
(2) in section 505A (21 U.S.C. 355a), by striking 
subsection (p); 
(3) in section 505B (21 U.S.C. 355c)— 
(A) by striking subsection (l); and 
(B) by redesignating subsection (m) as sub-
section (l); and 
(4) in section 523 (21 U.S.C. 360m), by striking 
subsection (d). 
TITLE IV—DELIVERY 
SEC. 4001. ASSISTING DOCTORS AND HOSPITALS IN IM-
PROVING QUALITY OF CARE FOR PATIENTS. 
(a) IN GENERAL.—The Health Information Tech-
nology for Economic and Clinical Health Act (title XIII 
of division A of Public Law 111–5) is amended— 
(1) by adding at the end of part 1 of subtitle A 
the following: 
‘‘SEC. 13103. ASSISTING DOCTORS AND HOSPITALS IN IM-
PROVING QUALITY OF CARE FOR PATIENTS. 
‘‘(a) REDUCTION IN BURDENS GOAL.—The Secretary 
of Health and Human Services (referred to in this section
321 
as the ‘Secretary’), in consultation with providers of health 
services, health care suppliers of services, health care payers, 
health professional societies, health information technology 
developers, health care quality organizations, health care 
accreditation organizations, public health entities, States, 
and other appropriate entities, shall, in accordance with 
subsection (b)— 
‘‘(1) establish a goal with respect to the reduction 
of regulatory or administrative burdens (such as doc-
umentation requirements) relating to the use of elec-
tronic health records; 
‘‘(2) develop a strategy for meeting the goal es-
tablished under paragraph (1); and 
‘‘(3) develop recommendations for meeting the 
goal established under paragraph (1). 
‘‘(b) STRATEGY AND RECOMMENDATIONS.— 
‘‘(1) IN GENERAL.—To achieve the goal estab-
lished under subsection (a)(1), the Secretary, in con-
sultation with the entities described in such sub-
section, shall, not later than 1 year after the date of 
enactment of the 21st Century Cures Act, develop a 
strategy and recommendations to meet the goal in ac-
cordance with this subsection. 
‘‘(2) STRATEGY.—The strategy developed under 
paragraph (1) shall address the regulatory and ad-
322 
ministrative burdens (such as documentation require-
ments) relating to the use of electronic health records. 
Such strategy shall include broad public comment 
and shall prioritize— 
‘‘(A)(i) incentives for meaningful use of cer-
tified EHR technology for eligible professionals 
and hospitals under sections 1848(a)(7) and 
1886(b)(3)(B)(ix), respectively, of the Social Se-
curity 
Act 
(42 
U.S.C. 
1395w–4(a)(7), 
1395ww(b)(3)(B)(ix)); 
‘‘(ii) the program for making payments 
under section 1903(a)(3)(F) of the Social Secu-
rity Act (42 U.S.C. 1396b(a)(3)(F)) to encourage 
the adoption and use of certified EHR tech-
nology by Medicaid providers; 
‘‘(iii) the Merit-based Incentive Payment 
System under section 1848(q) of the Social Secu-
rity Act (42 U.S.C. 1395w–4(q)); 
‘‘(iv) alternative payment models (as de-
fined in section 1833(z)(3)(C) of the Social Secu-
rity Act (42 U.S.C. 1395l(z)(3)(C)); 
‘‘(v) the Hospital Value-Based Purchasing 
Program under section 1886(o) of the Social Se-
curity Act (42 U.S.C. 1395ww(o)); and
323 
‘‘(vi) other value-based payment programs, 
as the Secretary determines appropriate; 
‘‘(B) health information technology certifi-
cation; 
‘‘(C) standards and implementation speci-
fications, as appropriate; 
‘‘(D) activities that provide individuals ac-
cess to their electronic health information; 
‘‘(E) activities related to protecting the pri-
vacy of electronic health information; 
‘‘(F) activities related to protecting the se-
curity of electronic health information; 
‘‘(G) activities related to facilitating health 
and clinical research; 
‘‘(H) activities related to public health; 
‘‘(I) activities related to aligning and sim-
plifying quality measures across Federal pro-
grams and other payers; 
‘‘(J) activities related to reporting clinical 
data for administrative purposes; and 
‘‘(K) other areas, as the Secretary deter-
mines appropriate. 
‘‘(3) 
RECOMMENDATIONS.—The 
recommenda-
tions developed under paragraph (1) shall address—
324 
‘‘(A) actions that improve the clinical docu-
mentation experience; 
‘‘(B) actions that improve patient care; 
‘‘(C) actions to be taken by the Secretary 
and by other entities; and 
‘‘(D) other areas, as the Secretary deter-
mines appropriate, to reduce the reporting bur-
den required of health care providers. 
‘‘(4) FACA.—The Federal Advisory Committee 
Act (5 U.S.C. App.) shall not apply to the develop-
ment of the goal, strategies, or recommendations de-
scribed in this section. 
‘‘(c) APPLICATION
OF CERTAIN REGULATORY RE-
QUIREMENTS.—A 
physician 
(as 
defined 
in 
section 
1861(r)(1) of the Social Security Act), to the extent con-
sistent with applicable State law, may delegate electronic 
medical record documentation requirements specified in 
regulations promulgated by the Centers for Medicare & 
Medicaid Services to a person performing a scribe function 
who is not such physician if such physician has signed and 
verified the documentation.’’; and 
(2) in the table of contents in section 13001(b), 
by inserting after the item relating to section 13102 
the following: 
‘‘13103. Assisting doctors and hospitals in improving the quality and care for pa-
tients.’’.
325 
(b) CERTIFICATION OF HEALTH INFORMATION TECH-
NOLOGY FOR MEDICAL SPECIALTIES AND SITES OF SERV-
ICE.—Section 3001(c)(5) of the Public Health Service Act 
(42 U.S.C. 300jj–11(c)(5)) is amended by adding at the end 
the following: 
‘‘(C) HEALTH
INFORMATION
TECHNOLOGY 
FOR MEDICAL SPECIALTIES AND SITES OF SERV-
ICE.— 
‘‘(i) IN GENERAL.—The National Coor-
dinator shall encourage, keep, or recognize, 
through existing authorities, the voluntary 
certification of health information tech-
nology under the program developed under 
subparagraph (A) for use in medical spe-
cialties and sites of service for which no 
such technology is available or where more 
technological advancement or integration is 
needed. 
‘‘(ii) 
SPECIFIC
MEDICAL
SPECIAL-
TIES.—The Secretary shall accept public 
comment on specific medical specialties and 
sites of service, in addition to those de-
scribed in clause (i), for the purpose of se-
lecting additional specialties and sites of 
service as necessary.
326 
‘‘(iii) HEALTH
INFORMATION
TECH-
NOLOGY FOR PEDIATRICS.—Not later than 
18 months after the date of enactment of the 
21st Century Cures Act, the Secretary, in 
consultation with relevant stakeholders, 
shall make recommendations for the vol-
untary certification of health information 
technology for use by pediatric health pro-
viders to support the health care of children. 
Not later than 2 years after the date of en-
actment of the 21st Century Cures Act, the 
Secretary shall adopt certification criteria 
under section 3004 to support the voluntary 
certification of health information tech-
nology for use by pediatric health providers 
to support the health care of children.’’. 
(c) MEANINGFUL USE STATISTICS.— 
(1) IN GENERAL.—Not later than 6 months after 
the date of enactment of this Act, the Secretary of 
Health and Human Services shall submit to the HIT 
Advisory Committee of the Office of the National Co-
ordinator for Health Information Technology, a re-
port concerning attestation statistics for the Medicare 
and Medicaid EHR Meaningful Use Incentive pro-
grams to assist in informing standards adoption and
327 
related practices. Such statistics shall include attesta-
tion information delineated by State, including, to 
the extent practicable, the number of providers who 
did not meet the minimum criteria necessary to attest 
for the Medicare and Medicaid EHR Meaningful Use 
Incentive programs for a calendar year, and shall be 
made publicly available on the Internet website of the 
Secretary on at least a quarterly basis. 
(2) AUTHORITY TO ALTER FORMAT.—The Sec-
retary of Health and Human Services may alter the 
format of the reports on the attestation of eligible 
health care professionals following the first perform-
ance year of the Merit-based Incentive Payment Sys-
tem to account for changes arising from the imple-
mentation of such payment system. 
SEC. 4002. TRANSPARENT REPORTING ON USABILITY, SECU-
RITY, AND FUNCTIONALITY. 
(a) ENHANCEMENTS
TO
CERTIFICATION.—Section 
3001(c)(5) of the Public Health Service Act (42 U.S.C. 
300jj–11), as amended by section 4001(b), is further amend-
ed by adding at the end the following: 
‘‘(D) CONDITIONS OF CERTIFICATION.—Not 
later than 1 year after the date of enactment of 
the 21st Century Cures Act, the Secretary, 
through notice and comment rulemaking, shall
328 
require, as a condition of certification and 
maintenance of certification for programs main-
tained or recognized under this paragraph, con-
sistent with other conditions and requirements 
under this title, that the health information tech-
nology developer or entity— 
‘‘(i) does not take any action that con-
stitutes information blocking as defined in 
section 3022(a); 
‘‘(ii) provides assurances satisfactory 
to the Secretary that such developer or enti-
ty, unless for legitimate purposes specified 
by the Secretary, will not take any action 
described in clause (i) or any other action 
that may inhibit the appropriate exchange, 
access, and use of electronic health informa-
tion; 
‘‘(iii) does not prohibit or restrict com-
munication regarding— 
‘‘(I) the usability of the health in-
formation technology; 
‘‘(II) the interoperability of the 
health information technology; 
‘‘(III) the security of the health 
information technology;
329 
‘‘(IV) relevant information re-
garding users’ experiences when using 
the health information technology; 
‘‘(V) the business practices of de-
velopers of health information tech-
nology related to exchanging electronic 
health information; and 
‘‘(VI) the manner in which a user 
of the health information technology 
has used such technology; 
‘‘(iv) has published application pro-
gramming interfaces and allows health in-
formation from such technology to be 
accessed, exchanged, and used without spe-
cial effort through the use of application 
programming interfaces or successor tech-
nology or standards, as provided for under 
applicable law, including providing access 
to all data elements of a patient’s electronic 
health record to the extent permissible under 
applicable privacy laws; 
‘‘(v) has successfully tested the real 
world use of the technology for interoper-
ability (as defined in section 3000) in the
330 
type of setting in which such technology 
would be marketed; 
‘‘(vi) provides to the Secretary an at-
testation that the developer or entity— 
‘‘(I) has not engaged in any of the 
conduct described in clause (i); 
‘‘(II) has provided assurances sat-
isfactory to the Secretary in accord-
ance with clause (ii); 
‘‘(III) does not prohibit or restrict 
communication as described in clause 
(iii); 
‘‘(IV) has published information 
in accordance with clause (iv); 
‘‘(V) ensures that its technology 
allows for health information to be ex-
changed, accessed, and used, in the 
manner described in clause (iv); and 
‘‘(VI) has undertaken real world 
testing as described in clause (v); and 
‘‘(vii) submits reporting criteria in ac-
cordance with section 3009A(b).’’. 
‘‘(E) COMPLIANCE
WITH
CONDITIONS
OF 
CERTIFICATION.—The Secretary may encourage 
compliance with the conditions of certification
331 
described in subparagraph (D) and take action 
to discourage noncompliance, as appropriate.’’. 
(b) EHR SIGNIFICANT HARDSHIP EXCEPTION.— 
(1) 
APPLICATION
TO
ELIGIBLE
PROFES-
SIONALS.— 
(A) IN CASE OF DECERTIFICATION.—Section 
1848(a)(7)(B) of the Social Security Act (42 
U.S.C. 1395w–4(a)(7)(B)) is amended by insert-
ing after the first sentence the following new sen-
tence: ‘‘The Secretary shall exempt an eligible 
professional from the application of the payment 
adjustment under subparagraph (A) with respect 
to a year, subject to annual renewal, if the Sec-
retary determines that compliance with the re-
quirement for being a meaningful EHR user is 
not possible because the certified EHR technology 
used by such professional has been decertified 
under a program kept or recognized pursuant to 
section 3001(c)(5) of the Public Health Service 
Act.’’. 
(B) 
CONTINUED
APPLICATION
UNDER 
MIPS.—Section 1848(o)(2)(D) of the Social Secu-
rity Act (42 U.S.C. 1395w–4(o)(2)(D)) is 
amended by adding at the end the following new 
sentence: ‘‘The provisions of subparagraphs (B)
332 
and (D) of subsection (a)(7), shall apply to as-
sessments of MIPS eligible professionals under 
subsection (q) with respect to the performance 
category described in subsection (q)(2)(A)(iv) in 
an appropriate manner which may be similar to 
the manner in which such provisions apply with 
respect to payment adjustments made under sub-
section (a)(7)(A).’’. 
(2) APPLICATION TO ELIGIBLE HOSPITALS.—Sec-
tion 1886(b)(3)(B)(ix)(II) of the Social Security Act 
(42 U.S.C. 1395ww(b)(3)(B)(ix)(II)) is amended by 
inserting after the first sentence the following new 
sentence: ‘‘The Secretary shall exempt an eligible hos-
pital from the application of the payment adjustment 
under subclause (I) with respect to a fiscal year, sub-
ject to annual renewal, if the Secretary determines 
that compliance with the requirement for being a 
meaningful EHR user is not possible because the cer-
tified EHR technology used by such hospital is decer-
tified under a program kept or recognized pursuant 
to section 3001(c)(5) of the Public Health Service 
Act.’’. 
(c) ELECTRONIC HEALTH RECORD REPORTING PRO-
GRAM.—Subtitle A of title XXX of the Public Health Service
333 
Act (42 U.S.C. 300jj–11 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 3009A. ELECTRONIC HEALTH RECORD REPORTING 
PROGRAM. 
‘‘(a) REPORTING CRITERIA.— 
‘‘(1) CONVENING OF STAKEHOLDERS.—Not later 
than 1 year after the date of enactment of the 21st 
Century Cures Act, the Secretary shall convene stake-
holders, as described in paragraph (2), for the pur-
pose of developing the reporting criteria in accordance 
with paragraph (3). 
‘‘(2) DEVELOPMENT OF REPORTING CRITERIA.— 
The reporting criteria under this subsection shall be 
developed through a public, transparent process that 
reflects input from relevant stakeholders, including— 
‘‘(A) health care providers, including pri-
mary care and specialty care health care profes-
sionals; 
‘‘(B) hospitals and hospital systems; 
‘‘(C) health information technology devel-
opers; 
‘‘(D) patients, consumers, and their advo-
cates; 
‘‘(E) data sharing networks, such as health 
information exchanges;
334 
‘‘(F) authorized certification bodies and 
testing laboratories; 
‘‘(G) security experts; 
‘‘(H) relevant manufacturers of medical de-
vices; 
‘‘(I) experts in health information tech-
nology market economics; 
‘‘(J) public and private entities engaged in 
the evaluation of health information technology 
performance; 
‘‘(K) quality organizations, including the 
consensus based entity described in section 1890 
of the Social Security Act; 
‘‘(L) experts in human factors engineering 
and the measurement of user-centered design; 
and 
‘‘(M) other entities or individuals, as the 
Secretary determines appropriate. 
‘‘(3) CONSIDERATIONS
FOR
REPORTING
CRI-
TERIA.—The reporting criteria developed under this 
subsection— 
‘‘(A) shall include measures that reflect cat-
egories including— 
‘‘(i) security;
335 
‘‘(ii) usability and user-centered de-
sign; 
‘‘(iii) interoperability; 
‘‘(iv) conformance to certification test-
ing; and 
‘‘(v) other categories, as appropriate to 
measure the performance of electronic health 
record technology; 
‘‘(B) may include categories such as— 
‘‘(i) enabling the user to order and 
view the results of laboratory tests, imaging 
tests, and other diagnostic tests; 
‘‘(ii) submitting, editing, and retriev-
ing data from registries such as clinician- 
led clinical data registries; 
‘‘(iii) accessing and exchanging infor-
mation and data from and through health 
information exchanges; 
‘‘(iv) accessing and exchanging infor-
mation and data from medical devices; 
‘‘(v) accessing and exchanging infor-
mation and data held by Federal, State, 
and local agencies and other applicable en-
tities useful to a health care provider or
336 
other applicable user in the furtherance of 
patient care; 
‘‘(vi) accessing and exchanging infor-
mation from other health care providers or 
applicable users; 
‘‘(vii) accessing and exchanging pa-
tient generated information; 
‘‘(viii) providing the patient or an au-
thorized designee with a complete copy of 
their health information from an electronic 
record in a computable format; 
‘‘(ix) providing accurate patient infor-
mation for the correct patient, including ex-
changing such information, and avoiding 
the duplication of patients records; and 
‘‘(x) other categories regarding per-
formance, accessibility, as the Secretary de-
termines appropriate; and 
‘‘(C) shall be designed to ensure that small 
and startup health information technology devel-
opers are not unduly disadvantaged by the re-
porting criteria. 
‘‘(4) MODIFICATIONS.—After the reporting cri-
teria have been developed under paragraph (3), the 
Secretary may convene stakeholders and conduct a
337 
public comment period for the purpose of modifying 
the reporting criteria developed under such para-
graph. 
‘‘(b) PARTICIPATION.—As a condition of maintaining 
certification under section 3001(c)(5)(D), a developer of cer-
tified electronic health records shall submit to an appro-
priate recipient of a grant, contract, or agreement under 
subsection (c)(1) responses to the criteria developed under 
subsection (a), with respect to all certified technology offered 
by such developer. 
‘‘(c) REPORTING PROGRAM.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of enactment of the 21st Century Cures Act, 
the Secretary shall award grants, contracts, or agree-
ments to independent entities on a competitive basis 
to support the convening of stakeholders as described 
in subsection (a)(2), collect the information required 
to be reported in accordance with the criteria estab-
lished as described subsection (a)(3), and develop and 
implement a process in accordance with paragraph 
(5) and report such information to the Secretary. 
‘‘(2) APPLICATIONS.—An independent entity 
that seeks a grant, contract, or agreement under this 
subsection shall submit an application to the Sec-
retary at such time, in such manner, and containing
338 
such information as the Secretary may reasonably re-
quire, including a description of— 
‘‘(A) the proposed method for reviewing and 
summarizing information gathered based on re-
porting criteria established under subsection (a); 
‘‘(B) if applicable, the intended focus on a 
specific subset of certified electronic health record 
technology users, such as health care providers, 
including primary care, specialty care, and care 
provided in rural settings; hospitals and hospital 
systems; and patients, consumers, and patients 
and consumer advocates; 
‘‘(C) the plan for widely distributing re-
ports described in paragraph (6); 
‘‘(D) the period for which the grant, con-
tract, or agreement is requested, which may be 
up to 2 years; and 
‘‘(E) the budget for reporting program par-
ticipation, and whether the eligible independent 
entity intends to continue participation after the 
period of the grant, contract, or agreement. 
‘‘(3) CONSIDERATIONS FOR INDEPENDENT ENTI-
TIES.—In awarding grants, contracts, and agree-
ments under paragraph (1), the Secretary shall give 
priority to independent entities with appropriate ex-
339 
pertise in health information technology usability, 
interoperability, and security (especially entities with 
such expertise in electronic health records) with re-
spect to— 
‘‘(A) health care providers, including pri-
mary care, specialty care, and care provided in 
rural settings; 
‘‘(B) hospitals and hospital systems; and 
‘‘(C) patients, consumers, and patient and 
consumer advocates. 
‘‘(4) LIMITATIONS.— 
‘‘(A) 
ASSESSMENT
AND
REDETERMINA-
TION.—Not later than 4 years after the date of 
enactment of the 21st Century Cures Act and 
every 2 years thereafter, the Secretary, in con-
sultation with stakeholders, shall— 
‘‘(i) assess performance of the recipi-
ents of the grants, contracts, and agreements 
under paragraph (1) based on quality and 
usability of reports described in paragraph 
(6); and 
‘‘(ii) re-determine grants, contracts, 
and agreements as necessary. 
‘‘(B) PROHIBITIONS
ON
PARTICIPATION.— 
The Secretary may not award a grant, contract,
340 
or cooperative agreement under paragraph (1) 
to— 
‘‘(i) a proprietor of certified health in-
formation technology or a business affiliate 
of such a proprietor; 
‘‘(ii) a developer of certified health in-
formation technology; or 
‘‘(iii) a State or local government 
agency. 
‘‘(5) FEEDBACK.—Based on reporting criteria 
established under subsection (a), the recipients of 
grants, contracts, and agreements under paragraph 
(1) shall develop and implement a process to collect 
and verify confidential feedback on such criteria 
from— 
‘‘(A) health care providers, patients, and 
other users of certified electronic health record 
technology; and 
‘‘(B) developers of certified electronic health 
record technology. 
‘‘(6) REPORTS.— 
‘‘(A) DEVELOPMENT
OF
REPORTS.—Each 
recipient of a grant, contract, or agreement 
under paragraph (1) shall report on the infor-
mation reported to such recipient pursuant to
341 
subsection (a) and the user feedback collected 
under paragraph (5) by preparing summary re-
ports and detailed reports of such information. 
‘‘(B) DISTRIBUTION
OF
REPORTS.—Each 
recipient of a grant, contract, or agreement 
under paragraph (1) shall submit the reports 
prepared under subparagraph (A) to the Sec-
retary for public distribution in accordance with 
subsection (d). 
‘‘(d) PUBLICATION.—The Secretary shall distribute 
widely, as appropriate, and publish, on the Internet website 
of the Office of the National Coordinator— 
‘‘(1) the reporting criteria developed under sub-
section (a); and 
‘‘(2) the summary and detailed reports under 
subsection (c)(6). 
‘‘(e) REVIEW.—Each recipient of a grant, contract, or 
agreement under paragraph (1) shall develop and imple-
ment a process through which participating electronic 
health record technology developers may review and rec-
ommend changes to the reports created under subsection 
(c)(6) for products developed by such developer prior to the 
publication of such report under subsection (d). 
‘‘(f) ADDITIONAL RESOURCES.—The Secretary may 
provide additional resources on the Internet website of the
342 
Office of the National Coordinator to better inform con-
sumers of health information technology. Such reports may 
be carried out through partnerships with private organiza-
tions with appropriate expertise.’’. 
(d) AUTHORIZATION OF APPROPRIATIONS.—There is 
authorized to be appropriated $15,000,000 for purposes of 
carrying out subparagraph (D) of section 3001(c)(5) of the 
Public Health Service Act (42 U.S.C. 300jj–11) (as added 
by subsection (a)) and section 3009A of the Public Health 
Service Act (as added by subsection (b)), including for pur-
poses of administering any contracts, grants, or agreements, 
to remain available until expended. 
SEC. 4003. INTEROPERABILITY. 
(a) DEFINITION.—Section 3000 of the Public Health 
Service Act (42 U.S.C. 300jj) is amended— 
(1) by redesignating paragraphs (10) through 
(14), as paragraphs (11) through (15), respectively; 
and 
(2) by inserting after paragraph (9) the fol-
lowing: 
‘‘(10) INTEROPERABILITY.—The term ‘interoper-
ability’, with respect to health information technology, 
means such health information technology that— 
‘‘(A) enables the secure exchange of elec-
tronic health information with, and use of elec-
343 
tronic health information from, other health in-
formation technology without special effort on 
the part of the user; 
‘‘(B) allows for complete access, exchange, 
and use of all electronically accessible health in-
formation for authorized use under applicable 
State or Federal law; and 
‘‘(C) does not constitute information block-
ing as defined in section 3022(a).’’. 
(b) SUPPORT
FOR INTEROPERABLE NETWORK EX-
CHANGE.—Section 3001(c) of the Public Health Service Act 
(42 U.S.C. 300jj–11(c)) is amended by adding at the end 
the following: 
‘‘(9) SUPPORT FOR INTEROPERABLE NETWORKS 
EXCHANGE.— 
‘‘(A) IN GENERAL.—The National Coordi-
nator shall, in collaboration with the National 
Institute of Standards and Technology and other 
relevant agencies within the Department of 
Health and Human Services, for the purpose of 
ensuring full network-to-network exchange of 
health information, convene public-private and 
public-public partnerships to build consensus 
and develop or support a trusted exchange 
framework, including a common agreement
344 
among health information networks nationally. 
Such convention may occur at a frequency deter-
mined appropriate by the Secretary. 
‘‘(B) ESTABLISHING A TRUSTED EXCHANGE 
FRAMEWORK.— 
‘‘(i) IN GENERAL.—Not later than 6 
months after the date of enactment of the 
21st Century Cures Act, the National Coor-
dinator shall convene appropriate public 
and private stakeholders to develop or sup-
port a trusted exchange framework for trust 
policies and practices and for a common 
agreement for exchange between health in-
formation networks. The common agreement 
may include— 
‘‘(I) a common method for au-
thenticating trusted health information 
network participants; 
‘‘(II) a common set of rules for 
trusted exchange; 
‘‘(III) organizational and oper-
ational policies to enable the exchange 
of health information among networks, 
including minimum conditions for 
such exchange to occur; and
345 
‘‘(IV) a process for filing and ad-
judicating noncompliance with the 
terms of the common agreement. 
‘‘(ii) TECHNICAL
ASSISTANCE.—The 
National Coordinator, in collaboration with 
the National Institute of Standards and 
Technology, shall provide technical assist-
ance on how to implement the trusted ex-
change framework and common agreement 
under this paragraph. 
‘‘(iii) PILOT TESTING.—The National 
Coordinator, in consultation with the Na-
tional Institute of Standards and Tech-
nology, shall provide for the pilot testing of 
the trusted exchange framework and com-
mon agreement established or supported 
under this subsection (as authorized under 
section 13201 of the Health Information 
Technology for Economic and Clinical 
Health Act). The National Coordinator, in 
consultation with the National Institute of 
Standards and Technology, may delegate 
pilot testing activities under this clause to 
independent entities with appropriate ex-
pertise.
346 
‘‘(C) PUBLICATION
OF
A
TRUSTED
EX-
CHANGE
FRAMEWORK
AND
COMMON
AGREE-
MENT.—Not later than 1 year after convening 
stakeholders under subparagraph (A), the Na-
tional Coordinator shall publish on its public 
Internet website, and in the Federal register, the 
trusted exchange framework and common agree-
ment developed or supported under subpara-
graph (B). Such trusted exchange framework and 
common agreement shall be published in a man-
ner that protects proprietary and security infor-
mation, including trade secrets and any other 
protected intellectual property. 
‘‘(D) 
DIRECTORY
OF
PARTICIPATING 
HEALTH INFORMATION NETWORKS.— 
‘‘(i) IN GENERAL.—Not later than 2 
years after convening stakeholders under 
subparagraph (A), and annually thereafter, 
the National Coordinator shall publish on 
its public Internet website a list of the 
health information networks that have 
adopted the common agreement and are ca-
pable of trusted exchange pursuant to the 
common agreement developed or supported 
under paragraph (B).
347 
‘‘(ii) PROCESS.—The Secretary shall, 
through notice and comment rulemaking, es-
tablish a process for health information net-
works that voluntarily elect to adopt the 
trusted exchange framework and common 
agreement to attest to such adoption of the 
framework and agreement. 
‘‘(E) APPLICATION OF THE TRUSTED EX-
CHANGE
FRAMEWORK
AND
COMMON
AGREE-
MENT.—As appropriate, Federal agencies con-
tracting or entering into agreements with health 
information exchange networks may require that 
as each such network upgrades health informa-
tion technology or trust and operational prac-
tices, such network may adopt, where available, 
the trusted exchange framework and common 
agreement published under subparagraph (C). 
‘‘(F) RULE OF CONSTRUCTION.— 
‘‘(i) GENERAL ADOPTION.—Nothing in 
this paragraph shall be construed to require 
a health information network to adopt the 
trusted exchange framework or common 
agreement. 
‘‘(ii) ADOPTION WHEN EXCHANGE OF 
INFORMATION IS WITHIN NETWORK.—Noth-
348 
ing in this paragraph shall be construed to 
require a health information network to 
adopt the trusted exchange framework or 
common agreement for the exchange of elec-
tronic health information between partici-
pants of the same network. 
‘‘(iii) EXISTING
FRAMEWORKS
AND 
AGREEMENTS.—The trusted exchange frame-
work and common agreement published 
under subparagraph (C) shall take into ac-
count existing trusted exchange frameworks 
and agreements used by health information 
networks to avoid the disruption of existing 
exchanges between participants of health in-
formation networks. 
‘‘(iv) APPLICATION BY FEDERAL AGEN-
CIES.—Notwithstanding clauses (i), (ii), 
and (iii), Federal agencies may require the 
adoption of the trusted exchange framework 
and common agreement published under 
subparagraph (C) for health information ex-
changes contracting with or entering into 
agreements pursuant to subparagraph (E). 
‘‘(v) 
CONSIDERATION
OF
ONGOING 
WORK.—In carrying out this paragraph, the
349 
Secretary shall ensure the consideration of 
activities carried out by public and private 
organizations related to exchange between 
health information exchanges to avoid du-
plication of efforts.’’. 
(c) 
PROVIDER
DIGITAL
CONTACT
INFORMATION 
INDEX.— 
(1) IN GENERAL.—Not later than 3 years after 
the date of enactment of this Act, the Secretary of 
Health and Human Services (referred to in this sub-
section as the ‘‘Secretary’’) shall, directly or through 
a partnership with a private entity, establish a pro-
vider digital contact information index to provide 
digital contact information for health professionals 
and health facilities. 
(2) USE OF EXISTING INDEX.—In establishing 
the initial index under paragraph (1), the Secretary 
may utilize an existing provider directory to make 
such digital contact information available. 
(3) CONTACT
INFORMATION.—An index estab-
lished under this subsection shall ensure that contact 
information is available at the individual health care 
provider level and at the health facility or practice 
level. 
(4) RULE OF CONSTRUCTION.—
350 
(A) IN GENERAL.—The purpose of this sub-
section is to encourage the exchange of electronic 
health information by providing the most useful, 
reliable, and comprehensive index of providers 
possible. In furthering such purpose, the Sec-
retary shall include all health professionals and 
health facilities applicable to provide a useful, 
reliable, and comprehensive index for use in the 
exchange of health information. 
(B) LIMITATION.—In no case shall exclusion 
from the index of providers be used as a measure 
to achieve objectives other the objectives described 
in subparagraph (A). 
(d) STANDARDS DEVELOPMENT ORGANIZATIONS.— 
Section 3004 of the Public Health Service Act (42 U.S.C. 
300jj–14) is amended by adding at the end the following: 
‘‘(c) DEFERENCE TO STANDARDS DEVELOPMENT OR-
GANIZATIONS.—In adopting and implementing standards 
under this section, the Secretary shall give deference to 
standards published by standards development organiza-
tions and voluntary consensus-based standards bodies.’’. 
(e) HEALTH INFORMATION TECHNOLOGY ADVISORY 
COMMITTEE.— 
(1) IN
GENERAL.—Title XXX of the Public 
Health Service Act (42 U.S.C. 300jj et seq.) is amend-
351 
ed by striking sections 3002 (42 U.S.C. 300jj–12) and 
3003 (42 U.S.C. 300jj–13) and inserting the fol-
lowing: 
‘‘SEC. 3002. HEALTH INFORMATION TECHNOLOGY ADVI-
SORY COMMITTEE. 
‘‘(a) ESTABLISHMENT.—There is established a Health 
Information Technology Advisory Committee (referred to in 
this section as the ‘HIT Advisory Committee’) to rec-
ommend to the National Coordinator, consistent with the 
implementation of the strategic plan described in section 
3001(c)(3), policies, and, for purposes of adoption under 
section 3004, standards, implementation specifications, and 
certification criteria, relating to the implementation of a 
health information technology infrastructure, nationally 
and locally, that advances the electronic access, exchange, 
and use of health information. Such Committee shall serve 
to unify the roles of, and replace, the HIT Policy Committee 
and the HIT Standards Committee, as in existence before 
the date of the enactment of the 21st Century Cures Act. 
‘‘(b) DUTIES.— 
‘‘(1) RECOMMENDATIONS ON POLICY FRAMEWORK 
TO ADVANCE AN INTEROPERABLE HEALTH INFORMA-
TION TECHNOLOGY INFRASTRUCTURE.— 
‘‘(A) IN
GENERAL.—The HIT Advisory 
Committee shall recommend to the National Co-
352 
ordinator a policy framework for adoption by 
the Secretary consistent with the strategic plan 
under section 3001(c)(3) for advancing the target 
areas described in this subsection. Such policy 
framework shall seek to prioritize achieving ad-
vancements in the target areas specified in sub-
paragraph (B) of paragraph (2) and may, to the 
extent consistent with this section, incorporate 
policy recommendations made by the HIT Policy 
Committee, as in existence before the date of the 
enactment of the 21st Century Cures Act. 
‘‘(B) UPDATES.—The HIT Advisory Com-
mittee shall propose updates to such rec-
ommendations to the policy framework and make 
new recommendations, as appropriate. 
‘‘(2) GENERAL DUTIES AND TARGET AREAS.— 
‘‘(A) IN
GENERAL.—The HIT Advisory 
Committee shall recommend to the National Co-
ordinator for purposes of adoption under section 
3004, standards, implementation specifications, 
and certification criteria and an order of pri-
ority for the development, harmonization, and 
recognition of such standards, specifications, and 
certification criteria. Such recommendations 
shall include recommended standards, architec-
353 
tures, and software schemes for access to elec-
tronic individually identifiable health informa-
tion across disparate systems including user vet-
ting, authentication, privilege management, and 
access control. 
‘‘(B) PRIORITY TARGET AREAS.—For pur-
poses of this section, the HIT Advisory Com-
mittee shall make recommendations under sub-
paragraph (A) with respect to at least each of the 
following target areas: 
‘‘(i) Achieving a health information 
technology infrastructure, nationally and 
locally, that allows for the electronic access, 
exchange, and use of health information, in-
cluding through technology that provides ac-
curate patient information for the correct 
patient, including exchanging such infor-
mation, and avoids the duplication of pa-
tient records. 
‘‘(ii) The promotion and protection of 
privacy and security of health information 
in health information technology, including 
technologies that allow for an accounting of 
disclosures and protections against disclo-
sures of individually identifiable health in-
354 
formation made by a covered entity for pur-
poses of treatment, payment, and health 
care operations (as such terms are defined 
for purposes of the regulation promulgated 
under section 264(c) of the Health Insur-
ance Portability and Accountability Act of 
1996), including for the segmentation and 
protection from disclosure of specific and 
sensitive individually identifiable health in-
formation with the goal of minimizing the 
reluctance of patients to seek care. 
‘‘(iii) The facilitation of secure access 
by an individual to such individual’s pro-
tected health information and access to such 
information by a family member, caregiver, 
or guardian acting on behalf of a patient, 
including due to age-related and other dis-
ability, cognitive impairment, or dementia. 
‘‘(iv) Subject to subparagraph (D), any 
other target area that the HIT Advisory 
Committee identifies as an appropriate tar-
get area to be considered under this sub-
paragraph. 
‘‘(C) ADDITIONAL
TARGET
AREAS.—For 
purposes of this section, the HIT Advisory Com-
355 
mittee may make recommendations under sub-
paragraph (A), in addition to areas described in 
subparagraph (B), with respect to any of the fol-
lowing areas: 
‘‘(i) The use of health information tech-
nology to improve the quality of health care, 
such as by promoting the coordination of 
health care and improving continuity of 
health care among health care providers, re-
ducing medical errors, improving popu-
lation health, reducing chronic disease, and 
advancing research and education. 
‘‘(ii) The use of technologies that ad-
dress the needs of children and other vulner-
able populations. 
‘‘(iii) The use of electronic systems to 
ensure the comprehensive collection of pa-
tient demographic data, including at a 
minimum, race, ethnicity, primary lan-
guage, and gender information. 
‘‘(iv) The use of self-service, telemedi-
cine, home health care, and remote moni-
toring technologies. 
‘‘(v) The use of technologies that meet 
the needs of diverse populations.
356 
‘‘(vi) The use of technologies that sup-
port— 
‘‘(I) data for use in quality and 
public reporting programs; 
‘‘(II) public health; or 
‘‘(III) drug safety. 
‘‘(vii) The use of technologies that 
allow individually identifiable health infor-
mation to be rendered unusable, unreadable, 
or indecipherable to unauthorized individ-
uals when such information is transmitted 
in a health information network or trans-
ported outside of the secure facilities or sys-
tems where the disclosing covered entity is 
responsible for security conditions. 
‘‘(viii) The use of a certified health in-
formation technology for each individual in 
the United States. 
‘‘(D) AUTHORITY
FOR
TEMPORARY
ADDI-
TIONAL PRIORITY TARGET AREAS.—For purposes 
of subparagraph (B)(iv), the HIT Advisory Com-
mittee may identify an area to be considered for 
purposes of recommendations under this sub-
section as a target area described in subpara-
graph (B) if—
357 
‘‘(i) the area is so identified for pur-
poses of responding to new circumstances 
that have arisen in the health information 
technology community that affect the inter-
operability, privacy, or security of health 
information, or affect patient safety; and 
‘‘(ii) at least 30 days prior to treating 
such area as if it were a target area de-
scribed in subparagraph (B), the National 
Coordinator provides adequate notice to 
Congress of the intent to treat such area as 
so described. 
‘‘(E) FOCUS OF COMMITTEE WORK.—It is 
the sense of Congress that the HIT Advisory 
Committee shall focus its work on the priority 
areas described in subparagraph (B) before pro-
ceeding to other work under subparagraph (C). 
‘‘(3) RULES
RELATING
TO
RECOMMENDATIONS 
FOR STANDARDS, IMPLEMENTATION SPECIFICATIONS, 
AND CERTIFICATION CRITERIA.— 
‘‘(A) IN
GENERAL.—The HIT Advisory 
Committee shall recommend to the National Co-
ordinator standards, implementation specifica-
tions, and certification criteria described in sub-
section (a), which may include standards, imple-
358 
mentation specifications, and certification cri-
teria that have been developed, harmonized, or 
recognized by the HIT Advisory Committee or 
predecessor committee. The HIT Advisory Com-
mittee shall update such recommendations and 
make new recommendations as appropriate, in-
cluding in response to a notification sent under 
section 3004(a)(2)(B). Such recommendations 
shall be consistent with the latest recommenda-
tions made by the Committee. 
‘‘(B) HARMONIZATION.—The HIT Advisory 
Committee may recognize harmonized or up-
dated standards from an entity or entities for the 
purpose of harmonizing or updating standards 
and implementation specifications in order to 
achieve uniform and consistent implementation 
of the standards and implementation specifica-
tion. 
‘‘(C) PILOT TESTING OF STANDARDS AND 
IMPLEMENTATION
SPECIFICATIONS.—In the de-
velopment, harmonization, or recognition of 
standards and implementation specifications, the 
HIT Advisory Committee for purposes of rec-
ommendations under paragraph (2)(B), shall, as 
appropriate, provide for the testing of such
359 
standards and specifications by the National In-
stitute for Standards and Technology under sec-
tion 13201(a) of the Health Information Tech-
nology for Economic and Clinical Health Act. 
‘‘(D) CONSISTENCY.—The standards, imple-
mentation specifications, and certification cri-
teria recommended under paragraph (2)(B) shall 
be consistent with the standards for information 
transactions and data elements adopted pursu-
ant to section 1173 of the Social Security Act. 
‘‘(E) SPECIAL RULE RELATED TO INTER-
OPERABILITY.—Any recommendation made by 
the HIT Advisory Committee after the date of 
the enactment of this subparagraph with respect 
to interoperability of health information tech-
nology shall be consistent with interoperability 
as described in section 3000. 
‘‘(4) FORUM.—The HIT Advisory Committee 
shall serve as a forum for the participation of a broad 
range of stakeholders with specific expertise in poli-
cies, including technical expertise, relating to the 
matters described in paragraphs (1), (2), and (3) to 
provide input on the development, harmonization, 
and recognition of standards, implementation speci-
fications, and certification criteria necessary for the
360 
development and adoption of health information tech-
nology infrastructure nationally and locally that al-
lows for the electronic access, exchange, and use of 
health information. 
‘‘(5) SCHEDULE.—Not later than 30 days after 
the date on which the HIT Advisory Committee first 
meets, such HIT Advisory Committee shall develop a 
schedule for the assessment of policy recommendations 
developed under paragraph (1). The HIT Advisory 
Committee shall update such schedule annually. The 
Secretary shall publish such schedule in the Federal 
Register. 
‘‘(6) PUBLIC INPUT.—The HIT Advisory Com-
mittee shall conduct open public meetings and develop 
a process to allow for public comment on the schedule 
described in paragraph (5) and recommendations de-
scribed in this subsection. Under such process com-
ments shall be submitted in a timely manner after the 
date of publication of a recommendation under this 
subsection. 
‘‘(c) MEASURED PROGRESS IN ADVANCING PRIORITY 
AREAS.— 
‘‘(1) IN GENERAL.—For purposes of this section, 
the National Coordinator, in collaboration with the 
Secretary, shall establish, and update as appropriate,
361 
objectives and benchmarks for advancing and meas-
uring the advancement of the priority target areas de-
scribed in subsection (b)(2)(B). 
‘‘(2) ANNUAL PROGRESS REPORTS ON ADVANCING 
INTEROPERABILITY.— 
‘‘(A) IN
GENERAL.—The HIT Advisory 
Committee, in consultation with the National 
Coordinator, shall annually submit to the Sec-
retary and Congress a report on the progress 
made during the preceding fiscal year in— 
‘‘(i) achieving a health information 
technology infrastructure, nationally and 
locally, that allows for the electronic access, 
exchange, and use of health information; 
and 
‘‘(ii) meeting the objectives and bench-
marks described in paragraph (1). 
‘‘(B) CONTENT.—Each such report shall in-
clude, for a fiscal year— 
‘‘(i) a description of the work con-
ducted by the HIT Advisory Committee 
during the preceding fiscal year with re-
spect to the areas described in subsection 
(b)(2)(B);
362 
‘‘(ii) an assessment of the status of the 
infrastructure described in subparagraph 
(A), including the extent to which electronic 
health information is appropriately and 
readily available to enhance the access, ex-
change, and the use of electronic health in-
formation between users and across tech-
nology offered by different developers; 
‘‘(iii) the extent to which advancements 
have been achieved with respect to areas de-
scribed in subsection (b)(2)(B); 
‘‘(iv) an analysis identifying existing 
gaps in policies and resources for— 
‘‘(I) achieving the objectives and 
benchmarks established under para-
graph (1); and 
‘‘(II) furthering interoperability 
throughout the health information tech-
nology infrastructure; 
‘‘(v) recommendations for addressing 
the gaps identified in clause (iii); and 
‘‘(vi) a description of additional ini-
tiatives as the HIT Advisory Committee 
and National Coordinator determine appro-
priate.
363 
‘‘(3) SIGNIFICANT
ADVANCEMENT
DETERMINA-
TION.—The Secretary shall periodically, based on the 
reports submitted under this subsection, review the 
target areas described in subsection (b)(2)(B), and, 
based on the objectives and benchmarks established 
under paragraph (1), the Secretary shall determine if 
significant advancement has been achieved with re-
spect to such an area. Such determination shall be 
taken into consideration by the HIT Advisory Com-
mittee when determining to what extent the Com-
mittee makes recommendations for an area other than 
an area described in subsection (b)(2)(B). 
‘‘(d) MEMBERSHIP AND OPERATIONS.— 
‘‘(1) IN
GENERAL.—The National Coordinator 
shall take a leading position in the establishment and 
operations of the HIT Advisory Committee. 
‘‘(2) MEMBERSHIP.—The membership of the HIT 
Advisory Committee shall— 
‘‘(A) include at least 25 members, of 
which— 
‘‘(i) no fewer than 2 members are ad-
vocates for patients or consumers of health 
information technology; 
‘‘(ii) 3 members are appointed by the 
Secretary, 1 of whom shall be appointed to
364 
represent the Department of Health and 
Human Services and 1 of whom shall be a 
public health official; 
‘‘(iii) 2 members are appointed by the 
majority leader of the Senate; 
‘‘(iv) 2 members are appointed by the 
minority leader of the Senate; 
‘‘(v) 2 members are appointed by the 
Speaker of the House of Representatives; 
‘‘(vi) 2 members are appointed by the 
minority leader of the House of Representa-
tives; and 
‘‘(vii) such other members are ap-
pointed by the Comptroller General of the 
United States; and 
‘‘(B) at least reflect providers, ancillary 
health care workers, consumers, purchasers, 
health plans, health information technology de-
velopers, researchers, patients, relevant Federal 
agencies, and individuals with technical exper-
tise on health care quality, system functions, pri-
vacy, security, and on the electronic exchange 
and use of health information, including the use 
standards for such activity.
365 
‘‘(3) PARTICIPATION.—The members of the HIT 
Advisory Committee shall represent a balance among 
various sectors of the health care system so that no 
single sector unduly influences the recommendations 
of the Committee. 
‘‘(4) TERMS.— 
‘‘(A) IN GENERAL.—The terms of the mem-
bers of the HIT Advisory Committee shall be for 
3 years, except that the Secretary shall designate 
staggered terms of the members first appointed. 
‘‘(B) VACANCIES.—Any member appointed 
to fill a vacancy in the membership of the HIT 
Advisory Committee that occurs prior to the ex-
piration of the term for which the member’s 
predecessor was appointed shall be appointed 
only for the remainder of that term. A member 
may serve after the expiration of that member’s 
term until a successor has been appointed. A va-
cancy in the HIT Advisory Committee shall be 
filled in the manner in which the original ap-
pointment was made. 
‘‘(C) LIMITS.—Members of the HIT Advi-
sory Committee shall be limited to two 3-year 
terms, for a total of not to exceed 6 years of serv-
ice on the Committee.
366 
‘‘(5) OUTSIDE INVOLVEMENT.—The HIT Advi-
sory Committee shall ensure an opportunity for the 
participation in activities of the Committee of outside 
advisors, including individuals with expertise in the 
development of policies and standards for the elec-
tronic exchange and use of health information, in-
cluding in the areas of health information privacy 
and security. 
‘‘(6) QUORUM.—A majority of the members of 
the HIT Advisory Committee shall constitute a 
quorum for purposes of voting, but a lesser number of 
members may meet and hold hearings. 
‘‘(7) CONSIDERATION.—The National Coordi-
nator shall ensure that the relevant and available rec-
ommendations and comments from the National Com-
mittee on Vital and Health Statistics are considered 
in the development of policies. 
‘‘(8) ASSISTANCE.—For the purposes of carrying 
out this section, the Secretary may provide or ensure 
that financial assistance is provided by the HIT Ad-
visory Committee to defray in whole or in part any 
membership fees or dues charged by such Committee 
to those consumer advocacy groups and not-for-profit 
entities that work in the public interest as a party of 
their mission.
367 
‘‘(e) APPLICATION OF FACA.—The Federal Advisory 
Committee Act (5 U.S.C. App.), other than section 14 of 
such Act, shall apply to the HIT Advisory Committee. 
‘‘(f) PUBLICATION.—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 all policy rec-
ommendations made by the HIT Advisory Committee under 
this section.’’. 
(2) 
TECHNICAL
AND
CONFORMING
AMEND-
MENTS.—Title XXX of the Public Health Service Act 
(42 U.S.C. 300jj et seq.) is amended— 
(A) by striking— 
(i) ‘‘HIT Policy Committee’’ and 
‘‘HIT Standards Committee’’ each place 
that such terms appear (other than within 
the term ‘‘HIT Policy Committee and the 
HIT Standards Committee’’ or within the 
term ‘‘HIT Policy Committee or the HIT 
Standards 
Committee’’) 
and 
inserting 
‘‘HIT Advisory Committee’’; 
(ii) ‘‘HIT Policy Committee and the 
HIT Standards Committee’’ each place that 
such term appears and inserting ‘‘HIT Ad-
visory Committee’’; and
368 
(iii) ‘‘HIT Policy Committee or the 
HIT Standards Committee’’ each place that 
such term appears and inserting ‘‘HIT Ad-
visory Committee’’; 
(B) in section 3000 (42 U.S.C. 300jj)— 
(i) by striking paragraphs (7) and (8) 
and redesignating paragraphs (9) through 
(14) as paragraphs (8) through (13), respec-
tively; and 
(ii) by inserting after paragraph (6) 
the following paragraph: 
‘‘(7) HIT
ADVISORY
COMMITTEE.—The term 
‘HIT Advisory Committee’ means such Committee es-
tablished under section 3002(a).’’; 
(C) in section 3001(c) (42 U.S.C. 300jj– 
11(c))— 
(i) in paragraph (1)(A), by striking 
‘‘under section 3003’’ and inserting ‘‘under 
section 3002’’; 
(ii) in paragraph (2), by striking sub-
paragraph (B) and inserting the following: 
‘‘(B) HIT ADVISORY COMMITTEE.—The Na-
tional Coordinator shall be a leading member in 
the establishment and operations of the HIT Ad-
visory Committee and shall serve as a liaison be-
369 
tween that Committee and the Federal Govern-
ment.’’; 
(D) in section 3004(b)(3) (42 U.S.C. 300jj– 
14(b)(3)), by striking ‘‘3003(b)(2)’’ and inserting 
‘‘3002(b)(4)’’; 
(E) in section 3007(b) (42 U.S.C. 300jj– 
17(b)), by striking ‘‘3003(a)’’ and inserting 
‘‘3002(a)(2)’’; and 
(F) in section 3008 (42 U.S.C. 300jj–18)— 
(i) in subsection (b), by striking ‘‘or 
3003’’; and 
(ii) in subsection (c), by striking 
‘‘3003(b)(1)(A)’’ 
and 
inserting 
‘‘3002(b)(2)’’. 
(3) TRANSITION
TO
THE
HIT
ADVISORY
COM-
MITTEE.—The Secretary of Health and Human Serv-
ices shall provide for an orderly and timely transition 
to the HIT Advisory Committee established under 
amendments made by this section. 
(f) PRIORITIES FOR ADOPTION OF STANDARDS, IMPLE-
MENTATION SPECIFICATIONS, AND CERTIFICATION CRI-
TERIA.—Title XXX of the Public Health Service Act (42 
U.S.C. 300jj et seq.), as amended by subsection (e), is fur-
ther amended by inserting after section 3002 the following:
370 
‘‘SEC. 3003. SETTING PRIORITIES FOR STANDARDS ADOP-
TION. 
‘‘(a) IDENTIFYING PRIORITIES.— 
‘‘(1) IN
GENERAL.—Not later than 6 months 
after the date on which the HIT Advisory Committee 
first meets, the National Coordinator shall periodi-
cally convene the HIT Advisory Committee to— 
‘‘(A) identify priority uses of health infor-
mation technology, focusing on priorities— 
‘‘(i) arising from the implementation 
of the incentive programs for the meaning-
ful use of certified EHR technology, the 
Merit-based Incentive Payment System, Al-
ternative Payment Models, the Hospital 
Value-Based Purchasing Program, and any 
other value-based payment program deter-
mined appropriate by the Secretary; 
‘‘(ii) related to the quality of patient 
care; 
‘‘(iii) related to public health; 
‘‘(iv) related to clinical research; 
‘‘(v) related to the privacy and security 
of electronic health information; 
‘‘(vi) related to innovation in the field 
of health information technology; 
‘‘(vii) related to patient safety;
371 
‘‘(viii) related to the usability of health 
information technology; 
‘‘(ix) related to individuals’ access to 
electronic health information; and 
‘‘(x) other priorities determined appro-
priate by the Secretary; 
‘‘(B) identify existing standards and imple-
mentation specifications that support the use 
and exchange of electronic health information 
needed to meet the priorities identified in sub-
paragraph (A); and 
‘‘(C) publish a report summarizing the 
findings of the analysis conducted under sub-
paragraphs (A) and (B) and make appropriate 
recommendations. 
‘‘(2) 
PRIORITIZATION.—In 
identifying 
such 
standards and implementation specifications under 
paragraph (1)(B), the HIT Advisory Committee shall 
prioritize standards and implementation specifica-
tions developed by consensus-based standards develop-
ment organizations. 
‘‘(3) GUIDELINES
FOR
REVIEW
OF
EXISTING 
STANDARDS
AND
SPECIFICATIONS.—In consultation 
with the consensus-based entity described in section 
1890 of the Social Security Act and other appropriate
372 
Federal agencies, the analysis of existing standards 
under paragraph (1)(B) shall include an evaluation 
of the need for a core set of common data elements 
and associated value sets to enhance the ability of cer-
tified health information technology to capture, use, 
and exchange structured electronic health informa-
tion. 
‘‘(b) REVIEW OF ADOPTED STANDARDS.— 
‘‘(1) IN GENERAL.—Beginning 5 years after the 
date of enactment of the 21st Century Cures Act and 
every 3 years thereafter, the National Coordinator 
shall convene stakeholders to review the existing set of 
adopted standards and implementation specifications 
and make recommendations with respect to whether 
to— 
‘‘(A) maintain the use of such standards 
and implementation specifications; or 
‘‘(B) phase out such standards and imple-
mentation specifications. 
‘‘(2) PRIORITIES.—The HIT Advisory Com-
mittee, in collaboration with the National Institute 
for Standards and Technology, shall annually and 
through the use of public input, review and publish 
priorities for the use of health information technology,
373 
standards, and implementation specifications to sup-
port those priorities. 
‘‘(c) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to prevent the use or adoption of 
novel standards that improve upon the existing health in-
formation technology infrastructure and facilitate the se-
cure exchange of health information.’’. 
SEC. 4004. INFORMATION BLOCKING. 
Subtitle C of title XXX of the Public Health Service 
Act (42 U.S.C. 300jj–51 et seq.) is amended by adding at 
the end the following: 
‘‘SEC. 3022. INFORMATION BLOCKING. 
‘‘(a) DEFINITION.— 
‘‘(1) IN GENERAL.—In this section, the term ‘in-
formation blocking’ means a practice that— 
‘‘(A) except as required by law or specified 
by the Secretary pursuant to rulemaking under 
paragraph (3), is likely to interfere with, pre-
vent, or materially discourage access, exchange, 
or use of electronic health information; and 
‘‘(B)(i) if conducted by a health informa-
tion technology developer, exchange, or network, 
such developer, exchange, or network knows, or 
should know, that such practice is likely to inter-
fere with, prevent, or materially discourage the
375 
to exporting complete information sets or in 
transitioning between health information 
technology systems; or 
‘‘(ii) lead to fraud, waste, or abuse, or 
impede innovations and advancements in 
health information access, exchange, and 
use, including care delivery enabled by 
health information technology. 
‘‘(3) 
RULEMAKING.—The 
Secretary, 
through 
rulemaking, shall identify reasonable and necessary 
activities that do not constitute information blocking 
for purposes of paragraph (1). 
‘‘(4) NO
ENFORCEMENT
BEFORE
EXCEPTION 
IDENTIFIED.—The term ‘information blocking’ does 
not include any practice or conduct occurring prior 
to the date that is 30 days after the date of enactment 
of the 21st Century Cures Act. 
‘‘(5) CONSULTATION.—The Secretary may con-
sult with the Federal Trade Commission in promul-
gating regulations under this subsection, to the extent 
that such regulations define practices that are nec-
essary to promote competition and consumer welfare. 
‘‘(6) 
APPLICATION.—The 
term 
‘information 
blocking’, with respect to an individual or entity,
376 
shall not include an act or practice other than an act 
or practice committed by such individual or entity. 
‘‘(7) CLARIFICATION.—In carrying out this sec-
tion, the Secretary shall ensure that health care pro-
viders are not penalized for the failure of developers 
of health information technology or other entities of-
fering health information technology to such providers 
to ensure that such technology meets the requirements 
to be certified under this title. 
‘‘(b) INSPECTOR GENERAL AUTHORITY.— 
‘‘(1) IN GENERAL.—The inspector general of the 
Department of Health and Human Services (referred 
to in this section as the ‘Inspector General’) may in-
vestigate any claim that— 
‘‘(A) a health information technology devel-
oper of certified health information technology or 
other entity offering certified health information 
technology— 
‘‘(i) submitted a false attestation under 
section 3001(c)(5)(D)(vii); or 
‘‘(ii) engaged in information blocking; 
‘‘(B) a health care provider engaged in in-
formation blocking; or 
‘‘(C) a health information exchange or net-
work engaged in information blocking.
377 
‘‘(2) PENALTIES.— 
‘‘(A) DEVELOPERS, NETWORKS, AND
EX-
CHANGES.—Any individual or entity described 
in subparagraph (A) or (C) of paragraph (1) 
that the Inspector General, following an inves-
tigation conducted under this subsection, deter-
mines to have committed information blocking 
shall be subject to a civil monetary penalty de-
termined by the Secretary for all such violations 
identified through such investigation, which may 
not exceed $1,000,000 per violation. Such deter-
mination shall take into account factors such as 
the nature and extent of the information blocking 
and harm resulting from such information block-
ing, including, where applicable, the number of 
patients affected, the number of providers af-
fected, and the number of days the information 
blocking persisted. 
‘‘(B) PROVIDERS.—Any individual or enti-
ty described in subparagraph (B) of paragraph 
(1) determined by the Inspector General to have 
committed information blocking shall be referred 
to the appropriate agency to be subject to appro-
priate disincentives using authorities under ap-
378 
plicable Federal law, as the Secretary sets forth 
through notice and comment rulemaking. 
‘‘(C) PROCEDURE.—The provisions of sec-
tion 1128A of the Social Security Act (other 
than subsections (a) and (b) of such section) 
shall apply to a civil money penalty applied 
under this paragraph in the same manner as 
such provisions apply to a civil money penalty 
or proceeding under such section 1128A(a). 
‘‘(D) RECOVERED
PENALTY
FUNDS.—The 
amounts recovered under this paragraph shall be 
allocated as follows: 
‘‘(i) ANNUAL OPERATING EXPENSES.— 
Each year following the establishment of the 
authority under this subsection, the Office of 
the Inspector General shall provide to the 
Secretary an estimate of the costs to carry 
out investigations under this section. Such 
estimate may include reasonable reserves to 
account for variance in annual amounts re-
covered under this paragraph. There is au-
thorized to be appropriated for purposes of 
carrying out this section an amount equal 
to the amount specified in such estimate for 
the fiscal year.
379 
‘‘(ii) APPLICATION
TO
OTHER
PRO-
GRAMS.—The amounts recovered under this 
paragraph and remaining after amounts 
are made available under clause (i) shall be 
transferred to the Federal Hospital Insur-
ance Trust Fund under section 1817 of the 
Social Security Act and the Federal Sup-
plementary Medical Insurance Trust Fund 
under section 1841 of such Act, in such pro-
portion as the Secretary determines appro-
priate. 
‘‘(E) 
AUTHORIZATION
OF
APPROPRIA-
TIONS.—There is authorized to be appropriated 
to the Office of the Inspector General to carry 
out this section $10,000,000, to remain available 
until expended. 
‘‘(3) RESOLUTION OF CLAIMS.— 
‘‘(A) IN GENERAL.—The Office of the In-
spector General, if such Office determines that a 
consultation regarding the health privacy and se-
curity rules promulgated under section 264(c) of 
the Health Insurance Portability and Account-
ability Act of 1996 (42 U.S.C. 1320d–2 note) 
will resolve an information blocking claim, may 
refer such instances of information blocking to
380 
the Office for Civil Rights of the Department of 
Health and Human Services for resolution. 
‘‘(B) LIMITATION
ON
LIABILITY.—If a 
health care provider or health information tech-
nology developer makes information available 
based on a good faith reliance on consultations 
with the Office for Civil Rights of the Depart-
ment of Health and Human Services pursuant 
to a referral under subparagraph (A), with re-
spect to such information, the health care pro-
vider or developer shall not be liable for such dis-
closure or disclosures made pursuant to subpara-
graph (A). 
‘‘(c) IDENTIFYING BARRIERS TO EXCHANGE OF CER-
TIFIED HEALTH INFORMATION TECHNOLOGY.— 
‘‘(1) TRUSTED
EXCHANGE
DEFINED.—In this 
section, the term ‘trusted exchange’ with respect to 
certified electronic health records means that the cer-
tified electronic health record technology has the tech-
nical capability to enable secure health information 
exchange between users and multiple certified elec-
tronic health record technology systems. 
‘‘(2) GUIDANCE.—The National Coordinator, in 
consultation with the Office for Civil Rights of the 
Department of Health and Human Services, shall
381 
issue guidance on common legal, governance, and se-
curity barriers that prevent the trusted exchange of 
electronic health information. 
‘‘(3) REFERRAL.—The National Coordinator and 
the Office for Civil Rights of the Department of 
Health and Human Services may refer to the Inspec-
tor General instances or patterns of refusal to ex-
change health information with an individual or enti-
ty using certified electronic health record technology 
that is technically capable of trusted exchange and 
under conditions when exchange is legally permis-
sible. 
‘‘(d) ADDITIONAL PROVISIONS.— 
‘‘(1) INFORMATION SHARING PROVISIONS.—The 
National Coordinator may serve as a technical con-
sultant to the Inspector General and the Federal 
Trade Commission for purposes of carrying out this 
section. The National Coordinator may, notwith-
standing any other provision of law, share informa-
tion related to claims or investigations under sub-
section (b) with the Federal Trade Commission for 
purposes of such investigations and shall share infor-
mation with the Inspector General, as required by 
law.
382 
‘‘(2) PROTECTION FROM DISCLOSURE OF INFOR-
MATION.—Any information that is received by the 
National Coordinator in connection with a claim or 
suggestion of possible information blocking and that 
could reasonably be expected to facilitate identifica-
tion of the source of the information— 
‘‘(A) shall not be disclosed by the National 
Coordinator except as may be necessary to carry 
out the purpose of this section; 
‘‘(B) shall be exempt from mandatory dis-
closure under section 552 of title 5, United 
States Code, as provided by subsection (b)(3) of 
such section; and 
‘‘(C) may be used by the Inspector General 
or Federal Trade Commission for reporting pur-
poses to the extent that such information could 
not reasonably be expected to facilitate identi-
fication of the source of such information. 
‘‘(3) STANDARDIZED PROCESS.— 
‘‘(A) IN GENERAL.—The National Coordi-
nator shall implement a standardized process for 
the public to submit reports on claims of— 
‘‘(i) health information technology 
products or developers of such products (or 
other entities offering such products to
383 
health care providers) not being interoper-
able or resulting in information blocking; 
‘‘(ii) actions described in subsection 
(b)(1) that result in information blocking as 
described in subsection (a); and 
‘‘(iii) any other act described in sub-
section (a). 
‘‘(B) COLLECTION
OF
INFORMATION.—The 
standardized process implemented under sub-
paragraph (A) shall provide for the collection of 
such information as the originating institution, 
location, type of transaction, system and version, 
timestamp, terminating institution, locations, 
system and version, failure notice, and other re-
lated information. 
‘‘(4) NONDUPLICATION
OF
PENALTY
STRUC-
TURES.—In carrying out this subsection, the Sec-
retary shall, to the extent possible, ensure that pen-
alties do not duplicate penalty structures that would 
otherwise apply with respect to information blocking 
and the type of individual or entity involved as of the 
day before the date of the enactment of this section.’’. 
SEC. 4005. LEVERAGING ELECTRONIC HEALTH RECORDS TO 
IMPROVE PATIENT CARE. 
(a) REQUIREMENT RELATING TO REGISTRIES.—
384 
(1) IN GENERAL.—To be certified in accordance 
with title XXX of the Public Health Service Act (42 
U.S.C. 300jj et seq.), electronic health records shall be 
capable of transmitting to, and where applicable, re-
ceiving and accepting data from, registries in accord-
ance with standards recognized by the Office of the 
National Coordinator for Health Information Tech-
nology, including clinician-led clinical data reg-
istries, that are also certified to be technically capable 
of receiving and accepting from, and where applica-
ble, transmitting data to certified electronic health 
record technology in accordance with such standards. 
(2) RULE OF CONSTRUCTION.—Nothing in this 
subsection shall be construed to require the certifi-
cation of registries beyond the technical capability to 
exchange data in accordance with applicable recog-
nized standards. 
(b) DEFINITION.—For purposes of this Act, the term 
‘‘clinician-led clinical data registry’’ means a clinical data 
repository— 
(1) that is established and operated by a clini-
cian-led or controlled, tax-exempt (pursuant to section 
501(c) of the Internal Revenue Code of 1986), profes-
sional society or other similar clinician-led or -con-
trolled organization, or such organization’s controlled
385 
affiliate, devoted to the care of a population defined 
by a particular disease, condition, exposure or ther-
apy; 
(2) that is designed to collect detailed, standard-
ized data on an ongoing basis for medical procedures, 
services, or therapies for particular diseases, condi-
tions, or exposures; 
(3) that provides feedback to participants who 
submit reports to the repository; 
(4) that meets standards for data quality includ-
ing— 
(A) systematically collecting clinical and 
other health care data, using standardized data 
elements and having procedures in place to 
verify the completeness and validity of those 
data; and 
(B) being subject to regular data checks or 
audits to verify completeness and validity; and 
(5) that provides ongoing participant training 
and support. 
(c) TREATMENT
OF HEALTH INFORMATION TECH-
NOLOGY DEVELOPERS WITH RESPECT TO PATIENT SAFETY 
ORGANIZATIONS.— 
(1) IN GENERAL.—In applying part C of title IX 
of the Public Health Service Act (42 U.S.C. 299b–21
386 
et seq.), a health information technology developer 
shall be treated as a provider (as defined in section 
921 of such Act) for purposes of reporting and con-
ducting patient safety activities concerning improv-
ing clinical care through the use of health information 
technology that could result in improved patient safe-
ty, health care quality, or health care outcomes. 
(2) REPORT.—Not later than 4 years after the 
date of enactment of this Act, the Secretary of Health 
and Human Services shall submit to the Committee 
on Health, Education, Labor, and Pensions of the 
Senate and the Committee on Energy and Commerce 
of the House of Representatives, a report concerning 
best practices and current trends voluntarily pro-
vided, without identifying individual providers or 
disclosing or using protected health information or 
individually identifiable information, by patient safe-
ty organizations to improve the integration of health 
information technology into clinical practice. 
SEC. 4006. EMPOWERING PATIENTS AND IMPROVING PA-
TIENT 
ACCESS 
TO 
THEIR 
ELECTRONIC 
HEALTH INFORMATION. 
(a) USE OF HEALTH INFORMATION EXCHANGES FOR 
PATIENT ACCESS.—Section 3009 of the Public Health Serv-
387 
ice Act (42 U.S.C. 300jj–19) is amended by adding at the 
end the following: 
‘‘(c) PROMOTING PATIENT ACCESS TO ELECTRONIC 
HEALTH INFORMATION THROUGH HEALTH INFORMATION 
EXCHANGES .— 
‘‘(1) IN GENERAL.—The Secretary shall use ex-
isting authorities to encourage partnerships between 
health information exchange organizations and net-
works and health care providers, health plans, and 
other appropriate entities with the goal of offering pa-
tients access to their electronic health information in 
a single, longitudinal format that is easy to under-
stand, secure, and may be updated automatically. 
‘‘(2) EDUCATION OF PROVIDERS.—The Secretary, 
in coordination with the Office for Civil Rights of the 
Department of Health and Human Services, shall— 
‘‘(A) educate health care providers on ways 
of leveraging the capabilities of health informa-
tion exchanges (or other relevant platforms) to 
provide patients with access to their electronic 
health information; 
‘‘(B) clarify misunderstandings by health 
care providers about using health information 
exchanges (or other relevant platforms) for pa-
tient access to electronic health information; and
431 
Act (42 U.S.C. 18043(c)(1)), $464,000,000 is rescinded im-
mediately upon the date of the enactment of this Act. 
SEC. 5012. MEDICARE COVERAGE OF HOME INFUSION THER-
APY. 
(a) IN GENERAL.—Section 1861 of the Social Security 
Act (42 U.S.C. 1395x) is amended— 
(1) in subsection (s)(2)— 
(A) by striking ‘‘and’’ at the end of sub-
paragraph (EE); 
(B) by inserting ‘‘and’’ at the end of sub-
paragraph (FF); and 
(C) by inserting at the end the following 
new subparagraph: 
‘‘(GG) home infusion therapy (as defined in sub-
section (iii)(1));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(iii) HOME INFUSION THERAPY.—(1) The term ‘home 
infusion therapy’ means the items and services described 
in paragraph (2) furnished by a qualified home infusion 
therapy supplier (as defined in paragraph (3)(D)) which 
are furnished in the individual’s home (as defined in para-
graph (3)(B)) to an individual— 
‘‘(A) who is under the care of an applicable pro-
vider (as defined in paragraph (3)(A)); and