‘‘(G) The submission of nonidentifiable in-
formation to the Agency consistent with stand-
ards established by the Secretary under section 
923(b) for any National Patient Safety Data-
base. 
‘‘(5) PATIENT SAFETY WORK PRODUCT.— 
‘‘(A) The term ‘patient safety work prod-
uct’ means any document or communication 
(including any information, report, record, 
memorandum, analysis, deliberative work, state-
ment, or root cause analysis) that— 
‘‘(i) except as provided in subpara-
graph (B), is developed by a provider for 
the purpose of reporting to a patient safety 
organization, and is reported to a patient 
safety organization; 
‘‘(ii) is created by a patient safety or-
ganization; or 
‘‘(iii) would reveal the deliberations or 
analytic process of a patient safety evalua-
tion system (as defined in paragraph (3)). 
‘‘(B)(i) Patient safety work product de-
scribed in subparagraph (A)(i)— 
‘‘(I) does not include any separate in-
formation described in clause (ii); and
‘‘(II) shall not be construed to include 
such separate information merely by rea-
son of inclusion of a copy of the document 
or communication involved in a submission 
to, or the fact of submission of such a copy 
to, a patient safety organization. 
‘‘(ii) Separate information described in this 
clause is a document or communication (includ-
ing a patient’s medical record or any other pa-
tient or hospital record) that is developed or 
maintained, or exists, separately from any pa-
tient safety evaluation system. 
‘‘(C) Information available from sources 
other than a patient safety work product under 
this section may be discovered or admitted in a 
civil or administrative proceeding, if discover-
able or admissible under applicable law. 
‘‘(6) PROVIDER.—The term ‘provider’ means— 
‘‘(A) an individual or entity licensed or 
otherwise authorized under State law to provide 
health care services, including— 
‘‘(i) a hospital, nursing facility, com-
prehensive outpatient rehabilitation facil-
ity, home health agency, and hospice pro-
gram;
‘‘(ii) a physician, physician assistant, 
nurse practitioner, clinical nurse specialist, 
certified nurse midwife, nurse anesthetist, 
psychologist, certified social worker, reg-
istered dietitian or nutrition professional, 
physical or occupational therapist, or other 
individual health care practitioner; 
‘‘(iii) a pharmacist; and 
‘‘(iv) a renal dialysis facility, ambula-
tory surgical center, pharmacy, physician 
or health care practitioner’s office, long- 
term care facility, behavioral health resi-
dential treatment facility, clinical labora-
tory, or community health center; or 
‘‘(B) any other person or entity specified 
in regulations by the Secretary after public no-
tice and comment. 
‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD-
UCT. 
‘‘(a) PRIVILEGE.—Notwithstanding any other provi-
sion of law and subject to subsection (c), patient safety 
work product shall not be— 
‘‘(1) subject to a civil or administrative sub-
poena or order;
‘‘(2) subject to discovery in connection with a 
civil or administrative proceeding; 
‘‘(3) subject to disclosure pursuant to section 
552 of title 5, United States Code (commonly known 
as the Freedom of Information Act), or any other 
similar Federal or State law; 
‘‘(4) required to be admitted as evidence or oth-
erwise disclosed in any State or Federal civil or ad-
ministrative proceeding; or 
‘‘(5) if the patient safety work product is identi-
fiable information and is received by a national ac-
creditation organization in its capacity as a patient 
safety organization— 
‘‘(A) used by a national accreditation orga-
nization in an accreditation action against the 
provider that reported the information; 
‘‘(B) shared by such organization with its 
survey team; or 
‘‘(C) required as a condition of accredita-
tion by a national accreditation association. 
‘‘(b) REPORTER PROTECTION.— 
‘‘(1) IN
GENERAL.—A provider may not use 
against an individual in an adverse employment ac-
tion described in paragraph (2) the fact that the in-
dividual in good faith reported information—
‘‘(A) to the provider with the intention of 
having the information reported to a patient 
safety organization; or 
‘‘(B) directly to a patient safety organiza-
tion. 
‘‘(2) ADVERSE
EMPLOYMENT
ACTION.—For 
purposes of this subsection, an ‘adverse employment 
action’ includes— 
‘‘(A) the failure to promote an individual 
or provide any other employment-related benefit 
for which the individual would otherwise be eli-
gible; 
‘‘(B) an adverse evaluation or decision 
made in relation to accreditation, certification, 
credentialing, or licensing of the individual; and 
‘‘(C) a personnel action that is adverse to 
the individual concerned. 
‘‘(3) REMEDIES.—Any provider that violates 
this subsection shall be subject to a civil monetary 
penalty of not more than $20,000 for each such vio-
lation involved. Such penalty shall be imposed and 
collected in the same manner as civil money pen-
alties under subsection (a) of section 1128A of the 
Social Security Act are imposed and collected.
‘‘(c) DISCLOSURES.—Nothing in this section pro-
hibits any of the following disclosures: 
‘‘(1) Voluntary disclosure of nonidentifiable in-
formation. 
‘‘(2) Voluntary disclosure of identifiable infor-
mation by a provider or patient safety organization, 
if such disclosure— 
‘‘(A) is authorized by the provider for the 
purposes of improving quality and safety; 
‘‘(B) is to an entity or person subject to 
the requirements of section 264(c) of the 
Health Insurance Portability and Accountability 
Act of 1996 (Public Law 104–191; 110 Stat. 
2033), or any regulation promulgated under 
such section; and 
‘‘(C) is not in conflict with such section or 
any regulation promulgated under such section. 
‘‘(3) Disclosure as required by law by a pro-
vider to the Food and Drug Administration, or on 
a voluntary basis by a provider to a federally estab-
lished patient safety program, with respect to an Ad-
ministration-regulated product or activity for which 
that entity has responsibility, for the purposes of ac-
tivities related to the quality, safety, or effectiveness 
of such Administration-regulated product or activity.
‘‘(4) Disclosures of patient safety work product 
in accordance with this part by a provider to a pa-
tient safety organization. 
‘‘(d) EFFECT OF TRANSFER, DISCLOSURE.—The fol-
lowing shall not be treated as a waiver of any privilege 
or protection established under this part: 
‘‘(1) The transfer of any patient safety work 
product between a provider and a patient safety or-
ganization. 
‘‘(2) Disclosure of patient safety work product 
as described in subsection (c). 
‘‘(3) The unauthorized disclosure of patient 
safety work product. 
‘‘(e) PENALTY.— 
‘‘(1) PROHIBITION.—Except as provided in this 
part, and subject to paragraphs (2) and (4), it shall 
be unlawful for any person to disclose patient safety 
work product in violation of this section, if such dis-
closure constitutes a negligent or knowing breach of 
confidentiality. 
‘‘(2) RELATION TO HIPAA.—The penalty under 
paragraph (3) for a disclosure in violation of para-
graph (1) does not apply if the person would be sub-
ject to a penalty under section 264(c) of the Health 
Insurance Portability and Accountability Act of
1996 (Public Law 104–191; 110 Stat. 2033), or any 
regulation promulgated under such section, for the 
same disclosure. 
‘‘(3) AMOUNT.—Any person who violates para-
graph (1) shall be subject to a civil monetary penalty 
of not more than $10,000 for each such violation in-
volved. Such penalty shall be imposed and collected 
in the same manner as civil money penalties under 
subsection (a) of section 1128A of the Social Secu-
rity Act are imposed and collected. 
‘‘(4) SUBSEQUENT
DISCLOSURE.—Paragraph 
(1) applies only to the first person that breaches 
confidentiality with respect to particular patient 
safety work product. 
‘‘(f) RELATION TO HIPAA.— 
‘‘(1) IN GENERAL.—For purposes of applying 
the regulations promulgated pursuant to section 
264(c) of the Health Insurance Portability and Ac-
countability Act of 1996 (Public Law 104–191; 110 
Stat. 2033)— 
‘‘(A) patient safety organizations shall be 
treated as business associates; and 
‘‘(B) activities of such organizations de-
scribed in section 921(4) in relation to a pro-
vider are deemed to be health care operations 
(as defined in such regulations) of the provider. 
‘‘(2) RULE
OF
CONSTRUCTION.—Nothing in 
this section shall be construed to alter or affect the 
implementation of such regulations or such section 
264(c). 
‘‘(g) NO LIMITATION
OF OTHER PRIVILEGES.— 
Nothing in this section shall be construed to affect privi-
leges, including peer review and confidentiality protec-
tions, that are otherwise available under Federal or State 
laws. 
‘‘(h) NO LIMITATION ON CONTRACTS.—Nothing in 
this section shall be construed to limit the power of a pro-
vider and a patient safety organization, or a patient safety 
organization and the Agency or any National Patient 
Safety Database, consistent with the provisions of this Act 
and other applicable law, to enter into a contract requiring 
greater confidentiality or delegating authority to make an 
authorized disclosure. 
‘‘(i) RELATION
TO STATE REPORTING REQUIRE-
MENTS.—Nothing in this part shall be construed as pre-
empting or otherwise affecting any State law requiring a 
provider to report information, including information de-
scribed in section 921(5)(B), that is not patient safety 
work product.
‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 
work product of an organization that is certified as a pa-
tient safety organization shall continue to be privileged 
and confidential, in accordance with this section, if the or-
ganization’s certification is terminated or revoked or if the 
organization otherwise ceases to qualify as a patient safety 
organization. 
‘‘(k) REPORTS
ON STRATEGIES
TO IMPROVE PA-
TIENT SAFETY.— 
‘‘(1) DRAFT REPORT.—Not later than the date 
that is 18 months after any National Patient Safety 
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