‘‘(C) CONSULTATION.—In developing and 
adopting standards, the Secretary shall consult 
with national organizations representing physi-
cians in clinical practice, hospitals, pharmacists, 
pharmacies, pharmaceutical manufacturers, pa-
tients, standard setting organizations, phar-
macy benefit managers, beneficiary information 
exchange networks, technology experts, and rep-
resentatives of the Departments of Veterans Af-
fairs and Defense and other interested parties. 
‘‘(D) ASSISTANCE TO THE SECRETARY.—
In complying with the requirements under this 
section, the Secretary shall rely on the rec-
ommendations of the National Committee on 
Vital and Health Statistics established under 
section 306(k) of the Public Health Service Act 
(42 U.S.C. 242k(k)), and shall consult with ap-
propriate Federal and State agencies and na-
tional organizations. The Secretary shall pub-
lish in the Federal Register any recommenda-
tions of the National Committee on Vital and 
Health Statistics regarding the adoption of a 
standard under this section.
‘‘(2) OBJECTIVE.—Any standards developed or 
adopted under this section shall be consistent with 
the objectives of improving—
‘‘(A) patient safety; and 
‘‘(B) the quality of care provided to pa-
tients. 
‘‘(3) REQUIREMENTS.—Any standards devel-
oped or adopted under this section shall comply with 
the following: 
‘‘(A) UNDUE
BURDEN.—The standards 
shall be designed so that, to the extent prac-
ticable, the standards do not impose an undue 
administrative or financial burden on the prac-
tice of medicine, or any other health care pro-
fession, particularly on small physician prac-
tices and practices in rural areas. 
‘‘(B) COMPATIBILITY
WITH
ADMINISTRA-
TIVE
SIMPLIFICATION
AND
PRIVACY
LAWS.—
The standards shall be—
‘‘(i) consistent with the Federal regu-
lations (concerning the privacy and secu-
rity of individually identifiable information) 
promulgated under section 264(c) of the 
Health Insurance Portability and Account-
ability Act of 1996, and any State privacy
laws preserved under the Federal regula-
tions promulgated under section 1178; and 
‘‘(ii) compatible with the standards 
under section 3. 
‘‘(b) TIMETABLE FOR ADOPTION OF STANDARDS.—
‘‘(1) IN GENERAL.—The Secretary shall adopt 
trial standards under this section two years after the 
date of the enactment of this part, or at a subse-
quent date determined by the Secretary, as may be 
required to complete development of the trial stand-
ards. 
‘‘(2) PILOT PROGRAM TO TEST TRIAL STAND-
ARDS.—
‘‘(A) PILOT
PROGRAM.—In accordance 
with the development and adoption of stand-
ards, the Secretary shall conduct a pilot pro-
gram to test the effectiveness and impact of 
trial standards for transaction and data ele-
ments as defined in subsection (a)(1)(A). 
‘‘(B) LOCATION OF PROGRAM.—The pilot 
program shall be conducted through various 
health care facilities, including small physician 
practices, throughout the country that capture 
both rural and urban settings.
‘‘(C) DURATION OF THE PROGRAM.—The 
pilot program shall be conducted during the 
two-year period beginning on the date of adop-
tion of the standards. 
‘‘(D) DESIGNATION
AND
SELECTION
OF 
PROGRAM SITES.—In designing the pilot pro-
gram and in selecting locations and sites for the 
pilot test, the Secretary shall consult with na-
tional organizations representing affected par-
ties, as defined in subsection (a)(1)(C), and ap-
propriate standard setting organizations, as de-
fined in subsection (a)(1)(B). 
‘‘(E) REPORT
OF
FINDINGS.—The Sec-
retary, consistent and accordance with sub-
sections (a)(1)(B) and (a)(1)(C), shall submit 
to Congress a report on the pilot program no 
earlier than one year following the completion 
of the pilot program. The Secretary shall in-
clude in the report the following: 
‘‘(i) The Secretary’s assessment of the 
impact and effectiveness of the trial stand-
ards, as applied to a variety of clinical and 
geographic setting as described under this 
section.
‘‘(ii) The Secretary’s assessment of 
the effect of the pilot program and trial 
standards on patient safety, including the 
effect on delivery and the quality of health 
care, and on the typical costs incurred by 
providers in acquiring necessary technology 
systems, and the necessary training to 
comply with the trial standards. 
‘‘(iii) The Secretary’s assessment of 
the clinical usefulness of health informa-
tion technologies that meet the trial stand-
ards, including the amount of time re-
quired of physicians, other health profes-
sionals and other office staff in sending, 
receiving, updating, maintaining, and re-
cording clinical information using such 
technologies. 
‘‘(iv) In consultation with appropriate 
standard setting organizations, as defined 
in subsection (a)(1)(B), and with national 
organizations representing affected parties, 
as defined in subsection (a)(1)(C), the 
findings and conclusions of the Secretary 
with respect to the pilot program and no-
tice of adoption of a modified standard.
‘‘(v) Any recommendations of the Sec-
retary for continuation of the pilot pro-
gram for further study or testing to other 
clinical or geographic service areas prior to 
full implementation. 
‘‘(3) 
ADDITIONS
AND
MODIFICATIONS
TO 
STANDARDS.—The Secretary shall, in consultation 
with appropriate representatives of interested par-
ties, as defined in subsection (a)(1)(C) of this sec-
tion, and with standard setting organizations, as de-
fined in subsection (a)(1)(B), review the standards 
developed or adopted under this section and adopt 
modifications to the standards (including additions 
to the standards), as determined appropriate. Any 
addition or modification to such standards shall be 
completed in a manner which minimizes the disrup-
tion and cost of compliance. 
‘‘(c) COMPLIANCE WITH STANDARDS.—
‘‘(1) REQUIREMENT FOR ALL INDIVIDUALS AND 
ENTITIES
THAT
UTILIZE
HEALTH
INFORMATION 
TECHNOLOGY.—
‘‘(A) IN GENERAL.—Individuals or entities 
that voluntarily utilize electronic health records, 
and other health information technology defined 
by the Secretary as being a key component of