190 
endpoints, and use of adaptive trial designs and 
Bayesian statistics, to the extent scientifically 
appropriate; 
‘‘(C) facilitate, to the extent scientifically 
appropriate, expedited and efficient develop-
ment and review of the device through utiliza-
tion of timely postmarket data collection, with 
regard to applications for approval under sec-
tion 515(c); and 
‘‘(D) agree to clinical protocols that the 
Secretary will consider binding on the Secretary 
and the sponsor, subject to— 
‘‘(i) changes agreed to by the sponsor 
and the Secretary; 
‘‘(ii) changes that the Secretary deter-
mines are required to prevent an unreason-
able risk to the public health; or 
‘‘(iii) the identification of a substan-
tial scientific issue determined by the Sec-
retary to be essential to the safety or effec-
tiveness of the device involved. 
‘‘(e) PRIORITY REVIEW GUIDANCE.— 
‘‘(1) CONTENT.—The Secretary shall issue 
guidance on the implementation of this section. Such 
guidance shall include the following:
191 
‘‘(A) The process for a person to seek a 
priority review designation. 
‘‘(B) A template for requests under sub-
section (b). 
‘‘(C) The criteria the Secretary will use in 
evaluating a request for priority review. 
‘‘(D) The standards the Secretary will use 
in assigning a team of staff, including team 
leaders, to review devices designated for priority 
review, including any training required for such 
personnel on effective and efficient review. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall pro-
pose such guidance for public comment. 
‘‘(f) CONSTRUCTION.— 
‘‘(1) PURPOSE.—This section is intended to en-
courage the Secretary and provide the Secretary suf-
ficient authorities to apply efficient and flexible ap-
proaches to expedite the development of, and 
prioritize the agency’s review of, devices that rep-
resent breakthrough technologies. 
‘‘(2) CONSTRUCTION.—Nothing in this section 
shall be construed to alter the criteria and standards 
for evaluating an application pursuant to section 
515(c), a report and request for classification under
192 
section 513(f)(2), or a report under section 510(k), 
including the recognition of valid scientific evidence 
as described in section 513(a)(3)(B), and consider-
ation of the least burdensome means of evaluating 
device effectiveness or demonstrating substantial 
equivalence between devices with differing techno-
logical characteristics, as applicable. Nothing in this 
section alters the authority of the Secretary to act 
on an application pursuant to section 515(d) before 
completion of an establishment inspection, as the 
Secretary deems appropriate.’’. 
(b) CONFORMING AMENDMENT RELATED TO DES-
IGNATION DETERMINATIONS.—Section 517A(a)(1) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g– 
1(a)(1)) is amended by inserting ‘‘a request for designa-
tion under section 515B,’’ after ‘‘an application under sec-
tion 515,’’. 
Subtitle M—Medical Device 
Regulatory Process Improvements 
SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
(a) ESTABLISHMENT
OF THIRD-PARTY QUALITY 
SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed-
eral Food, Drug, and Cosmetic Act is amended by insert-
ing after section 524A (21 U.S.C. 360n–1) the following 
new section:
193 
‘‘SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
‘‘(a) ACCREDITATION AND ASSESSMENT.— 
‘‘(1) IN GENERAL; CERTIFICATION OF DEVICE 
QUALITY SYSTEM.—The Secretary shall, in accord-
ance with this section, establish a third-party quality 
system assessment program— 
‘‘(A) to accredit persons to assess whether 
a requestor’s quality system, including its de-
sign controls, can reasonably assure the safety 
and effectiveness of in-scope devices subject to 
device-related changes; 
‘‘(B) under which accredited persons shall 
(as applicable) certify that a requestor’s quality 
system meets the criteria included in the guid-
ance issued under paragraph (5) with respect to 
the in-scope devices at issue; and 
‘‘(C) under which the Secretary shall rely 
on such certifications for purposes of deter-
mining the safety and effectiveness (or as appli-
cable, substantial equivalence) of in-scope de-
vices subject to the device-related changes in-
volved, in lieu of compliance with the following 
submission requirements: 
‘‘(i) A premarket notification. 
‘‘(ii) A 30-day notice. 
‘‘(iii) A Special PMA supplement.
194 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tionƒ 
‘‘(A) the term ‘device-related changes’ 
means changes made by a requestor with re-
spect to in-scope devices, which are— 
‘‘(i) changes to a device found to be 
substantially equivalent under sections 
513(i) and 510(k) to a predicate device, 
that— 
‘‘(I) would otherwise be subject 
to a premarket notification; and 
‘‘(II) do not alter— 
‘‘(aa) the intended use of 
the changed device; or 
‘‘(bb) the fundamental sci-
entific technology of such device; 
‘‘(ii) manufacturing changes subject 
to a 30-day notice; 
‘‘(iii) changes that qualify for a Spe-
cial PMA Supplement; and 
‘‘(iv) such other changes relating to 
the devices or the device manufacturing 
process as the Secretary determines appro-
priate;
195 
‘‘(B) the term ‘in-scope device’ means a 
device within the scope of devices agreed to by 
the requestor and the accredited person for pur-
poses of a request for certification under this 
section; 
‘‘(C) the term ‘premarket notification’ 
means a premarket notification under section 
510(k); 
‘‘(D) the term ‘quality system’ means the 
methods used in, and the facilities and controls 
used for, the design, manufacture, packaging, 
labeling, storage, installation, and servicing of 
devices, as described in section 520(f); 
‘‘(E) the term ‘requestor’ means a device 
manufacturer that is seeking certification under 
this section of a quality system used by such 
manufacturer; 
‘‘(F) the term ‘Special PMA’ means a Spe-
cial PMA supplement under section 814.39(d) 
of title 21, Code of Federal Regulations (or any 
successor regulations); and 
‘‘(G) the term ‘30-day notice’ means a no-
tice described in section 515(d)(6). 
‘‘(3) ACCREDITATION PROCESS; ACCREDITATION 
RENEWAL.—Except as inconsistent with this section,
196 
the process and qualifications for accreditation of 
persons and renewal of such accreditation under sec-
tion 704(g) shall apply with respect to accreditation 
of persons and renewal of such accreditation under 
this section. 
‘‘(4) USE OF ACCREDITED PARTIES TO CON-
DUCT ASSESSMENTS.— 
‘‘(A) INITIATION
OF
ASSESSMENT
SERV-
ICES.— 
‘‘(i) DATE
ASSESSMENTS
AUTHOR-
IZED.—Beginning after the date on which 
the final guidance is issued under para-
graph (5), an accredited person may con-
duct an assessment under this section. 
‘‘(ii) INITIATION OF ASSESSMENTS.— 
Use of one or more accredited persons to 
assess a requestor’s quality system under 
this section with respect to in-scope devices 
shall be at the initiation of the person who 
registers and lists the devices at issue 
under section 510. 
‘‘(B) COMPENSATION.—Compensation for 
such accredited persons shall— 
‘‘(i) be determined by agreement be-
tween the accredited person and the person
197 
who engages the services of the accredited 
person; and 
‘‘(ii) be paid by the person who en-
gages such services. 
‘‘(C) ACCREDITED PERSON SELECTION.— 
Each person who chooses to use an accredited 
person to assess a requestor’s quality system, 
as described in this section, shall select the ac-
credited person from a list of such persons pub-
lished by the Secretary in accordance with sec-
tion 704(g)(4). 
‘‘(5) 
GUIDANCE; 
CRITERIA
FOR
CERTIFI-
CATION.— 
‘‘(A) IN GENERAL.—The criteria for cer-
tification of a quality system under this section 
shall be as specified by the Secretary in guid-
ance issued under this paragraph. 
‘‘(B) CONTENTS; CRITERIA.—The guidance 
under this paragraph shall include specification 
of— 
‘‘(i) evaluative criteria to be used by 
an accredited person to assess and, as ap-
plicable, certify a requestor’s quality sys-
tem under this section with respect to in- 
scope devices; and
198 
‘‘(ii) criteria for accredited persons to 
apply for a waiver of, and exemptions 
from, the criteria under clause (i). 
‘‘(C) TIMEFRAME
FOR
ISSUING
GUID-
ANCE.—The Secretary shall issue under this 
paragraph— 
‘‘(i) draft guidance not later than 12 
months after the enactment of the 21st 
Century Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after issuance of the draft guid-
ance under clause (i). 
‘‘(b) USE OF THIRD-PARTY ASSESSMENT.— 
‘‘(1) 
ASSESSMENT
SUMMARY; 
CERTIFI-
CATION.— 
‘‘(A) SUBMISSION OF ASSESSMENT TO SEC-
RETARY.—An accredited person who assesses a 
requestor’s quality system under subsection (a) 
shall submit to the Secretary a summary of the 
assessment— 
‘‘(i) within 30 days of the assessment; 
and 
‘‘(ii) which shall include (as applica-
ble)—
199 
‘‘(I) the accredited person’s cer-
tification that the requestor has satis-
fied the criteria specified in the guid-
ance issued under subsection (a)(5) 
for quality system certification with 
respect to the in-scope devices at 
issue; and 
‘‘(II) any waivers or exemptions 
from such criteria applied by the ac-
credited person. 
‘‘(B) TREATMENT
OF
ASSESSMENTS.— 
Subject to action by the Secretary under sub-
paragraph (C), with respect to assessments 
which include a certification under this sec-
tion— 
‘‘(i) the Secretary’s review of the as-
sessment summary shall be deemed com-
plete on the day that is 30 days after the 
date on which the Secretary receives the 
summary under subparagraph (A); and 
‘‘(ii) the assessment summary and 
certification of the quality system of a re-
questor shall be deemed accepted by the 
Secretary on such 30th day. 
‘‘(C) ACTIONS BY SECRETARY.—
200 
‘‘(i) IN GENERAL.—Within 30 days of 
receiving an assessment summary and cer-
tification under subparagraph (A), the Sec-
retary may, by written notice to the ac-
credited person submitting such assess-
ment certification, deem any such certifi-
cation to be provisional beyond such 30- 
day period, suspended pending further re-
view by the Secretary, or otherwise quali-
fied or cancelled, based on the Secretary’s 
determination that (as applicable)— 
‘‘(I) additional information is 
needed to support such certification; 
‘‘(II) such assessment or certifi-
cation is unwarranted; or 
‘‘(III) such action with regard to 
the certification is otherwise justified 
according to such factors and criteria 
as the Secretary finds appropriate. 
‘‘(ii) 
ACCEPTANCE
OF
CERTIFI-
CATION.—If following action by the Sec-
retary under clause (i) with respect to a 
certification, the Secretary determines that 
such certification is acceptable, the Sec-
retary shall issue written notice to the ap-
201 
plicable accredited person indicating such 
acceptance. 
‘‘(2) NOTIFICATIONS TO SECRETARY BY CER-
TIFIED REQUESTORS OR ACCREDITED PERSONS FOR 
PROGRAM EVALUATION PURPOSES.— 
‘‘(A) ANNUAL SUMMARY REPORT FOR DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
PREMARKET
NOTIFICATION.—A requestor 
whose quality system is certified under this sec-
tion that effectuates device-related changes with 
respect to in-scope devices, without prior sub-
mission of a premarket notification, shall en-
sure that an annual summary report is sub-
mitted to the Secretary by the accredited per-
son which— 
‘‘(i) describes the changes made to the 
in-scope device; and 
‘‘(ii) indicates the effective dates of 
such changes. 
‘‘(B) PERIODIC NOTIFICATION FOR MANU-
FACTURING CHANGES OTHERWISE SUBJECT TO 
30-DAY
NOTICE.—A requestor whose quality 
system is certified under this section that effec-
tuates device-related changes with respect to in- 
scope devices, without prior submission of a 30-
202 
day notice, shall provide notification to the Sec-
retary of such changes in the requestor’s next 
periodic report under section 814.84(b) of title 
21, Code of Federal Regulations (or any suc-
cessor regulation). Such notification shall— 
‘‘(i) describe the changes made; and 
‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(C) PERIODIC
NOTIFICATION
FOR
DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
SPECIAL
PMA
SUPPLEMENT.—A requestor 
whose quality system is certified under this sec-
tion that effectuates device-related changes with 
respect to in-scope devices, without prior sub-
mission of a Special PMA Supplement, shall 
provide notification to the Secretary of such 
changes in the requestor’s next periodic report 
under section 814.84(b) of title 21, Code of 
Federal Regulations (or any successor regula-
tion). Such notification shall— 
‘‘(i) describe the changes made, in-
cluding a full explanation of the basis for 
the changes; and 
‘‘(ii) indicate the effective dates of 
such changes.
203 
‘‘(D) USE
OF
NOTIFICATIONS
FOR
PRO-
GRAM
EVALUATION
PURPOSES.—Information 
submitted to the Secretary under subpara-
graphs (A) through (C) shall be used by the 
Secretary for purposes of the program evalua-
tion under subsection (d). 
‘‘(c) DURATION AND EFFECT OF CERTIFICATION.— 
A certification under this section— 
‘‘(1) shall remain in effect for a period of 2 
years from the date such certification is accepted by 
the Secretary, subject to paragraph (6); 
‘‘(2) may be renewed through the process de-
scribed in subsection (a)(3); 
‘‘(3) shall continue to apply with respect to de-
vice-related changes made during such 2-year period, 
provided the certification remains in effect, irrespec-
tive of whether such certification is renewed after 
such 2-year period; 
‘‘(4) shall have no effect on the need to comply 
with applicable submission requirements specified in 
subsection (a)(1)(C) with respect to any change per-
taining to in-scope devices which is not a device-re-
lated change under subsection (a)(2); 
‘‘(5) shall have no effect on the authority of the 
Secretary to conduct an inspection or otherwise de-
204 
termine whether the requestor has complied with the 
applicable requirements of this Act; and 
‘‘(6) may be revoked by the Secretary upon a 
determination that the requestor’s quality system no 
longer meets the criteria specified in the guidance 
issued under subsection (a)(5) with respect to the 
in-scope devices at issue. 
‘‘(d) NOTICE OF REVOCATION.—The Secretary shall 
provide written notification to the requestor of a revoca-
tion pursuant to subsection (c)(6) not later than 10 busi-
ness days after the determination described in such sub-
section. Upon receipt of the written notification, the re-
questor shall satisfy the applicable submission require-
ments specified in subsection (a)(1)(C) for any device-re-
lated changes effectuated after the date of such deter-
mination. After such revocation, such requestor is eligible 
to seek re-certification under this section of its quality sys-
tem. 
‘‘(e) PROGRAM EVALUATION; SUNSET.— 
‘‘(1) PROGRAM EVALUATION AND REPORT.— 
‘‘(A) EVALUATION.—The Secretary shall 
complete an evaluation of the third-party qual-
ity system assessment program under this sec-
tion no later than January 31, 2021, based 
on—
205 
‘‘(i) analysis of information from a 
representative group of device manufactur-
ers obtained from notifications provided by 
certified requestors or accredited persons 
under subsection (b)(2); and 
‘‘(ii) such other available information 
and data as the Secretary determines ap-
propriate. 
‘‘(B) REPORT.—No later than 1 year after 
completing the evaluation under subparagraph 
(A), the Secretary shall issue a report of the 
evaluation’s findings on the website of the Food 
and Drug Administration, which shall include 
the Secretary’s recommendations with respect 
to continuation and as applicable expansion of 
the program under this section to encompass— 
‘‘(i) device submissions beyond those 
identified in subsection (a)(1)(C); and 
‘‘(ii) device changes beyond those de-
scribed in subsection (a)(2)(A). 
‘‘(2) SUNSET.—This section shall cease to be 
effective October 1, 2022. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit the authority of the Sec-
retary to request and review the complete assessment of
206 
a certified requestor under this section on a for-cause 
basis.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) REQUIREMENTS
FOR
PREMARKET
AP-
PROVAL SUPPLEMENTS.—Section 515(d)(5)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(d)(5)(A)(i)), as redesignated by section 
2201, is further amended by inserting ‘‘, subject to 
section 524B’’ after ‘‘that affects safety or effective-
ness’’. 
(2) REQUIREMENTS FOR 30-DAY NOTICE.—Sec-
tion 515(d)(5)(A)(ii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)), as 
redesignated by section 2201, is further amended by 
inserting ‘‘, subject to section 524B’’ after ‘‘the date 
on which the Secretary receives the notice’’. 
(3) REQUIREMENTS FOR PREMARKET NOTIFI-
CATION; TECHNICAL
CORRECTION
TO
REFERENCE 
TO SECTION 510(K).—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended by striking ‘‘of this subsection under sub-
section (m)’’ and inserting ‘‘of subsection (k) under 
subsection (m) or section 524B’’. 
(4) MISBRANDED DEVICES.—Section 502(t) of 
the Federal Food, Drug, and Cosmetic Act (21
207 
U.S.C. 352(t)) is amended by inserting ‘‘or 524B’’ 
after ‘‘section 519’’. 
SEC. 2222. VALID SCIENTIFIC EVIDENCE. 
Section 513(a)(3)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended— 
(1) by redesignating clauses (i) and (ii) as sub-
clauses (I) and (II), respectively; 
(2) by striking ‘‘(B) If the Secretary’’ and in-
serting ‘‘(B)(i) If the Secretary’’; and 
(3) by adding at the end the following: 
‘‘(ii) For purposes of clause (i), valid scientific evi-
dence may include— 
‘‘(I) evidence described in well-documented case 
histories, including registry data, that are collected 
and monitored under a protocol determined to be ac-
ceptable by the Secretary; 
‘‘(II) studies published in peer-reviewed jour-
nals; and 
‘‘(III) data collected in countries other than the 
United States so long as such data otherwise meet 
the criteria specified in this subparagraph. 
‘‘(iii) In the case of a study published in a peer-re-
viewed journal that is offered as valid scientific evidence 
for purposes of clause (i), the Secretary may request data 
underlying the study if—
208 
‘‘(I) the Secretary, in making such request, 
complies with the requirement of subparagraph 
(D)(ii) to consider the least burdensome appropriate 
means of evaluating device effectiveness or sub-
section (i)(1)(D) to consider the least burdensome 
means of determining substantial equivalence, as ap-
plicable; 
‘‘(II) the Secretary furnishes a written rationale 
for so requesting the underlying data together with 
such request; and 
‘‘(III) if the requested underlying data for such 
a study are unavailable, the Secretary shall consider 
such study to be part of the totality of the evidence 
with respect to the device, as the Secretary deter-
mines appropriate.’’. 
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT. 
(a) IN GENERAL.—Section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
adding at the end the following: 
‘‘(j) TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT.— 
‘‘(1) TRAINING.—Each employee of the Food 
and Drug Administration who is involved in the re-
view of premarket submissions under section 515 or
209 
section 510(k), including supervisors, shall receive 
training regarding the meaning and implementation 
of the least burdensome appropriate means concept 
in the context of the use of that term in subsections 
(a)(3)(D) and (i)(1)(D) of this section and in section 
515(c)(5). 
‘‘(2) GUIDANCE DOCUMENTS.— 
‘‘(A) DRAFT
UPDATED
GUIDANCE.—Not 
later than 12 months after the date of enact-
ment of the 21st Century Cures Act, the Sec-
retary shall issue a draft guidance document 
updating the October 4, 2002, guidance docu-
ment entitled ‘The Least Burdensome Provision 
of the FDA Modernization Act of 1997: Con-
cept and Principles; Final Guidance for FDA 
and Industry’. 
‘‘(B) MEETING
OF
STAKEHOLDERS.—In 
developing such draft guidance document, the 
Secretary shall convene a meeting of stake-
holders to ensure a full record to support the 
publication of such document. 
‘‘(3) OMBUDSMAN AUDIT.—Not later than 18 
months after the date of issuance of final version of 
the draft guidance under paragraph (2), the om-
budsman for the organizational unit of the Food and
210 
Drug Administration responsible for the premarket 
review of devices shall— 
‘‘(A) conduct, or have conducted, an audit 
of the training described in paragraph (1); and 
‘‘(B) include in such audit interviews with 
a representative sample of persons from indus-
try regarding their experience in the device pre-
market review process.’’. 
(b) ADDITIONAL INFORMATION REGARDING PRE-
MARKET APPLICATIONS.—Subsection (c) of section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e) is amended by adding at the end the following: 
‘‘(5)(A) Whenever the Secretary requests additional 
information from an applicant regarding an application 
under paragraph (1), the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate 
device safety and effectiveness, and request information 
accordingly. 
‘‘(B) For purposes of subparagraph (A), the term 
‘necessary’ means the minimum required information that 
would support a determination by the Secretary that an 
application provides a reasonable assurance of the safety 
and effectiveness of the device. 
‘‘(C) Nothing in this paragraph alters the standards 
for premarket approval of a device.’’.
211 
SEC. 2224. RECOGNITION OF STANDARDS. 
Section 514(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (B) the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request for recogni-
tion under subparagraph (A) of all or part of an appro-
priate standard established by a nationally or internation-
ally recognized standard organization. 
‘‘(ii) Not later than 60 days after the Secretary re-
ceives such a request, the Secretary shall— 
‘‘(I) make a determination to recognize all, 
part, or none of the standard that is the subject of 
the request; and 
‘‘(II) issue to the person who submitted such 
request a response in writing that states the Sec-
retary’s rationale for that determination, including 
the scientific, technical, regulatory, or other basis for 
such determination. 
‘‘(iii) The Secretary shall make a response issued 
under clause (ii)(II) publicly available, in such manner as 
the Secretary determines appropriate. 
‘‘(iv) The Secretary shall take such actions as may 
be necessary to implement all or part of a standard recog-
nized under clause (i)(I), in accordance with subparagraph 
(A).
212 
‘‘(D) The Secretary shall make publicly available, in 
such manner as the Secretary determines appropriate, the 
rationale for recognition under subparagraph (A) of part 
of a standard, including the scientific, technical, regu-
latory, or other basis for such recognition.’’; and 
(2) by adding at the end the following new 
paragraphs: 
‘‘(4) TRAINING ON USE OF STANDARDS.—The 
Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket sub-
missions for devices periodic training on the concept 
and use of recognized standards for purposes of 
meeting a premarket submission requirement or 
other applicable requirement under this Act, includ-
ing standards relevant to an employee’s area of de-
vice review. 
‘‘(5) GUIDANCE.— 
‘‘(A) DRAFT
GUIDANCE.—The Secretary 
shall publish guidance identifying the principles 
for recognizing standards under this section. In 
publishing such guidance, the Secretary shall 
consider— 
‘‘(i) the experience with, and reliance 
on, a standard by other Federal regulatory 
authorities and the device industry; and
213 
‘‘(ii) whether recognition of a stand-
ard will promote harmonization among reg-
ulatory authorities in the regulation of de-
vices. 
‘‘(B) TIMING.—The Secretary shall pub-
lish— 
‘‘(i) draft guidance under subpara-
graph (A) not later than 12 months after 
the date of the enactment of the 21st Cen-
tury Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after the close of the public com-
ment period for the draft guidance under 
clause (i).’’. 
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT 
TO CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended— 
(1) by striking ‘‘A report under subsection (k)’’ 
and inserting ‘‘(1) A report under subsection (k)’’; 
and 
(2) by adding at the end the following new 
paragraph:
216 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
SEC. 2226. ADVISORY COMMITTEE PROCESS. 
(a) CLASSIFICATION PANELS.—Paragraph (5) of sec-
tion 513(b) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360c(b)) is amended— 
(1) by striking ‘‘(5)’’ and inserting ‘‘(5)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) When a device is specifically the subject of re-
view by a classification panel, the Secretary shall— 
‘‘(i) ensure that adequate expertise is rep-
resented on the classification panel to assess— 
‘‘(I) the disease or condition which the de-
vice is intended to cure, treat, mitigate, prevent, 
or diagnose; and 
‘‘(II) the technology of the device; and 
‘‘(ii) as part of the process to ensure adequate 
expertise under clause (i), give due consideration to 
the recommendations of the person whose premarket 
submission is subject to panel review on the exper-
tise needed among the voting members of the panel. 
‘‘(C) For purposes of subparagraph (B)(ii), the term 
‘adequate expertise’ means, with respect to the member-
217 
ship of the classification panel reviewing a premarket sub-
mission, that such membership includes— 
‘‘(i) two or more voting members, with a spe-
cialty or other expertise clinically relevant to the de-
vice under review; and 
‘‘(ii) at least one voting member who is knowl-
edgeable about the technology of the device.’’. 
(b) PANEL REVIEW PROCESS.—Section 513(b)(6) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360c(b)(6)) is amended— 
(1) in subparagraph (A)(iii), by inserting before 
the period at the end ‘‘, including by designating a 
representative who will be provided a time during 
the panel meeting to address the panel individually 
(or accompanied by experts selected by such rep-
resentative) 
for 
the 
purpose 
of 
correcting 
misstatements of fact or providing clarifying infor-
mation, subject to the discretion of the panel chair-
person’’; and 
(2) by striking subparagraph (B) and inserting 
the following new subparagraph: 
‘‘(B)(i) Any meeting of a classification panel for a 
device that is specifically the subject of review shall— 
‘‘(I) provide adequate time for initial presen-
tations by the person whose device is specifically the
218 
subject of a classification panel review and by the 
Secretary; and 
‘‘(II) encourage free and open participation by 
all interested persons. 
‘‘(ii) Following the initial presentations described in 
clause (i), the panel may— 
‘‘(I) pose questions to a designated representa-
tive described in subparagraph (A)(iii); and 
‘‘(II) consider the responses to such questions 
in the panel’s review of the device that is specifically 
the subject of review by the panel.’’. 
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICA-
TION. 
(a) IN GENERAL.—Section 520(m) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amend-
ed— 
(1) in paragraph (1) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; 
(2) in paragraph (2)(A) by striking ‘‘fewer than 
4,000’’ and inserting ‘‘not more than 8,000’’; and 
(3) in paragraph (6)(A)(ii), by striking ‘‘4,000’’ 
and inserting ‘‘8,000’’. 
(b) GUIDANCE DOCUMENT
ON PROBABLE BEN-
EFIT.—Not later than 18 months after the date of enact-
ment of this Act, the Secretary of Health and Human
219 
Services, acting through the Commissioner of Food and 
Drugs, shall publish a draft guidance document that de-
fines the criteria for establishing ‘‘probable benefit’’ as 
that term is used in section 520(m)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)). 
SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN 
VITRO DIAGNOSTICS. 
(a) DRAFT REVISED GUIDANCE.—Not later than 12 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall publish a 
draft guidance that— 
(1) revises ‘‘Section V. Demonstrating Insignifi-
cant Risk of an Erroneous Result—‘Accuracy’ ’’ of 
the guidance entitled ‘‘Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 
(CLIA) Waiver Applications for Manufacturers of In 
Vitro Diagnostic Devices’’ and dated January 30, 
2008; and 
(2) includes guidance on the appropriate use of 
comparable performance between a waived user and 
a moderately complex laboratory user to dem-
onstrate accuracy. 
(b) FINAL REVISED GUIDANCE.—The Secretary of 
Health and Human Services shall finalize the draft guid-
ance published under subsection (a) not later than 12
220 
months after the comment period for such draft guidance 
closes. 
Subtitle N—Sensible Oversight for 
Technology 
Which 
Advances 
Regulatory Efficiency 
SEC. 2241. HEALTH SOFTWARE. 
Section 201 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321) is amended by adding at the end the 
following: 
‘‘(ss)(1) The term ‘health software’ means software 
that does not, through use of an in vitro diagnostic device 
or signal acquisition system, acquire, process, or analyze 
an image or physiological signal, is not an accessory, is 
not an integral part of a device necessary to support the 
use of the device, is not used in the manufacture and 
transfusion of blood and blood components to assist in the 
prevention of disease in humans, and— 
‘‘(A) is intended for use for administrative or 
operational support or the processing and mainte-
nance of financial records; 
‘‘(B) is intended for use in clinical, laboratory, 
or administrative workflow and related record-
keeping; 
‘‘(C)(i) is intended for use solely in the trans-
fer, aggregation, conversion (in accordance with a
221 
present specification), storage, management, re-
trieval, or transmission of data or information; 
‘‘(ii) utilizes a connectivity software platform, 
electronic or electrical hardware, or a physical com-
munications infrastructure; and 
‘‘(iii) is not intended for use— 
‘‘(I) in active patient monitoring; or 
‘‘(II) in controlling or altering the func-
tions or parameters of a device that is con-
nected to such software; 
‘‘(D) is intended for use to organize and 
present information for health or wellness education 
or for use in maintaining a healthy lifestyle, includ-
ing medication adherence and health management 
tools; 
‘‘(E) is intended for use to analyze information 
to provide general health information that does not 
include patient-specific recommended options to con-
sider in the prevention, diagnosis, treatment, cure, 
or mitigation of a particular disease or condition; or 
‘‘(F) is intended for use to analyze information 
to provide patient-specific recommended options to 
consider in the prevention, diagnosis, treatment, 
cure, or mitigation of a particular disease or condi-
tion.
222 
‘‘(2) The term ‘accessory’ means a product that— 
‘‘(A) is intended for use with one or more par-
ent devices; 
‘‘(B) is intended to support, supplement, or 
augment the performance of one or more parent de-
vices; and 
‘‘(C) shall be classified by the Secretary— 
‘‘(i) according to its intended use; and 
‘‘(ii) independently of any classification of 
any parent device with which it is used.’’. 
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGU-
LATION. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as 
amended by section 2221(a), is further amended by add-
ing at the end the following: 
‘‘SEC. 524C. HEALTH SOFTWARE. 
‘‘(a) INAPPLICABILITY OF REGULATION TO HEALTH 
SOFTWARE.—Except as provided in subsection (b), health 
software shall not be subject to regulation under this Act. 
‘‘(b) EXCEPTION.— 
‘‘(1) IN
GENERAL.—Subsection (a) shall not 
apply with respect to a software product— 
‘‘(A) of a type described in subparagraph 
(F) of section 201(ss)(1); and
223 
‘‘(B) that the Secretary determines poses a 
significant risk to patient safety. 
‘‘(2) CONSIDERATIONS.—In making a deter-
mination under subparagraph (B) of paragraph (1) 
with respect to a product to which such paragraph 
applies, the Secretary shall consider the following: 
‘‘(A) The likelihood and severity of patient 
harm if the product were to not perform as in-
tended. 
‘‘(B) The extent to which the product is 
intended to support the clinical judgment of a 
medical professional. 
‘‘(C) Whether there is a reasonable oppor-
tunity for a medical professional to review the 
basis of the information or treatment rec-
ommendation provided by the product. 
‘‘(D) The intended user and user environ-
ment, such as whether a medical professional 
will use a software product of a type described 
in subparagraph (F) of section 201(ss)(1). 
‘‘(c) DELEGATION.—The Secretary shall delegate pri-
mary jurisdiction for regulating a software product deter-
mined under subsection (b) to be subject to regulation 
under this Act to the center at the Food and Drug Admin-
istration charged with regulating devices.
224 
‘‘(d) REGULATION OF SOFTWARE.— 
‘‘(1) IN GENERAL.—The Secretary shall review 
existing regulations and guidance regarding the reg-
ulation of software under this Act. The Secretary 
may implement a new framework for the regulation 
of software and shall, as appropriate, modify such 
regulations and guidance or issue new regulations or 
guidance. 
‘‘(2) ISSUANCE
BY
ORDER.—Notwithstanding 
subchapter II of chapter 5 of title 5, United States 
Code, the Secretary may modify or issue regulations 
for the regulation of software under this Act by ad-
ministrative order published in the Federal Register 
following the publication of a proposed order. 
‘‘(3) AREAS UNDER REVIEW.—The review of ex-
isting regulations and guidance under paragraph (1) 
may include review of the following areas: 
‘‘(A) Classification of software. 
‘‘(B) Standards for development of soft-
ware. 
‘‘(C) 
Standards 
for 
validation 
and 
verification of software. 
‘‘(D) Review of software. 
‘‘(E) Modifications to software. 
‘‘(F) Manufacturing of software.
225 
‘‘(G) Quality systems for software. 
‘‘(H) Labeling requirements for software. 
‘‘(I) Postmarketing requirements for re-
porting of adverse events. 
‘‘(4) PROCESS FOR ISSUING PROPOSED REGU-
LATIONS, 
ADMINISTRATIVE
ORDER, 
AND
GUID-
ANCE.—Not later than 18 months after the date of 
enactment of this section, the Secretary shall consult 
with external stakeholders (including patients, indus-
try, health care providers, academia, and govern-
ment) to gather input before issuing regulations, an 
administrative order, and guidance under this sub-
section. 
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed as providing the Secretary with the 
authority to regulate under this Act any health software 
product of the type described in subparagraph (F) of sec-
tion 201(ss)(1) unless and until the Secretary has made 
a determination described in subsection (b)(1)(B) with re-
spect to such product.’’. 
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE. 
Section 201(h) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321) is amended— 
(1) in subparagraph (2), by striking ‘‘or’’ after 
‘‘or other animals,’’;
226 
(2) in subparagraph (3), by striking ‘‘and’’ and 
inserting ‘‘or’’; and 
(3) by inserting after subparagraph (3) the fol-
lowing: 
‘‘(4) not health software (other than software 
determined to be a risk to patient safety under sec-
tion 524B(b)), and’’. 
Subtitle O—Streamlining Clinical 
Trials 
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RE-
SEARCH; APPLICABILITY OF RULES. 
(a) IN GENERAL.—In order to simplify and facilitate 
compliance by researchers with applicable regulations for 
the protection of human subjects in research, the Sec-
retary of Health and Human Services shall, to the extent 
possible and consistent with other statutory provisions, 
harmonize differences between the HHS Human Subject 
Regulations and the FDA Human Subject Regulations in 
accordance with subsection (b). 
(b) AVOIDING REGULATORY DUPLICATION AND UN-
NECESSARY DELAYS.— 
(1) IN GENERAL.—The Secretary shall— 
(A) make such modifications to the provi-
sions of the HHS Human Subject Regulations, 
the FDA Human Subject Regulations, and the
227 
vulnerable-populations rules as may be nec-
essary— 
(i) to reduce regulatory duplication 
and unnecessary delays; 
(ii) to modernize such provisions in 
the context of multisite and cooperative re-
search projects; and 
(iii) to incorporate local consider-
ations, community values, and mechanisms 
to protect vulnerable populations; and 
(B) ensure that human subject research 
that is subject to the HHS Human Subject 
Regulations or to the FDA Human Subject 
Regulations may— 
(i) use joint or shared review; 
(ii) rely upon the review of— 
(I) an independent institutional 
review board; or 
(II) an institutional review board 
of an entity other than the sponsor of 
the research; or 
(iii) use similar arrangements to avoid 
duplication of effort. 
(2) REGULATIONS AND GUIDANCE.—Not later 
than 36 months after the date of enactment of this
228 
Act, the Secretary, acting through the relevant agen-
cies and offices of the Department of Health and 
Human Services, including the Office for Human 
Research Protections and relevant agencies and of-
fices of the Food and Drug Administration, shall 
issue such regulations and guidance and take such 
other actions as may be necessary to implement this 
section and help to facilitate the broader use of sin-
gle, central, or lead institutional review boards. Such 
regulations and guidance shall clarify the require-
ments and policies relating to the following: 
(A) Arrangements to avoid duplication de-
scribed in paragraph (1)(A)(i), including— 
(i) delineating the roles of institu-
tional review boards in multisite or cooper-
ative, multisite studies where one or more 
local institutional review boards are relied 
upon, or similar arrangements are used; 
(ii) the risks and benefits to human 
subjects; 
(iii) standardizing the informed con-
sent and other processes and legal docu-
ments; and 
(iv) incorporating community values 
through the use of local institutional re-
229 
view boards while continuing to use central 
or lead institutional review boards. 
(B) Concerns about regulatory and legal li-
ability contributing to decisions by the sponsors 
of research to rely on local institutional review 
boards for multisite research. 
(3) CONSULTATION.—In issuing regulations or 
guidance under paragraph (2), the Secretary shall 
consult with stakeholders (including researchers, 
academic organizations, hospitals, institutional re-
search boards, pharmaceutical, biotechnology and 
medical device developers, clinical research organiza-
tions, patient groups, and others). 
(c) TIMING.—The Secretary shall complete the har-
monization described in subsection (a) not later than 36 
months after the date of enactment of this Act. 
(d) PROGRESS REPORT.—Not later than 24 months 
after the date of enactment of this Act, the Secretary shall 
submit to Congress a report on the progress made toward 
completing such harmonization. 
(e) DRAFT NIH POLICY.—Not later than 12 months 
after the date of enactment of this Act, the Secretary, act-
ing through the Director of the National Institutes of 
Health, shall finalize the draft policy entitled ‘‘Draft NIH
230 
Policy on Use of a Single Institutional Review Board for 
Multi-Site Research’’. 
(f) DEFINITIONS.— 
(1) HUMAN SUBJECT REGULATIONS.—In this 
section: 
(A) 
FDA 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘FDA Human Subject Reg-
ulations’’ means the provisions of parts 50, 56, 
312, and 812 of title 21, Code of Federal Regu-
lations (or any successor regulations). 
(B) HHS 
HUMAN
SUBJECT
REGULA-
TIONS.—The term ‘‘HHS Human Subject Reg-
ulations’’ means the provisions of subpart A of 
part 46 of title 45, Code of Federal Regulations 
(or any successor regulations). 
(C) VULNERABLE-POPULATIONS RULES.— 
The term ‘‘vulnerable-populations rules’’— 
(i) subject to clause (ii), means the 
provisions of subparts B through D of 
such part 46 (or any successor regula-
tions); or 
(ii) as applicable to research that is 
subject to the FDA Human Subject Regu-
lations, means the provisions applicable to 
vulnerable populations under part 56 of
231 
such title 21 (or any successor regulations) 
and subpart D of part 50 of such title 21 
(or any successor regulations). 
(2) OTHER DEFINITIONS.—In this section: 
(A) INSTITUTIONAL REVIEW BOARD.—The 
term ‘‘institutional review board’’ has the mean-
ing that applies to the term ‘‘institutional re-
view board’’ under the HHS Human Subject 
Regulations. 
(B) 
LEAD
INSTITUTIONAL
REVIEW 
BOARD.—The term ‘‘lead institutional review 
board’’ means an institutional review board that 
otherwise meets the requirements of the HHS 
Human Subject Regulations and enters into a 
written agreement with an institution, another 
institutional review board, a sponsor, or a prin-
cipal investigator to approve and oversee human 
subject research that is conducted at multiple 
locations. References to an institutional review 
board include an institutional review board that 
serves a single institution as well as a lead in-
stitutional review board.
232 
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW 
BOARDS FOR REVIEW OF INVESTIGATIONAL 
DEVICE EXEMPTIONS AND HUMAN DEVICE 
EXEMPTIONS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended— 
(1) in subsection (g)(3)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) in subparagraph (A)(i), by striking 
‘‘which has been’’; and 
(2) in subsection (m)(4)— 
(A) by striking ‘‘local’’ each place it ap-
pears; and 
(B) by striking subparagraph (A) and in-
serting the following new subparagraph: 
‘‘(A) in facilities in which clinical testing of de-
vices is supervised by an institutional review com-
mittee established in accordance with the regulations 
of the Secretary, and’’. 
(b) REGULATIONS.—Not later than 12 months after 
the date of the enactment of this Act, the Secretary of 
Health and Human Services shall revise or issue such reg-
ulations or guidance as may be necessary to carry out the 
amendments made by subsection (a).
233 
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CON-
SENT FOR CLINICAL INVESTIGATIONS. 
(a) DEVICES.—Section 520(g)(3) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is 
amended— 
(1) in subparagraph (D), by striking ‘‘except 
where subject to such conditions as the Secretary 
may prescribe, the investigator’’ and inserting the 
following: ‘‘except where, subject to such conditions 
as the Secretary may prescribe— 
‘‘(i) the proposed clinical testing poses no 
more than minimal risk to the human subject 
and includes appropriate safeguards to protect 
the rights, safety, and welfare of the human 
subject; or 
‘‘(ii) the investigator’’; and 
(2) in the matter following subparagraph (D), 
by striking ‘‘subparagraph (D)’’ and inserting ‘‘sub-
paragraph (D)(ii)’’. 
(b) DRUGS.—Section 505(i)(4) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended 
by striking ‘‘except where it is not feasible or it is contrary 
to the best interests of such human beings’’ and inserting 
‘‘except where it is not feasible, it is contrary to the best 
interests of such human beings, or the proposed clinical 
testing poses no more than minimal risk to such human
234 
beings and includes appropriate safeguards as prescribed 
to protect the rights, safety, and welfare of such human 
beings’’. 
Subtitle P—Improving Scientific 
Expertise and Outreach at FDA 
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RE-
SEARCH SERVICE. 
(a) HIRING AND RETENTION AUTHORITY.—Section 
228 of the Public Health Service Act (42 U.S.C. 237) is 
amended— 
(1) in the section heading, by inserting ‘‘AND 
BIOMEDICAL
PRODUCT
ASSESSMENT’’ after ‘‘RE-
SEARCH’’; 
(2) in subsection (a)(1), by striking ‘‘Silvio O. 
Conte Senior Biomedical Research Service, not to 
exceed 500 members’’ and inserting ‘‘Silvio O. Conte 
Senior Biomedical Research and Biomedical Product 
Assessment Service (in this section referred to as the 
‘Service’), the purpose of which is to recruit and re-
tain competitive and qualified scientific and tech-
nical experts outstanding in the field of biomedical 
research, clinical research evaluation, and biomedical 
product assessment’’; 
(3) by amending subsection (a)(2) to read as 
follows:
235 
‘‘(2) The authority established in paragraph (1) may 
not be construed to require the Secretary to reduce the 
number of employees serving under any other employment 
system in order to offset the number of members serving 
in the Service.’’; 
(4) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘or clinical research evaluation’’ and 
inserting ‘‘, clinical research evaluation or bio-
medical product assessment’’; and 
(B) in paragraph (1), by inserting ‘‘or a 
master’s 
level 
degree 
in 
engineering, 
bioinformatics, or a related or emerging field,’’ 
after the comma; 
(5) in subsection (d)(2), by striking ‘‘and shall 
not exceed the rate payable for level I of the Execu-
tive Schedule unless approved by the President 
under section 5377(d)(2) of title 5, United States 
Code’’ and inserting ‘‘and shall not exceed the rate 
payable for the President’’; 
(6) by striking subsection (e); and 
(7) by redesignating subsections (f) and (g) as 
subsections (e) and (f), respectively. 
(b) REPORT.—Not later than 3 years after the date 
of the enactment of this Act, the Secretary of Health and
236 
Human Services shall submit, and publish on the website 
of the Department of Health and Human Services a report 
on the implementation of the amendments made by sub-
section (a), including whether the amendments have im-
proved the ability of the Food and Drug Administration 
to hire and retain qualified experts to fulfill obligations 
specified under user fee agreements. 
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT. 
It is the sense of Congress that the participation in, 
or sponsorship of, scientific conferences and meetings is 
essential to the mission of the Food and Drug Administra-
tion. 
SEC. 2283. REAGAN-UDALL FOUNDATION FOR THE FOOD 
AND DRUG ADMINISTRATION. 
(a) BOARD OF DIRECTORS.— 
(1) 
COMPOSITION
AND
SIZE.—Section 
770(d)(1)(C) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 379dd(d)(1)(C)) is amended— 
(A) by redesignating clause (ii) as clause 
(iii); 
(B) by inserting after clause (i) the fol-
lowing: 
‘‘(ii) 
ADDITIONAL
MEMBERS.—The 
Board, through amendments to the bylaws 
of the Foundation, may provide that the
237 
number of voting members of the Board 
shall be a number (to be specified in such 
amendment) greater than 14. Any Board 
positions that are established by any such 
amendment shall be appointed (by majority 
vote) by the individuals who, as of the date 
of such amendment, are voting members of 
the Board and persons so appointed may 
represent any of the categories specified in 
subclauses (I) through (V) of clause (i), so 
long as no more than 30 percent of the 
total voting members of the Board (includ-
ing members whose positions are estab-
lished by such amendment) are representa-
tives of the general pharmaceutical, device, 
food, cosmetic, and biotechnology indus-
tries.’’; and 
(C) in clause (iii)(I), as redesignated by 
subparagraph (A), by striking ‘‘The ex officio 
members shall ensure’’ and inserting ‘‘The ex 
officio members, acting pursuant to clause (i), 
and the Board, acting pursuant to clause (ii), 
shall ensure’’. 
(2) FEDERAL EMPLOYEES ALLOWED TO SERVE 
ON BOARD.—Clause (iii)(II) of section 770(d)(1)(C)
238 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379dd(d)(1)(C)), as redesignated by para-
graph (1)(A), is amended by adding at the end the 
following: ‘‘For purposes of this section, the term 
‘employee of the Federal Government’ does not in-
clude a ‘special Government employee’, as that term 
is defined in section 202(a) of title 18, United 
States Code.’’. 
(3) STAGGERED TERMS.—Subparagraph (A) of 
section 770(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended 
to read as follows: 
‘‘(A) TERM.—The term of office of each 
member of the Board appointed under para-
graph (1)(C)(i), and the term of office of any 
member of the Board whose position is estab-
lished pursuant to paragraph (1)(C)(ii), shall be 
4 years, except that— 
‘‘(i) the terms of offices for the mem-
bers of the Board initially appointed under 
paragraph (1)(C)(i) shall expire on a stag-
gered basis as determined by the ex officio 
members; and 
‘‘(ii) the terms of office for the per-
sons initially appointed to positions estab-
239 
lished pursuant to paragraph (1)(C)(ii) 
may be made to expire on a staggered 
basis, as determined by the individuals 
who, as of the date of the amendment es-
tablishing such positions, are members of 
the Board.’’. 
(b) EXECUTIVE DIRECTOR COMPENSATION.—Section 
770(g)(2) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 379dd(g)(2)) is amended by striking ‘‘but shall 
not be greater than the compensation of the Commis-
sioner’’. 
(c) SEPARATION OF FUNDS.—Section 770(m) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379dd(m)) is amended by striking ‘‘are held in separate 
accounts from funds received from entities under sub-
section (i)’’ and inserting ‘‘are managed as individual pro-
grammatic funds under subsection (i), according to best 
accounting practices’’. 
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
Chapter VII of the Federal Food, Drug, and Cos-
metic Act is amended by inserting after section 708 of 
such Act (21 U.S.C. 379) the following:
240 
‘‘SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFOR-
MATION EXEMPTED FROM PAPERWORK RE-
DUCTION ACT. 
‘‘Chapter 35 of title 44, United States Code, shall 
not apply to the collection from patients, industry, aca-
demia, and other stakeholders, of voluntary information 
such as through voluntary surveys or questionnaires, initi-
ated by the Secretary.’’. 
SEC. 2285. HIRING AUTHORITY FOR SCIENTIFIC, TECH-
NICAL, AND PROFESSIONAL PERSONNEL. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 714 
(21 U.S.C. 379d–3) the following: 
‘‘SEC. 714A. ADDITIONAL HIRING AUTHORITY. 
‘‘(a) IN GENERAL.—The Secretary may, without re-
gard to the provisions of title 5, United States Code, gov-
erning appointments in the competitive service, appoint 
qualified candidates to scientific, technical, or professional 
positions within the following centers of the Food and 
Drug Administration: 
‘‘(1) The Center for Drug Evaluation and Re-
search. 
‘‘(2) The Center for Biologics Evaluation and 
Research. 
‘‘(3) The Center for Devices and Radiological 
Health.
241 
Such positions shall be within the competitive service. 
‘‘(b) COMPENSATION.— 
‘‘(1) IN GENERAL.—Notwithstanding any other 
provision of law, including any requirement with re-
spect to General Schedule pay rates under sub-
chapter III of chapter 53 of title 5, United States 
Code, and consistent with the requirements of para-
graph (2), the Secretary may determine and fix— 
‘‘(A) the annual rate of pay of any indi-
vidual appointed under subsection (a); and 
‘‘(B) for purposes of retaining qualified 
employees, the annual rate of pay for any high-
ly qualified scientific, technical, or professional 
personnel appointed to a position at any of the 
centers listed under subsection (a) before the 
date of enactment of this section. 
‘‘(2) LIMITATION.—The annual rate of pay es-
tablished pursuant to paragraph (1) may not exceed 
the annual rate of pay of the President. 
‘‘(c) REPORT.— 
‘‘(1) IN GENERAL.—Not later than September 
30, 2021, the Secretary shall submit a report to 
Congress that examines the extent to which the au-
thority to appoint and retain personnel under this 
section enhanced the Food and Drug Administra-
242 
tion’s ability to meet the agency’s critical need for 
highly qualified individuals for scientific, technical, 
or professional positions. 
‘‘(2) RECOMMENDATIONS.—The report under 
paragraph (1) shall include the recommendations of 
the Secretary on— 
‘‘(A) whether the authority to appoint per-
sonnel under this section should be reauthor-
ized; and 
‘‘(B) other personnel authorities that 
would help the Food and Drug Administration 
to better recruit and retain highly qualified in-
dividuals for scientific, technical, or professional 
positions in the agency’s medical product cen-
ters.’’. 
(b) RULE OF CONSTRUCTION.—The authority pro-
vided by section 714A of the Federal Food, Drug, and 
Cosmetic Act (as added by subsection (a)) shall not be 
construed to affect the authority provided under section 
714 of such Act.
243 
Subtitle Q—Exempting From 
Sequestration Certain User Fees 
SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN 
USER FEES OF FOOD AND DRUG ADMINIS-
TRATION. 
The Balanced Budget and Emergency Deficit Control 
Act of 1985 is amended— 
(1) 
in 
section 
255(g)(1)(A) 
(2 
U.S.C. 
905(g)(1)(A)), by inserting after the item relating to 
‘‘Financial Agent Services’’ the following new item: 
‘‘Food and Drug Administration, Salaries 
and Expenses, but only the portion of appro-
priations under such account corresponding to 
fees collected under sections 736, 738, 740, 
741, 744B, and 744H of the Federal Food, 
Drug, and Cosmetic Act (75–9911–0–1–554).’’; 
and 
(2) in section 256(h) (2 U.S.C. 906(h)), by 
adding at the end the following new paragraph: 
‘‘(5) Notwithstanding any other provision of 
law, this subsection shall not apply with respect to 
the portion of administrative expenses incurred by 
the Food and Drug Administration that are funded 
through fees collected under sections 736, 738, 740,
244 
741, 744B, and 744H of the Federal Food, Drug, 
and Cosmetic Act.’’. 
Subtitle R—Other Provisions 
SEC. 2321. SENSE OF CONGRESS. 
It is the sense of the Congress that recording unique 
device identifiers at the point-of-care in electronic health 
record systems could significantly enhance the availability 
of medical device data for postmarket surveillance pur-
poses. 
TITLE III—DELIVERY 
Subtitle A—Interoperability 
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
(a) INTEROPERABILITY STANDARDS.— 
(1) IN GENERAL.—Subtitle A of title XXX of 
the Public Health Service Act (42 U.S.C. 300jj–11 
et seq.) is amended by adding at the end the fol-
lowing new section: 
‘‘SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH IN-
FORMATION TECHNOLOGY. 
‘‘(a) INTEROPERABILITY.—In order for health infor-
mation technology to be considered interoperable, such 
technology must satisfy the following criteria: 
‘‘(1) SECURE TRANSFER.—The technology al-
lows the secure transfer of all electronically acces-
245 
sible health information to and from any and all 
health information technology for authorized use 
under applicable State or Federal law. 
‘‘(2) COMPLETE ACCESS TO HEALTH INFORMA-
TION.—The technology allows for complete access, 
exchange, and use of all electronically accessible 
health information for authorized use under applica-
ble State or Federal law without special effort by the 
requestor of such health information. 
‘‘(3) NO INFORMATION BLOCKING.—The tech-
nology is not configured, set up, or implemented to 
information block, as defined in section 3010A(d). 
‘‘(b) CATEGORIES FOR INTEROPERABILITY STAND-
ARDS.—The categories described in this subsection, with 
respect to standards and the corresponding implementa-
tion specifications for determining if health information 
technology is interoperable, consistent with the criteria de-
scribed in subsection (a), include at least categories of 
standards and implementation specifications with respect 
to the following: 
‘‘(1) Vocabulary and terminology. 
‘‘(2) Content and structure. 
‘‘(3) Transport. 
‘‘(4) Security. 
‘‘(5) Services.
246 
‘‘(6) Querying and requesting health informa-
tion for access, exchange, and use. 
‘‘(c) ALLOWING FOR FLEXIBILITY.—A standard and 
implementation specification, with respect to such stand-
ard, that is determined under section 3001(c)(5)(D) to be 
compatible with baseline standards and implementation 
specifications (as defined in clause (ii) of such section) 
shall be treated as in compliance with this section.’’. 
(2) GUIDANCE.—Not later than January 1, 
2017, the Secretary of Health and Human Services, 
in consultation with the National Coordinator of the 
Office of the National Coordinator for Health Infor-
mation Technology, shall issue guidance with respect 
to the implementation of section 3010 of the Public 
Health Service Act, as added by paragraph (1), in-
cluding with respect to defining and providing exam-
ples of authorized use under applicable State or 
Federal law of health information. 
(b) IMPROVEMENTS
TO RECOMMENDATION PROC-
ESS.— 
(1) HIT POLICY COMMITTEE TO INCORPORATE 
POLICIES
FOR
UPDATES
TO
INTEROPERABILITY 
STANDARDS.—Section 3002 of the Public Health 
Service Act (42 U.S.C. 300jj–12) is amended— 
(A) in subsection (a)—
247 
(i) by striking ‘‘National Coordinator’’ 
and inserting ‘‘Secretary, in consultation 
with the National Coordinator,’’; and 
(ii) by adding at the end the following 
new sentence: ‘‘The HIT Policy Committee 
is authorized only to provide policy and 
priority recommendations to the Secretary 
and not authorized to otherwise affect the 
development or modification of any stand-
ard, implementation specification, or cer-
tification criterion under this title.’’; and 
(B) in subsection (b)(2)— 
(i) in subparagraph (A), in the first 
sentence— 
(I) by striking ‘‘The HIT Policy 
Committee’’ and inserting ‘‘Subject to 
subparagraph (D), the HIT Policy 
Committee’’; and 
(II) by inserting ‘‘(including the 
areas in which modifications and addi-
tions to interoperability standards and 
implementation specifications, with re-
spect to such interoperability stand-
ards, under section 3010 are needed 
for the electronic access, exchange,
248 
and use of health information for pur-
poses of adoption of such modifica-
tions and additions under section 
3004)’’ after ‘‘section 3004’’. 
(ii) by adding at the end the following 
new subparagraph: 
‘‘(D) SPECIAL RULE RELATED TO INTER-
OPERABILITY.—Any recommendation made by 
the HIT Policy Committee on or after the date 
of the enactment of this subparagraph with re-
spect to interoperability of health information 
technology shall be consistent with the criteria 
described in subsection (a) of section 3010.’’. 
(2) SUNSET OF HIT STANDARDS COMMITTEE.— 
Section 3003 of the Public Health Service Act (42 
U.S.C. 300jj–13) is amended by adding at the end 
the following new subsection: 
‘‘(f) TERMINATION.—The HIT Standards Committee 
shall terminate on the date that is 90 days after the date 
of the enactment of this subsection.’’. 
(3) 
STANDARDS
DEVELOPMENT
ORGANIZA-
TIONS.—Title XXX of the Public Health Service Act 
is amended by inserting after section 3003 the fol-
lowing new section:
249 
‘‘SEC. 
3003A. 
RECOMMENDATIONS 
FOR 
STANDARDS 
THROUGH CONTRACTS WITH STANDARDS DE-
VELOPMENT ORGANIZATIONS. 
‘‘(a) CONTRACTS.— 
‘‘(1) IN GENERAL.—For purposes of activities 
conducted under this title, the Secretary shall enter 
into one or more contracts with health care stand-
ards development organizations accredited by the 
American National Standards Institute (or with the 
American National Standards Institute) to carry 
out, directly or through contracts with subcontrac-
tors, the duties described in subsection (b), as appli-
cable. 
‘‘(2) TIMING FOR FIRST CONTRACT.—As soon 
as practicable after the date of the enactment of this 
section, the Secretary shall enter into the first con-
tracts under paragraph (1). 
‘‘(3) PERIOD
OF
CONTRACT.—Each contract 
under paragraph (1) shall be for a period deter-
mined necessary by the Secretary, in consultation 
with the National Coordinator, to carry out the ap-
plicable duties described in subsection (b). 
‘‘(4) APPROPRIATE ENTITIES.—The Secretary 
shall ensure the most appropriate entities described 
in paragraph (1) are selected for each contract 
under such paragraph.
250 
‘‘(b) DUTIES.— 
‘‘(1) INITIAL CONTRACT.—The Secretary shall 
initially enter into one or more contracts under sub-
section (a)(1) with entities described in such sub-
section, under which the entities— 
‘‘(A) shall recommend to the Secretary— 
‘‘(i) for adoption under section 3004, 
an initial set of interoperability standards 
and implementation specifications, with re-
spect to such standards, identified or, as 
appropriate, developed by such entities 
that are consistent with the criteria de-
scribed in subsection (a) of section 3010, 
and with respect to the categories de-
scribed in subsection (b) of such section; 
and 
‘‘(ii) as applicable, for purposes of 
section 3001(c)(5)(D), methods to test if 
health information technology is compat-
ible with health information technology 
that applies baseline standards and imple-
mentation specifications (as defined in 
clause (ii) of such section); and 
‘‘(B) may provide to the Secretary rec-
ommendations described in paragraph (2).
251 
‘‘(2) SUBSEQUENT
CONTRACTS.—Under each 
subsequent contract entered into under this section 
with entities described in subsection (a)(1) pursuant 
to subsection (c), the entities shall recommend to the 
Secretary— 
‘‘(A) for adoption under section 3004 any 
standards (including interoperability stand-
ards), implementation specifications, and, to the 
extent necessary, certification criteria (and 
modifications, including additions, to such 
standards, specifications, and, to the extent 
necessary, criteria), which are in accordance 
with the criteria described in section 3010; and 
‘‘(B) as applicable, for purposes of section 
3001(c)(5)(D), methods to test if health infor-
mation technology is compatible with baseline 
standards and implementation specifications (as 
defined in clause (ii) of such section). 
‘‘(3) SUBMISSION TO NIST.—Under each con-
tract with an entity under this section, the entity 
shall submit to the Director of the National Institute 
of Standards and Technology each recommendation 
submitted to the Secretary by such entity under this 
section.
252 
‘‘(4) CONSULTATION.—For the purposes of de-
veloping methods to test interoperability standards 
and implementation specifications with respect to 
such standards, the entities with a contract under 
this section may consult with the Director of the Na-
tional Institute of Standards and Technology. 
‘‘(c) 
MODIFICATIONS
AND
SUBSEQUENT
CON-
TRACTS.— 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the National Coordinator, shall periodically 
conduct hearings to evaluate and review the stand-
ards, implementation specifications, and certification 
criteria adopted under section 3004 for purposes of 
determining if modifications, including any addi-
tions, are needed with respect to such standards, 
specifications, and criteria. 
‘‘(2) CONTRACT TRIGGER.—Based on the needs 
for standards, implementation specifications, and 
certification criteria (and modifications, including 
additions, to such standards, specifications, and cri-
teria) under this title, as determined by the Sec-
retary, with due consideration to section 3010(b) 
and in consultation with the National Coordinator, 
the Secretary shall, as needed, enter into contracts 
under subsection (a) to carry out the duties de-
253 
scribed in subsection (b)(2) in addition to any con-
tract entered into to carry out the duties described 
in subsection (b)(1). 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated $10,000,000 for contracts 
under subsection (a), to remain available until expended.’’. 
(4) MODIFICATIONS
TO
ROLE
OF
THE
NA-
TIONAL
COORDINATOR.—Section 3001(c)(1)(A) of 
the Public Health Service Act (42 U.S.C. 300jj– 
11(c)(1)(A)) is amended by inserting ‘‘for rec-
ommendations made before the date of the enact-
ment of the 21st Century Cures Act,’’ before ‘‘review 
and determine’’. 
(c) ADOPTION.—Section 3004 of the Public Health 
Service Act (42 U.S.C. 300jj–14) is amended— 
(1) in subsection (a)— 
(A) in paragraph (1), by inserting after 
‘‘section 3001(c)’’ the following: ‘‘(or, subject to 
subsection (c), in the case of a standard, imple-
mentation 
specification, 
or 
criterion 
rec-
ommended on or after the date of the enact-
ment of the 21st Century Cures Act, after the 
date of submission of the recommendation to 
the Secretary under section 3003A)’’; and
254 
(B) in paragraph (2)(B), by striking ‘‘and 
the HIT Standards Committee’’; 
(2) in subsection (b)— 
(A) in paragraph (3), by striking ‘‘with the 
schedule published under section 3003(b)(2)’’ 
and inserting ‘‘with subsection (d)’’; and 
(B) by adding at the end the following new 
paragraph: 
‘‘(4) LIMITATION.—The Secretary may not 
adopt any policies, priorities, standards, implementa-
tion specifications, or certification criteria under this 
subsection or subsection (a) that are inconsistent 
with or duplicative of an interoperability standard or 
implementation specification with respect to such 
standard adopted under this section, in accordance 
with subsections (c) and (d). In the case of a stand-
ard, specification, or criterion that has been adopted 
under this section and is inconsistent or duplicative 
of such an interoperability standard or specification 
that is subsequently adopted under this section, such 
interoperability 
standard 
or 
specification 
shall 
supercede such other standard, specification, or cri-
terion and such other standard, specification, or cri-
terion shall no longer be considered adopted under 
this section beginning on the date that such inter-
255 
operability standard or specification becomes effec-
tive.’’; and 
(3) by adding at the end the following new sub-
sections: 
‘‘(c) ADOPTION
OF
INITIAL
INTEROPERABILITY 
STANDARDS AND IMPLEMENTATION SPECIFICATIONS.— 
Notwithstanding the previous subsections of this section, 
the following shall apply in the case of the initial set of 
interoperability standards and implementation specifica-
tions with respect to such standards recommended under 
section 3003A: 
‘‘(1) REVIEW OF STANDARDS.—Not later than 
90 days after the date of receipt of recommendations 
for such interoperability standards and implementa-
tion specifications, the Secretary, in consultation 
with the National Coordinator and representatives of 
other relevant Federal agencies, such as the Na-
tional Institute of Standards and Technology, shall 
jointly review such standards and implementation 
specifications and shall determine whether or not to 
propose adoption of such standards and implementa-
tion specifications. 
‘‘(2) DETERMINATION TO ADOPT.—If, subject 
to subsection (d)(3), the Secretary determines—
256 
‘‘(A) to propose adoption of such standards 
and implementation specifications, the Sec-
retary shall, by regulation under section 553 of 
title 5, United States Code, determine whether 
or not to adopt such standards and implemen-
tation specifications; or 
‘‘(B) not to propose adoption of such 
standards and implementation specifications, 
the Secretary shall notify the applicable entity 
with a contract under section 3003A in writing 
of such determination and the reasons for not 
proposing the adoption of the recommendation 
for such standards and implementation speci-
fications. 
‘‘(3) PUBLICATION.—The Secretary shall pro-
vide for publication in the Federal Register of all de-
terminations made by the Secretary under para-
graph (1). 
‘‘(d) RULES FOR ADOPTION.—In the case of a stand-
ard (including interoperability standard), implementation 
specification, or certification criterion adopted under this 
section on or after the date of the enactment of the 21st 
Century Cures Act, the following shall apply: 
‘‘(1) IN GENERAL.—Except as provided in para-
graphs (2) and (3), any such standard (including
257 
interoperability standard), implementation specifica-
tion, or certification criterion shall be a standard, 
specification, or criterion that has been rec-
ommended by the entities with which the Secretary 
has entered into a contract under section 3003A. 
‘‘(2) SPECIAL RULE IF NO STANDARD, SPECI-
FICATION, OR
CRITERION
RECOMMENDED.—If no 
standard, implementation specification, or, to the ex-
tent 
necessary, 
certification 
criterion 
is 
rec-
ommended under paragraph (1)— 
‘‘(A) in the case of interoperability stand-
ards and implementation specifications with re-
spect to such standards, relating to a category 
described in section 3010(b)— 
‘‘(i) paragraph (1) shall not apply; 
and 
‘‘(ii) paragraph (4) shall apply; or 
‘‘(B) in the case of any other standard, im-
plementation specification, or, to the extent nec-
essary, certification criterion, relating to a pol-
icy or priority to carry out this title, as deter-
mined by the Secretary, in consultation with the 
National Coordinator— 
‘‘(i) paragraph (1) shall not apply; 
and
258 
‘‘(ii) paragraph (4) shall apply. 
‘‘(3) AUTHORITY TO MODIFY IMPLEMENTATION 
SPECIFICATIONS.—If, following public comment pur-
suant to subsection (c), the Secretary would propose 
adoption of interoperability standards recommended 
under section 3003A but for the implementation 
specifications, with respect to such standards, so 
recommended, the Secretary may modify such imple-
mentation specifications and adopt such standards 
and specifications in accordance with subsection 
(c)(2). 
‘‘(4) EFFECTIVE
DATE.—In the case of a 
standard, implementation specification, or certifi-
cation criterion for which there is a determination to 
adopt such standard, implementation specification, 
or certification criterion, such standard, implementa-
tion specification, or certification criterion shall be 
considered adopted under this section and shall be 
effective beginning on the date that is 12 months 
after the date of publication of the final rule to 
adopt such standard, implementation specification, 
or certification criterion. 
‘‘(5) ASSISTANCE
TO
THE
SECRETARY.—In 
complying with the requirements of this subsection, 
the Secretary shall give due consideration to any rec-
259 
ommendations of the National Committee on Vital 
and Health Statistics established under section 
306(k), and shall consult with appropriate Federal 
and State agencies and private organizations. The 
Secretary shall publish in the Federal Register any 
recommendation of the National Committee on Vital 
and Health Statistics regarding the adoption of a 
standard, implementation specification, or certifi-
cation criterion under this section. Any standard, 
implementation specification, or certification cri-
terion adopted pursuant to this paragraph shall be 
promulgated in accordance with the rulemaking pro-
cedures of subchapter III of chapter 5 of title 5, 
United States Code. 
‘‘(e) ALLOWING FOR FLEXIBILITY THROUGH COM-
PATIBILITY WITH BASELINE STANDARDS
AND IMPLE-
MENTATION SPECIFICATIONS.—For purposes of this title, 
title XVIII of the Social Security Act, title XIX of such 
Act, and any other provision of law, a standard and imple-
mentation specification, with respect to such standard, 
that is determined under section 3001(c)(5)(D) to be com-
patible with baseline standards and implementation speci-
fications (as defined in clause (ii) of such section) shall 
be treated as if such standard and specification were an 
interoperability standard and implementation specifica-
260 
tion, with respect to such interoperability standard, adopt-
ed under this section.’’. 
(d) REPORTS AND NOTIFICATIONS.—Section 3010 of 
the Public Health Service Act, as added by subsection (a), 
is amended by adding at the end the following new sub-
section: 
‘‘(c) DISSEMINATION OF INFORMATION.— 
‘‘(1) INITIAL
SUMMARY
REPORT.—Not later 
than July 1, 2017, the Secretary, after consultation 
with relevant stakeholders, shall submit to Congress 
and provide for publication in the Federal Register 
and the posting on the Internet website of the Office 
of the National Coordinator for Health Information 
Technology a report on the following: 
‘‘(A) The initial set of interoperability 
standards and implementation specifications 
adopted under section 3004(c). 
‘‘(B) The strategies for achieving wide-
spread interoperability. 
‘‘(C) Any barriers that are preventing 
widespread interoperability. 
‘‘(D) The plan and milestones, including 
specific steps, to achieve widespread interoper-
ability.
261 
‘‘(2) ONGOING PUBLICATION OF RECOMMENDA-
TIONS.—The Secretary shall provide for publication 
in the Federal Register, and the posting on the 
Internet website of the Office of the National Coor-
dinator for Health Information Technology, of all 
recommendations made under this section.’’. 
(e) CERTIFICATION
AND
OTHER
ENFORCEMENT 
PROVISIONS.— 
(1) CERTIFICATION OF QUALIFIED ELECTRONIC 
HEALTH RECORDS.— 
(A) IN GENERAL.—Section 3007(b) of the 
Public Health Service Act (42 U.S.C. 300jj– 
17(b)) is amended by striking ‘‘under section 
3001(c)(3) to be in compliance with’’ and all 
that follows through the period at the end and 
inserting ‘‘under section 3001(c)(3)— 
‘‘(1) for certifications made before January 1, 
2018, to be in compliance with applicable standards 
adopted under subsections (a) and (b) of section 
3004; and 
‘‘(2) for certifications made on or after January 
1, 2018, to be in compliance with applicable stand-
ards adopted under subsections (a) and (b) of sec-
tion 3004 and to be interoperable in accordance with
262 
section 3010 and in compliance with interoperability 
standards adopted under section 3004.’’. 
(B) REQUIREMENTS OF SECRETARY.—Sec-
tion 3001(c)(5) of the Public Health Service 
Act (42 U.S.C. 300jj–11(c)(5)) is amended— 
(i) in subparagraph (B), by inserting 
before the period at the end the following: 
‘‘and, for certifications made on or after 
January 1, 2018, with respect to health in-
formation technology, additional criteria to 
establish that the technology is interoper-
able, in accordance with section 3010, and 
in compliance with interoperability stand-
ards and implementation specifications, 
with respect to such standards, adopted 
under section 3004’’; and 
(ii) by adding at the end the following 
new subparagraphs: 
‘‘(C) 
ENFORCEMENT; 
DECERTIFICATIONS.— 
‘‘(i) 
REQUIREMENTS.—Under 
any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
any vendor of or other entity offering to 
health care providers (as defined in section
263 
3010A(g)) 
qualified 
electronic 
health 
records seeking a certification of such 
records under such program on or after 
January 1, 2018, shall, as a condition of 
certification (and maintenance of certifi-
cation) of such a record under such pro-
gram— 
‘‘(I) provide to the Secretary an 
attestation— 
‘‘(aa) the entity has imple-
mented interoperability standards 
and 
implementation 
specifica-
tions, with respect to such stand-
ards, adopted under section 3004 
(including through application of 
subsection (e) of such section); 
‘‘(bb) that the entity, unless 
for a legitimate purpose specified 
by the Secretary, has not taken 
and will not take any action that 
constitutes information blocking 
(as defined in section 3010A(d)), 
with respect to such qualified 
electronic health records;
264 
‘‘(cc) that includes the pric-
ing 
information 
described 
in 
clause (iii) for purposes of inclu-
sion under subsection (f) of such 
information 
on 
the 
Internet 
website of the Department of 
Health and Human Services; that 
such information will be available 
on a public Internet website of 
such entity; and that the entity 
will voluntarily provide such in-
formation to customers prior to 
offering any qualified electronic 
health records or related product 
or service (including subsequent 
updates, add-ons, or additional 
products or services to be pro-
vided during the course of an on- 
going contract), prospective cus-
tomers (such as persons who re-
quest or receive a quotation or 
estimate), and other persons who 
request such information; 
‘‘(dd) that the technology 
with respect to such records has
265 
published application program-
ming interfaces, with respect to 
health information within such 
records, for search and indexing, 
semantic harmonization and vo-
cabulary translation, and user 
interface applications; 
‘‘(ee) that the entity has 
successfully and rigorously tested 
the real world use of the record 
in the type of setting in which it 
would be marketed; and 
‘‘(ff) that the entity has in 
place data sharing programs or 
capabilities based on common 
data 
elements 
through 
such 
mechanisms as application pro-
gramming interfaces without the 
requirement for vendor-specific 
interfaces; 
‘‘(II) publish application pro-
gramming interfaces and associated 
documentation, with respect to health 
information within such records, for 
search and indexing, semantic harmo-
266 
nization and vocabulary translation, 
and user interface applications; and 
‘‘(III) demonstrate to the satis-
faction of the Secretary that health 
information from such records are 
able to be exchanged, accessed, and 
used through the use of application 
programming interfaces without spe-
cial effort, as authorized under appli-
cable law. 
‘‘(ii) DECERTIFICATION.—Under any 
program kept or recognized under subpara-
graph (A), the Secretary shall ensure that 
beginning January 1, 2019, any qualified 
electronic health records that do not sat-
isfy the certification criteria described in 
subparagraph (B) or with respect to which 
the vendor or other entity described in 
clause (i) does not satisfy the requirements 
under such clause (or is determined to be 
in violation of the terms of the attestation 
or other requirements under such clause) 
shall no longer be considered as certified 
under such program.
267 
‘‘(iii) PRICING
INFORMATION.—For 
purposes of clause (i)(I)(cc), the pricing in-
formation described in this clause, with re-
spect to a vendor of or other entity offer-
ing a qualified electronic health record, is 
the following: 
‘‘(I) Additional types of costs or 
fees (whether fixed, recurring, trans-
action based, or otherwise) imposed by 
the entity (or any third-party from 
whom the entity purchases, licenses, 
or obtains any technology, products, 
or services in connection with the 
qualified electronic health record) to 
purchase, license, implement, main-
tain, upgrade, use, or otherwise enable 
and support the use of capabilities to 
which such record is to be certified 
under this section; or in connection 
with any health information generated 
in the course of using any capability 
to which the record is to be so cer-
tified. 
‘‘(II) Limitations, whether by 
contract or otherwise, on the use of
268 
any capability to which the record is 
to be certified under this section for 
any purpose within the scope of the 
record’s certification; or in connection 
with any health information generated 
in the course of using any capability 
to which the record is to be certified 
under this section. 
‘‘(III) 
Limitations, 
including 
technical or practical limitations of 
technology or its capabilities, that 
could prevent or impair the successful 
implementation, 
configuration, 
customization, maintenance, support, 
or use of any capabilities to which the 
record is to be certified under this 
section; or that could prevent or limit 
the access, use, exchange, or port-
ability of any health information gen-
erated in the course of using any ca-
pability to which the record is to be so 
certified. 
‘‘(D) FLEXIBILITY
THROUGH
COMPAT-
IBILITY.—
269 
‘‘(i) IN
GENERAL.—Under any pro-
gram kept or recognized under subpara-
graph (A), the Secretary shall provide for 
a method and process by which a vendor of 
or other entity offering to health care pro-
viders (as defined in section 3010A(g)) 
qualified electronic health records seeking 
a certification of such records under such 
program on or after January 1, 2018, may 
demonstrate, using such mechanisms as a 
reference implementation model or other 
means, that the standards and implemen-
tation specifications applied by such entity 
with respect to such records are compatible 
with baseline standards and implementa-
tion specifications, including by dem-
onstrating such records are able to trans-
mit information that is compatible with 
qualified electronic health records that 
would receive such information and that 
apply the baseline standards and imple-
mentation specifications. Such a method 
and process shall ensure that any such en-
tity using a standard or implementation 
specification other than a baseline stand-
270 
ard or implementation specification dem-
onstrates, through testing, compatibility 
with the baseline standard and implemen-
tation specification with respect to receiv-
ing information. 
‘‘(ii) BASELINE STANDARDS AND IM-
PLEMENTATION
SPECIFICATIONS.—For 
purposes of clause (i), the term ‘baseline 
standards and implementation specifica-
tions’ means the interoperability standards 
and implementation specifications, with re-
spect to such standards, adopted under 
section 3004 (without application of sub-
section (e) of such section).’’. 
(2) ADDITIONAL
ENFORCEMENT
PROVISIONS 
UNDER THE PUBLIC HEALTH SERVICE ACT.—Sub-
title A of title XXX of the Public Health Service Act 
(42 U.S.C. 300jj–11 et seq.), as amended by sub-
sections (a)(1) and (d), is further amended by add-
ing at the end the following new section: 
‘‘SEC. 3010A. ENFORCEMENT MECHANISMS. 
‘‘(a) INSPECTOR GENERAL AUTHORITY.—The In-
spector General of the Department of Health and Human 
Services shall have the authority to investigate claims of—
271 
‘‘(1)(A) vendors of, or other entities offering to 
health care providers (as defined in subsection (g)), 
qualified electronic health records (as defined in sec-
tion 3000(13)) being in violation of an attestation 
(whether providing false information at the time of 
such attestation or by act or practice conducted 
after 
such 
attestation) 
made 
under 
section 
3001(c)(5)(C)(i)(I), with respect to the use of such 
records by a health care provider with respect to 
items and services furnished under the Medicare 
Program under title XVIII of the Social Security 
Act or Medicaid program under title XIX of such 
Act; and 
‘‘(B) vendors of, or other entities offering to 
health care providers (as defined in subsection (g)), 
health information technology having engaged in in-
formation blocking (as defined in subsection (d)), 
unless for a legitimate purpose specified by the Sec-
retary, with respect to the use of such technology by 
a health care provider with respect to items and 
services furnished under such a program; 
‘‘(2) health care providers having engaged in in-
formation blocking (as so defined), with respect to 
the use of health information technology with re-
spect to items and services furnished under such a
272 
program, unless for a legitimate purpose specified by 
the Secretary; and 
‘‘(3) health information system providers (such 
as operators of health information exchanges, clin-
ical data registries, and other systems that facilitate 
the exchange of information) having engaged in in-
formation blocking (as so defined), unless for a le-
gitimate purpose specified by the Secretary, with re-
spect to the use of health information technology 
with respect to items and services furnished under 
such a program. 
‘‘(b) INFORMATION SHARING PROVISIONS.— 
‘‘(1) IN GENERAL.—The National Coordinator 
may serve as a technical consultant to the Inspector 
General of the Department of Health and Human 
Services and the Federal Trade Commission for pur-
poses of carrying out this section. As such technical 
consultant, the National Coordinator may, notwith-
standing any other provision of law, share informa-
tion related to claims or investigations under sub-
section (a) with the Federal Trade Commission for 
purposes of such investigations and shall share in-
formation with the Inspector General, as required by 
law.
273 
‘‘(2) PROTECTION
FROM
DISCLOSURE
OF
IN-
FORMATION.—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 identi-
fication 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; and 
‘‘(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. 
Such information may be used by the Inspector Gen-
eral of the Department of Health and Human Serv-
ices or Federal Trade Commission for reporting pur-
poses to the extent that such information could not 
reasonably be expected to facilitate identification of 
the source of such information. 
‘‘(3) NON-APPLICATION OF PAPERWORK REDUC-
TION ACT.—Chapter 35 of title 44, United States 
Code (commonly referred to as the Paperwork Re-
duction Act of 1995) shall not apply to the National 
Coordinator or to the Office of the National Coordi-
nator for Health Information Technology with re-
274 
spect to the collection of complaints relating to 
claims described in subsection (a). 
‘‘(4) STANDARDIZED PROCESS.—The National 
Coordinator shall implement a standardized process 
for the public to submit reports on claims of— 
‘‘(A) health information technology prod-
ucts of vendors (or other entities offering such 
products to health care providers (as defined in 
subsection (g))) not being interoperable or re-
sulting in information blocking; or 
‘‘(B) actions by such entities, health care 
providers, or health information system pro-
viders that result in such technology not being 
interoperable or in information blocking with 
respect to such technology; and 
‘‘(C) any other act described in subsection 
(a). 
The standardized process shall provide for the collec-
tion of such information as the originating institu-
tion, location, type of transaction, system and 
version, timestamp, terminating institution, loca-
tions, system and version, failure notice, and other 
related information. 
‘‘(c) PENALTY.—