I
107TH CONGRESS
2D SESSION
H. R. 4889
To amend title XI of the Social Security Act to improve patient safety.
IN THE HOUSE OF REPRESENTATIVES
JUNE 6, 2002
Mrs. JOHNSON of Connecticut (for herself, Mr. THOMAS, Mr. HOUGHTON, Mr.
FLETCHER, Mrs. MORELLA, Mr. HAYWORTH, Mr. WELLER, and Mr.
CAMP) introduced the following bill; which was referred to the Committee
on Ways and Means, and in addition to the Committee on Energy and
Commerce, for a period to be subsequently determined by the Speaker,
in each case for consideration of such provisions as fall within the juris-
diction of the committee concerned
A BILL
To amend title XI of the Social Security Act to improve
patient safety.
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
‘‘Patient Safety Improvement Act of 2002’’.
(b) TABLE OF CONTENTS.—The table of contents of
this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. Patient safety improvements.
‘‘PART D—PATIENT SAFETY IMPROVEMENTS
‘‘Sec. 1181. Voluntary reporting of patient safety data; definitions.
‘‘Sec. 1182. Confidentiality and peer review protections.
‘‘Sec. 1183. Reduction of medical errors using non-identifiable patient
safety data reported to patient safety organization.
‘‘Sec. 1184. Technical assistance.
‘‘Sec. 1185. Interoperability standards for health care information tech-
nology systems.
Sec. 3. Medical Information Technology Advisory Board.
SEC. 2. PATIENT SAFETY IMPROVEMENTS.
(a) IN GENERAL.—Title XI of the Social Security Act
is amended by adding at the end the following new part:
‘‘PART D—PATIENT SAFETY IMPROVEMENTS
‘‘VOLUNTARY REPORTING OF PATIENT SAFETY DATA;
DEFINITIONS
‘‘SEC. 1181. (a) VOLUNTARY REPORTING.—The re-
porting of patient safety data by health care providers
under this part is voluntary.
‘‘(b) DEFINITIONS.—In this part:
‘‘(1) PATIENT SAFETY DATA.—The term ‘pa-
tient safety data’ means—
‘‘(A) any data, reports, records, memo-
randa, analyses, deliberative work, statements,
root cause analyses, or quality improvement
processes that could result in improved patient
safety or health care quality, that are—
‘‘(i) collected or developed by a health
care provider for the purpose of reporting
to a patient safety organization;
‘‘(ii) reported to a patient safety orga-
nization for patient safety or quality im-
provement processes;
‘‘(iii) requested by a patient safety or-
ganization (including the contents of such
request);
‘‘(iv) reported to a health care pro-
vider by a patient safety organization;
‘‘(v) collected or developed by a pa-
tient safety organization; or
‘‘(vi) reported among patient safety
organizations; or
‘‘(B) information related to corrective ac-
tions taken in response to patient safety data;
for the purpose of improving patient safety, health
care quality, or health care outcomes.
‘‘(2) PATIENT SAFETY ORGANIZATION.—
‘‘(A) IN
GENERAL.—The term ‘patient
safety organization’ means a private or public
organization or component thereof that certifies
to the Secretary that it performs each of the ac-
tivities described in subparagraph (B) (which
are necessary for the proper management and
administration of such organization or compo-
nent) and meets the conflict of interest stand-
ard under subparagraph (C).
‘‘(B) ACTIVITIES DESCRIBED.—The activi-
ties referred to in subparagraph (A) are the fol-
lowing:
‘‘(i) The conduct, as its primary activ-
ity, of efforts to improve patient safety and
the quality of health care delivery by as-
sisting health care providers that report to
such organizations.
‘‘(ii) The collection and analysis of pa-
tient safety data that are voluntarily sub-
mitted by a health care provider.
‘‘(iii) The development and dissemina-
tion of information to health care providers
with respect to improving patient safety,
such as recommendations, protocols, or in-
formation regarding best practices.
‘‘(iv) The utilization of patient safety
data to carry out activities under this sub-
paragraph and for the purposes of encour-
aging a culture of safety and of providing
direct feedback and assistance to health
care providers to effectively minimize pa-
tient risk.
‘‘(v) The maintenance of confiden-
tiality with respect to individually identifi-
able health information.
‘‘(vi) The provision of appropriate se-
curity measures with respect to patient
safety data.
‘‘(C) CONFLICT
OF
INTEREST
STAND-
ARD.—The conflict of interest standard referred
to in subparagraph (A) for a patient safety or-
ganization, with respect to a health care pro-
vider, is that the organization does not use pa-
tient safety data submitted under this part to
take regulatory or enforcement actions it other-
wise performs (or is responsible for performing)
in relation to such provider.
‘‘(3) HEALTH
CARE
PROVIDER.—The term
‘health care provider’ means—
‘‘(A) a provider of services (as defined in
section 1861(u), and including a hospital,
skilled nursing facility, home health agency, and
hospice program) that provides services for
which payment may be made under part A of
title XVIII;
‘‘(B) a health care entity or individual that
furnishes medical or other health services (as
defined in section 1861(s)) or other services de-
scribed in section 1832(a)(2) for which payment
may be made under part B of such title, includ-
ing a physician (as defined in section 1861(r));
and
‘‘(C) 
a 
Medicare+Choice 
organization
under part C of such title.
‘‘CONFIDENTIALITY AND PEER REVIEW PROTECTIONS
‘‘SEC. 1182. (a) IN GENERAL.—Notwithstanding any
other provision of law, and subject to subsection (b), pa-
tient safety data shall be privileged and confidential and
shall not be—
‘‘(1) subject to a civil, criminal, or administra-
tive subpoena;
‘‘(2) subject to discovery in connection with a
civil, criminal, or administrative proceeding;
‘‘(3) disclosed 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) admitted as evidence or otherwise disclosed
in any civil, criminal, or administrative proceeding;
or
‘‘(5) utilized in an adverse employment action
or in the evaluation or decisions made in relation to
accreditation, certification, credentialing or licensing
of an individual, that is based on such individual’s
participation in the development, collection, report-
ing, or storage of patient safety data.
‘‘(b) DISCLOSURE REQUIREMENTS.—Nothing in this
section shall be construed to prohibit one or more of the
following disclosures:
‘‘(1) Disclosures by a health care provider in
complying with authorized requests for the provision
of patient safety information (such as a patient’s
medical record or other relevant information) that is
in the control of such a health care provider and
that has been developed, maintained, or exists sepa-
rately from the process by which the health care pro-
vider collects or develops information for reporting
to a patient safety organization.
‘‘(2) Disclosures by a health care provider or
patient safety organization of patient safety data as
part of a disciplinary proceeding relating to a health
care provider, or a criminal proceeding, if such a
disclosure of such patient safety data is—
‘‘(A) material to the proceeding;
‘‘(B) within the public interest; and
‘‘(C) not available from any other source.
‘‘(3) Disclosures by a health care provider or
patient safety organization of relevant information
to the Food and Drug Administration, or to a per-
son that is subject to the jurisdiction of such Admin-
istration, with respect to an Administration-regu-
lated product or activity for which that entity has
responsibility, for the purposes of activities related
to the quality, safety, or effectiveness of such Ad-
ministration-regulated product or activity.
‘‘(4) Disclosures by a health care provider or
patient safety organization of information to which
subsection (a) applies to carry out activities de-
scribed in section 1181(b)(2)(B).
‘‘(c) PENALTY.—It is unlawful for any person to dis-
close any patient safety data in violation of the provisions
of this section. Any person violating such provisions shall
be subject to the same sanctions under section 1160(c)
as a person who discloses any information described in
section 1160(a).
‘‘(d) NO LIMITATION
OF OTHER PRIVILEGES.—
Nothing in this section shall be construed to limit other
privileges that are available under Federal or State laws
that provide greater peer review or confidentiality protec-
tions than the peer review and confidentiality protections
provided for in this section.
‘‘(e) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to alter or affect the implementa-
tion of any provision of section 264(c) of the Health Insur-
ance Portability and Accountability Act of 1996 (Public
Law 104–191; 110 Stat. 2033) or any regulation promul-
gated under such section.
‘‘(f) TREATMENT OF RESIDUAL PATIENT SAFETY
DATA.—In the case of a patient safety organization which
no longer qualifies as a patient safety organization under
section 1181(b)(2) that received patient safety data from
a health care provider, the organization shall return the
data to the provider, if practicable, or destroy the data.
‘‘REDUCTION OF MEDICAL ERRORS USING AGGREGATED
NON-IDENTIFIABLE
PATIENT
SAFETY
DATA
RE-
PORTED TO PATIENT SAFETY ORGANIZATION
‘‘SEC. 1183. (a) ANALYSIS OF PATTERNS OF MED-
ICAL ERRORS.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish one or more mechanisms—
‘‘(A) to analyze aggregate non-identifiable
patient safety data (as defined in paragraph
(3))—
‘‘(i) to identify patterns of medical er-
rors; and
‘‘(ii) to disseminate to health care
providers methods that can be systemati-
cally employed; and
‘‘(B) to analyze system changes adopted by
patient safety organizations and health care
providers;
in order to reduce such errors and improve patient
safety and health care quality.
‘‘(2) PERIODIC REPORTS.—The Secretary shall
periodically report to Congress on mechanisms es-
tablished under paragraph (1) and on changes that
should be made to the provisions of this part in
order to best promote system-wide improvements in
patient safety and quality.
‘‘(3) 
NON-IDENTIFIABLE
PATIENT
SAFETY
DATA DEFINED.—For purposes of this section, the
term ‘non-identifiable patient safety data’ means pa-
tient safety data voluntarily reported to a patient
safety organization under this part that are pre-
sented in a form and manner that prevent the iden-
tification of any health care provider, patient, and
the reporter of the data.
‘‘(b) CONFIDENTIALITY.—Any patient safety data
that are used under this section shall be privileged and
confidential in the same manner as provided under section
1182 with respect to such data reported to a patient safety
organization.
‘‘TECHNICAL ASSISTANCE
‘‘SEC. 1184. The Secretary may provide technical as-
sistance to patient safety organizations in providing rec-
ommendations and advice to health care providers submit-
ting patient safety data under this part. Such assistance
shall include advice with respect to methodology, commu-
nication, data collection, security, and confidentiality con-
cerns.
‘‘INTEROPERABILITY STANDARDS FOR HEALTH CARE
INFORMATION TECHNOLOGY SYSTEMS
‘‘SEC. 1185. (a) IN GENERAL.—By not later than 2
years after the date of the enactment of this part, the Sec-
retary shall develop (and shall periodically review and up-
date) voluntary, national standards that promote the
interoperability of health care information technology sys-
tems across all health care settings.
‘‘(b) CONSULTATION.—The Secretary shall develop
and update such standards in consultation with—
‘‘(1) the National Committee for Vital and
Health Statistics,
‘‘(2) the organizations referred to in section
1172(c)(3)(B), and
‘‘(3) the Medical Information Technology Advi-
sory Board (established under section 3 of the Pa-
tient Safety Improvement Act of 2002).
‘‘(c) DISSEMINATION.—The Secretary shall provide
for the dissemination of the standards developed and up-
dated under this section.’’.
SEC. 3. MEDICAL INFORMATION TECHNOLOGY ADVISORY
BOARD.
(a) ESTABLISHMENT.—
(1) IN
GENERAL.—Not later than 3 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 appoint an
advisory board to be known as the ‘‘Medical Infor-
mation Technology Advisory Board’’ (in this section
referred to as the ‘‘MITAB’’).
(2) CHAIRMAN; VICE
CHAIRMAN.—The Sec-
retary shall designate one member as chairman and
one as vice chairman. The chairman shall be an indi-
vidual affiliated with an organization having exper-
tise creating American National Standards Institute
(ANSI) accepted standards in health care informa-
tion technology.
(b) COMPOSITION.—
(1) IN GENERAL.—The MITAB shall consist of
not more than 17 members that include—
(A) experts from the fields of medical in-
formation, information technology, medical con-
tinuous quality improvement, medical records
security and privacy, individual and institu-
tional health care clinical providers, health re-
searchers, and health care purchasers;
(B) one or more staff experts from the
Centers for Medicare & Medicaid Services;
(C) one or more staff experts from the
Agency for Healthcare Research and Quality;
(D) one or more staff experts from the In-
stitute of Medicine of the National Academy of
Sciences;
(E) representatives of private organizations
with expertise in medical infomatics;
(F) one or more staff experts of a public
health agency;
(G) a representative of a teaching hospital;
and
(H) one or more representatives of the
health care information technology industry.
(2) TERMS
OF
APPOINTMENT.—The term of
any appointment under paragraph (1) to the
MITAB shall be for the life of the MITAB.
(3) MEETINGS.—The MITAB shall meet at the
call of its chairman or a majority of its members.
(4) VACANCIES.—A vacancy on the MITAB
shall be filled in the same manner in which the origi-
nal appointment was made not later than 30 days
after the MITAB is given notice of the vacancy and
shall not affect the power of the remaining members
to execute the duties of the MITAB.
(5) COMPENSATION.—Members of the MITAB
shall receive no additional pay, allowances, or bene-
fits by reason of their service on the MITAB.
(6) EXPENSES.—Each member of the MITAB
shall receive travel expenses and per diem in lieu of
subsistence in accordance with sections 5702 and
5703 of title 5, United States Code.
(c) DUTIES.—
(1) INITIAL REPORT.—No later than 30 months
after the date of the enactment of this Act, the
MITAB shall submit to Congress and the Secretary
a report on the following:
(A) The best current practices in medical
information technology.
(B) Methods of implementing—
(i) health care information technology
interoperability standardization; and
(ii) records security