I 
110TH CONGRESS 
2D SESSION 
H. R. 6357 
To amend the Public Health Service Act to promote the adoption of health 
information technology, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JUNE 24, 2008 
Mr. DINGELL (for himself, Mr. BARTON of Texas, Mr. PALLONE, Mr. DEAL 
of Georgia, Mr. GORDON of Tennessee, Mr. HALL of Texas, Mr. TOWNS, 
Mr. UPTON, Mr. ENGEL, Mrs. WILSON of New Mexico, Mr. GONZALEZ, 
Mr. GINGREY, and Mrs. BIGGERT) introduced the following bill; which 
was referred to the Committee on Energy and Commerce, and in addition 
to the Committees on Science and Technology and Ways and Means, for 
a period to be subsequently determined by the Speaker, in each case for 
consideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend the Public Health Service Act to promote the 
adoption of health information technology, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Protecting Records, Optimizing Treatment, and Easing 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
Communication through Healthcare Technology Act of 
2008’’ or the ‘‘PRO(TECH)T Act of 2008’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
TITLE I—HEALTH INFORMATION TECHNOLOGY 
Subtitle A—Promotion of Health Information Technology 
PART I—IMPROVING HEALTH CARE QUALITY, SAFETY, AND EFFICIENCY 
Sec. 101. ONCHIT; standards development and adoption; health information 
technology resource center. 
‘‘TITLE XXX—HEALTH INFORMATION TECHNOLOGY AND 
QUALITY 
‘‘Sec. 3000. Definitions. 
‘‘Subtitle A—Promotion of Health Information Technology 
‘‘Sec. 3001. Office of the National Coordinator for Health Information 
Technology. 
‘‘Sec. 3002. HIT Policy Committee. 
‘‘Sec. 3003. HIT Standards Committee. 
‘‘Sec. 3004. Process for adoption of endorsed recommendations. 
‘‘Sec. 3005. Application and use of adopted standards and implementation 
specifications by Federal agencies. 
‘‘Sec. 3006. Voluntary application and use of adopted standards and im-
plementation specifications by private entities. 
‘‘Sec. 3007. Health Information Technology Resource Center. 
Sec. 102. Transitions. 
PART II—APPLICATION AND USE OF ADOPTED HEALTH INFORMATION 
TECHNOLOGY STANDARDS; REPORTS 
Sec. 111. Coordination of Federal activities with adopted standards and imple-
mentation specifications. 
Sec. 112. Application to private entities. 
Sec. 113. Reports. 
Subtitle B—Incentives for the Use of Health Information Technology 
Sec. 121. Grant, loan, and demonstration programs. 
‘‘Subtitle B—Incentives for the Use of Health Information Technology 
‘‘Sec. 3011. Grants and loans to facilitate the widespread adoption of 
qualified health information technology. 
‘‘Sec. 3012. Demonstration program to integrate information technology 
into clinical education. 
TITLE II—TESTING OF HEALTH INFORMATION TECHNOLOGY 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6211
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
Sec. 201. National Institute for Standards and Technology testing. 
Sec. 202. Research and development programs. 
TITLE III—PRIVACY AND SECURITY PROVISIONS 
Sec. 300. Definitions. 
Subtitle A—Security Provisions 
Sec. 301. Application of security provisions and penalties to business associates 
of covered entities; annual guidance on security provisions. 
Sec. 302. Notification in the case of breach. 
Sec. 303. Education on Health Information Privacy and report on compliance. 
Subtitle B—Improved Privacy Provisions and Additional Security Provisions 
Sec. 311. Application of penalties to business associates of covered entities for 
violations of privacy contract requirements. 
Sec. 312. Restrictions on certain disclosures of health information; accounting 
of certain protected health information disclosures. 
Sec. 313. Conditions on certain contacts as part of health care operations. 
Sec. 314. Study on application of privacy and security requirements to vendors 
of personal health records. 
Sec. 315. Temporary breach notification requirement for vendors of personal 
health records. 
Sec. 316. Business associate contracts required for certain entities. 
Sec. 317. Guidance on implementation specification to de-identify protected 
health information. 
Sec. 318. GAO report on treatment disclosures. 
Sec. 319. Clarification of application of wrongful disclosures criminal penalties. 
Subtitle C—Relationship to Other Laws; Clarification; Effective Date 
Sec. 321. Relationship to other laws. 
Sec. 322. Effective date. 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6211
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
TITLE I—HEALTH INFORMATION 
TECHNOLOGY 
Subtitle A—Promotion of Health 
Information Technology 
PART I—IMPROVING HEALTH CARE QUALITY, 
SAFETY, AND EFFICIENCY 
SEC. 101. ONCHIT; STANDARDS DEVELOPMENT AND ADOP-
TION; HEALTH INFORMATION TECHNOLOGY 
RESOURCE CENTER. 
(a) IN GENERAL.—The Public Health Service Act 
(42 U.S.C. 201 et seq.) is amended by adding at the end 
the following: 
‘‘TITLE XXX—HEALTH INFORMA-
TION 
TECHNOLOGY 
AND 
QUALITY 
‘‘SEC. 3000. DEFINITIONS. 
‘‘In this title: 
‘‘(1) ENTERPRISE
INTEGRATION.—The term 
‘enterprise integration’ means the electronic linkage 
of health care providers, health plans, the govern-
ment, and other interested parties, to enable the 
electronic exchange and use of health information 
among all the components in the health care infra-
structure in accordance with applicable law, and 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
such term includes related application protocols and 
other related standards. 
‘‘(2) HEALTH
CARE
PROVIDER.—The term 
‘health care provider’ means a hospital, skilled nurs-
ing facility, nursing facility, home health entity, 
health care clinic, Federally qualified health center, 
group practice (as defined in section 1877(h)(4) of 
the Social Security Act), a pharmacist, a pharmacy, 
a laboratory, a physician (as defined in section 
1861(r) of the Social Security Act), a practitioner 
(as described in section 1842(b)(18)(C) of the Social 
Security Act), a provider operated by, or under con-
tract with, the Indian Health Service or by an In-
dian tribe (as defined in the Indian Self-Determina-
tion and Education Assistance Act), tribal organiza-
tion, or urban Indian organization (as defined in 
section 4 of the Indian Health Care Improvement 
Act), a rural health clinic, and any other category of 
facility or clinician determined appropriate by the 
Secretary. 
‘‘(3) HEALTH INFORMATION.—The term ‘health 
information’ has the meaning given such term in 
section 1171(4) of the Social Security Act. 
‘‘(4) HEALTH
INFORMATION
TECHNOLOGY.— 
The term ‘health information technology’ means 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
of the National Coordinator for Health Information 
Technology established under section 3001(a). 
‘‘(11) PHARMACIST.—The term ‘pharmacist’ 
has the meaning given such term in section 804(2) 
of the Federal Food, Drug, and Cosmetic Act. 
‘‘(12) STATE.—The term ‘State’ means each of 
the several States, the District of Columbia, Puerto 
Rico, the Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands. 
‘‘Subtitle A—Promotion of Health 
Information Technology 
‘‘SEC. 3001. OFFICE OF THE NATIONAL COORDINATOR FOR 
HEALTH INFORMATION TECHNOLOGY. 
‘‘(a) ESTABLISHMENT.—There is established within 
the Department of Health and Human Services an Office 
of the National Coordinator for Health Information Tech-
nology (referred to in this section as the ‘Office’). The Of-
fice shall be headed by a National Coordinator who shall 
be appointed by the Secretary and shall report directly to 
the Secretary. 
‘‘(b) PURPOSE.—The National Coordinator shall per-
form the duties under subsection (c) in a manner con-
sistent with the development of a nationwide interoperable 
health information technology infrastructure that— 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
‘‘(1) ensures that each patient’s health informa-
tion is secure and protected, in accordance with ap-
plicable law; 
‘‘(2) improves health care quality, reduces med-
ical errors, and advances the delivery of patient-cen-
tered medical care; 
‘‘(3) reduces health care costs resulting from 
inefficiency, medical errors, inappropriate care, du-
plicative care, and incomplete information; 
‘‘(4) ensures that appropriate information to 
help guide medical decisions is available at the time 
and place of care; 
‘‘(5) ensures the inclusion of meaningful public 
input in such development of such infrastructure; 
‘‘(6) improves the coordination of care and in-
formation among hospitals, laboratories, physician 
offices, and other entities through an effective infra-
structure for the secure and authorized exchange of 
health care information; 
‘‘(7) improves public health reporting and facili-
tates the early identification and rapid response to 
public health threats and emergencies, including bio-
terror events and infectious disease outbreaks; 
‘‘(8) facilitates health and clinical research and 
health care quality; 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
‘‘(9) promotes prevention of chronic diseases; 
‘‘(10) promotes a more effective marketplace, 
greater competition, greater systems analysis, in-
creased consumer choice, and improved outcomes in 
health care services; and 
‘‘(11) improves efforts to reduce health dispari-
ties. 
‘‘(c) DUTIES OF THE NATIONAL COORDINATOR.— 
‘‘(1) STANDARDS.—The National Coordinator 
shall review and determine whether to endorse each 
standard, implementation specification, and certifi-
cation criterion for the electronic exchange and use 
of health information that is recommended by the 
HIT Standards Committee under section 3003 for 
purposes of adoption under section 3004(b). The Co-
ordinator shall make such determination, and report 
to the Secretary such determination, not later than 
90 days after the date the recommendation is re-
ceived by the Coordinator. 
‘‘(2) HIT POLICY
COORDINATION.—The Na-
tional Coordinator shall coordinate health informa-
tion technology policy and programs of the Depart-
ment with those of other relevant executive branch 
agencies with a goal of avoiding duplication of ef-
forts and of helping to ensure that each agency un-
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
dertakes health information technology activities pri-
marily within the areas of its greatest expertise and 
technical capability. 
‘‘(3) STRATEGIC PLAN.— 
‘‘(A) IN GENERAL.—The National Coordi-
nator shall, in consultation with other appro-
priate Federal agencies (including the National 
Institute of Standards and Technology), main-
tain and update a strategic plan with specific 
objectives, milestones, and metrics for the fol-
lowing: 
‘‘(i) The electronic exchange and use 
of health information and the enterprise 
integration of such information. 
‘‘(ii) The utilization of an electronic 
health record for each person in the United 
States by 2014. 
‘‘(iii) The incorporation of privacy and 
security protections for the electronic ex-
change of an individual’s individually iden-
tifiable health information. 
‘‘(iv) Ensuring security methods to 
ensure appropriate authorization, elec-
tronic authentication, and encryption of 
health information. 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
‘‘(v) Specifying a framework for co-
ordination and flow of recommendations 
and policies under this subtitle among the 
Secretary, the National Coordinator, the 
HIT Policy Committee, the HIT Standards 
Committee, and other health information 
exchanges and other relevant entities. 
‘‘(vi) Methods to foster the public un-
derstanding of health information tech-
nology. 
‘‘(vii) Strategies to enhance the use of 
health information technology in improving 
the quality of health care, reducing medical 
errors, reducing health disparities, and in 
improving the continuity of care among 
health care settings. 
‘‘(B) 
COLLABORATION.—The 
strategic 
plan shall be developed and updated through 
collaboration of public and private interests. 
‘‘(C) MEASURABLE
OUTCOME
GOALS.— 
The strategic plan shall include measurable out-
come goals. 
‘‘(D) PUBLICATION.—The National Coor-
dinator shall publish the strategic plan, includ-
ing all updates. 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
‘‘(4) WEBSITE.—The National Coordinator 
shall maintain and frequently update an Internet 
website on which there is posted information that in-
cludes the following: 
‘‘(A) The schedule developed by the HIT 
Standards Committee under section 3003(b)(3). 
‘‘(B) The recommendations of the HIT 
Policy Committee under section 3002. 
‘‘(C) Recommendations of the HIT Stand-
ards Committee under section 3003. 
‘‘(D) Sources of Federal grant funds and 
technical assistance that are available to facili-
tate the purchase of, or enhance the utilization 
of, health information technology systems. 
‘‘(E) The report prepared by the National 
Coordinator under paragraph (5). 
‘‘(F) The assessment by the National Co-
ordinator under paragraph (6). 
‘‘(G) The evaluation by the National Coor-
dinator under paragraph (7). 
‘‘(H) The annual estimate of resources re-
quired under paragraph (8). 
‘‘(5) IMPLEMENTATION REPORT.—The National 
Coordinator shall prepare a report that identifies 
lessons learned from major public and private health 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
care systems in their implementation of health infor-
mation technology systems, including information on 
whether the systems and practices developed by such 
systems may be applicable to and usable in whole or 
in part by other health care providers. 
‘‘(6) ASSESSMENT OF IMPACT OF HIT ON COM-
MUNITIES
WITH
HEALTH
DISPARITIES
AND
UNIN-
SURED, UNDERINSURED, AND MEDICALLY UNDER-
SERVED AREAS.—The National Coordinator shall as-
sess and publish the impact of health information 
technology in communities with health disparities 
and in areas that serve uninsured, underinsured, 
and medically underserved individuals (including 
urban and rural areas) and identify practices to in-
crease the adoption of such technology by health 
care providers in such communities. 
‘‘(7) EVALUATION OF BENEFITS AND COSTS OF 
THE ELECTRONIC USE AND EXCHANGE OF HEALTH 
INFORMATION.—The National Coordinator shall 
evaluate and publish evidence on the benefits and 
costs of the electronic use and exchange of health in-
formation and assess to whom these benefits and 
costs accrue. 
‘‘(8) RESOURCE
REQUIREMENTS.—The Na-
tional Coordinator shall estimate and publish re-
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
sources required annually to reach the goal of utili-
zation of an electronic health record for each person 
in the United States by 2014, including the required 
level of Federal funding, expectations for regional, 
State, and private investment, and the expected con-
tributions by volunteers to activities for the utiliza-
tion of such records. 
‘‘(9) CERTIFICATION.— 
‘‘(A) IN GENERAL.—The National Coordi-
nator, in consultation with the Director of the 
National Institute of Standards and Tech-
nology, shall develop a program (either directly 
or by contract) for the voluntary certification of 
health information technology as being in com-
pliance with applicable certification criteria 
adopted under this subtitle. Such program shall 
include testing of the technology in accordance 
with section 201(b) of the PRO(TECH)T Act 
of 2008. 
‘‘(B) 
CERTIFICATION
CRITERIA
DE-
SCRIBED.—In this title, the term ‘certification 
criteria’ means, with respect to standards and 
implementation specifications for health infor-
mation technology, criteria to establish that the 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
technology meets such standards and implemen-
tation specifications. 
‘‘(d) DETAIL OF FEDERAL EMPLOYEES.— 
‘‘(1) IN GENERAL.—Upon the request of the 
National Coordinator, the head of any Federal agen-
cy is authorized to detail, with or without reimburse-
ment from the Office, any of the personnel of such 
agency to the Office to assist it in carrying out its 
duties under this section. 
‘‘(2) EFFECT OF DETAIL.—Any detail of per-
sonnel under paragraph (1) shall— 
‘‘(A) not interrupt or otherwise affect the 
civil service status or privileges of the Federal 
employee; and 
‘‘(B) be in addition to any other staff of 
the Department employed by the National Co-
ordinator. 
‘‘(3) ACCEPTANCE
OF
DETAILEES.—Notwith-
standing any other provision of law, the Office may 
accept detailed personnel from other Federal agen-
cies without regard to whether the agency described 
under paragraph (1) is reimbursed. 
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There 
are authorized to be appropriated to carry out this section 
$66,000,000 for fiscal year 2009. 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
‘‘SEC. 3002. HIT POLICY COMMITTEE. 
‘‘(a) ESTABLISHMENT.—There is established a HIT 
Policy Committee to make policy recommendations to the 
National Coordinator relating to the implementation of a 
nationwide health information technology infrastructure, 
including implementation of the strategic plan described 
in section 3001(c)(3). 
‘‘(b) DUTIES.— 
‘‘(1) RECOMMENDATIONS ON HEALTH INFOR-
MATION TECHNOLOGY INFRASTRUCTURE.—Not later 
than 1 year after the date of the enactment of this 
title, the HIT Policy Committee shall recommend a 
policy framework for the development and adoption 
of a nationwide health information technology infra-
structure that permits the electronic exchange and 
use of health information as is consistent with the 
strategic plan under section 3001(c)(3) and that in-
cludes the recommendations under paragraph (2). 
Annually thereafter the Committee shall update such 
recommendations and make new recommendations 
as appropriate. 
‘‘(2) SPECIFIC AREAS OF STANDARD DEVELOP-
MENT.— 
‘‘(A) IN GENERAL.—The HIT Policy Com-
mittee shall recommend the areas in which 
standards, implementation specifications, and 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS
certification criteria are needed for the elec-
tronic exchange and use of health information 
for purposes of adoption under section 3004(b) 
and shall recommend an order of priority for 
the development, harmonization, and recogni-
tion of such standards, specifications, and cri-
teria among the areas so recommended. Such 
standards and implementation specifications 
shall include named standards, architectures, 
and software schemes for the authentication 
and security of individually identifiable health 
information and other information as needed to 
ensure the reproducible development of common 
solutions across disparate entities. 
‘‘(B) AREAS
REQUIRED
FOR
CONSIDER-
ATION.—In making recommendations under 
subparagraph (A), the HIT Policy Committee 
shall consider at least the following areas: 
‘‘(i) Technologies that protect the pri-
vacy of health information and promote se-
curity, including for the protection from 
disclosure of specific individually identifi-
able health information, in accordance with 
applicable law, and for the use and disclo-
sure of limited data sets (as defined for 
VerDate Aug 31 2005 
00:58 Jun 26, 2008
Jkt 069200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H6357.IH
H6357
jbell on PROD1PC69 with BILLS