229
‘‘(C) SPECIAL
RULES
FOR
INDIVIDUALS
RECEIVING IMMEDIATE FEDERAL ANNUITIES.—
‘‘(i) 
IN
GENERAL.—Subparagraph
(A)(iii) and subsection (b)(4) shall not
apply for any month to an individual—
‘‘(I) who, as of the first day of
such month, is enrolled in a high de-
ductible health plan under chapter 89
of title 5, United States Code; and
‘‘(II) who is entitled to receive
for such month any amount by reason
of being an annuitant (as defined in
section 8901(3) of such title 5).
‘‘(ii) SPECIAL RULE FOR SPOUSE OF
ANNUITANT.—In the case of the spouse of
an individual described in clause (i) who is
not also described in clause (i), subsection
(b)(4) shall not apply to such spouse if
such individual and spouse have family
coverage under the same plan described in
clause (i)(I).’’.
(h) EFFECTIVE DATE.—The amendments made by
this section shall apply to taxable years ending after the
date of the enactment of this Act.
230
SEC. 3202. EXCEPTION FROM INSURANCE LIMITATION IN
CASE OF MEDICAL SAVINGS ACCOUNTS.
(a) IN GENERAL.—Section 220(d)(2)(B) of the Inter-
nal Revenue Code of 1986 is amended by adding at the
end the following new clause:
‘‘(iii) INSURANCE OFFERED BY COM-
MUNITY HEALTH CENTERS.—
‘‘(I) IN
GENERAL.—Subject to
subclauses (II) and (III), clause (i)
shall not apply to any expense for cov-
erage under insurance offered by a
health center (as defined in section
330(a)(1) of the Public Health Serv-
ice Act) if the coverage consists solely
of coverage for required primary
health benefits (as defined in section
330(b)(1)(A) of such Act) provided on
a capitated basis.
‘‘(II) INCOME LIMITATION.—Sub-
clause (I) shall only apply to expenses
for coverage of an individual who, in
the taxable year involved, has income
that is less than 200 percent of the
income official poverty line (as defined
by the Office of Management and
Budget, and revised annually in ac-
231
cordance with section 673(2) of the
Omnibus Budget Reconciliation Act of
1981) applicable to a family of the
size involved.
‘‘(III) LIMITATION
ON
NUMBER
OF CONTRACTS.—For a taxable year
ending in a calendar year, subclause
(I) shall apply only to expenses for
coverage for the first 15,000 individ-
uals enrolled in insurance described in
such subclause in the year.’’.
(b) REPORTS ON ENROLLMENT.—Section 330(j)(3)
of the Public Health Service Act (42 U.S.C. 254c(j)(3))
is amended—
(1) by striking ‘‘and’’ at the end of subpara-
graph (K);
(2) by striking the period at the end of sub-
paragraph (L) and inserting ‘‘; and’’; and
(3) by inserting after subparagraph (L) the fol-
lowing new subparagraph:
‘‘(M) if the center offers insurance cov-
erage to an individual with a medical savings
account 
under 
subclause 
(I) 
of 
section
220(d)(2)(B)(iii), the center shall provide such
reports in such time and manner as may be re-
232
quired by the Secretary and the Secretary of
the Treasury in order to carry out subclause
(III) of such section.’’.
SEC. 3203. SENSE OF THE HOUSE OF REPRESENTATIVES.
It is the sense of the House of Representatives that
patients are best served when they are empowered to make
informed choices about their own health care. The same
is true regarding an individual’s choice of health insur-
ance. A system that gives people the power to choose the
coverage that best meets their needs, combined with insur-
ance market reforms, offers great promise of increased
choices and greater access to health insurance for Ameri-
cans.
TITLE IV—HEALTH CARE
LAWSUIT REFORM
Subtitle A—General Provisions
SEC. 4001. FEDERAL REFORM OF HEALTH CARE LIABILITY
ACTIONS.
(a) APPLICABILITY.—This title shall apply with re-
spect to any health care liability action brought in any
State or Federal court, except that this title shall not
apply to—
(1) an action for damages arising from a vac-
cine-related injury or death to the extent that title
233
XXI of the Public Health Service Act applies to the
action; or
(2) an action under the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1001 et
seq.).
(b) PREEMPTION.—This title shall preempt any State
law to the extent such law is inconsistent with the limita-
tions contained in this title. This title shall not preempt
any State law that provides for defenses or places limita-
tions on a person’s liability in addition to those contained
in this title or otherwise imposes greater restrictions than
those provided in this title.
(c) EFFECT ON SOVEREIGN IMMUNITY AND CHOICE
OF LAW OR VENUE.—Nothing in subsection (b) shall be
construed 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;
(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
234
(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 of inconvenient
forum.
(d) AMOUNT
IN CONTROVERSY.—In an action to
which this title applies and which is brought under section
1332 of title 28, United States Code, the amount of non-
economic damages or punitive damages, and attorneys’
fees or costs, shall not be included in determining whether
the matter in controversy exceeds the sum or value of
$50,000.
(e) FEDERAL COURT JURISDICTION NOT ESTAB-
LISHED ON FEDERAL QUESTION GROUNDS.—Nothing in
this title shall be construed to establish any jurisdiction
in the district courts of the United States over health care
liability actions on the basis of section 1331 or 1337 of
title 28, United States Code.
SEC. 4002. DEFINITIONS.
As used in this title:
(1) ACTUAL DAMAGES.—The term ‘‘actual dam-
ages’’ means damages awarded to pay for economic
loss.
(2) ALTERNATIVE DISPUTE RESOLUTION SYS-
TEM; ADR.—The term ‘‘alternative dispute resolution
235
system’’ or ‘‘ADR’’ means a system established
under Federal or State law that provides for the res-
olution of health care liability claims in a manner
other than through health care liability actions.
(3) CLAIMANT.—The term ‘‘claimant’’ means
any person who brings a health care liability action
and any person on whose behalf such an action is
brought. If such action is brought through or on be-
half of an estate, the term includes the claimant’s
decedent. If such action is brought through or on be-
half of a minor or incompetent, the term includes
the claimant’s legal guardian.
(4) 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.
Such measure or degree of proof is more than that
required under preponderance of the evidence but
less than that required for proof beyond a reason-
able doubt.
(5) COLLATERAL
SOURCE
PAYMENTS.—The
term ‘‘collateral source payments’’ means any
amount paid or reasonably likely to be paid in the
future to or on behalf of a claimant, or any service,
236
product, or other benefit provided or reasonably like-
ly to be provided in the future to or on behalf of a
claimant, as a result of an injury or wrongful death,
pursuant to—
(A) any State or Federal health, sickness,
income-disability, accident or workers’ com-
pensation Act;
(B) any health, sickness, income-disability,
or accident insurance that provides health bene-
fits or income-disability coverage;
(C) any contract or agreement of any
group, organization, partnership, or corporation
to provide, pay for, or reimburse the cost of
medical, hospital, dental, or income disability
benefits; and
(D) any other publicly or privately funded
program.
(6) DRUG.—The term ‘‘drug’’ has the meaning
given such term in section 201(g)(1) of the Federal
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C.
321(g)(1)).
(7) ECONOMIC
LOSS.—The term ‘‘economic
loss’’ means any pecuniary loss resulting from injury
(including the loss of earnings or other benefits re-
lated to employment, medical expense loss, replace-
237
ment services loss, loss due to death, burial costs,
and loss of business or employment opportunities),
to the extent recovery for such loss is allowed under
applicable State law.
(8) HARM.—The term ‘‘harm’’ means any le-
gally cognizable wrong or injury for which punitive
damages may be imposed.
(9) 
HEALTH
BENEFIT
PLAN.—The 
term
‘‘health benefit plan’’ means—
(A) a hospital or medical expense incurred
policy or certificate;
(B) a hospital or medical service plan con-
tract;
(C) a health maintenance subscriber con-
tract; or
(D) a Medicare+Choice plan (offered
under part C of title XVIII of the Social Secu-
rity Act),
that provides benefits with respect to health care
services.
(10) HEALTH
CARE
LIABILITY
ACTION.—The
term ‘‘health care liability action’’ means a civil ac-
tion brought in a State or Federal court against—
(A) a health care provider;
238
(B) an entity which is obligated to provide
or pay for health benefits under any health ben-
efit plan (including any person or entity acting
under a contract or arrangement to provide or
administer any health benefit); or
(C) the manufacturer, distributor, supplier,
marketer, promoter, or seller of a medical prod-
uct,
in which the claimant alleges a claim (including third
party claims, cross claims, counter claims, or contribution
claims) based upon the provision of (or the failure to pro-
vide or pay for) health care services or the use of a medical
product, regardless of the theory of liability on which the
claim is based or the number of plaintiffs, defendants, or
causes of action.
(11) HEALTH
CARE
LIABILITY
CLAIM.—The
term ‘‘health care liability claim’’ means a claim in
which the claimant alleges that injury was caused by
the provision of (or the failure to provide) health
care services.
(12) HEALTH
CARE
PROVIDER.—The term
‘‘health care provider’’ means any person that is en-
gaged in the delivery of health care services in a
State and that is required by the laws or regulations
of the State to be licensed or certified by the State
239
to engage in the delivery of such services in the
State.
(13) 
HEALTH
CARE
SERVICE.—The 
term
‘‘health care service’’ means any service eligible for
payment under a health benefit plan, including serv-
ices related to the delivery or administration of such
service.
(14) MEDICAL DEVICE.—The term ‘‘medical de-
vice’’ has the meaning given such term in section
201(h) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(h)).
(15) 
NONECONOMIC
DAMAGES.—The 
term
‘‘noneconomic damages’’ means damages paid to an
individual for pain and suffering, inconvenience,
emotional distress, mental anguish, loss of consor-
tium, injury to reputation, humiliation, and other
nonpecuniary losses.
(16) PERSON.—The term ‘‘person’’ means any
individual, corporation, company, association, firm,
partnership, society, joint stock company, or any
other entity, including any governmental entity.
(17) PRODUCT SELLER.—
(A) IN
GENERAL.—Subject to subpara-
graph (B), the term ‘‘product seller’’ means a
240
person who, in the course of a business con-
ducted for that purpose—
(i) sells, distributes, rents, leases, pre-
pares, blends, packages, labels, or is other-
wise involved in placing, a product in the
stream of commerce; or
(ii) installs, repairs, or maintains the
harm-causing aspect of a product.
(B) EXCLUSION.—Such term does not
include—
(i) a seller or lessor of real property;
(ii) a provider of professional services
in any case in which the sale or use of a
product is incidental to the transaction and
the essence of the transaction is the fur-
nishing of judgment, skill, or services; or
(iii) any person who—
(I) acts in only a financial capac-
ity with respect to the sale of a prod-
uct; or
(II) leases a product under a
lease arrangement in which the selec-
tion, possession, maintenance, and op-
eration of the product are controlled
by a person other than the lessor.
241
(18) PUNITIVE DAMAGES.—The term ‘‘punitive
damages’’ means damages awarded against any per-
son not to compensate for actual injury suffered, but
to punish or deter such person or others from en-
gaging in similar behavior in the future.
(19) STATE.—The term ‘‘State’’ means each of
the several States, the District of Columbia, Puerto
Rico, the Virgin Islands, Guam, American Samoa,
the Northern Mariana Islands, and any other terri-
tory or possession of the United States.
SEC. 4003. EFFECTIVE DATE.
This title will apply to—
(1) any health care liability action brought in a
Federal or State court; and
(2) any health care liability claim subject to an
alternative dispute resolution system,
that is initiated on or after the date of enactment of this
title, except that any health care liability claim or action
arising from an injury occurring before the date of enact-
ment of this title shall be governed by the applicable stat-
ute of limitations provisions in effect at the time the injury
occurred.
242
Subtitle B—Uniform Standards for
Health Care Liability Actions
SEC. 4011. STATUTE OF LIMITATIONS.
A health care liability action may not be brought
after the expiration of the 2-year period that begins on
the date on which the alleged injury that is the subject
of the action was discovered or should reasonably have
been discovered, but in no case after the expiration of the
5-year period that begins on the date the alleged injury
occurred.
SEC. 4012. CALCULATION AND PAYMENT OF DAMAGES.
(a) TREATMENT OF NONECONOMIC DAMAGES.—
(1) LIMITATION ON NONECONOMIC DAMAGES.—
The total amount of noneconomic damages that may
be awarded to a claimant for losses resulting from
the injury which is the subject of a health care liabil-
ity action may not exceed $250,000, regardless of
the number of parties against whom the action is
brought or the number of actions brought with re-
spect to the injury. The limitation under this para-
graph shall not apply to an action for damages
based solely on intentional denial of medical treat-
ment necessary to preserve a patient’s life that the
patient is otherwise qualified to receive, against the
wishes of a patient, or if the patient is incompetent,
243
against the wishes of the patient’s guardian, on the
basis of the patient’s present or predicated age, dis-
ability, degree of medical dependency, or quality of
life.
(2) LIMIT.—If, after the date of the enactment
of this Act, a State enacts a law which prescribes
the amount of noneconomic damages which may be
awarded in a health care liability action which is dif-
ferent from the amount prescribed by section
4012(a)(1), the State amount shall apply in lieu of
the amount prescribed by such section. If, after the
date of the enactment of this Act, a State enacts a
law which limits the amount of recovery in a health
care liability action without delineating between eco-
nomic and noneconomic damages, the State amount
shall apply in lieu of the amount prescribed by such
section.
(3) JOINT AND SEVERAL LIABILITY.—In any
health care liability action brought in State or Fed-
eral court, a defendant shall be liable only for the
amount of noneconomic damages attributable to
such defendant in direct proportion to such defend-
ant’s share of fault or responsibility for the claim-
ant’s actual damages, as determined by the trier of
fact. In all such cases, the liability of a defendant
244
for noneconomic damages shall be several and not
joint and a separate judgment shall be rendered
against each defendant for the amount allocated to
such defendant.
(b) TREATMENT OF PUNITIVE DAMAGES.—
(1) GENERAL RULE.—Punitive damages may,
to the extent permitted by applicable State law, be
awarded in any health care liability action for harm
in any Federal or State court against a defendant if
the claimant establishes by clear and convincing evi-
dence that the harm suffered was the result of
conduct—
(A) specifically intended to cause harm; or
(B) conduct manifesting a conscious, fla-
grant indifference to the rights or safety of oth-
ers.
(2) 
APPLICABILITY.—This 
subsection 
shall
apply to any health care liability action brought in
any Federal or State court on any theory where pu-
nitive damages are sought. This subsection does not
create a cause of action for punitive damages. This
subsection does not preempt or supersede any State
or Federal law to the extent that such law would
further limit the award of punitive damages.
245
(3) BIFURCATION.—At the request of any
party, the trier of fact shall consider in a separate
proceeding whether punitive damages are to be
awarded and the amount of such award. If a sepa-
rate proceeding is requested, evidence relevant only
to the claim of punitive damages, as determined by
applicable State law, shall be inadmissible in any
proceeding to determine whether actual damages are
to be awarded.
(4) DRUGS AND DEVICES.—
(A) IN GENERAL.—
(i) 
PUNITIVE
DAMAGES.—Punitive
damages shall not be awarded against a
manufacturer or product seller of a drug
or medical device which caused the claim-
ant’s harm where—
(I) such drug or device was sub-
ject to premarket approval by the
Food and Drug Administration with
respect to the safety of the formula-
tion or performance of the aspect of
such drug or device which caused the
claimant’s harm, or the adequacy of
the packaging or labeling of such drug
or device which caused the harm, and
246
such drug, device, packaging, or label-
ing was approved by the Food and
Drug Administration; or
(II) the drug is generally recog-
nized as safe and effective pursuant to
conditions established by the Food
and Drug Administration and applica-
ble regulations, including packaging
and labeling regulations.
(ii) APPLICATION.—Clause (i) shall
not apply in any case in which the defend-
ant, before or after premarket approval of
a drug or device—
(I) intentionally and wrongfully
withheld from or misrepresented to
the Food and Drug Administration in-
formation concerning such drug or de-
vice required to be submitted under
the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 301 et seq.) or
section 351 of the Public Health Serv-
ice Act (42 U.S.C. 262) that is mate-
rial and relevant to the harm suffered
by the claimant; or
247
(II) made an illegal payment to
an official or employee of the Food
and Drug Administration for the pur-
pose of securing or maintaining ap-
proval of such drug or device.
(B) PACKAGING.—In a health care liability
action for harm which is alleged to relate to the
adequacy of the packaging or labeling of a drug
which is required to have tamper-resistant
packaging under regulations of the Secretary of
Health and Human Services (including labeling
regulations related to such packaging), the
manufacturer or product seller of the drug shall
not be held liable for punitive damages unless
such packaging or labeling is found by the court
by clear and convincing evidence to be substan-
tially out of compliance with such regulations.
(c) PERIODIC PAYMENTS FOR FUTURE LOSSES.—
(1) GENERAL RULE.—In any health care liabil-
ity action in which the damages awarded for future
economic and noneconomic loss exceeds $50,000, a
person shall not be required to pay such damages in
a single, lump-sum payment, but shall be permitted
to make such payments periodically based on when
248
the damages are likely to occur, as such payments
are determined by the court.
(2) FINALITY OF JUDGMENT.—The judgment
of the court awarding periodic payments under this
subsection may not, in the absence of fraud, be re-
opened at any time to contest, amend, or modify the
schedule or amount of the payments.
(3) 
LUMP-SUM
SETTLEMENTS.—This 
sub-
section shall not be construed to preclude a settle-
ment providing for a single, lump-sum payment.
(d) TREATMENT
OF COLLATERAL SOURCE PAY-
MENTS.—
(1) INTRODUCTION
INTO
EVIDENCE.—In any
health care liability action, any defendant may intro-
duce evidence of collateral source payments. If any
defendant elects to introduce such evidence, the
claimant may introduce evidence of any amount paid
or contributed or reasonably likely to be paid or con-
tributed in the future by or on behalf of the claim-
ant to secure the right to such collateral source pay-
ments.
(2) NO SUBROGATION.—No provider of collat-
eral source payments shall recover any amount
against the claimant or receive any lien or credit
against the claimant’s recovery or be equitably or le-
249
gally subrogated to the right of the claimant in a
health care liability action.
(3) APPLICATION TO SETTLEMENTS.—This sub-
section shall apply to an action that is settled as well
as an action that is resolved by a fact finder.
SEC. 4013. ALTERNATIVE DISPUTE RESOLUTION.
Any ADR used to resolve a health care liability action
or claim shall contain provisions relating to statute of limi-
tations, noneconomic damages, joint and several liability,
punitive damages, collateral source rule, and periodic pay-
ments which are consistent with the provisions relating to
such matters in this title.
SEC. 4014. REPORTING ON FRAUD AND ABUSE ENFORCE-
MENT ACTIVITIES.
The General Accounting Office shall—
(1) monitor—
(A) the compliance of the Department of
Justice and all United States Attorneys-with
the guideline entitled ‘‘Guidance on the Use of
the False Claims Act in Civil Health Care Mat-
ters’’ issued by the Department on June 3,
1998, including any revisions to that guideline;
and
(B) the compliance of the Office of the In-
spector General of the Department of Health
250
and Human Services with the protocols and
guidelines entitled ‘‘National Project Proto-
cols—Best Practice Guidelines’’ issued by the
Inspector General on June 3, 1998, including
any revisions to such protocols and guidelines;
and
(2) submit a report on such compliance to the
Committee on Commerce, the Committee on the Ju-
diciary, and the Committee on Ways and Means of
the House of Representatives and the Committee on
the Judiciary and the Committee on Finance of the
Senate not later than February 1, 2000, and every
year thereafter for a period of 4 years ending Feb-
ruary 1, 2003.
TITLE V—CONFIDENTIALITY OF
HEALTH INFORMATION
SEC. 5001. CONFIDENTIALITY OF PROTECTED HEALTH IN-
FORMATION.
(a) IN GENERAL.—Title XI of the Social Security Act
(42 U.S.C. 1301 et seq.) is amended by adding at the end
the following:
251
‘‘PART D—CONFIDENTIALITY OF PROTECTED HEALTH
INFORMATION
‘‘INSPECTION AND COPYING OF PROTECTED HEALTH
INFORMATION
‘‘SEC. 1181. (a) IN GENERAL.—Subject to the suc-
ceeding provisions of this section, upon the request of an
individual who is the subject of protected health informa-
tion, a person who is a health care provider, health plan,
employer, health or life insurer, or educational institution
shall make available to the individual (or, in the discretion
of the person, to a health care provider designated by the
individual), for inspection and copying, protected health
information concerning the individual that the person
maintains, including records created under section 1182.
‘‘(b) ACCESS THROUGH ORIGINATING PROVIDER.—
Protected health information that is created by an origi-
nating provider, and subsequently received by another
health care provider or a health plan as part of treatment
or payment activities, shall be made available for inspec-
tion and copying as provided in this section through the
originating provider, rather than the receiving health care
provider or health plan, unless the originating provider
does not maintain the information.
‘‘(c) INVESTIGATIONAL INFORMATION.—With respect
to protected health information that was created as part
252
of the requesting individual’s participation in a clinical
trial monitored by an institutional review board estab-
lished to review health research with respect to potential
risks to human subjects pursuant to Federal regulations
adopted under section 1802(b) of the Public Health Serv-
ice Act (42 U.S.C. 300v–1(b)) and the notice (informally
referred to as the ‘Common Rule’) promulgated in the
Federal Register at 56 Fed. Reg. 28003), a request under
subsection (a) shall be granted only to the extent and in
a manner consistent with such regulations.
‘‘(d) OTHER EXCEPTIONS.—Unless ordered by a
court of competent jurisdiction, a person to whom a re-
quest under subsection (a) is made is not required to grant
the request, if—
‘‘(1) the person determines that the disclosure
of the information could reasonably be expected to
endanger the life or physical safety of, or cause sub-
stantial harm to, any individual; or
‘‘(2) the information is compiled principally—
‘‘(A) in anticipation of a civil, criminal, or
administrative action or proceeding; or
‘‘(B) for use in such action or proceeding.
‘‘(e) DENIAL
OF REQUEST
FOR INSPECTION
OR
COPYING.—If a person to whom a request under sub-
section (a) is made denies a request for inspection or copy-
253
ing pursuant to this section, the person shall inform the
individual making the request, in writing, of—
‘‘(1) the reasons for the denial of the request;
‘‘(2) the availability of procedures for further
review of the denial; and
‘‘(3) the individual’s right to file with the per-
son a concise statement setting forth the request.
‘‘(f) STATEMENT REGARDING REQUEST.—If an indi-
vidual has filed with a person a statement under sub-
section (e)(3) with respect to protected health information,
the person, in any subsequent disclosure of the
information—
‘‘(1) shall include a notation concerning the in-
dividual’s statement; and
‘‘(2) may include a concise statement of the
reasons for denying the request for inspection or
copying.
‘‘(g) PROCEDURES.—A person providing access to
protected health information for inspection or copying
under this section may set forth appropriate procedures
to be followed for such inspection or copying and may re-
quire an individual to pay reasonable costs associated with
such inspection or copying.
‘‘(h) INSPECTION
AND COPYING
OF SEGREGABLE
PORTION.—A person to whom a request under subsection
254
(a) is made shall permit the inspection and copying of any
reasonably segregable portion of a record after deletion of
any portion that the person is not required to disclose
under this section.
‘‘(i) DEADLINE.—A person described in subsection
(a) shall comply with or deny, in accordance with this sec-
tion, a request for inspection or copying of protected
health information under this section not later than 30
days after the date on which the person receives the re-
quest.
‘‘(j) RULES GOVERNING AGENTS.—An agent of a
person described in subsection (a) shall not be required
to provide for the inspection and copying of protected
health information, except where—
‘‘(1) the protected health information is re-
tained by the agent; and
‘‘(2) the agent has been asked by the person to
fulfill the requirements of this section.
‘‘SUPPLEMENTATION OF PROTECTED HEALTH
INFORMATION
‘‘SEC. 1182. (a) IN GENERAL.—Subject to subsection
(b), not later than 45 days after the date on which a per-
son who is a health care provider, health plan, employer,
health or life insurer, or educational institution receives,
from an individual who is a subject of protected health
information that is maintained by the person, a request
255
in writing to amend the information by adding a concise
written supplement to it, the person—
‘‘(1) shall make the amendment requested;
‘‘(2) shall inform the individual of the amend-
ment that has been made; and
‘‘(3) shall make reasonable efforts to inform
any person who is identified by the individual, who
is not an officer, employer, or agent of the person
receiving the request, and to whom the unamended
portion of the information was disclosed during the
preceding year, by sending a notice to the person’s
last known address that an amendment, consisting
of the addition of a supplement, has been made to
the protected health information of the individual.
‘‘(b) REFUSAL TO AMEND.—If a person described in
subsection (a) refuses to make an amendment requested
by an individual under such subsection, the person shall
inform the individual, in writing, of—
‘‘(1) the reasons for the refusal to make the
amendment;
‘‘(2) any procedures for further review of the
refusal; and
‘‘(3) the individual’s right to file with the per-
son a concise statement setting forth the requested
256
amendment and the individual’s reasons for dis-
agreeing with the refusal.
‘‘(c) STATEMENT OF DISAGREEMENT.—If an individ-
ual has filed a statement of disagreement with a person
under subsection (b)(3), the person, in any subsequent dis-
closure of the disputed portion of the information—
‘‘(1) shall include a notation that such individ-
ual has filed a statement of disagreement; and
‘‘(2) may include a concise statement of the
reasons for not making the requested amendment.
‘‘(d) RULES GOVERNING AGENTS.—The agent of a
person described in subsection (a) shall not be required
to make amendments to individually identifiable health in-
formation, except where—
‘‘(1) the information is retained by the agent;
and
‘‘(2) the agent has been asked by such person
to fulfill the requirements of this section.
‘‘(e) DUPLICATIVE REQUESTS FOR AMENDMENTS.—
If a person described in subsection (a) receives a duplica-
tive request for an amendment of information as provided
for in such subsection and a statement of disagreement
with respect to the request has been filed pursuant to sub-
section (c), the person shall inform the individual of such
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filing and shall not be required to carry out the procedures
under this section.
‘‘(f) RULE OF CONSTRUCTION.—This section shall
not be construed—
‘‘(1) to permit an individual to modify state-
ments in his or her record that document the factual
observations of another individual or state the re-
sults of diagnostic tests; or
‘‘(2) to permit an individual to amend his or
her record as to the type, duration, or quality of
treatment the individual believes he or she should
have been provided.
‘‘NOTICE OF CONFIDENTIALITY PRACTICES
‘‘SEC. 1183. (a) PREPARATION OF WRITTEN NO-
TICE.—A person who is a health care provider, health
plan, health oversight agency, public health authority, em-
ployer, health or life insurer, health researcher, or edu-
cational institution shall post or provide, in writing and
in a clear and conspicuous manner, notice of the person’s
protected health information confidentiality practices. The
notice shall include—
‘‘(1) a description of an individual’s rights with
respect to protected health information;
‘‘(2) the intended uses and disclosures of pro-
tected health information;
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‘‘(3) the procedures established by the person
for the exercise of an individual’s rights with respect
to protected health information; and
‘‘(4) the procedures established by the person
for obtaining copies of the notice.
‘‘(b) MODEL NOTICE.—The Secretary, after notice
and opportunity for public comment, and based on the ad-
vice of the National Committee on Vital and Health Sta-
tistics established under section 306(k) of the Public
Health Service Act (42 U.S.C. 242k(k)), shall develop and
disseminate, not later than 6 months after the date of the
enactment of the Patient Protection Act of 1999, model
notices of confidentiality practices, for use under this sec-
tion. Use of a model notice developed by the Secretary
shall serve as a complete defense in any civil action to an
allegation that a violation of this section has occurred.
‘‘ESTABLISHMENT OF SAFEGUARDS
‘‘SEC. 1184. (a) IN GENERAL.—A person who is a
health care provider, health plan, health oversight agency,
public health authority, employer, health or life insurer,
health researcher, or educational institution shall estab-
lish, maintain, and enforce reasonable and appropriate ad-
ministrative, technical, and physical safeguards to protect
the confidentiality, security, accuracy, and integrity of
protected health information created, received, obtained,
259
maintained, used, transmitted, or disposed of by the per-
son.
‘‘(b) FACTORS TO BE CONSIDERED.—A person sub-
ject to subsection (a) shall consider the following factors
in establishing safeguards under such subsection:
‘‘(1) The need for protected health information.
‘‘(2) The categories of personnel who will have
access to protected health information.
‘‘(3) The feasibility of limiting access to individ-
ual identifiers.
‘‘(4) The appropriateness of the policy or proce-
dure to the person, and to the medium in which pro-
tected health information is stored and transmitted.
‘‘(5) The value of audit trails in computerized
records.
‘‘(c) RELATIONSHIP TO PART C REQUIREMENT.—
Any safeguard established under this section shall be con-
sistent with the requirement in section 1173(d)(2).
‘‘(d) CONVERSION TO NONIDENTIFIABLE HEALTH
INFORMATION.—A person subject to subsection (a) shall,
to the extent practicable and consistent with the purpose
for which protected health information is maintained, con-
vert such information into nonidentifiable health informa-
tion.
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‘‘AVAILABILITY OF PROTECTED HEALTH INFORMATION
FOR PURPOSES OF HEALTH CARE OPERATIONS
‘‘SEC. 1185. (a) DISCLOSURE.—Any person who
maintains protected health information may disclose the
information to a health care provider or a health plan for
the purpose of permitting the provider or plan to conduct
health care operations.
‘‘(b) USE.—A health care provider or a health plan
that maintains protected health information may use it for
the purpose described in subsection (a).
‘‘(c) LIMITATION ON SALE OR BARTER.—Notwith-
standing subsection (b), no health care provider or health
plan may, as part of conducting health care operations,
sell or barter protected health information.
‘‘RELATIONSHIP TO OTHER LAWS
‘‘SEC. 1186. (a) STATE LAW.—
‘‘(1) IN GENERAL.—Except as provided in para-
graphs (2) and (3), the provisions of this part shall
preempt a provision of State law to the extent that
such provision—
‘‘(A) otherwise would be preempted as in-
consistent with this part under article VI of the
Constitution of the United States;
‘‘(B) relates to authorization for the use or
disclosure of—
261
‘‘(i) protected health information for
health care operations; or
‘‘(ii) nonidentifiable health informa-
tion; or
‘‘(C) relates to any of the following:
‘‘(i) Inspection or copying of protected
health information by a person who is a
subject of the information.
‘‘(ii) Amendment of protected health
information by a person who is a subject
of the information.
‘‘(iii) Notice of confidentiality prac-
tices with respect to protected health infor-
mation.
‘‘(iv) Establishment of safeguards for
protected health information.
‘‘(2) EXCEPTIONS.—Nothing in this part shall
be construed to preempt or modify a provision of
State law to the extent that such provision relates
to protected health information and—
‘‘(A) the confidentiality of the records
maintained by a licensed mental health profes-
sional;
262
‘‘(B) the provision of health care to a
minor, or the disclosure of information about a
minor to a parent or guardian of the minor;
‘‘(C) condition-specific limitations on dis-
closure;
‘‘(D) the use or disclosure of information
for use in legally authorized—
‘‘(i) disease or injury reporting;
‘‘(ii) public health surveillance, inves-
tigation, or intervention;
‘‘(iii) vital statistics reporting, such as
reporting of birth or death information;
‘‘(iv) reporting of abuse or neglect in-
formation;
‘‘(v) reporting of information concern-
ing a communicable disease status; or
‘‘(vi) reporting concerning the safety
or effectiveness of a biological product reg-
ulated under section 351 of the Public
Health Service Act (42 U.S.C. 262) or a
drug or device regulated under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.);
‘‘(E) the disclosure to a person by a health
care provider of information about an individ-
263
ual, in any case in which the provider has
determined—
‘‘(i) in the provider’s reasonable medi-
cal judgment, that the individual is uncon-
scious, incompetent, or otherwise incapable
of deciding whether to authorize disclosure
of the protected health information; and
‘‘(ii) in the provider’s reasonable judg-
ment, that the person is a spouse, relative,
guardian, or close friend of the individ-
ual’s; or
‘‘(F) the use of information by, or the dis-
closure of information to, a person holding a
valid and applicable power of attorney that in-
cludes the authority to make health care deci-
sions on behalf of an individual who is a subject
of the information.
‘‘(3) PRIVILEGES.—Nothing in this part shall
be construed to preempt or modify a provision of
State law to the extent that such provision relates
to a privilege of a witness or other person in a court
of that State.
‘‘(b) FEDERAL LAW.—Nothing in this part shall be
construed to preempt, modify, or repeal a provision of any
other Federal law relating to protected health information