Database is operational, the Secretary, in consulta-
tion with the Director, shall prepare a draft report 
on effective strategies for reducing medical errors 
and increasing patient safety. The draft report shall 
include any measure determined appropriate by the 
Secretary to encourage the appropriate use of such 
strategies, including use in any federally funded pro-
grams. The Secretary shall make the draft report 
available for public comment and submit the draft 
report to the Institute of Medicine for review. 
‘‘(2) FINAL REPORT.—Not later than 1 year 
after the date described in paragraph (1), the Sec-
retary shall submit a final report to the Congress 
that includes, in an appendix, any findings by the 
Institute of Medicine concerning research on the 
strategies discussed in the draft report and any 
modifications made by the Secretary based on such 
findings. 
‘‘SEC. 923. NATIONAL PATIENT SAFETY DATABASE. 
‘‘(a) AUTHORITY.— 
‘‘(1) IN
GENERAL.—In conducting activities 
under this part, the Secretary shall provide for the 
establishment and maintenance of a database to re-
ceive relevant nonidentifiable patient safety work 
product, and may designate entities to collect rel-
evant nonidentifiable patient safety work product 
that is voluntarily reported by patient safety organi-
zations upon the request of the Secretary. Any data-
base established or designated under this paragraph 
may be referred to as a ‘National Patient Safety 
Database’. 
‘‘(2) USE OF INFORMATION.—Information re-
ported to any National Patient Safety Database 
shall be used to analyze national and regional statis-
tics, including trends and patterns of health care er-
rors. The information resulting from such analyses 
may be included in the annual quality reports pre-
pared under section 913(b)(2). 
‘‘(3) ADVISORY
ROLE.—The Secretary shall 
provide scientific support to patient safety organiza-
tions, including the dissemination of methodologies 
and evidence-based information related to root 
causes and quality improvement. 
‘‘(b) STANDARDS.—In establishing or designating a 
database under subsection (a)(1), the Secretary shall, in 
consultation with representatives of patient safety organi-
zations, the provider community, and the health informa-
tion technology industry, determine common formats for 
the voluntary reporting of nonidentifiable patient safety 
work product, including necessary elements, common and
consistent definitions, and a standardized computer inter-
face for the processing of the work product. To the extent 
practicable, such standards shall be consistent with the 
administrative simplification provisions of part C of title 
XI of the Social Security Act. 
‘‘(c) CERTAIN METHODOLOGIES FOR COLLECTION.— 
The Secretary shall ensure that the methodologies for the 
collection of nonidentifiable patient safety work product 
for any National Patient Safety Database include the 
methodologies developed or recommended by the Patient 
Safety Task Force of the Department of Health and 
Human Services. 
‘‘(d) FACILITATION OF INFORMATION EXCHANGE.— 
To the extent practicable, the Secretary may facilitate the 
direct link of information between providers and patient 
safety organizations and between patient safety organiza-
tions and any National Patient Safety Database. 
‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi-
able information may be transferred to any National Pa-
tient Safety Database. 
‘‘SEC. 924. TECHNICAL ASSISTANCE. 
‘‘(a) IN GENERAL.—The Secretary, acting through 
the Director, may—
‘‘(1) provide technical assistance to patient 
safety organizations, and to States with reporting 
systems for health care errors; and 
‘‘(2) provide guidance on the type of data to be 
voluntarily submitted to any National Patient Safety 
Database. 
‘‘(b) 
ANNUAL
MEETINGS.—Assistance 
provided 
under subsection (a) may include annual meetings for pa-
tient safety organizations to discuss methodology, commu-
nication, information collection, or privacy concerns. 
‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA-
TIONS. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of enactment of the Patient Safety and Quality 
Improvement Act, the Secretary shall establish a process 
for certifying patient safety organizations. 
‘‘(b) PROCESS.—The process established under sub-
section (a) shall include the following: 
‘‘(1) Certification of patient safety organiza-
tions by the Secretary or by such other national or 
State governmental organizations as the Secretary 
determines appropriate. 
‘‘(2) If the Secretary allows other governmental 
organizations to certify patient safety organizations 
under paragraph (1), the Secretary shall establish a
process for approving such organizations. Any such 
approved organization shall conduct certifications 
and reviews in accordance with this section. 
‘‘(3) A review of each certification under para-
graph (1) (including a review of compliance with 
each criterion in this section and any related imple-
menting standards as determined by the Secretary 
through rulemaking) not less often than every 3 
years, as determined by the Secretary. 
‘‘(4) Revocation of any such certification by the 
Secretary or other such governmental organization 
that issued the certification, upon a showing of 
cause. 
‘‘(c) CRITERIA.—A patient safety organization must 
meet the following criteria as conditions of certification: 
‘‘(1) The mission of the patient safety organiza-
tion is to conduct activities that are to improve pa-
tient safety and the quality of health care delivery 
and is not in conflict of interest with the providers 
that contract with the patient safety organization. 
‘‘(2) The patient safety organization has appro-
priately qualified staff, including licensed or certified 
medical professionals. 
‘‘(3) The patient safety organization, within any 
2 year period, contracts with more than 1 provider
for the purpose of receiving and reviewing patient 
safety work product. 
‘‘(4) The patient safety organization is not a 
component of a health insurer or other entity that 
offers a group health plan or health insurance cov-
erage. 
‘‘(5) The patient safety organization is man-
aged, controlled, and operated independently from 
any provider that contracts with the patient safety 
organization for reporting patient safety work prod-
uct. 
‘‘(6) To the extent practical and appropriate, 
the patient safety organization collects patient safety 
work product from providers in a standardized man-
ner that permits valid comparisons of similar cases 
among similar providers. 
‘‘(d) ADDITIONAL CRITERIA FOR COMPONENT ORGA-
NIZATIONS.—If a patient safety organization is a compo-
nent of another organization, the patient safety organiza-
tion must, in addition to meeting the criteria described 
in subsection (c), meet the following criteria as conditions 
of certification: 
‘‘(1) The patient safety organization maintains 
patient safety work product separately from the rest 
of the organization, and establishes appropriate se-
curity measures to maintain the confidentiality of 
the patient safety work product. 
‘‘(2) The patient safety organization does not 
make an unauthorized disclosure under this Act of 
patient safety work product to the rest of the orga-
nization in breach of confidentiality. 
‘‘(3) The mission of the patient safety organiza-
tion does not create a conflict of interest with the 
rest of the organization.’’. 
(b) AUTHORIZATION OF APPROPRIATIONS.—Section 
937 of the Public Health Service Act (as redesignated by 
subsection (a)) is amended by adding at the end the fol-
lowing: 
‘‘(e) PATIENT SAFETY
AND QUALITY IMPROVE-
MENT.—For the purpose of carrying out part C, there are 
authorized to be appropriated such sums as may be nec-
essary for each of the fiscal years 2006 through 2010.’’. 
SEC. 4. PROMOTING THE DIFFUSION AND INTEROPER-
ABILITY OF INFORMATION TECHNOLOGY SYS-
TEMS INVOLVED WITH HEALTH CARE DELIV-
ERY. 
(a) VOLUNTARY STANDARDS.— 
(1) IN GENERAL.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
retary of Health and Human Services (in this sec-
tion referred to as the ‘‘Secretary’’) shall— 
(A) develop or adopt voluntary national 
standards that promote the interoperability of 
information technology systems involved with 
health care delivery, including but not limited to 
computerized physician order entry; 
(B) in developing or adopting such stand-
ards, take into account— 
(i) the ability of such systems to cap-
ture and aggregate clinically specific data 
to enable evidence-based medicine and 
other applications that promote the elec-
tronic exchange of patient medical record 
information; and 
(ii) the cost that meeting such stand-
ards would have on providing health care 
in the United States and the increased effi-
ciencies in providing such care achieved 
under the standards; 
(C) in developing or adopting such stand-
ards and to the extent practicable, test the effi-
cacy, usability, and scalability of proposed inter-
operability standards within a variety of clinical 
settings, including an urban academic medical
center, a rural hospital, a community health 
center, and a community hospital; and 
(D) submit a report to the Congress con-
taining recommendations on such standards. 
(2) CONSULTATION.—In developing or adopting 
standards under paragraph (1)(A), the Secretary 
shall consider the recommendations of the National 
Committee on Vital Health Statistics for the stand-
ardization of message formatting, coding, and vocab-
ulary for interoperability of information technology 
systems involved with health care delivery. The Sec-
retary shall consult with representatives of the 
health information technology industry and the pro-
vider community who are involved with the develop-
ment of interoperability standards. 
(b) UPDATES.—The Secretary shall provide for the 
ongoing review and periodic updating of the standards de-
veloped under subsection (a). 
SEC. 5. REQUIRED USE OF PRODUCT IDENTIFICATION 
TECHNOLOGY. 
The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended— 
(1) in section 502, by adding at the end the fol-
lowing:
‘‘(x) If it is a drug or biological product, unless it 
includes a unique product identifier for the drug or bio-
logical product as required by regulations under section 
510(q).’’; and 
(2) in section 510, by adding at the end the fol-
lowing: 
‘‘(q)(1) The Secretary shall issue, and may periodi-
cally revise, regulations requiring the manufacturer of any 
drug or biological product that is subject to regulation by 
the Food and Drug Administration, or the packager or 
labeler of a drug or biological product that is subject to 
regulation by the Food and Drug Administration, to in-
clude a unique product identifier on the packaging of the 
drug or biological product. 
‘‘(2) For purposes of this subsection, the term 
‘unique product identifier’ means an identification that— 
‘‘(A) is affixed by the manufacturer, labeler, or 
packager to each drug or biological product de-
scribed in paragraph (1) at each packaging level; 
‘‘(B) uniquely identifies the item and meets the 
standards required by this section; and 
‘‘(C) can be read by a scanning device or other 
technology acceptable to the Secretary.
‘‘(3) A unique product identifier required by regula-
tions issued or revised under paragraph (1) shall be based 
on— 
‘‘(A) the National Drug Code maintained by 
the Food and Drug Administration; 
‘‘(B) commercially accepted standards estab-
lished by organizations that are accredited by the 
American National Standards Institute, such as the 
Health Industry Business Communication Council or 
the Uniform Code Council; or 
‘‘(C) other identification formats that the Sec-
retary deems appropriate. 
‘‘(4) The Secretary may, at the Secretary’s discre-
tion, waive the requirements of this section, or add addi-
tional provisions that are necessary to safeguard the pub-
lic health.’’. 
SEC. 6. GRANTS FOR ELECTRONIC PRESCRIPTION PRO-
GRAMS. 
(a) GRANTS.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services (in this section referred to as the 
‘‘Secretary’’) may make grants to qualified practi-
tioners for the purpose of establishing electronic pre-
scription programs. 
(2) MATCHING FUNDS.—
(A) IN
GENERAL.—With respect to the 
costs of establishing an electronic prescription 
program, a condition for the receipt of a grant 
under paragraph (1) is that the qualified practi-
tioner involved agree to make available (directly 
or through donations from public or private en-
tities) non-Federal contributions toward such 
costs in an amount that is not less than 50 per-
cent of such costs. 
(B) DETERMINATION
OF
AMOUNT
CON-
TRIBUTED.—Non-Federal 
contributions 
re-
quired in subparagraph (A) may be in cash or 
in kind, fairly evaluated, including equipment or 
services. Amounts provided by the Federal Gov-
ernment, or services assisted or subsidized to 
any significant extent by the Federal Govern-
ment, may not be included in determining the 
amount of such non-Federal contributions. 
(b) STUDY.— 
(1) 
IN
GENERAL.—The 
Secretary, 
acting 
through the Director of the Agency for Healthcare 
Research and Quality, shall support a study to as-
sess existing scientific evidence regarding the effec-
tiveness and cost-effectiveness of the use of elec-
tronic prescription programs intended to improve the