456
Title VI, Subtitle C
(iv) the ruling was based on an error
of law;
(B) the party contesting the ruling made
under the alternative dispute resolution system
presents new evidence before the trier of fact
that was not available for presentation under
the ADR system;
(C) the medical malpractice liability action
raised a novel issue of law; or
(D) the court finds that the application of
such paragraph to a party would constitute an
undue hardship, and issues an order waiving or
modifying the application of such paragraph
that specifies the grounds for the court’s deci-
sion.
(3) LIMIT ON ATTORNEYS’ FEES PAID.—Attor-
neys’ fees that are required to be paid under para-
graph (1) by the contesting party shall not exceed
the amount of the attorneys’ fees incurred by the
contesting party in the action. If the attorneys’ fees
of the contesting party are based on a contingency
fee agreement, the amount of attorneys’ fees for
purposes of the preceding sentence shall not exceed
the reasonable value of those services.
457
Title VI, Subtitle C
(4) RECORDS.—In order to receive attorneys’
fees under paragraph (1), counsel of record in the
medical malpractice liability action involved shall
maintain accurate, complete records of hours worked
on the action, regardless of the fee arrangement
with the client involved.
(b) CONTINGENCY FEE DEFINED.—As used in this
section, the term ‘‘contingency fee’’ means any fee for pro-
fessional legal services which is, in whole or in part, con-
tingent upon the recovery of any amount of damages,
whether through judgment or settlement.
SEC. 6207. UNIFORM STATUTE OF LIMITATIONS.
(a) IN GENERAL.—Except as provided in subsection
(b), no medical malpractice claim may be initiated after
the expiration of the 2-year period that begins on the date
on which the alleged injury that is the subject of such
claim was discovered, but in no event may such a claim
be initiated after the expiration of the 4-year period that
begins on the date on which the alleged injury that is the
subject of such claim occurred.
(b) EXCEPTION FOR MINORS.—In the case of an al-
leged injury suffered by a minor who has not attained 6
years of age, a medical malpractice claim may not be initi-
ated after the expiration of the 2-year period that begins
on the date on which the alleged injury that is the subject
458
Title VI, Subtitle C
of such claim was discovered or should reasonably have
been discovered, but in no event may such a claim be initi-
ated after the date on which the minor attains 12 years
of age.
SEC. 6208. SPECIAL PROVISION FOR CERTAIN OBSTETRIC
SERVICES.
(a) IN GENERAL.—In the case of a medical mal-
practice claim relating to services provided during labor
or the delivery of a baby, if the health care professional
or health care provider against whom the claim is brought
did not previously treat the claimant for the pregnancy,
the trier of fact may not find that such professional or
provider committed malpractice and may not assess dam-
ages against such professional or provider unless the mal-
practice is proven by clear and convincing evidence.
(b) APPLICABILITY
TO
GROUP
PRACTICES
OR
AGREEMENTS AMONG PROVIDERS.—For purposes of sub-
section (a), a health care professional shall be considered
to have previously treated an individual for a pregnancy
if the professional is a member of a group practice whose
members previously treated the individual for the preg-
nancy or is providing services to the individual during
labor or the delivery of a baby pursuant to an agreement
with another professional.
459
Title VI, Subtitle C
SEC. 6209. JURISDICTION OF FEDERAL COURTS.
Nothing in this part shall be construed to establish
any jurisdiction over any medical malpractice liability ac-
tion in the district courts of the United States on the basis
of sections 1331 or 1337 of title 28, United States Code.
SEC. 6210. PREEMPTION.
(a) IN GENERAL.—The provisions of this part shall
preempt any State law to the extent such law is inconsist-
ent with such provisions, except that the provisions of this
part shall not preempt any State law that provides for de-
fenses or places limitations on a person’s liability in addi-
tion to those contained in this part, places greater limita-
tions on the amount of attorneys’ fees that can be col-
lected, or otherwise imposes greater restrictions than those
provided in this part.
(b) EFFECT ON SOVEREIGN IMMUNITY AND CHOICE
OF LAW OR VENUE.—Nothing in this part shall be con-
strued to—
(1) waive or affect any defense of sovereign im-
munity asserted by any State under any provision of
law;
(2) waive or affect any defense of sovereign im-
munity asserted by the United States;
(3) affect the applicability of any provision of
the Foreign Sovereign Immunities Act of 1976;
460
Title VI, Subtitle C
(4) preempt State choice-of-law rules with re-
spect to claims brought by a foreign nation or a citi-
zen of a foreign nation; or
(5) affect the right of any court to transfer
venue or to apply the law of a foreign nation or to
dismiss a claim of a foreign nation or of a citizen
of a foreign nation on the ground in inconvenient
forum.
PART 2—REQUIREMENTS FOR STATE ALTER-
NATIVE 
DISPUTE 
RESOLUTION 
SYSTEMS
(ADR)
SEC. 6221. BASIC REQUIREMENTS.
(a) IN GENERAL.—A State’s alternative dispute reso-
lution system meets the requirements of this section if the
system—
(1) applies to all medical malpractice liability
claims under the jurisdiction of the courts of that
State;
(2) requires that a written opinion resolving the
dispute be issued not later than 6 months after the
date by which each party against whom the claim is
filed has received notice of the claim (other than in
exceptional cases for which a longer period is re-
quired for the issuance of such an opinion), and that
the opinion contain—
461
Title VI, Subtitle C
(A) findings of fact relating to the dispute,
and
(B) a description of the costs incurred in
resolving the dispute under the system (includ-
ing any fees paid to the individuals hearing and
resolving the claim), together with an appro-
priate assessment of the costs against any of
the parties;
(3) requires individuals who hear and resolve
claims under the system to meet such qualifications
as the State may require (in accordance with regula-
tions of the Secretary);
(4) is approved by the State or by local govern-
ments in the State;
(5) with respect to a State system that consists
of multiple dispute resolution procedures—
(A) permits the parties to a dispute to se-
lect the procedure to be used for the resolution
of the dispute under the system, and
(B) if the parties do not agree on the pro-
cedure to be used for the resolution of the dis-
pute, assigns a particular procedure to the
parties;
(6) provides for the transmittal to the State
agency responsible for monitoring or disciplining
462
Title VI, Subtitle C
health care professionals and health care providers
of any findings made under the system that such a
professional or provider committed malpractice, un-
less, during the 90-day period beginning on the date
the system resolves the claim against the profes-
sional or provider, the professional or provider
brings an action contesting the decision made under
the system; and
(7) provides for the regular transmittal to the
Administrator for Health Care Policy and Research
of information on disputes resolved under the sys-
tem, in a manner that assures that the identity of
the parties to a dispute shall not be revealed.
(b) APPLICATION
OF
MALPRACTICE
LIABILITY
STANDARDS TO ALTERNATIVE DISPUTE RESOLUTION.—
The provisions of part 1 (other than section 6202) shall
apply with respect to claims brought under a State alter-
native dispute resolution system or the alternative Federal
system in the same manner as such provisions apply with
respect to medical malpractice liability actions brought in
the State.
SEC. 6222. CERTIFICATION OF STATE SYSTEMS; APPLICA-
BILITY OF ALTERNATIVE FEDERAL SYSTEM.
(a) CERTIFICATION.—
463
Title VI, Subtitle C
(1) IN GENERAL.—Not later than October 1 of
each year (beginning with 1995), the Secretary, in
consultation with the Attorney General, shall deter-
mine whether a State’s alternative dispute resolution
system meets the requirements of this part for the
following calendar year.
(2) BASIS FOR CERTIFICATION.—The Secretary
shall certify a State’s alternative dispute resolution
system under this subsection for a calendar year if
the Secretary determines under paragraph (1) that
the system meets the requirements of section 6221,
including the requirement described in section 6204
that punitive damages awarded under the system are
paid to the State for the uses described in such
section.
(b) APPLICABILITY
OF
ALTERNATIVE
FEDERAL
SYSTEM.—
(1) ESTABLISHMENT
AND
APPLICABILITY.—
Not later than October 1, 1995, the Secretary, in
consultation with the Attorney General, shall estab-
lish by rule an alternative Federal ADR system for
the resolution of medical malpractice liability claims
during a calendar year in States that do not have
in effect an alternative dispute resolution system
certified under subsection (a) for the year.
464
Title VI, Subtitle C
(2) REQUIREMENTS FOR SYSTEM.—Under the
alternative Federal ADR system established under
paragraph (1)—
(A) paragraphs (1), (2), (6), and (7) of
section 6221(a) shall apply to claims brought
under the system;
(B) if the system provides for the resolu-
tion of claims through arbitration, the claims
brought under the system shall be heard and
resolved by arbitrators appointed by the Sec-
retary in consultation with the Attorney Gen-
eral; and
(C) with respect to a State in which the
system is in effect, the Secretary may (at the
State’s request) modify the system to take into
account the existence of dispute resolution pro-
cedures in the State that affect the resolution
of medical malpractice liability claims.
(3) TREATMENT
OF
STATES
WITH
ALTER-
NATIVE SYSTEM IN EFFECT.—If the alternative Fed-
eral ADR system established under this subsection is
applied with respect to a State for a calendar year,
the State shall make a payment to the United States
(at such time and in such manner as the Secretary
may require) in an amount equal to 110 percent of
465
Title VI, Subtitle C
the costs incurred by the United States during the
year as a result of the application of the system with
respect to the State.
SEC. 6223. REPORTS ON IMPLEMENTATION AND EFFEC-
TIVENESS OF ALTERNATIVE DISPUTE RESO-
LUTION SYSTEMS.
(a) IN GENERAL.—Not later than 5 years after the
date of the enactment of this Act, the Secretary shall pre-
pare and submit to the Congress a report describing and
evaluating State alternative dispute resolution systems op-
erated pursuant to this part and the alternative Federal
system established under section 6222(b).
(b) CONTENTS OF REPORT.—The Secretary shall in-
clude in the report prepared and submitted under sub-
section (a)—
(1) information on—
(A) the effect of the alternative dispute
resolution systems on the cost of health care
within each State,
(B) the impact of such systems on the ac-
cess of individuals to health care within the
State, and
(C) the effect of such systems on the qual-
ity of health care provided within the State; and
466
Title VI, Subtitle C
(2) to the extent that such report does not pro-
vide information on no-fault systems operated by
States as alternative dispute resolution systems pur-
suant to this part, an analysis of the feasibility and
desirability of establishing a system under which
medical malpractice liability claims shall be resolved
on a no-fault basis.
PART 3—DEFINITIONS
SEC. 6231. DEFINITIONS.
As used in this subtitle:
(1) ALTERNATIVE DISPUTE RESOLUTION SYS-
TEM.—The term ‘‘alternative dispute resolution sys-
tem’’ means a system that is enacted or adopted by
a State to resolve medical malpractice claims other
than through a medical malpractice liability action.
(2) CLAIMANT.—The term ‘‘claimant’’ means
any person who brings a health care liability action
and, in the case of an individual who is deceased, in-
competent, or a minor, the person on whose behalf
such an action is brought.
(3) CLEAR AND CONVINCING EVIDENCE.—The
term ‘‘clear and convincing evidence’’ is that meas-
ure or degree of proof that will produce in the mind
of the trier of fact a firm belief or conviction as to
the truth of the allegations sought to be established,
467
Title VI, Subtitle C
except that such measure or degree of proof is more
than that required under preponderance of the evi-
dence, but less than that required for proof beyond
a reasonable doubt.
(4) ECONOMIC DAMAGES.—The term ‘‘economic
damages’’ means damages paid to compensate an in-
dividual for losses for hospital and other medical ex-
penses, lost wages, lost employment, and other pecu-
niary losses.
(5) HEALTH CARE PROFESSIONAL.—The term
‘‘health care professional’’ means any individual who
provides health care services in a State and who is
required by State law or regulation to be licensed or
certified by the State to provide such services in the
State.
(6) HEALTH
CARE
PROVIDER.—The term
‘‘health care provider’’ means any organization or
institution that is engaged in the delivery of health
care services in a State that is required by State law
or regulation to be licensed or certified by the State
to engage in the delivery of such services in the
State.
(7) INJURY.—The term ‘‘injury’’ means any ill-
ness, disease, or other harm that is the subject of
a medical malpractice claim.
468
Title VI, Subtitle C
(8) MEDICAL
MALPRACTICE
LIABILITY
AC-
TION.—The term ‘‘medical malpractice liability ac-
tion’’ means any civil action brought pursuant to
State law in which a plaintiff alleges a medical mal-
practice claim against a health care provider or
health care professional, but does not include any
action in which the plaintiff’s sole allegation is an al-
legation of an intentional tort.
(9) MEDICAL MALPRACTICE CLAIM.—The term
‘‘medical malpractice claim’’ means any claim relat-
ing to the provision of (or the failure to provide)
health care services or the use of a medical product,
without regard to the theory of liability asserted,
and includes any third-party claim, cross-claim,
counterclaim, or contribution claim in a medical
malpractice liability action.
(10) MEDICAL PRODUCT.—
(A) IN
GENERAL.—The term ‘‘medical
product’’ means, with respect to the allegation
of a claimant, a drug (as defined in section
201(g)(1) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 321(g)(1)) or a medical
device (as defined in section 201(h) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C.
321(h)) if—
469
Title VI, Subtitle C
(i) such drug or device was subject to
premarket approval under section 505,
507, or 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355, 357, or
360e) or section 351 of the Public Health
Service Act (42 U.S.C. 262) with respect
to the safety of the formulation or per-
formance of the aspect of such drug or de-
vice which is the subject of the claimant’s
allegation or the adequacy of the packag-
ing or labeling of such drug or device, and
such drug or device is approved by the
Food and Drug Administration; or
(ii) the drug or device is generally rec-
ognized as safe and effective under regula-
tions issued by the Secretary of Health
and Human Services under section 201(p)
of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(p)).
(B) EXCEPTION
IN
CASE
OF
MISREPRE-
SENTATION OR FRAUD.—Notwithstanding sub-
paragraph (A), the term ‘‘medical product’’
shall not include any product described in such
subparagraph if the claimant shows that the
product is approved by the Food and Drug Ad-
470
Title VI, Subtitle D
ministration for marketing as a result of with-
held information, misrepresentation, or an ille-
gal payment by manufacturer of the product.
(11) 
NONECONOMIC
DAMAGES.—The 
term
‘‘noneconomic damages’’ means damages paid to
compensate an individual for losses for physical and
emotional pain, suffering, inconvenience, physical
impairment, mental anguish, disfigurement, loss of
enjoyment of life, loss of consortium, and other
nonpecuniary losses, but does not include punitive
damages.
(12) PUNITIVE DAMAGES.—The term ‘‘punitive
damages’’ means compensation, in addition to com-
pensation for actual harm suffered, that is awarded
for the purpose of punishing a person for conduct
deemed to be malicious, wanton, willful, or exces-
sively reckless.
Subtitle D—Administrative
Simplification
SEC. 6300. PURPOSE.
It is the purpose of this subtitle to improve the effi-
ciency and effectiveness of the health care system, includ-
ing the medicare program under title XVIII of the Social
Security Act and the medicaid program under title XIX
of such Act, by encouraging the development of a health
471
Title VI, Subtitle D
information network through the adoption of standards
and the establishment of requirements for the electronic
transmission of certain health information.
SEC. 6301. DEFINITIONS.
For purposes of this subtitle:
(1) CODE SET.—The term ‘‘code set’’ means
any set of codes used for encoding data elements,
such as tables of terms, medical concepts, medical
diagnostic codes, or medical procedure codes.
(2) COORDINATION OF BENEFITS.—The term
‘‘coordination of benefits’’ means determining and
coordinating the financial obligations of plan spon-
sors when health care benefits are payable by more
than one such sponsor.
(3) HEALTH INFORMATION.—The term ‘‘health
information’’ means any information that relates to
the past, present, or future physical or mental health
or condition or functional status of an individual,
the provision of health care to an individual, or pay-
ment for the provision of health care to an individ-
ual.
(4) HEALTH
INFORMATION
NETWORK.—The
term ‘‘health information network’’ means the health
information system that is formed through the appli-
472
Title VI, Subtitle D
cation of the requirements and standards established
under this subtitle.
(5) HEALTH
INFORMATION
NETWORK
SERV-
ICE.—The term ‘‘health information network serv-
ice’’—
(A) means a private entity or an entity op-
erated by a State that enters into contracts—
(i) to process or facilitate the process-
ing of nonstandard data elements of health
information into standard data elements;
(ii) to provide the means by which
persons are connected to the health infor-
mation network for purposes of meeting
the requirements of this subtitle, including
the holding of standard data elements of
health information;
(iii) to provide authorized access to
health information through the health in-
formation network; or
(iv) to provide specific information
processing services, such as automated co-
ordination of benefits and claims trans-
action routing; and
(B) includes a health information security
organization.
473
Title VI, Subtitle D
(6) HEALTH INFORMATION SECURITY ORGANI-
ZATION.—The term ‘‘health information security or-
ganization’’ means a private entity or an entity oper-
ated by a State that accesses standard data elements
of health information through the health information
network, processes such information into non-identi-
fiable health information, and may store such infor-
mation.
(7) HEALTH
PROVIDER.—The term ‘‘health
provider’’ includes a provider of services (as defined
in section 1861(u) of the Social Security Act), a pro-
vider of medical or other health services (as defined
in section 1861(s) of such Act), and any other per-
son (other than a plan sponsor) furnishing health
care items or services.
(8) NON-IDENTIFIABLE
HEALTH
INFORMA-
TION.—The term ‘‘non-identifiable health informa-
tion’’ means health information that is not protected
health information (as defined in subtitle E).
(9) PLAN SPONSOR.—The term ‘‘plan sponsor’’
means—
(A) a carrier (as defined in section
1903(2)) providing health insurance coverage
(as defined in section 1903(7));
(B) a group health plan;
474
Title VI, Subtitle D
(C) an association or other entity which es-
tablishes or maintains a multiple employer wel-
fare 
arrangement 
(as 
defined 
in 
section
1903(12)) providing benefits consisting of medi-
cal care described in section 607(1) of the Em-
ployee Retirement Income Security Act of 1974;
and
(D) a State, or the Federal Government,
acting in a capacity as a provider of health ben-
efits to eligible individuals that is equivalent to
that of a carrier.
(10) STANDARD.—The term ‘‘standard’’, when
used with reference to a transaction or to data ele-
ments of health information, means that the trans-
action or data elements meet any standard adopted
by the Secretary under part 1 that applies to the
transaction or data elements.
PART 1—STANDARDS FOR DATA ELEMENTS AND
TRANSACTIONS
SEC. 6311. GENERAL REQUIREMENTS ON SECRETARY.
(a) IN GENERAL.—The Secretary shall adopt stand-
ards and modifications to standards under this part that
are—
(1) consistent with the objective of reducing the
costs of providing and paying for health care; and
475
Title VI, Subtitle D
(2) in use and generally accepted, developed, or
modified by the standard-setting organizations ac-
credited by the American National Standard Insti-
tute.
(b) INITIAL STANDARDS.—The Secretary may de-
velop an expedited process for the adoption of initial
standards under this part.
(c) PROTECTION OF COMMERCIAL INFORMATION.—
In adopting standards under this part, the Secretary may
not require disclosure of trade secrets and confidential
commercial information by any person.
SEC. 6312. STANDARDS FOR DATA ELEMENTS OF HEALTH
INFORMATION.
(a) IN GENERAL.—The Secretary shall adopt stand-
ards necessary to make uniform and compatible for elec-
tronic transmission through the health information net-
work the data elements of any health information that the
Secretary determines is appropriate for transmission in
connection with a transaction described in section 6321.
(b) ADDITIONS.—The Secretary may make additions
to any set of data elements adopted under subsection (a)
as the Secretary determines appropriate in a manner that
minimizes the disruption and cost of compliance with such
additions.
(c) CERTAIN DATA ELEMENTS.—
476
Title VI, Subtitle D
(1) UNIQUE HEALTH IDENTIFIERS.—The Sec-
retary shall establish a system to provide for a
standard unique health identifier for each individual,
employer, plan sponsor, and health provider for use
in the health care system.
(2) CODE SETS.—
(A) IN GENERAL.—The Secretary, in con-
sultation with experts from the private sector
and Federal agencies, shall—
(i) select code sets for appropriate
data elements from among the code sets
that have been developed by private and
public entities; or
(ii) establish code sets for such data
elements if no code sets for the data ele-
ments have been developed.
(B) DISTRIBUTION.—The Secretary shall
establish efficient and low-cost procedures for
distribution of code sets and modifications to
code sets.
SEC. 6313. INFORMATION TRANSACTION STANDARDS.
(a) IN GENERAL.—The Secretary shall adopt tech-
nical standards that are consistent with subtitle E relating
to the method by which standard data elements of health
information may be transmitted electronically, including
477
Title VI, Subtitle D
standards with respect to the format in which such data
elements may be transmitted.
(b) SPECIAL RULE FOR COORDINATION OF BENE-
FITS.—Any standard adopted by the Secretary under
paragraph (1) that relates to coordination of benefits shall
provide that a claim for reimbursement for health services
furnished shall be tested, by an algorithm specified by the
Secretary, against all records of enrollment and eligibility
for the individual who received such services that are avail-
able to the recipient of the claim through the health infor-
mation network to determine any primary and secondary
obligors for payment.
(c) ELECTRONIC SIGNATURE.—The Secretary, in co-
ordination with the Secretary of Commerce, shall promul-
gate regulations specifying procedures for the electronic
transmission and authentication of signatures, compliance
with which shall be deemed to satisfy State and Federal
statutory requirements for written signatures with respect
to transactions described in section 6321 and written sig-
natures on health records and prescriptions.
(d) STANDARDS FOR CLAIMS FOR CLINICAL LABORA-
TORY TESTS.—The standards under this section shall pro-
vide that claims for clinical laboratory tests for which ben-
efits are payable by a plan sponsor shall be submitted di-
rectly by the person or entity that performed (or super-
478
Title VI, Subtitle D
vised the performance of) the tests to the sponsor in a
manner consistent with (and subject to such exceptions
as are provided under) the requirement for direct submis-
sion of such claims under the medicare program.
SEC. 6314. TIMETABLES FOR ADOPTION OF STANDARDS.
(a) INITIAL STANDARDS FOR DATA ELEMENTS.—
The Secretary shall adopt standards relating to—
(1) the data elements for the information de-
scribed in section 6312(a) not later than 9 months
after the date of the enactment of this Act (except
in the case of standards with respect to data ele-
ments for claims attachments, which shall be adopt-
ed not later than 24 months after the date of the
enactment of this Act); and
(2) any addition to a set of data elements, in
conjunction with making such an addition.
(b) INITIAL STANDARDS FOR INFORMATION TRANS-
ACTIONS.—The Secretary shall adopt standards relating
to information transactions under section 6313 not later
than 9 months after the date of the enactment of this Act
(except in the case of standards for claims attachments,
which shall be adopted not later than 24 months after the
date of the enactment of this Act).
(c) MODIFICATIONS TO STANDARDS.—
479
Title VI, Subtitle D
(1) IN GENERAL.—Except as provided in para-
graph (2), the Secretary shall review the standards
adopted under this part and shall adopt modified
standards as determined appropriate, but not more
frequently than once every 6 months. Any modifica-
tion to standards shall be completed in a manner
which minimizes the disruption to, and costs of com-
pliance incurred by, a plan sponsor, health provider,
or health plan purchasing organization that is re-
quired to comply with part 2.
(2) SPECIAL RULES.—
(A) MODIFICATIONS
DURING
FIRST
12-
MONTH PERIOD.—Except with respect to addi-
tions and modifications to code sets under sub-
paragraph (B), the Secretary may not adopt
any modification to a standard adopted under
this part during the 12-month period beginning
on the date the standard is adopted, unless the
Secretary determines that the modification is
necessary in order to permit a plan sponsor, a
health provider, or a health plan purchasing or-
ganization to comply with part 2.
(B) ADDITIONS
AND
MODIFICATIONS
TO
CODE SETS.—
480
Title VI, Subtitle D
(i) IN GENERAL.—The Secretary shall
ensure that procedures exist for the rou-
tine maintenance, testing, enhancement,
and expansion of code sets.
(ii) ADDITIONAL
RULES.—If a code
set is modified under this subsection, the
modified code set shall include instructions
on how data elements that were encoded
prior to the modification are to be con-
verted or translated so as to preserve the
value of the data elements. Any modifica-
tion to a code set under this subsection
shall be implemented in a manner that
minimizes the disruption to, and costs of
compliance incurred by, a plan sponsor,
health provider, or health plan purchasing
organization that is required to comply
with part 2.
(d) EVALUATION
OF STANDARDS.—The Secretary
may establish a process to measure or verify the consist-
ency of standards adopted or modified under this part.
Such process may include demonstration projects and
analyses of the cost of implementing such standards and
modifications.
481
Title VI, Subtitle D
PART 2—REQUIREMENTS WITH RESPECT TO
CERTAIN TRANSACTIONS AND INFORMATION
SEC. 6321. STANDARD TRANSACTIONS AND INFORMATION.
(a) TRANSACTIONS BY SPONSORS.—
(1) TRANSACTIONS
WITH
PROVIDERS.—If a
plan sponsor conducts any of the transactions de-
scribed in paragraph (3) with a health provider—
(A) the transaction shall be a standard
transaction; and
(B) the health information transmitted by
the sponsor to the provider or by the provider
to the sponsor in connection with the trans-
action shall be in the form of standard data ele-
ments.
(2) TRANSACTIONS WITH SPONSORS.—If a plan
sponsor conducts any of the transactions described
in paragraph (3) with another plan sponsor—
(A) the transaction shall be a standard
transaction; and
(B) the health information transmitted by
either sponsor in connection with the trans-
action shall be in the form of standard data ele-
ments.
(3) TRANSACTIONS.—The transactions referred
to in paragraphs (1) and (2) are the following:
(A) Verification of eligibility for benefits.
482
Title VI, Subtitle D
(B) Coordination of benefits.
(C) Claim submission.
(D) Claim attachment submission.
(E) Claim status notification.
(F) Claim status verification.
(G) Claim adjudication.
(H) Payment and remittance advice.
(I) Certification or authorization of a re-
ferral to a health provider who is not part of a
provider network.
(b) TRANSACTIONS
BY
PURCHASING
ORGANIZA-
TIONS.—
(1) IN GENERAL.—If a health plan purchasing
organization conducts any of the transactions de-
scribed in paragraph (2) with a plan sponsor—
(A) the transaction shall be a standard
transaction; and
(B) the health information transmitted by
the organization to the sponsor or by the spon-
sor to the organization in connection with the
transaction shall be in the form of standard
data elements.
(2) TRANSACTIONS.—The transactions referred
to in paragraph (1) are the following:
(A) Enrollment and disenrollment.
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Title VI, Subtitle D
(B) Premium payment.
(c) USE OF HEALTH INFORMATION NETWORK SERV-
ICES.—A plan sponsor, a health provider, or a health plan
purchasing organization may comply with any provision
of this section by entering into an agreement or other ar-
rangement with a health information network service cer-
tified under section 6331 pursuant to which the service
undertakes the duties applicable to the sponsor, provider,
or organization under the provision.
SEC. 6322. ACCESSING HEALTH INFORMATION FOR AU-
THORIZED PURPOSES.
(a) PROCUREMENT RULE FOR GOVERNMENT AGEN-
CIES.—
(1) IN GENERAL.—A health information secu-
rity organization that is certified under section 6331
shall make available to a Federal or State agency,
pursuant to a cost-type contract (as defined under
the Federal Acquisition Regulation), any non-identi-
fiable health information, including non-identifiable
health information that is derived from protected
health information, that—
(A) is held by the service or may be ob-
tained by the service under paragraph (2) or
subsection (b);
484
Title VI, Subtitle D
(B) consists of data elements that are sub-
ject to a standard under part 1; and
(C) is requested by the agency to fulfill a
requirement under this Act.
(2) CERTAIN INFORMATION AVAILABLE AT LOW
COST.—If a health information security organization
requires health information consisting of data ele-
ments that are subject to a standard under part 1
from a plan sponsor or a health provider in order to
comply with a request made by a Federal or State
agency under paragraph (1), the sponsor or provider
shall make such information available to such orga-
nization for a charge that does not exceed the rea-
sonable cost of transmitting the information.
(b) PROCUREMENT RULE FOR INFORMATION SECU-
RITY ORGANIZATIONS.—A health information security or-
ganization that makes non-identifiable health information
available to a Federal or State agency under subsection
(a) shall make such non-identifiable information available,
for a charge that does not exceed the reasonable cost of
transmitting the information, to any other health informa-
tion security organization that—
(A) is certified under section 6331; and
(B) requests the information.
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Title VI, Subtitle D
SEC. 6323. ENSURING AVAILABILITY OF INFORMATION.
The Secretary shall establish a procedure under
which a plan sponsor or health provider that does not have
the ability to transmit standard data elements directly,
and does not have access to a health information network
service certified under section 6331, may comply with the
provisions of this part.
SEC. 6324. TIMETABLES FOR COMPLIANCE WITH REQUIRE-
MENTS.
(a) INITIAL COMPLIANCE.—
(1) IN GENERAL.—Not later than 12 months
after the date on which standards are adopted under
part 1 with respect to a type of transaction, or data
elements for a type of health information, a plan
sponsor, health provider, or health plan purchasing
organization shall comply with the requirements of
this part with respect to such transaction or infor-
mation.
(2) ADDITIONAL DATA ELEMENTS.—Not later
than 12 months after the date on which the Sec-
retary adopts an addition to a set of data elements
for health information under section 6312, a plan
sponsor, health provider, or health plan purchasing
organization shall comply with the requirements of
this part using such data elements.
(b) COMPLIANCE WITH MODIFIED STANDARDS.—
486
Title VI, Subtitle D
(1) IN GENERAL.—If the Secretary adopts a
modified standard under section 6314(c), a plan
sponsor, health provider, or health plan purchasing
organization shall comply with the modified standard
at such time as the Secretary determines appro-
priate, taking into account the time needed to com-
ply due to the nature and extent of the modification.
(2) SPECIAL RULE.—In the case of a modifica-
tion to a standard that does not occur within the 12-
month period beginning on the date the standard is
adopted, the time determined appropriate by the
Secretary under paragraph (1) may not be—
(A) earlier than the last day of the 90-day
period beginning on the date the modified
standard is adopted; or
(B) later than the last day of the 12-
month period beginning on the date the modi-
fied standard is adopted.
PART 3—MISCELLANEOUS PROVISIONS
SEC. 6331. STANDARDS AND CERTIFICATION FOR HEALTH
INFORMATION NETWORK SERVICES.
(a) STANDARDS
FOR OPERATION.—The Secretary
shall establish standards with respect to the operation of
health information network services, including standards
ensuring that such services—
487
Title VI, Subtitle D
(1) develop, operate, and cooperate with one an-
other to form the health information network;
(2) meet all of the requirements under subtitle
E that are applicable to the services;
(3) make public information concerning their
performance, as measured by uniform indicators
such as accessibility, transaction responsiveness, ad-
ministrative efficiency, reliability, dependability, and
any other indicator determined appropriate by the
Secretary;
(4) have security procedures that are consistent
with the requirements under subtitle E, including se-
cure methods of accessing and transmitting data;
and
(5) if they are part of a larger organization,
have policies and procedures in place which isolate
their activities with respect to processing informa-
tion in a manner that prevents access to such infor-
mation by such larger organization.
(b) CERTIFICATION BY THE SECRETARY.—
(1) ESTABLISHMENT.—Not later than 12
months after the date of the enactment of this Act,
the Secretary shall establish a certification proce-
dure for health information network services which
ensures that certified services are qualified to meet
491
Title VI, Subtitle D
(2) an inquiry with respect to the transaction.
(c) EXCEPTION.—Subsections (a) and (b) do not
apply if—
(1) an individual or entity voluntarily agrees to
provide the additional data element; or
(2) a waiver is granted under subsection (d) to
permit the requirement to be imposed.
(d) CONDITIONS FOR WAIVERS.—
(1) IN GENERAL.—An individual or entity may
request a waiver from the Secretary in order to im-
pose on an individual or entity a requirement other-
wise prohibited under subsection (a) or (b). Subject
to paragraph (2), the Secretary may grant such a
waiver.
(2) CONSIDERATION OF WAIVER REQUESTS.—A
waiver may not be granted under this subsection to
impose an otherwise prohibited requirement unless
the Secretary determines that the value of any addi-
tional information to be provided under the require-
ment for research or other purposes significantly
outweighs the administrative cost of the imposition
of the requirement, taking into account the burden
of the timing of the imposition of the requirement.
(e) ANONYMOUS REPORTING.—If an individual or en-
tity attempts to impose on an individual or entity a re-
492
Title VI, Subtitle D
quirement prohibited under subsection (a) or (b), the indi-
vidual or entity on whom the requirement is being imposed
may contact the Secretary. The Secretary shall develop a
procedure under which an individual or entity that con-
tacts the Secretary under the preceding sentence shall re-
main anonymous. The Secretary shall notify the individual
or entity imposing the requirement that the requirement
may not be imposed unless the other individual or entity
voluntarily agrees to such requirement or a waiver is ob-
tained under subsection (d).
SEC. 6333. EFFECT ON STATE LAW.
(a) IN GENERAL.—Except as otherwise provided in
this section, a provision, requirement, or standard under
this subtitle shall supersede any contrary provision of
State law.
(b) STATE ‘‘QUILL AND PEN’’ LAWS.—A State may
not establish, continue in effect, or enforce any provision
of State law that requires medical or health plan records
(including billing information) to be maintained or trans-
mitted in written rather than electronic form, except
where the Secretary determines that the provision is nec-
essary to prevent fraud and abuse, with respect to con-
trolled substances, or for other purposes.
(c) PUBLIC HEALTH REPORTING.—Nothing in this
subtitle shall be construed to invalidate or limit the au-
493
Title VI, Subtitle D
thority, power, or procedures established under any law
providing for the reporting of disease or injury, child
abuse, birth, or death, public health surveillance, or public
health investigation or intervention.
(d) PUBLIC USE FUNCTIONS.—Nothing in this sub-
title shall be construed to limit the authority of a Federal
or State agency to make non-identifiable health informa-
tion available for public use.
(e) PAYMENT FOR HEALTH CARE SERVICES OR PRE-
MIUMS.—Nothing in this subtitle shall be construed to
prohibit a consumer from paying for health care items or
services, or plan or health insurance coverage premiums,
by debit, credit, or other payment cards or numbers or
other electronic payment means.
SEC. 6334. GRANTS FOR DEMONSTRATION PROJECTS.
(a) IN GENERAL.—The Secretary may make grants
for demonstration projects to promote the development
and use of electronically integrated community-based clini-
cal information systems and computerized patient medical
records.
(b) APPLICATIONS.—
(1) SUBMISSION.—To apply for a grant under
this section for any fiscal year, an applicant shall
submit an application to the Secretary in accordance
with the procedures established by the Secretary.
494
Title VI, Subtitle D
(2) CRITERIA FOR APPROVAL.—The Secretary
may not approve an application submitted under
paragraph (1) unless the application includes assur-
ances satisfactory to the Secretary regarding the fol-
lowing:
(A) USE
OF
EXISTING
TECHNOLOGY.—
Funds received under this section will be used
to apply telecommunications and information
systems technology that is in existence on the
date the application is submitted in a manner
that improves the quality of health care, re-
duces the costs of such care, and protects the
privacy and confidentiality of information relat-
ing to the physical or mental condition of an in-
dividual.
(B) USE OF EXISTING INFORMATION SYS-
TEMS.—Funds received under this section will
be used—
(i) to enhance telecommunications or
information systems that are operating on
the date the application is submitted;
(ii) to integrate telecommunications or
information systems that are operating on
the date the application is submitted; or
495
Title VI, Subtitle D
(iii) to connect additional users to
telecommunications or information net-
works or systems that are operating on the
date the application is submitted.
(C) CONSISTENCY
WITH
OTHER
PROVI-
SIONS.—Funds received under this section will
be used for demonstration projects whose infor-
mation collection and disclosure requirements
are consistent with this subtitle and subtitle A
of title V.
(D) MATCHING
FUNDS.—The applicant
shall make available funds for the demonstra-
tion project in an amount that equals at least
20 percent of the cost of the project.
(c) GEOGRAPHIC DIVERSITY.—In making any grants
under this section, the Secretary shall, to the extent prac-
ticable, make grants to persons representing different geo-
graphic areas of the United States, including urban and
rural areas.
(d) REVIEW AND SANCTIONS.—The Secretary shall
review at least annually the compliance of a person receiv-
ing a grant under this section with the provisions of this
section. The Secretary shall establish a procedure for de-
termining whether such a person has failed to comply sub-
496
Title VI, Subtitle D
stantially within the provisions of this section and the
sanctions to be imposed for any such noncompliance.
(e) ANNUAL REPORT.—The Secretary shall submit
an annual report to the President for transmittal to Con-
gress containing a description of the activities carried out
under this section. The report shall evalute each dem-
onstration project that received funds under this section
in the year to which the report pertains with respect to
the following:
(1) The usefulness of the project in facilitating
outcomes measurement, health provider decision-
making, and health research.
(2) The cost and burden of the project on
health providers and other participants in the
project.
(3) Efficiency and effectiveness of the project in
improving health care delivery and evaluation.
PART 4—ASSISTANCE TO THE SECRETARY
SEC. 6341. GENERAL REQUIREMENT ON SECRETARY.
In complying with any requirements imposed on the
Secretary under this subtitle, the Secretary shall rely on
recommendations of the Health Information Advisory
Committee established under section 6342 and shall con-
sult with appropriate Federal agencies.
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Title VI, Subtitle D
SEC. 6342. HEALTH INFORMATION ADVISORY COMMITTEE.
(a) ESTABLISHMENT.—There is established a com-
mittee to be known as the Health Care Information Advi-
sory Committee.
(b) DUTY.—
(1) IN GENERAL.—The committee shall—
(A) provide assistance to the Secretary in
complying with the requirements imposed on
the Secretary under this subtitle and subtitle E;
(B) be generally responsible for advising
the Secretary and the Congress on the status of
the health information network; and
(C) make recommendations to correct any
problems that may occur in the network’s im-
plementation and ongoing operations and to re-
fine and improve the network.
(2) TECHNICAL
ASSISTANCE.—In performing
its duties under this subsection, the committee shall
receive technical assistance from appropriate Federal
agencies.
(c) MEMBERSHIP.—
(1) IN GENERAL.—The committee shall consist
of 15 members to be appointed by the President not
later than 60 days after the date of the enactment
of this Act. The President shall designate 1 member
as the Chair.
498
Title VI, Subtitle D
(2) EXPERTISE.—The membership of the com-
mittee shall consist of individuals who are of recog-
nized standing and distinction and who possess the
demonstrated capacity to discharge the duties im-
posed on the committee. At least 1 member of the
committee shall be a member of the Health Quality
Advisory Council established under section 4001.
(3) TERMS.—Each member of the committee
shall be appointed for a term of 5 years, except that
the members first appointed shall serve staggered
terms such that the terms of no more than 3 mem-
bers expire at one time.
(4) VACANCIES.—
(A) IN GENERAL.—A vacancy on the com-
mittee shall be filled in the manner in which the
original appointment was made and shall be
subject to any conditions which applied with re-
spect to the original appointment.
(B) FILLING UNEXPIRED TERM.—An indi-
vidual chosen to fill a vacancy shall be ap-
pointed for the unexpired term of the member
replaced.
(C) EXPIRATION OF TERMS.—The term of
any member shall not expire before the date on
which the member’s successor takes office.
499
Title VI, Subtitle D
(5) CONFLICTS OF INTEREST.—Members of the
committee shall disclose upon appointment to the
committee or at any subsequent time that it may
occur, conflicts of interest.
(d) MEETINGS.—
(1) IN GENERAL.—Except as provided in para-
graph (2), the committee shall meet at the call of
the Chair.
(2) INITIAL MEETING.—Not later than 30 days
after the date on which all members of the commit-
tee have been appointed, the committee shall hold its
first meeting.
(3) QUORUM.—A majority of the members of
the committee shall constitute a quorum, but a less-
er number of members may hold hearings.
(e) POWER TO HOLD HEARINGS.—The committee
may hold such hearings, sit and act at such times and
places, take such testimony, and receive such evidence as
the committee considers advisable to carry out the pur-
poses of this section.
(f) OTHER ADMINISTRATIVE PROVISIONS.—Subpara-
graphs (C), (D), and (H) of section 1886(e)(6) of the So-
cial Security Act shall apply to the committee in the same
manner as they apply to the Prospective Payment Assess-
ment Commission.
500
Title VI, Subtitle D
(g) REPORTS.—
(1) IN GENERAL.—The committee shall annu-
ally prepare and submit to Congress and the Sec-
retary a report including at least an analysis of—
(A) the status of the health information
network established under this subtitle, includ-
ing whether the network is fulfilling the pur-
pose described in section 6300;
(B) the savings and costs of the network;
(C) the activities of health information net-
work services certified under section 6331,
health providers, and plan sponsors under this
subtitle;
(D) the extent to which entities described
in subparagraph (C) are meeting the standards
adopted under this subtitle and working to-
gether to form an integrated network that
meets the needs of its users;
(E) the extent to which entities described
in subparagraph (C) are meeting the privacy
and security protections of subtitle E;
(F) whether the Federal Government and
State Governments are receiving information of
sufficient quality to meet their responsibilities
under this Act;
501
Title VI, Subtitle E
(G) any problems with respect to imple-
mentation of the network;
(H) the extent to which timetables under
this subtitle for the adoption and implementa-
tion of standards are being met; and
(I) any legislative recommendations related
to the health information network.
(2) AVAILABILITY TO THE PUBLIC.—Any infor-
mation in the report submitted to Congress under
paragraph (1) shall be made available to the public,
unless such information may not be disclosed by law.
(h) DURATION.—Notwithstanding section 14(a) of
the Federal Advisory Committee Act, the committee shall
continue in existence until otherwise provided by law.
Subtitle E—Fair Health
Information Practices
SEC. 6400. DEFINITIONS.
(a) 
DEFINITIONS
RELATING
TO
PROTECTED
HEALTH INFORMATION.—For purposes of this subtitle:
(1) DISCLOSE.—The term ‘‘disclose’’, when
used with respect to protected health information
that is held by a health information trustee, means
to provide access to the information, but only if such
access is provided by the trustee to a person other
than—
502
Title VI, Subtitle E
(A) the trustee or an officer or employee of
the trustee;
(B) an affiliated person of the trustee; or
(C) a protected individual who is a subject
of the information.
(2) 
DISCLOSURE.—The 
term 
‘‘disclosure’’
means the act or an instance of disclosing.
(3) PROTECTED HEALTH INFORMATION.—The
term ‘‘protected health information’’ means any in-
formation, whether oral or recorded in any form or
medium—
(A) that is created or received in a State
by—
(i) a health care provider;
(ii) a health benefit plan sponsor;
(iii) a health oversight agency;
(iv) a health information service orga-
nization; or
(v) a public health authority;
(B) that relates in any way to the past,
present, or future physical or mental health or
condition or functional status of a protected in-
dividual, the provision of health care to a pro-
tected individual, or payment for the provision
of health care to a protected individual; and
503
Title VI, Subtitle E
(C) that—
(i) identifies the individual; or
(ii) with respect to which there is a
reasonable basis to believe that the infor-
mation can be used to identify the individ-
ual.
(4) PROTECTED INDIVIDUAL.—The term ‘‘pro-
tected individual’’ means an individual who, with re-
spect to a date—
(A) is living on the date; or
(B) has died within the 2-year period end-
ing on the date.
(5) USE.—The term ‘‘use’’, when used with re-
spect to protected health information that is held by
a health information trustee, means—
(A) to use, or provide access to, the infor-
mation in any manner that does not constitute
a disclosure; or
(B) any act or instance of using, or provid-
ing access, described in subparagraph (A).
(b) DEFINITIONS RELATING TO HEALTH INFORMA-
TION TRUSTEES.—For purposes of this subtitle:
(1) 
HEALTH
BENEFIT
PLAN.—The 
term
‘‘health benefit plan’’ means—
504
Title VI, Subtitle E
(A) any contract of health insurance, in-
cluding any hospital or medical service policy or
certificate, hospital or medical service plan con-
tract, or health maintenance organization group
contract, that is provided by a carrier; and
(B) an employee welfare benefit plan or
other arrangement insofar as the plan or ar-
rangement provides health benefits and is fund-
ed in a manner other than through the pur-
chase of one or more policies or contracts de-
scribed in subparagraph (A).
(2) HEALTH
BENEFIT
PLAN
SPONSOR.—The
term ‘‘health benefit plan sponsor’’ means a person
who, with respect to a specific item of protected
health information, receives, creates, uses, main-
tains, or discloses the information while acting in
whole or in part in the capacity of—
(A) a carrier providing a health benefit
plan;
(B) any other provider of a health benefit
plan, including any public entity that provides
payments for health care items and services
under a health benefit plan that are equivalent
to payments provided by a private person under
such a plan; or
505
Title VI, Subtitle E
(C) an officer or employee of a person de-
scribed in subparagraph (A) or (B).
(3) HEALTH
CARE
PROVIDER.—The term
‘‘health care provider’’ means a person who, with re-
spect to a specific item of protected health informa-
tion, receives, creates, uses, maintains, or discloses
the information while acting in whole or in part in
the capacity of—
(A) a person who is licensed, certified, reg-
istered, or otherwise authorized by law to pro-
vide an item or service that constitutes health
care in the ordinary course of business or prac-
tice of a profession;
(B) a Federal or State program that di-
rectly provides items or services that constitute
health care to beneficiaries; or
(C) an officer or employee of a person de-
scribed in subparagraph (A) or (B).
(4) HEALTH INFORMATION SERVICE ORGANIZA-
TION.—The term ‘‘health information service organi-
zation’’ means a person who, with respect to a spe-
cific item of protected health information, receives,
creates, uses, maintains, or discloses the information
while acting in whole or in part in the capacity of—
506
Title VI, Subtitle E
(A) a person, other than an affiliated per-
son, who performs specific functions for which
the Secretary has authorized (by means of a
designation or certification) the person to re-
ceive access to health care data in electronic or
magnetic form that are regulated by this Act;
or
(B) an officer or employee of a person de-
scribed in subparagraph (A).
(5) HEALTH
INFORMATION
TRUSTEE.—The
term ‘‘health information trustee’’ means—
(A) a health care provider;
(B) a health information service organiza-
tion;
(C) a health oversight agency;
(D) a health benefit plan sponsor;
(E) a public health authority;
(F) a health researcher;
(G) a person who, with respect to a spe-
cific item of protected health information, is not
described in subparagraphs (A) through (F) but
receives the information—
(i) pursuant to—
(I) section 6417 (relating to
emergency circumstances);
507
Title VI, Subtitle E
(II) section 6418 (relating to ju-
dicial and administrative purposes);
(III) section 6419 (relating to
law enforcement); or
(IV) section 6420 (relating to
subpoenas, warrants, and search war-
rants); or
(ii) while acting in whole or in part in
the capacity of an officer or employee of a
person described in clause (i).
(6) HEALTH OVERSIGHT AGENCY.—The term
‘‘health oversight agency’’ means a person who, with
respect to a specific item of protected health infor-
mation, receives, creates, uses, maintains, or dis-
closes the information while acting in whole or in
part in the capacity of—
(A) a person who performs or oversees the
performance of an assessment, evaluation, de-
termination, or investigation relating to the li-
censing, accreditation, or certification of health
care providers;
(B) a person who—
(i) performs or oversees the perform-
ance of an audit, assessment, evaluation,
determination, or investigation relating to
508
Title VI, Subtitle E
the effectiveness of, compliance with, or
applicability of, legal, fiscal, medical, or
scientific standards or aspects of perform-
ance related to the delivery of, or payment
for, health care; and
(ii) is a public agency, acting on be-
half of a public agency, acting pursuant to
a requirement of a public agency, or carry-
ing out activities under a State or Federal
statute regulating the assessment, evalua-
tion, determination, or investigation; or
(C) an officer or employee of a person de-
scribed in subparagraph (A) or (B).
(7) HEALTH RESEARCHER.—The term ‘‘health
researcher’’ means a person who, with respect to a
specific item of protected health information, re-
ceives the information—
(A) pursuant to section 6416 (relating to
health research); or
(B) while acting in whole or in part in the
capacity of an officer or employee of a person
described in subparagraph (A).
(8) PUBLIC
HEALTH
AUTHORITY.—The term
‘‘public health authority’’ means a person who, with
respect to a specific item of protected health infor-
509
Title VI, Subtitle E
mation, receives, creates, uses, maintains, or dis-
closes the information while acting in whole or in
part in the capacity of—
(A) an authority of the United States, a
State, or a political subdivision of a State that
is responsible for public health matters;
(B) a person acting under the direction of
such an authority; or
(C) an officer or employee of a person de-
scribed in subparagraph (A) or (B).
(c) OTHER DEFINITIONS.—For purposes of this sub-
title:
(1) AFFILIATED PERSON.—The term ‘‘affiliated
person’’ means a person who—
(A) is not a health information trustee;
(B) is a contractor, subcontractor, associ-
ate, or subsidiary of a person who is a health
information trustee; and
(C) pursuant to an agreement or other re-
lationship with such trustee, receives, creates,
uses, maintains, or discloses protected health
information.
(2) APPROVED HEALTH RESEARCH PROJECT.—
The term ‘‘approved health research project’’ means
a biomedical, epidemiological, or health services re-
510
Title VI, Subtitle E
search or statistics project, or a research project on
behavioral and social factors affecting health, that
has been approved by a certified institutional review
board.
(3) 
CERTIFIED
INSTITUTIONAL
REVIEW
BOARD.—The term ‘‘certified institutional review
board’’ means a board—
(A) established by an entity to review re-
search involving protected health information
and the rights of protected individuals con-
ducted at or supported by the entity;
(B) established in accordance with regula-
tions of the Secretary under section 6416(e)(1);
and
(C) certified by the Secretary under section
6416(e)(2).
(4) HEALTH CARE.—The term ‘‘health care’’—
(A) means—
(i) any preventive, diagnostic, thera-
peutic, rehabilitative, maintenance, or pal-
liative care, counseling, service, or proce-
dure—
(I) with respect to the physical or
mental condition, or functional status,
of an individual; or
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Title VI, Subtitle E
(II) affecting the structure or
function of the human body or any
part of the human body, including
banking of blood, sperm, organs, or
any other tissue; or
(ii) any sale or dispensing of a drug,
device, equipment, or other item to an indi-
vidual, or for the use of an individual, pur-
suant to a prescription; but
(B) does not include any item or service
that is not furnished for the purpose of main-
taining or improving the health of an individual.
(5) LAW ENFORCEMENT INQUIRY.—The term
‘‘law enforcement inquiry’’ means a lawful investiga-
tion or official proceeding inquiring into a violation
of, or failure to comply with, any criminal or civil
statute or any regulation, rule, or order issued pur-
suant to such a statute.
(6) PERSON.—The term ‘‘person’’ includes an
authority of the United States, a State, or a political
subdivision of a State.
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Title VI, Subtitle E
PART 1—DUTIES OF HEALTH INFORMATION
TRUSTEES
SEC. 6401. INSPECTION OF PROTECTED HEALTH INFORMA-
TION.
(a) IN GENERAL.—Except as provided in subsection
(b), a health information trustee described in subsection
(g)—
(1) shall permit a protected individual to in-
spect any protected health information about the in-
dividual that the trustee maintains, any accounting
with respect to such information required under sec-
tion 6404, and any copy of an authorization re-
quired under section 6412 that pertains to such in-
formation;
(2) shall provide the protected individual with a
copy of the information upon request by the individ-
ual and subject to any conditions imposed by the
trustee under subsection (d);
(3) shall permit a person who has been des-
ignated in writing by the protected individual to in-
spect the information on behalf of the individual or
to accompany the individual during the inspection;
and
(4) may offer to explain or interpret informa-
tion that is inspected or copied under this sub-
section.
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Title VI, Subtitle E
(b) EXCEPTIONS.—A health information trustee is
not required by this section to permit inspection or copy-
ing of protected health information by a protected individ-
ual if any of the following conditions apply:
(1) MENTAL
HEALTH
TREATMENT
NOTES.—
The information consists of psychiatric, psycho-
logical, or mental health treatment notes about the
individual, the trustee determines in the exercise of
reasonable professional judgment that inspection or
copying of the notes would cause sufficient harm to
the protected individual so as to outweigh the desir-
ability of permitting access, and the trustee does not
disclose the notes to any person not directly engaged
in treating the individual, except with the authoriza-
tion of the individual or under compulsion of law.
(2) INFORMATION ABOUT OTHERS.—The infor-
mation relates to an individual, other than the pro-
tected individual or a health care provider, and the
trustee determines in the exercise of reasonable pro-
fessional judgment that inspection or copying of the
information would cause sufficient harm to one or
both of the individuals so as to outweigh the desir-
ability of permitting access.
(3) ENDANGERMENT TO LIFE OR SAFETY.—In-
spection or copying of the information could reason-
514
Title VI, Subtitle E
ably be expected to endanger the life or physical
safety of an individual.
(4) CONFIDENTIAL SOURCE.—The information
identifies or could reasonably lead to the identifica-
tion of an individual (other than a health care pro-
vider) who provided information under a promise of
confidentiality to a health care provider concerning
a protected individual who is a subject of the infor-
mation.
(5) ADMINISTRATIVE PURPOSES.—The informa-
tion—
(A) is used by the trustee solely for admin-
istrative purposes and not in the provision of
health care to a protected individual who is a
subject of the information; and
(B) is not disclosed by the trustee to any
person.
(6) DUPLICATIVE INFORMATION.—The informa-
tion duplicates information available for inspection
under subsection (a).
(7) INFORMATION COMPILED IN ANTICIPATION
OF LITIGATION.—The information is compiled prin-
cipally—
(A) in anticipation of a civil, criminal, or
administrative action or proceeding; or
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Title VI, Subtitle E
(B) for use in such an action or proceed-
ing.
(c) INSPECTION AND COPYING OF SEGREGABLE POR-
TION.—A health information trustee shall permit inspec-
tion and copying under subsection (a) of any reasonably
segregable portion of a record after deletion of any portion
that is exempt under subsection (b).
(d) CONDITIONS.—A health information trustee
may—
(1) require a written request for the inspection
and copying of protected health information under
this section; and
(2) charge a reasonable cost-based fee for—
(A) permitting inspection of information
under this section; and
(B) providing a copy of protected health
information under this section.
(e) STATEMENT OF REASONS FOR DENIAL.—If a
health information trustee denies in whole or in part a
request for inspection or copying under this section, the
trustee shall provide the protected individual who made
the request with a written statement of the reasons for
the denial.
(f) DEADLINE.—A health information trustee shall
comply with or deny a request for inspection or copying
516
Title VI, Subtitle E
of protected health information under this section within
the 30-day period beginning on the date the trustee re-
ceives the request.
(g) APPLICABILITY.—This section applies to a health
information trustee who is—
(1) a health benefit plan sponsor;
(2) a health care provider;
(3) a health information service organization;
(4) a health oversight agency; or
(5) a public health authority.
SEC. 6402. AMENDMENT OF PROTECTED HEALTH INFORMA-
TION.
(a) IN GENERAL.—A health information trustee de-
scribed in subsection (f) shall, within the 45-day period
beginning on the date the trustee receives from a protected
individual about whom the trustee maintains protected
health information a written request that the trustee cor-
rect or amend the information, complete the duties de-
scribed in one of the following paragraphs:
(1) CORRECTION OR AMENDMENT AND NOTIFI-
CATION.—The trustee shall—
(A) make the correction or amendment re-
quested;
(B) inform the protected individual of the
amendment or correction that has been made;
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Title VI, Subtitle E
(C) make reasonable efforts to inform any
person who is identified by the protected indi-
vidual, who is not an employee of the trustee,
and to whom the uncorrected or unamended
portion of the information was previously dis-
closed of the correction or amendment that has
been made; and
(D) at the request of the individual, make
reasonable efforts to inform any known source
of the uncorrected or unamended portion of the
information about the correction or amendment
that has been made.
(2) REASONS FOR REFUSAL AND REVIEW PRO-
CEDURES.—The trustee shall inform the protected
individual of—
(A) the reasons for the refusal of the trust-
ee to make the correction or amendment;
(B) any procedures for further review of
the refusal; and
(C) the individual’s right to file with the
trustee a concise statement setting forth the re-
quested correction or amendment and the indi-
vidual’s reasons for disagreeing with the refusal
of the trustee.
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Title VI, Subtitle E
(b) STANDARDS
FOR
CORRECTION
OR
AMEND-
MENT.—A trustee shall correct or amend protected health
information in accordance with a request made under sub-
section (a) if the trustee determines that the information
is not accurate, relevant, timely, or complete for the pur-
poses for which the information may be used or disclosed
by the trustee.
(c) STATEMENT OF DISAGREEMENT.—After a pro-
tected individual has filed a statement of disagreement
under subsection (a)(2)(C), the trustee, in any subsequent
disclosure of the disputed portion of the information, shall
include a copy of the individual’s statement and may in-
clude a concise statement of the trustee’s reasons for not
making the requested correction or amendment.
(d) CONSTRUCTION.—This section may not be con-
strued to require a health information trustee to conduct
a hearing or proceeding concerning a request for a correc-
tion or amendment to protected health information the
trustee maintains.
(e) CORRECTION.—For purposes of subsection (a), a
correction is deemed to have been made to protected
health information when—
(1) information that is not timely, accurate, rel-
evant, or complete is clearly marked as incorrect; or
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Title VI, Subtitle E
(2) supplementary correct information is made
part of the information and adequately cross-ref-
erenced.
(f) APPLICABILITY.—This section applies to a health
information trustee who is—
(1) a health benefit plan sponsor;
(2) a health care provider;
(3) a health information service organization;
(4) a health oversight agency; or
(5) a public health authority.
SEC. 6403. NOTICE OF INFORMATION PRACTICES.
(a) PREPARATION OF NOTICE.—A health information
trustee described in subsection (d) shall prepare a written
notice of information practices describing the following:
(1) The rights under this subtitle of a protected
individual who is the subject of protected health in-
formation, including the right to inspect and copy
such information and the right to seek amendments
to such information, and the procedures for author-
izing disclosures of protected health information and
for revoking such authorizations.
(2) The procedures established by the trustee
for the exercise of such rights.
(3) The uses and disclosures of protected health
information that are authorized under this subtitle.
520
Title VI, Subtitle E
(b) DISSEMINATION OF NOTICE.—A health informa-
tion trustee—
(1) shall, upon request, provide any person with
a copy of the trustee’s notice of information prac-
tices (described in subsection (a)); and
(2) shall make reasonable efforts to inform per-
sons in a clear and conspicuous manner of the exist-
ence and availability of such notice.
(c) MODEL NOTICES.—Not later than July 1, 1996,
the Secretary, after notice and opportunity for public com-
ment, shall develop and disseminate model notices of infor-
mation practices for use by health information trustees
under this section.
(d) APPLICABILITY.—This section applies to a health
information trustee who is—
(1) a health benefit plan sponsor;
(2) a health care provider;
(3) a health information service organization; or
(4) a health oversight agency.
SEC. 6404. ACCOUNTING FOR DISCLOSURES.
(a) IN GENERAL.—Except as provided in subsection
(b) and section 6414, each health information trustee shall
create and maintain, with respect to any protected health
information the trustee discloses, a record of—
(1) the date and purpose of the disclosure;
521
Title VI, Subtitle E
(2) the name of the person to whom the disclo-
sure was made;
(3) the address of the person to whom the dis-
closure was made or the location to which the disclo-
sure was made; and
(4) where practicable, a description of the infor-
mation disclosed.
(b) REGULATIONS.—Not later than July 1, 1996, the
Secretary shall promulgate regulations that exempt a
health information trustee from maintaining a record
under subsection (a) with respect protected health infor-
mation disclosed by the trustee for purposes of peer re-
view, licensing, certification, accreditation, and similar ac-
tivities.
SEC. 6405. SECURITY.
(a) IN GENERAL.—Each health information trustee
who receives or creates protected health information that
is subject to this subtitle shall maintain reasonable and
appropriate administrative, technical, and physical safe-
guards—
(1) to ensure the integrity and confidentiality of
the information;
(2) to protect against any reasonably antici-
pated—
522
Title VI, Subtitle E
(A) threats or hazards to the security or
integrity of the information; and
(B) unauthorized uses or disclosures of the
information; and
(3) otherwise ensure compliance with this sub-
title by the trustee and the officers and employees
of the trustee.
(b) GUIDELINES.—Not later than July 1, 1996, the
Secretary, after notice and opportunity for public com-
ment, shall develop and disseminate guidelines for the im-
plementation of this section. The guidelines shall take into
account—
(1) the technical capabilities of record systems
used to maintain protected health information;
(2) the costs of security measures;
(3) the need for training persons who have ac-
cess to protected health information; and
(4) the value of audit trails in computerized
record systems.
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Title VI, Subtitle E
PART 2—USE AND DISCLOSURE OF PROTECTED
HEALTH INFORMATION
SEC. 6411. GENERAL LIMITATIONS ON USE AND DISCLO-
SURE.
(a) USE.—Except as otherwise provided under this
subtitle, a health information trustee may use protected
health information only for a purpose—
(1) that is compatible with and directly related
to the purpose for which the information—
(A) was collected; or
(B) was received by the trustee; or
(2) for which the trustee is authorized to dis-
close the information under this subtitle.
(b) DISCLOSURE.—A health information trustee may
disclose protected health information only as authorized
under this subtitle.
(c) SCOPE OF USES AND DISCLOSURES.—
(1) IN GENERAL.—A use or disclosure of pro-
tected health information by a health information
trustee shall be limited, when practicable, to the
minimum amount of information necessary to ac-
complish the purpose for which the information is
used or disclosed.
(2) GUIDELINES.—Not later than July 1, 1996,
the Secretary, after notice and opportunity for pub-
lic comment, shall issue guidelines to implement
524
Title VI, Subtitle E
paragraph (1), which shall take into account the
technical capabilities of the record systems used to
maintain protected health information and the costs
of limiting use and disclosure.
(d) IDENTIFICATION OF DISCLOSED INFORMATION
AS PROTECTED INFORMATION.—Except with respect to
protected health information that is disclosed under sec-
tion 6414 (relating to next of kin and directory informa-
tion), a health information trustee may disclose protected
health information only if the recipient has been notified
that the information is protected health information that
is subject to this subtitle.
(e) AGREEMENT TO LIMIT USE OR DISCLOSURE.—
A health information trustee who receives protected health
information from any person pursuant to a written agree-
ment to restrict use or disclosure of the information to
a greater extent than otherwise would be required under
this subtitle shall comply with the terms of the agreement,
except where use or disclosure of the information in viola-
tion of the agreement is required by law. A trustee who
fails to comply with the preceding sentence shall be subject
to section 6451 (relating to civil actions) with respect to
such failure.
(f) NO GENERAL REQUIREMENT TO DISCLOSE.—
Nothing in this subtitle shall be construed to require a
525
Title VI, Subtitle E
health information trustee to disclose protected health in-
formation not otherwise required to be disclosed by law.
SEC. 6412. AUTHORIZATIONS FOR DISCLOSURE OF PRO-
TECTED HEALTH INFORMATION.
(a) WRITTEN AUTHORIZATIONS.—A health informa-
tion trustee, other than a health information service orga-
nization, may disclose protected health information pursu-
ant to an authorization executed by the protected individ-
ual who is the subject of the information, if each of the
following requirements is satisfied:
(1) WRITING.—The authorization is in writing,
signed by the individual, and dated on the date of
such signature.
(2) SEPARATE FORM.—The authorization is not
on a form used to authorize or facilitate the provi-
sion of, or payment for, health care.
(3) TRUSTEE DESCRIBED.—The trustee is spe-
cifically named or generically described in the au-
thorization as authorized to disclose such informa-
tion.
(4) RECIPIENT
DESCRIBED.—The person to
whom the information is to be disclosed is specifi-
cally named or generically described in the author-
ization as a person to whom such information may
be disclosed.
526
Title VI, Subtitle E
(5) STATEMENT OF INTENDED USES AND DIS-
CLOSURES
RECEIVED.—The authorization contains
an acknowledgment that the individual has received
a statement described in subsection (b) from such
person.
(6) INFORMATION
DESCRIBED.—The informa-
tion to be disclosed is described in the authorization.
(7) AUTHORIZATION TIMELY RECEIVED.—The
authorization is received by the trustee during a pe-
riod described in subsection (c)(1).
(8) DISCLOSURE
TIMELY
MADE.—The disclo-
sure occurs during a period described in subsection
(c)(2).
(b) STATEMENT OF INTENDED USES AND DISCLO-
SURES.—
(1) IN GENERAL.—A person who wishes to re-
ceive from a health information trustee protected
health information about a protected individual pur-
suant to an authorization executed by the individual
shall supply the individual, in writing and on a form
that is distinct from the authorization, with a state-
ment of the uses for which the person intends the
information and the disclosures the person intends
to make of the information. Such statement shall be
supplied before the authorization is executed.
527
Title VI, Subtitle E
(2) ENFORCEMENT.—If the person uses or dis-
closes the information in a manner that is inconsist-
ent with such statement, the person shall be subject
to section 6451 (relating to civil actions) with re-
spect to such failure, except where such use or dis-
closure is required by law.
(3) MODEL STATEMENTS.—Not later than July
1, 1996, the Secretary, after notice and opportunity
for public comment, shall develop and disseminate
model statements of intended uses and disclosures of
the type described in paragraph (1).
(c) TIME LIMITATIONS ON AUTHORIZATIONS.—
(1) RECEIPT BY TRUSTEE.—For purposes of
subsection (a)(7), an authorization is timely received
if it is received by the trustee during—
(A) the 1-year period beginning on the
date that the authorization is signed under sub-
section (a)(1), if the authorization permits the
disclosure of protected health information to—
(i) a health benefit plan sponsor;
(ii) a health care provider;
(iii) a health oversight agency;
(iv) a public health authority;
(v) a health researcher; or
528
Title VI, Subtitle E
(vi) a person who provides counseling
or social services to individuals; or
(B) the 30-day period beginning on the
date that the authorization is signed under sub-
section (a)(1), if the authorization permits the
disclosure of protected health information to a
person other than a person described in sub-
paragraph (A).
(2) DISCLOSURE BY TRUSTEE.—For purposes
of subsection (a)(8), a disclosure is timely made if
it occurs before—
(A) the date or event (if any) specified in
the authorization upon which the authorization
expires; and
(B) the expiration of the 6-month period
beginning on the date the trustee receives the
authorization.
(d) REVOCATION OR AMENDMENT OF AUTHORIZA-
TION.—
(1) IN
GENERAL.—A protected individual in
writing may revoke or amend an authorization de-
scribed in subsection (a), in whole or in part, at any
time, except insofar as—
(A) disclosure of protected health informa-
tion has been authorized to permit validation of
529
Title VI, Subtitle E
expenditures based on health condition by a
government authority; or
(B) action has been taken in reliance on
the authorization.
(2) NOTICE OF REVOCATION.—A health infor-
mation trustee who discloses protected health infor-
mation in reliance on an authorization that has been
revoked shall not be subject to any liability or pen-
alty under this subtitle if—
(A) the reliance was in good faith;
(B) the trustee had no notice of the rev-
ocation; and
(C) the disclosure was otherwise in accord-
ance with the requirements of this section.
(e) ADDITIONAL REQUIREMENTS OF TRUSTEE.—A
health information trustee may impose requirements for
an authorization that are in addition to the requirements
in this section.
(f) COPY.—A health information trustee who dis-
closes protected health information pursuant to an author-
ization under this section shall maintain a copy of the au-
thorization.
(g) CONSTRUCTION.—This section may not be con-
strued—
530
Title VI, Subtitle E
(1) to require a health information trustee to
disclose protected health information; or
(2) to limit the right of a health information
trustee to charge a fee for the disclosure or repro-
duction of protected health information.
(h) SUBPOENAS, WARRANTS, AND SEARCH WAR-
RANTS.—If a health information trustee discloses pro-
tected health information pursuant to an authorization in
order to comply with an administrative subpoena or war-
rant or a judicial subpoena or search warrant, the author-
ization—
(1) shall specifically authorize the disclosure for
the purpose of permitting the trustee to comply with
the subpoena, warrant, or search warrant; and
(2) shall otherwise meet the requirements in
this section.
SEC. 6413. TREATMENT, PAYMENT, AND OVERSIGHT.
(a) DISCLOSURES
BY
PLANS, PROVIDERS, AND
OVERSIGHT AGENCIES.—A health information trustee de-
scribed in subsection (d) may disclose protected health in-
formation to a health benefit plan sponsor, health care
provider, or health oversight agency if the disclosure is—
(1) for the purpose of providing health care and
a protected individual who is a subject of the infor-
531
Title VI, Subtitle E
mation has not previously objected to the disclosure
in writing;
(2) for the purpose of providing for the pay-
ment for health care furnished to an individual; or
(3) for use by a health oversight agency for a
purpose that is described in subparagraph (A) or
(B)(i) of section 6400(b)(6).
(b) DISCLOSURES BY CERTAIN OTHER TRUSTEES.—
A health information trustee may disclose protected health
information to a health care provider if—
(1) the disclosure is for the purpose described
in subsection (a)(1); and
(2) the trustee—
(A) is a public health authority;
(B) received protected health information
pursuant to section 6417 (relating to emergency
circumstances); or
(C) is an officer or employee of a trustee
described in subsection (B).
(c) USE IN ACTION AGAINST INDIVIDUAL.—A person
who receives protected health information about a pro-
tected individual through a disclosure under this section
may not use or disclose the information in any administra-
tive, civil, or criminal action or investigation directed
against the individual, except an action or investigation
532
Title VI, Subtitle E
arising out of and related to receipt of health care or pay-
ment for health care.
(d) APPLICABILITY.—A health information trustee
referred to in subsection (a) is any of the following:
(1) A health benefit plan sponsor.
(2) A health care provider.
(3) A health oversight agency.
(4) A health information service organization.
SEC. 6414. NEXT OF KIN AND DIRECTORY INFORMATION.
(a) NEXT OF KIN.—A health information trustee who
is a health care provider, who received protected health
information pursuant to section 6417 (relating to emer-
gency circumstances), or who is an officer or employee of
such a recipient may orally disclose protected health infor-
mation about a protected individual to the next of kin of
the individual (as defined under State law), or to a person
with whom the individual has a close personal relationship,
if—
(1) the trustee has no reason to believe that the
individual would consider the information especially
sensitive;
(2) the individual has not previously objected to
the disclosure;
(3) the disclosure is consistent with good medi-
cal or other professional practice; and
533
Title VI, Subtitle E
(4) the information disclosed is limited to infor-
mation about health care that is being provided to
the individual at or about the time of the disclosure.
(b) DIRECTORY INFORMATION.—
(1) IN GENERAL.—A health information trustee
who is a health care provider, who received protected
health information pursuant to section 6417 (relat-
ing to emergency circumstances), or who is an offi-
cer or employee of a such a recipient may disclose
to any person the information described in para-
graph (2) if—
(A) a protected individual who is a subject
of the information has not objected in writing
to the disclosure;
(B) the disclosure is otherwise consistent
with good medical and other professional prac-
tice; and
(C) the information does not reveal specific
information about the physical or mental condi-
tion or functional status of a protected individ-
ual or about the health care provided to a pro-
tected individual.
(2) INFORMATION
DESCRIBED.—The informa-
tion referred to in paragraph (1) is the following:
534
Title VI, Subtitle E
(A) The name of an individual receiving
health care from a health care provider on a
premises controlled by the provider.
(B) The location of the individual on such
premises.
(C) The general health status of the indi-
vidual, described in terms of critical, poor, fair,
stable, satisfactory, or terms denoting similar
conditions.
(c) NO ACCOUNTING REQUIRED.—A health informa-
tion trustee who discloses protected health information
under this section is not required to maintain an account-
ing of the disclosure under section 6404.
(d) RECIPIENTS.—A person to whom protected
health information is disclosed under this section shall not,
by reason of such disclosure, be subject to any require-
ment under this subtitle.
SEC. 6415. PUBLIC HEALTH.
(a) IN GENERAL.—A health information trustee who
is a health care provider or a public health authority may
disclose protected health information to—
(1) a public health authority for use in legally
authorized—
(A) disease or injury reporting;
(B) public health surveillance; or
535
Title VI, Subtitle E
(C) public health investigation or interven-
tion; or
(2) an individual who is authorized by law to
receive the information in a public health interven-
tion.
(b) USE IN ACTION AGAINST INDIVIDUAL.—A public
health authority who receives protected health information
about a protected individual through a disclosure under
this section may not use or disclose the information in any
administrative, civil, or criminal action or investigation di-
rected against the individual, except where the use or dis-
closure is authorized by law for protection of the public
health.
(c) INDIVIDUAL
RECIPIENTS.—An individual to
whom protected health information is disclosed under sub-
section (a)(2) shall not, by reason of such disclosure, be
subject to any requirement under this subtitle.
SEC. 6416. HEALTH RESEARCH.
(a) IN GENERAL.—A health information trustee de-
scribed in subsection (d) may disclose protected health in-
formation to a person if—
(1) the person is conducting an approved health
research project;
(2) the information is to be used in the project;
and
536
Title VI, Subtitle E
(3) the project has been determined by a cer-
tified institutional review board to be—
(A) of sufficient importance so as to out-
weigh the intrusion into the privacy of the pro-
tected individual who is the subject of the infor-
mation that would result from the disclosure;
and
(B) impracticable to conduct without the
information.
(b) DISCLOSURES BY HEALTH INFORMATION SERV-
ICE ORGANIZATIONS.—A health information service orga-
nization may disclose protected health information under
subsection (a) only if the certified institutional review
board referred to in subsection (a)(3) has been certified
as being qualified to make determinations under such sub-
section with respect to disclosures by such organizations.
(c) LIMITATIONS ON USE AND DISCLOSURE; OBLIGA-
TIONS OF RECIPIENT.—A health researcher who receives
protected health information about a protected individual
pursuant to subsection (a)—
(1) may use the information solely for purposes
of an approved health research project;
(2) may not use or disclose the information in
any administrative, civil, or criminal action or inves-
tigation directed against the individual; and
537
Title VI, Subtitle E
(3) shall remove or destroy, at the earliest op-
portunity consistent with the purposes of the ap-
proved health research project in connection with
which the disclosure was made, information that
would enable an individual to be identified, unless a
certified institutional review board has determined
that there is a health or research justification for re-
tention of such identifiers and there is an adequate
plan to protect the identifiers from use and disclo-
sure that is inconsistent with this subtitle.
(d) APPLICABILITY.—A health information trustee
referred to in subsection (a) is any health information
trustee other than a person who, with respect to the spe-
cific protected health information to be disclosed under
such subsection, received the information—
(1) pursuant to—
(A) section 6418 (relating to judicial and
administrative purposes);
(B) paragraph (1), (2), or (3) of section
6419(a) (relating to law enforcement); or
(C) section 6420 (relating to subpoenas,
warrants, and search warrants); or
(2) while acting in whole or in part in the ca-
pacity of an officer or employee of a person de-
scribed in paragraph (1).
538
Title VI, Subtitle E
(e) REQUIREMENTS
FOR INSTITUTIONAL REVIEW
BOARDS.—
(1) REGULATIONS.—Not later than July 1,
1996, the Secretary, after opportunity for notice and
comment, shall promulgate regulations establishing
requirements for certified institutional review boards
under this subtitle. The regulations shall be based
on regulations promulgated under section 491(a) of
the Public Health Service Act and shall ensure that
certified institutional review boards are qualified to
assess and protect the confidentiality of research
subjects. The regulations shall include specific re-
quirements for certified institutional review boards
that make determinations under subsection (a)(3)
with respect to disclosures by health information
service organizations.
(2) CERTIFICATION.—The Secretary shall cer-
tify that an institutional review board satisfies the
requirements of the regulations promulgated under
paragraph (1).
SEC. 6417. EMERGENCY CIRCUMSTANCES.
(a) IN GENERAL.—A health information trustee may
disclose protected health information if the trustee be-
lieves, on reasonable grounds, that the disclosure is nec-
539
Title VI, Subtitle E
essary to prevent or lessen a serious and imminent threat
to the health or safety of an individual.
(b) USE IN ACTION AGAINST INDIVIDUAL.—A person
who receives protected health information about a pro-
tected individual through a disclosure under this section
may not use or disclose the information in any administra-
tive, civil, or criminal action or investigation directed
against the individual, except an action or investigation
arising out of and related to receipt of health care or pay-
ment for health care.
SEC. 6418. JUDICIAL AND ADMINISTRATIVE PURPOSES.
(a) IN GENERAL.—A health information trustee de-
scribed in subsection (d) may disclose protected health in-
formation—
(1) pursuant to the Federal Rules of Civil Pro-
cedure, the Federal Rules of Criminal Procedure, or
comparable rules of other courts or administrative
agencies in connection with litigation or proceedings
to which a protected individual who is a subject of
the information is a party and in which the individ-
ual has placed the individual’s physical or mental
condition or functional status in issue;
(2) if directed by a court in connection with a
court-ordered examination of an individual; or
540
Title VI, Subtitle E
(3) to assist in the identification of a dead indi-
vidual.
(b) WRITTEN STATEMENT.—A person seeking pro-
tected health information about a protected individual held
by health information trustee under—
(1) subsection (a)(1)—
(A) shall notify the protected individual or
the attorney of the protected individual of the
request for the information;
(B) shall provide the trustee with a signed
document attesting—
(i) that the protected individual is a
party to the litigation or proceedings for
which the information is sought;
(ii) that the individual has placed the
individual’s physical or mental condition or
functional status in issue; and
(iii) the date on which the protected
individual or the attorney of the protected
individual was notified under subparagraph
(A); and
(C) shall not accept any requested pro-
tected health information from the trustee until
the termination of the 10-day period beginning
541
Title VI, Subtitle E
on the date notice was given under subpara-
graph (A); or
(2) subsection (a)(3) shall provide the trustee
with a written statement that the information is
sought to assist in the identification of a dead indi-
vidual.
(c) USE AND DISCLOSURE.—A person to whom pro-
tected health information is disclosed under this section
may use and disclose the information only to accomplish
the purpose for which the disclosure was made.
(d) APPLICABILITY.—A health information trustee
referred to in subsection (a) is any of the following:
(1) A health benefit plan sponsor.
(2) A health care provider.
(3) A health oversight agency.
(4) A person who, with respect to the specific
protected health information to be disclosed under
such subsection, received the information—
(A) pursuant to—
(i) section 6417 (relating to emer-
gency circumstances); or
(ii) section 6420 (relating to subpoe-
nas, warrants, and search warrants); or
542
Title VI, Subtitle E
(B) while acting in whole or in part in the
capacity of an officer or employee of a person
described in subparagraph (A).
SEC. 6419. LAW ENFORCEMENT.
(a) IN GENERAL.—A health information trustee,
other than a health information service organization, may
disclose protected health information to a law enforcement
agency, other than a health oversight agency—
(1) if the information is disclosed for use in an
investigation or prosecution of a health information
trustee;
(2) in connection with criminal activity commit-
ted against the trustee or an affiliated person of the
trustee or on premises controlled by the trustee; or
(3) if the information is needed to determine
whether a crime has been committed and the nature
of any crime that may have been committed (other
than a crime that may have been committed by the
protected individual who is the subject of the infor-
mation).
(b) ADDITIONAL AUTHORITY OF CERTAIN TRUST-
EES.—A health information trustee who is not a health
information service organization, a public health author-
ity, or a health researcher may disclose protected health
543
Title VI, Subtitle E
information to a law enforcement agency (other than a
health oversight agency)—
(1) to assist in the identification or location of
a victim, fugitive, or witness in a law enforcement
inquiry;
(2) pursuant to a law requiring the reporting of
specific health care information to law enforcement
authorities; or
(3) if the information is specific health informa-
tion described in paragraph (2) and the trustee is
operated by a Federal agency;
(c) CERTIFICATION.—Where a law enforcement agen-
cy requests a health information trustee to disclose pro-
tected health information under subsection (a) or (b)(1),
the agency shall provide the trustee with a written certifi-
cation that—
(1) is signed by a supervisory official of a rank
designated by the head of the agency;
(2) specifies the information requested; and
(3) states that the information is needed for a
lawful purpose under this section.
(d) RESTRICTIONS ON DISCLOSURE AND USE.—A
person who receives protected health information about a
protected individual through a disclosure under this sec-
tion may not use or disclose the information—
544
Title VI, Subtitle E
(1) in any administrative, civil, or criminal ac-
tion or investigation directed against the individual,
except an action or investigation arising out of and
directly related to the action or investigation for
which the information was obtained; and
(2) otherwise unless the use or disclosure is
necessary to fulfill the purpose for which the infor-
mation was obtained and is not prohibited by any
other provision of law.
SEC. 6420. SUBPOENAS, WARRANTS, AND SEARCH WAR-
RANTS.
(a) IN GENERAL.—A health information trustee de-
scribed in subsection (g) may disclose protected health in-
formation if the disclosure is pursuant to any of the fol-
lowing:
(1) A subpoena issued under the authority of a
grand jury and the trustee is provided a written cer-
tification by the grand jury that the grand jury has
complied with the applicable access provisions of sec-
tion 6431.
(2) An administrative subpoena or warrant or
a judicial subpoena or search warrant and the trust-
ee is provided a written certification by the person
seeking the information that the person has com-
545
Title VI, Subtitle E
plied with the applicable access provisions of section
6431 or 6433(a).
(3) An administrative subpoena or warrant or
a judicial subpoena or search warrant and the dis-
closure otherwise meets the conditions of one of sec-
tions 6413 through 6419.
(b) AUTHORITY OF ALL TRUSTEES.—Any health in-
formation trustee may disclose protected health informa-
tion if the disclosure is pursuant to subsection (a)(3).
(c) RESTRICTIONS ON USE AND DISCLOSURE.—Pro-
tected health information about a protected individual that
is disclosed by a health information trustee pursuant to—
(1) subsection (a)(2) may not be otherwise used
or disclosed by the recipient unless the use or disclo-
sure is necessary to fulfill the purpose for which the
information was obtained; and
(2) subsection (a)(3) may not be used or dis-
closed by the recipient unless the recipient complies
with the conditions and restrictions on use and dis-
closure with which the recipient would have been re-
quired to comply if the disclosure by the trustee had
been made under the section referred to in sub-
section (a)(3) the conditions of which were met by
the disclosure.
546
Title VI, Subtitle E
(d) RESTRICTIONS ON GRAND JURIES.—Protected
health information that is disclosed by a health informa-
tion trustee under subsection (a)(1)—
(1) shall be returnable on a date when the
grand jury is in session and actually presented to
the grand jury;
(2) shall be used only for the purpose of consid-
ering whether to issue an indictment or report by
that grand jury, or for the purpose of prosecuting a
crime for which that indictment or report is issued,
or for a purpose authorized by rule 6(e) of the Fed-
eral Rules of Criminal Procedure or a comparable
State rule;
(3) shall be destroyed or returned to the trustee
if not used for one of the purposes specified in para-
graph (2); and
(4) shall not be maintained, or a description of
the contents of such information shall not be main-
tained, by any government authority other than in
the sealed records of the grand jury, unless such in-
formation has been used in the prosecution of a
crime for which the grand jury issued an indictment
or presentment or for a purpose authorized by rule
6(e) of the Federal Rules of Criminal Procedure or
a comparable State rule.
547
Title VI, Subtitle E
(e) USE IN ACTION AGAINST INDIVIDUAL.—A person
who receives protected health information about a pro-
tected individual through a disclosure under this section
may not use or disclose the information in any administra-
tive, civil, or criminal action or investigation directed
against the individual, except an action or investigation
arising out of and directly related to the inquiry for which
the information was obtained;
(f) CONSTRUCTION.—Nothing in this section shall be
construed as authority for a health information trustee to
refuse to comply with a valid administrative subpoena or
warrant or a valid judicial subpoena or search warrant
that meets the requirements of this subtitle.
(g) APPLICABILITY.—A health information trustee
referred to in subsection (a) is any trustee other than the
following:
(1) A health information service organization.
(2) A public health authority.
(3) A health researcher.
SEC. 6421. HEALTH INFORMATION SERVICE ORGANIZA-
TIONS.
A health information trustee may disclose protected
health information to a health information service organi-
zation for the purpose of permitting the organization to
perform a function for which the Secretary has authorized
548
Title VI, Subtitle E
(by means of a designation or certification) the organiza-
tion to receive access to health care data in electronic or
magnetic form that are regulated by this Act.
PART 3—ACCESS PROCEDURES AND CHALLENGE
RIGHTS
SEC. 6431. ACCESS PROCEDURES FOR LAW ENFORCEMENT
SUBPOENAS, WARRANTS, AND SEARCH WAR-
RANTS.
(a) PROBABLE CAUSE REQUIREMENT.—A govern-
ment authority may not obtain protected health informa-
tion about a protected individual from a health informa-
tion trustee under paragraph (1) or (2) of section 6420(a)
for use in a law enforcement inquiry unless there is prob-
able cause to believe that the information is relevant to
a legitimate law enforcement inquiry being conducted by
the government authority.
(b) WARRANTS AND SEARCH WARRANTS.—A govern-
ment authority that obtains protected health information
about a protected individual from a health information
trustee under circumstances described in subsection (a)
and pursuant to a warrant or search warrant shall, not
later than 30 days after the date the warrant was served
on the trustee, serve the individual with, or mail to the
last known address of the individual, a copy of the
warrant.
549
Title VI, Subtitle E
(c) SUBPOENAS.—Except as provided in subsection
(d), a government authority may not obtain protected
health information about a protected individual from a
health information trustee under circumstances described
in subsection (a) and pursuant to a subpoena unless a
copy of the subpoena has been served by hand delivery
upon the individual, or mailed to the last known address
of the individual, on or before the date on which the sub-
poena was served on the trustee, together with a notice
(published by the Secretary under section 6435(1)) of the
individual’s right to challenge the subpoena in accordance
with section 6432, and—
(1) 30 days have passed from the date of serv-
ice, or 30 days have passed from the date of mailing,
and within such time period the individual has not
initiated a challenge in accordance with section
6432; or
(2) disclosure is ordered by a court under sec-
tion 6432.
(d) APPLICATION FOR DELAY.—
(1) IN GENERAL.—A government authority may
apply to an appropriate court to delay (for an initial
period of not longer than 90 days) serving a copy of
a subpoena and a notice otherwise required under
subsection (c) with respect to a law enforcement in-
550
Title VI, Subtitle E
quiry. The government authority may apply to the
court for extensions of the delay.
(2) REASONS FOR DELAY.—An application for
a delay, or extension of a delay, under this sub-
section shall state, with reasonable specificity, the
reasons why the delay or extension is being sought.
(3) EX PARTE ORDER.—The court shall enter
an ex parte order delaying, or extending the delay
of, the notice and an order prohibiting the trustee
from revealing the request for, or the disclosure of,
the protected health information being sought if the
court finds that—
(A) the inquiry being conducted is within
the lawful jurisdiction of the government
authority 
seeking 
the 
protected 
health
information;
(B) there is probable cause to believe that
the protected health information being sought is
relevant to a legitimate law enforcement inquiry
being conducted by the government authority;
(C) the government authority’s need for
the information outweighs the privacy interest
of the protected individual who is the subject of
the information; and
551
Title VI, Subtitle E
(D) there are reasonable grounds to believe
that receipt of a notice by the individual will re-
sult in—
(i) endangering the life or physical
safety of any individual;
(ii) flight from prosecution;
(iii) destruction of or tampering with
evidence or the information being sought;
or
(iv) intimidation of potential wit-
nesses.
(4) SERVICE
OF
APPLICATION
ON
INDIVID-
UAL.—Upon the expiration of a period of delay of
notice under this subsection, the government author-
ity shall serve upon the individual, with the service
of the subpoena and the notice, a copy of any appli-
cations filed and approved under this subsection.
SEC. 6432. CHALLENGE PROCEDURES FOR LAW ENFORCE-
MENT SUBPOENAS.
(a) MOTION TO QUASH SUBPOENA.—Within 30 days
of the date of service, or 30 days of the date of mailing,
of a subpoena of a government authority seeking protected
health information about a protected individual from a
health information trustee under paragraph (1) or (2) of
section 6420(a) (except a subpoena to which section 6433
552
Title VI, Subtitle E
applies), the individual may file (without filing fee) a mo-
tion to quash the subpoena—
(1) in the case of a State judicial subpoena, in
the court which issued the subpoena;
(2) in the case of a subpoena issued under the
authority of a State that is not a State judicial sub-
poena, in a court of competent jurisdiction;
(3) in the case of a subpoena issued under the
authority of a Federal court, in any court of the
United States of competent jurisdiction; or
(4) in the case of any other subpoena issued
under the authority of the United States, in—
(A) the United States district court for the
district in which the individual resides or in
which the subpoena was issued; or
(B) another United States district court of
competent jurisdiction.
(b) COPY.—A copy of the motion shall be served by
the individual upon the government authority by delivery
of registered or certified mail.
(c) AFFIDAVITS AND SWORN DOCUMENTS.—The gov-
ernment authority may file with the court such affidavits
and other sworn documents as sustain the validity of the
subpoena. The individual may file with the court, within
5 days of the date of the authority’s filing, affidavits and
553
Title VI, Subtitle E
sworn documents in response to the authority’s filing. The
court, upon the request of the individual, the government
authority, or both, may proceed in camera.
(d) PROCEEDINGS AND DECISION ON MOTION.—The
court may conduct such proceedings as it deems appro-
priate to rule on the motion. All such proceedings shall
be completed, and the motion ruled on, within 10 calendar
days of the date of the government authority’s filing.
(e) EXTENSION
OF
TIME
LIMITS
FOR
GOOD
CAUSE.—The court, for good cause shown, may at any
time in its discretion enlarge the time limits established
by subsections (c) and (d).
(f) STANDARD FOR DECISION.—A court may deny a
motion under subsection (a) if it finds that there is prob-
able cause to believe that the protected health information
being sought is relevant to a legitimate law enforcement
inquiry being conducted by the government authority, un-
less the court finds that the individual’s privacy interest
outweighs the government authority’s need for the infor-
mation. The individual shall have the burden of dem-
onstrating that the individual’s privacy interest outweighs
the need established by the government authority for the
information.
(g) SPECIFIC CONSIDERATIONS WITH RESPECT TO
PRIVACY INTEREST.—In determining under subsection (f)
554
Title VI, Subtitle E
whether an individual’s privacy interest outweighs the gov-
ernment authority’s need for the information, the court
shall consider—
(1) the particular purpose for which the infor-
mation was collected by the trustee;
(2) the degree to which disclosure of the infor-
mation will embarrass, injure, or invade the privacy
of the individual;
(3) the effect of the disclosure on the individ-
ual’s future health care;
(4) the importance of the inquiry being con-
ducted by the government authority, and the impor-
tance of the information to that inquiry; and
(5) any other factor deemed relevant by the
court.
(h) ATTORNEY’S FEES.—In the case of any motion
brought under subsection (a) in which the individual has
substantially prevailed, the court, in its discretion, may as-
sess against a government authority a reasonable attor-
ney’s fee and other litigation costs (including expert fees)
reasonably incurred.
(i) NO INTERLOCUTORY APPEAL.—A court ruling de-
nying a motion to quash under this section shall not be
deemed a final order and no interlocutory appeal may be
taken therefrom by the individual. An appeal of such a
555
Title VI, Subtitle E
ruling may be taken by the individual within such period
of time as is provided by law as part of any appeal from
a final order in any legal proceeding initiated against the
individual arising out of or based upon the protect health
information disclosed.
SEC. 6433. ACCESS AND CHALLENGE PROCEDURES FOR
OTHER SUBPOENAS.
(a) IN GENERAL.—A person (other than a govern-
ment authority seeking protected health information under
circumstances described in section 6431(a)) may not ob-
tain protected health information about a protected indi-
vidual from a health information trustee pursuant to a
subpoena under section 6420(a)(2) unless—
(1) a copy of the subpoena has been served
upon the individual or mailed to the last known ad-
dress of the individual on or before the date on
which the subpoena was served on the trustee, to-
gether with a notice (published by the Secretary
under section 6435(2)) of the individual’s right to
challenge the subpoena, in accordance with sub-
section (b); and
(2) either—
(A) 30 days have passed from the date of
service or 30 days have passed from the date of
the mailing and within such time period the in-
556
Title VI, Subtitle E
dividual has not initiated a challenge in accord-
ance with subsection (b); or
(B) disclosure is ordered by a court under
such subsection.
(b) MOTION TO QUASH.—Within 30 days of the date
of service or 30 days of the date of mailing of a subpoena
seeking protected health information about a protected in-
dividual from a health information trustee under sub-
section (a), the individual may file (without filing fee) in
any court of competent jurisdiction, a motion to quash the
subpoena, with a copy served on the person seeking the
information. The individual may oppose, or seek to limit,
the subpoena on any grounds that would otherwise be
available if the individual were in possession of the infor-
mation.
(c) STANDARD
FOR DECISION.—The court shall
grant an individual’s motion under subsection (b) if the
person seeking the information has not sustained the bur-
den of demonstrating that—
(1) there are reasonable grounds to believe that
the information will be relevant to a lawsuit or other
judicial or administrative proceeding; and
(2) the need of the person for the information
outweighs the privacy interest of the individual.
557
Title VI, Subtitle E
(d) SPECIFIC CONSIDERATIONS WITH RESPECT TO
PRIVACY INTEREST.—In determining under subsection (c)
whether the need of the person for the information out-
weighs the privacy interest of the individual, the court
shall consider—
(1) the particular purpose for which the infor-
mation was collected by the trustee;
(2) the degree to which disclosure of the infor-
mation will embarrass, injure, or invade the privacy
of the individual;
(3) the effect of the disclosure on the individ-
ual’s future health care;
(4) the importance of the information to the
lawsuit or proceeding; and
(5) any other factor deemed relevant by the
court.
(e) ATTORNEY’S FEES.—In the case of any motion
brought under subsection (b) by an individual against a
person in which the individual has substantially prevailed,
the court, in its discretion, may assess against the person
a reasonable attorney’s fee and other litigation costs (in-
cluding expert fees) reasonably incurred.
558
Title VI, Subtitle E
SEC. 6434. CONSTRUCTION OF PART; SUSPENSION OF STAT-
UTE OF LIMITATIONS.
(a) IN GENERAL.—Nothing in this part shall affect
the right of a health information trustee to challenge a
request for protected health information. Nothing in this
part shall entitle a protected individual to assert the rights
of a health information trustee.
(b) EFFECT OF MOTION ON STATUTE OF LIMITA-
TIONS.—If an individual who is the subject of protected
health information files a motion under this part which
has the effect of delaying the access of a government au-
thority to such information, the period beginning on the
date such motion was filed and ending on the date on
which the motion is decided shall be excluded in computing
any period of limitations within which the government au-
thority may commence any civil or criminal action in con-
nection with which the access is sought.
SEC. 6435. RESPONSIBILITIES OF SECRETARY.
Not later than July 1, 1996, the Secretary, after no-
tice and opportunity for public comment, shall develop and
disseminate brief, clear, and easily understood model no-
tices—
(1) for use under subsection (c) of section
6431, detailing the rights of a protected individual
who wishes to challenge, under section 6432, the dis-
559
Title VI, Subtitle E
closure of protected health information about the in-
dividual under such subsection; and
(2) for use under subsection (a) of section
6433, detailing the rights of a protected individual
who wishes to challenge, under subsection (b) of
such section, the disclosure of protected health infor-
mation about the individual under such section.
PART 4—MISCELLANEOUS PROVISIONS
SEC. 6441. PAYMENT CARD AND ELECTRONIC PAYMENT
TRANSACTIONS.
(a) PAYMENT FOR HEALTH CARE THROUGH CARD
OR ELECTRONIC MEANS.—If a protected individual pays
a health information trustee for health care by presenting
a debit, credit, or other payment card or account number,
or by any other electronic payment means, the trustee may
disclose to a person described in subsection (b) only such
protected health information about the individual as is
necessary for the processing of the payment transaction
or the billing or collection of amounts charged to, debited
from, or otherwise paid by, the individual using the card,
number, or other electronic payment means.
(b) TRANSACTION PROCESSING.—A person who is a
debit, credit, or other payment card issuer, is otherwise
directly involved in the processing of payment transactions
involving such cards or other electronic payment trans-
560
Title VI, Subtitle E
actions, or is otherwise directly involved in the billing or
collection of amounts paid through such means, may only
use or disclose protected health information about a pro-
tected individual that has been disclosed in accordance
with subsection (a) when necessary for—
(1) the authorization, settlement, billing or col-
lection of amounts charged to, debited from, or oth-
erwise paid by, the individual using a debit, credit,
or other payment card or account number, or by
other electronic payment means;
(2) the transfer of receivables, accounts, or in-
terest therein;
(3) the audit of the credit, debit, or other pay-
ment card account information;
(4) compliance with Federal, State, or local law;
or
(5) a properly authorized civil, criminal, or reg-
ulatory investigation by Federal, State, or local au-
thorities.
SEC. 6442. ACCESS TO PROTECTED HEALTH INFORMATION
OUTSIDE OF THE UNITED STATES.
(a) IN GENERAL.—Notwithstanding the provisions of
part 2, and except as provided in subsection (b), a health
information trustee may not permit any person who is not
in a State to have access to protected health information
561
Title VI, Subtitle E
about a protected individual unless one or more of the fol-
lowing conditions exist:
(1) SPECIFIC AUTHORIZATION.—The individual
has specifically consented to the provision of such
access outside of the United States in an authoriza-
tion that meets the requirements of section 6412.
(2) EQUIVALENT PROTECTION.—The provision
of such access is authorized under this subtitle and
the Secretary has determined that there are fair in-
formation practices for protected health information
in the jurisdiction where the access will be provided
that provide protections for individuals and pro-
tected health information that are equivalent to the
protections provided for by this subtitle.
(3) ACCESS REQUIRED BY LAW.—The provision
of such access is required under—
(A) a Federal statute; or
(B) a treaty or other international agree-
ment applicable to the United States.
(b) EXCEPTIONS.—Subsection (a) does not apply
where the provision of access to protected health informa-
tion—
(1) is to a foreign public health authority;
(2) is authorized under section 6414 (relating
to next of kin and directory information), 6416 (re-