I 
109TH CONGRESS 
1ST SESSION H. R. 2599 
To improve the quality, availability, diversity, personal privacy, and innovation 
of health care in the United States. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 24, 2005 
Mr. ROHRABACHER introduced the following bill; which was referred to the 
Committee on Ways and Means, and in addition to the Committees on 
Energy and Commerce and Judiciary, for a period to be subsequently de-
termined by the Speaker, in each case for consideration of such provisions 
as fall within the jurisdiction of the committee concerned 
A BILL 
To improve the quality, availability, diversity, personal 
privacy, and innovation of health care in the United States. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Medical Independence, Privacy, and Innovation Act of 
2005’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents.
TITLE I—TAX-RELATED PROVISIONS 
Sec. 101. Findings. 
Sec. 102. Deduction of medical expenses for individuals. 
Sec. 103. Medical checking accounts. 
Sec. 104. Decrease in minimum annual deductibles under a high deductible 
health plan for purposes of health savings accounts and Archer 
MSAs. 
TITLE II—MEDICAL PRIVACY 
Sec. 201. Findings. 
Sec. 202. Modification of regulations on privacy of individually identifiable 
health information. 
TITLE III—MODIFICATIONS REGARDING REGULATION OF DRUGS 
UNDER FEDERAL FOOD, DRUG, AND COSMETIC ACT 
Sec. 301. Definition of drug. 
Sec. 302. Striking of effectiveness requirement; modifications regarding patent 
listings, patent certifications, and thirty-month rule. 
Sec. 303. Granting of exclusive or partially exclusive licenses regarding inven-
tions made with Federal assistance. 
Sec. 304. Importation of certain drugs. 
TITLE I—TAX-RELATED 
PROVISIONS 
SEC. 101. FINDINGS. 
The Congress finds the following: 
(1) Current law confers tax benefits for health 
insurance provided as an employee fringe benefit, 
but no similar tax benefit for health insurance pur-
chased by individuals thus creating an unfair bias 
toward employer provided medical insurance plans 
and an unfair discrimination against individuals who 
seek marketplace alternatives to health insurance. 
(2) Current law confers a tax benefits for third 
party payment of medical expenses but no similar 
tax benefits for direct individual payment of medical 
expenses. This has promoted employer-provided
third party payment systems and discouraged direct 
doctor-patient relationships. 
(3) The current tax treatment of medical ex-
penses has resulted in a greatly distorted market-
place in medical insurance where decreased opportu-
nities for private personal health insurance has re-
duced competition both for medical insurance and 
health care services. This has resulted in an in-
creased costs of both health insurance and health 
care services and fostered over use of low high pre-
mium health insurance plans. 
(4) The current tax treatment of medical ex-
penses has restricted the freedom of individuals to 
exercise direct control over their health care dollars. 
The exclusion from gross income for employer-pro-
vided health care with no corresponding tax benefit 
for health insurance and health care costs bourn by 
individuals represents a strong incentive toward em-
ployers group plans. 
(5) The tax code’s preferment of employer-pro-
vided group plans has triggered a marketplace re-
sponse reflected in the significant increases in large 
health care delivery, and the creation of a relative 
few health care conglomerates in lieu of thousands 
of competitive providers of medical insurance and
services. This has increasingly placed medical deci-
sions in the hands of health care bureaucracies and 
has eroded doctor-patient relationships. 
(6) The role of the marketplace in both medical 
insurance and medical services should be strength-
ened. The discriminatory tax policies in the area of 
health insurance and health care should be ended. 
Private individuals should be able to contract for 
their health insurance and health care delivery in at-
mosphere free of discriminatory tax pressures. High 
deductible low premium as well as catastrophic alter-
natives in health insurance should be viable options 
for all Americans. 
SEC. 102. DEDUCTION OF MEDICAL EXPENSES FOR INDI-
VIDUALS. 
(a) IN GENERAL.—Subsection (a) of section 213 of 
the Internal Revenue Code of 1986 (relating to treatment 
of medical, dental, etc., expenses) is amended to read as 
follows: 
‘‘(a) ALLOWANCE OF DEDUCTION.—There shall be 
allowed as a deduction the expenses paid during the tax-
able year, not compensated for by insurance or otherwise, 
for medical care of the taxpayer, his spouse, or a depend-
ent (as defined by section 152, determined without regard 
to subsections (b)(1), (b)(2), and (d)(1)(B) thereof).’’.
(b) DEDUCTION
ALLOWED
IN
COMPUTING
AD-
JUSTED GROSS INCOME.—Subsection (a) of section 62 of 
such Code is amended by redesignating paragraph (19) 
(relating to costs involving discrimination suits, etc.) as 
paragraph (20) and by inserting after paragraph (20) the 
following new paragraph: 
‘‘(21) MEDICAL CARE.—The deduction allowed 
by section 213.’’. 
(c) CONFORMING AMENDMENTS.— 
(1) Section 56(b)(1) of such Code is amended 
by striking subparagraph (B). 
(2) Section 67(b) of such Code is amended by 
striking paragraph (5). 
(3) Section 72(t)(2)(B) of such Code is amend-
ed by striking ‘‘to the extent such distributions do 
not exceed the amount’’ and inserting ‘‘which are’’. 
(4) Sections 104(a) and 105(b) of such Code 
are both amended by striking ‘‘(and not in excess 
of)’’. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2005.
SEC. 103. MEDICAL CHECKING ACCOUNTS. 
(a) IN GENERAL.—Subchapter F of chapter 1 of the 
Internal Revenue Code of 1986 (relating to exempt organi-
zations) is amended by adding at the end the following: 
‘‘PART IX—MEDICAL CHECKING ACCOUNTS 
‘‘Sec. 530A. Medical checking accounts. 
‘‘SEC. 530A. MEDICAL CHECKING ACCOUNTS. 
‘‘(a) GENERAL RULE.—A medical checking account 
shall be exempt from taxation under this subtitle. Not-
withstanding the preceding sentence, any medical checking 
account shall be subject to the taxes imposed by section 
511 (relating to imposition of tax on unrelated business 
income of charitable, etc., organizations). Rules similar to 
the rules of paragraphs (2) and (4) of section 408(e) shall 
apply to medical checking accounts, and any amount treat-
ed as distributed under such rules shall be treated as not 
used to pay qualified medical expenses. 
‘‘(b) DEDUCTION FOR CONTRIBUTIONS.— 
‘‘(1) IN
GENERAL.—In the case of an indi-
vidual, there shall be allowed as a deduction an 
amount equal to the aggregate amount paid in cash 
during the taxable year to a medical checking ac-
count of the taxpayer. 
‘‘(2) LIMITATIONS.— 
‘‘(A) MAXIMUM ANNUAL CONTRIBUTION.— 
The deduction under paragraph (1) for a tax-
able year shall not exceed $1,000 ($2,000 in 
the case of a joint return). 
‘‘(B) MAXIMUM
ALLOWABLE
DEDUCTION 
BASED ON BALANCE IN ACCOUNT.—No deduc-
tion shall be allowed for a taxable year for any 
amount contributed to a medical checking ac-
count if the sum of such amount plus the bal-
ance in the account determined as of the end of 
the taxable year would exceed $2,000 ($4,000 
in the case of married individuals filing a joint 
return, a surviving spouse, and a head of house-
hold). 
‘‘(c) CREDIT FOR CONTRIBUTIONS.— 
‘‘(1) IN
GENERAL.—In the case of an indi-
vidual, there shall be allowed as a credit against the 
tax imposed by this chapter for the taxable year an 
amount equal to the credit amount with respect to 
contributions made during the taxable year to the 
medical checking account of the taxpayer. 
‘‘(2) CREDIT AMOUNT.—For purposes of para-
graph (1), the credit amount is the lesser of— 
‘‘(A) the total amount of contributions to 
the medical checking account for the taxable 
year reduced by the amount of contributions al-
lowed as a deduction under subsection (b), and
‘‘(B) $1,000. 
‘‘(d) DEFINITIONS AND SPECIAL RULES.—For pur-
poses of this section— 
‘‘(1) MEDICAL CHECKING ACCOUNT.—The term 
‘medical checking account’ means a trust created or 
organized in the United States for the exclusive ben-
efit of a qualified individual or his beneficiaries, but 
only if the written governing instrument creating the 
trust meets the following requirements: 
‘‘(A) Except in the case of a rollover con-
tribution described in paragraph (4)(D), no 
contribution will be accepted unless it is in 
cash, or it exceeds $1,000 ($2,000 in the case 
of married individuals filing a joint return, a 
surviving spouse, and a head of household). 
‘‘(B) The trustee is a bank (as defined in 
section 408(n), an insurance company (as de-
fined in section 816), or another person who 
demonstrates to the satisfaction of the Sec-
retary that the manner in which such person 
will administer the trust will be consistent with 
the requirements of this section. 
‘‘(C) No part of the trust assets will be in-
vested in life insurance contracts.
‘‘(D) The assets of the trust will not be 
commingled with other property except in a 
common trust fund or common investment 
fund. 
‘‘(E) The interest of an individual in the 
balance in his account is nonforfeitable. 
‘‘(2) QUALIFIED
MEDICAL
EXPENSES.—The 
term ‘qualified medical expenses’ means, with re-
spect to an account holder, amounts paid by such 
holder for medical care (as defined in section 
213(d)) for such individual, the spouse of such indi-
vidual, and any dependent (as defined in section 
152, determined without regard to subsections 
(b)(1), (b)(2), and (d)(1)(B) thereof) of such indi-
vidual, but only to the extent such amounts are not 
compensated for by insurance or otherwise (includ-
ing distributions from an Archer MSA which are not 
includible in gross income by reason of section 
220(f)(1) or from a health savings account which 
are not includible in gross income by reason of sec-
tion 223(f)(1)). 
‘‘(3) CHANGE IN FILING STATUS.—In the case 
of a taxpayer whose filing status changes during the 
taxable year, the limitation under paragraph (1)(A) 
shall be apportioned among the filing statuses of the
taxpayer in accordance with regulations prescribed 
by the Secretary. 
‘‘(4) CERTAIN RULES TO APPLY.—Rules similar 
to the following rules shall apply for purposes of this 
section: 
‘‘(A) Section 219(d)(2) (relating to no de-
duction for rollovers). 
‘‘(B) Section 219(f)(3) (relating to time 
when contributions deemed made). 
‘‘(C) Section 219(f)(5) (relating to em-
ployer payments). 
‘‘(D) Section 220(f)(5) (relating to rollover 
contributions). 
‘‘(E) Section 220(f)(7) (relating to trans-
fer of account incident to divorce). 
‘‘(F) Section 220(f)(8) (relating to treat-
ment after death of account holder). 
‘‘(G) Section 408(g) (relating to commu-
nity property laws). 
‘‘(H) Section 408(h) (relating to custodial 
accounts). 
‘‘(e) TAX TREATMENT OF DISTRIBUTIONS.— 
‘‘(1) AMOUNTS USED FOR QUALIFIED MEDICAL 
EXPENSES.—Any amount paid or distributed out of 
a medical checking account which is used exclusively
to pay qualified medical expenses of any account 
holder shall not be includible in gross income. 
‘‘(2) INCLUSION OF AMOUNTS NOT USED FOR 
QUALIFIED MEDICAL EXPENSES.—Any amount paid 
or distributed out of a medical checking account 
which is not used exclusively to pay the qualified 
medical expenses of the account holder shall be in-
cluded in the gross income of such holder. 
‘‘(3) ADDITIONAL TAX ON DISTRIBUTIONS NOT 
USED
FOR
QUALIFIED
MEDICAL
EXPENSES.—For 
purposes of this section, rules similar to the rules of 
section 220(f)(4) shall apply. 
‘‘(4) COORDINATION WITH MEDICAL EXPENSE 
DEDUCTION.—For purposes of determining the 
amount of the deduction under section 213, any pay-
ment or distribution out of a medical checking ac-
count for qualified medical expenses shall not be 
treated as an expense paid for medical care. 
‘‘(f) REPORTS.—The Secretary may require the 
trustee of a medical checking account to make such re-
ports regarding such account to the Secretary and to the 
account holder with respect to contributions, distributions, 
and such other matters as the Secretary determines appro-
priate. The reports required by this subsection shall be 
filed at such time and in such manner and furnished to
such individuals at such time and in such manner as may 
be required by the Secretary.’’. 
(b) TAX ON EXCESS CONTRIBUTIONS.—Section 4973 
of such Code (relating to tax on excess contributions to 
individual retirement accounts, certain section 403(b) con-
tracts, and certain individual retirement annuities) is 
amended— 
(1) in subsection (a) by striking ‘‘or’’ at the end 
of paragraph (4), by inserting ‘‘or’’ at the end of 
paragraph (5), and by inserting after paragraph (5) 
the following: 
‘‘(6) a medical checking account (within the 
meaning of section 530A(d)),’’, and 
(2) by adding at the end the following new sub-
section: 
‘‘(h) EXCESS CONTRIBUTIONS TO MEDICAL CHECK-
ING ACCOUNTS.—For purposes of this section, in the case 
of medical checking accounts (within the meaning of sec-
tion 530A(d)), the term ‘excess contributions’ means the 
sum of— 
‘‘(1) the aggregate amount contributed for the 
taxable year to such accounts (other than rollover 
contributions referred to in section 530A(d)(4)(D)) 
which is not allowable as a deduction or credit under 
section 530A for such year, and
‘‘(2) the amount determined under this sub-
section for the preceding taxable year, reduced by 
the sum of— 
‘‘(A) the distributions out of the accounts 
which were included in gross income under sec-
tion 530A(e)(2), and 
‘‘(B) the excess (if any) of— 
‘‘(i) the sum of the maximum amount 
allowable as a deduction or credit under 
section 530A for the taxable year, over 
‘‘(ii) the amount contributed to such 
accounts for the taxable year. 
For purposes of this subsection, any contribution which 
is distributed out of the medical checking account in a dis-
tribution to which section 530A(d)(4)(B) applies shall be 
treated as an amount not contributed.’’. 
(c) TAX ON PROHIBITED TRANSACTIONS.— 
(1) Subsection (c) of section 4975 of such Code 
(relating to tax on prohibited transactions) is 
amended by adding at the end the following new 
paragraph: 
‘‘(6) SPECIAL RULE FOR MEDICAL CHECKING 
ACCOUNTS.—An individual for whose benefit a med-
ical checking account (within the meaning of section 
530A(d)) is established shall be exempt from the tax
imposed by this section with respect to any trans-
action concerning such account (which would other-
wise be taxable under this section) if, with respect 
to such transaction, the account ceases to be a med-
ical checking account by reason of the application of 
section 530A(e)(2) to such account.’’. 
(2) Paragraph (1) of section 4975(e) of such 
Code is amended by striking ‘‘or’’ at the end of sub-
paragraph (F), by redesignating subparagraph (G) 
as subparagraph (H), and by inserting after sub-
paragraph (F) the following new subparagraph: 
‘‘(G) a medical checking account described 
in section 530A(d), or’’. 
(d) FAILURE TO PROVIDE REPORTS ON MEDICAL 
CHECKING ACCOUNTS.—Paragraph (2) of section 6693(a) 
of such Code (relating to general rule on reports) is 
amended by striking ‘‘and’’ at the end of subparagraph 
(D), by striking the period at the end of subparagraph 
(E) and inserting ‘‘, and’’, and by inserting after subpara-
graph (E) the following new subparagraph: 
‘‘(F) section 530A(g) (relating to medical 
savings accounts).’’. 
(e) CLERICAL AMENDMENT.—The table of parts for 
subchapter F of chapter 1 of such Code is amended by 
adding at the end the following new item: 
‘‘PART IX. MEDICAL CHECKING ACCOUNTS’’.
(f) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2005. 
SEC. 104. DECREASE IN MINIMUM ANNUAL DEDUCTIBLES 
UNDER A HIGH DEDUCTIBLE HEALTH PLAN 
FOR PURPOSES OF HEALTH SAVINGS AC-
COUNTS AND ARCHER MSAS. 
(a) ANNUAL DEDUCTIBLE AND OUT-OF-POCKET EX-
PENSES
WITH
RESPECT
TO
HEALTH
SAVINGS
AC-
COUNTS.— 
(1) IN
GENERAL.—Subclause (I) of section 
223(c)(2)(A) (ii) of the Internal Revenue Code of 
1986 (defining high deductible health plan) is 
amended by striking ‘‘$5,000’’ and inserting 
‘‘$4,000’’. 
(2) 
MINIMUM
DEDUCTIBLE
DECREASED; 
AMOUNTS
NOT
INCREASED
BY
INFLATION.—Para-
graph (1) of section 223(g) of such Code is amend-
ed— 
(A) in the matter preceding subparagraph 
(A) 
by 
striking 
‘‘subsections 
(b)(2) 
and 
(c)(2)(A)’’ and inserting ‘‘subsection (b)(2)’’, 
and 
(B) in subparagraph (B) by striking ‘‘sub-
stituting’’ and all that follows and inserting
‘‘substituting calendar year 1997 for ‘calendar 
year 1992’ in subparagraph (B) thereof.’’. 
(b) ARCHER MSAS.— 
(1) DECREASE
IN
MINIMUM
DEDUCTIBLE.— 
Subparagraph (A) of section 220(c)(2) of the Inter-
nal Revenue Code of 1986 (defining high deductible 
health plan) is amended— 
(A) in clause (i) by striking ‘‘$1,500’’ and 
inserting ‘‘$1,000’’, and 
(B) in clause (ii) by striking ‘‘$3,000’’ and 
inserting ‘‘$2,000’’. 
(2) MINIMUM
NOT
INCREASED
BY
INFLA-
TION.—Section 220(g) of such Code is amended by 
inserting ‘‘(other than the $1,000 amount in sub-
paragraph (A)(i) and the $2,000 amount in sub-
paragraph 
(A)(ii) 
thereof)’’ 
after 
‘‘subsection 
(c)(2)’’. 
(c) EFFECTIVE DATE.—The amendments made by 
this section shall apply to taxable years beginning after 
December 31, 2005. 
TITLE II—MEDICAL PRIVACY 
SEC. 201. FINDINGS. 
The Congress finds the following: 
(1) Medical privacy is an issue that concerns a 
growing number of people in the United States. The
culture of the United States has always strongly fa-
vored a close physician-patient relationship. One of 
the key elements of this relationship is the trust that 
a patient has that their personal information will be 
treated as confidential by medical personnel and will 
not be made public or accessible to other persons 
without their permission. 
(2) In our increasingly complex times, two 
trends are combining to exert pressure on maintain-
ing the confidentiality of health care information. 
First, public policy favors an increased ability to 
provide protection against harmful prescription 
interactions and for the reporting of medications’ se-
rious side effects. Second, health care insurers desire 
to take advantage of economies of scale in control-
ling health care costs. These trends have greatly re-
duced expectations for the privacy of health care in-
formation. 
(3) For the first time in our Nation’s history, 
serious loopholes have been written into privacy pro-
tections that were created to protect the right of in-
dividuals. Positive changes in privacy law have been 
made in recent years to guarantee that patients are 
notified regarding the use of their health informa-
tion, have access to their own medical records, and
are able to request corrections of such records. 
These protections must be maintained and strength-
ened. 
(4) One of the greatest needs in the area of 
health privacy is to protect individuals against the 
use of their confidential health information for prof-
it-generating consumer marketing. Patients justifi-
ably have objections to this use of their information 
without their consent. 
(5) There recently have been implemented a se-
ries of alarming modifications to the standards pre-
viously finalized to protect the privacy of individually 
identifiable 
health 
information. 
These 
include 
changes in important definitions, additions to the 
category of health care operations for which patient 
consent for the use of their information is not re-
quired, and changes in permitted use of patient in-
formation without consent for public health pur-
poses. 
(6) Recent rollbacks in health privacy need to 
be reversed, and the individuals’ confidence that 
their private conversations with medical personnel 
will remain private needs to be strengthened. 
(7) There is also a need to protect the integrity 
and confidentiality of social security account num-
bers and to prohibit Federal agencies from imposing 
national standards for identification of individuals. 
SEC. 202. MODIFICATION OF REGULATIONS ON PRIVACY OF 
INDIVIDUALLY IDENTIFIABLE HEALTH IN-
FORMATION. 
(a) MARKETING.— 
(1) IN GENERAL.—The modifications made by 
the August 2002 medical privacy rule to the defini-
tion of the term ‘‘marketing’’ in section 164.501 of 
title 45, Code of Federal Regulations, shall have no 
force or effect. 
(2) AUTHORIZATIONS
FOR
MARKETING.—Sec-
tion 164.508 of title 45, Code of Federal Regula-
tions, shall be construed and applied so as to require 
that, if an authorization is required for a use or dis-
closure of protected health information for mar-
keting, the authorization shall be considered invalid 
unless it— 
(A) uses the term ‘‘marketing’’; 
(B) states that the purpose of the use or 
disclosure involved is marketing; and 
(C) describes the specific marketing uses 
and disclosures authorized.
(b) CONSENT FOR USES OR DISCLOSURES TO CARRY 
OUT TREATMENT, PAYMENT, OR HEALTH CARE OPER-
ATIONS.— 
(1) IN GENERAL.—The modifications made to 
section 164.506 of title 45, Code of Federal Regula-
tions, by the August 2002 medical privacy rule shall 
have no force or effect. 
(2) USE OR DISCLOSURE WITHOUT CONSENT.— 
(A) IN GENERAL.—Section 164.506 of title 
45, Code of Federal Regulations, insofar as it 
permits any use or disclosure of protected 
health information without consent, shall have 
no force or effect. 
(B) CIRCUMSTANCES
WHERE
CONSENT 
NOT REQUIRED.—A health care provider may 
use or disclose an individual’s protected health 
information without obtaining the prior consent 
of the individual only in the following cir-
cumstances: 
(i) To fill or dispense a prescription, 
and to search for drug interactions related 
to that prescription, if the health care pro-
vider obtains written consent from the in-
dividual as soon as practicable.
(ii) To carry out treatment of that in-
dividual if— 
(I) the individual has not exe-
cuted a Universal Health Privacy 
Declaration promulgated under sub-
paragraph (C); 
(II) the individual and the health 
care provider have not had in-person 
communication regarding such treat-
ment; and 
(III) obtaining consent would be 
impracticable. 
(C) UNIVERSAL
HEALTH
PRIVACY
DEC-
LARATION.— 
(i) IN
GENERAL.—The Secretary of 
Health and Human Services shall promul-
gate a document which shall be known as 
the ‘‘Universal Health Privacy Declara-
tion’’. 
(ii) 
ELIGIBILITY.—A 
Universal 
Health Privacy Declaration may be exe-
cuted by any individual who is a citizen of 
the United States or an alien lawfully ad-
mitted to the United States for permanent 
residence.
(iii) PURPOSE.—A Universal Health 
Privacy Declaration, once executed by an 
individual described in clause (ii) and not 
revoked, shall be considered to prohibit, as 
provided under subparagraph (B), a health 
care provider from using or disclosing the 
individual’s protected health information 
for treatment without obtaining the prior 
consent of the individual. 
(iv) ENFORCEMENT.—There is estab-
lished in the Department of Health and 
Human Services an Office of the Health 
Privacy Ombudsman, which shall be head-
ed by an individual known as the ‘‘Health 
Privacy Ombudsman’’. The Health Privacy 
Ombudsman shall be charged with inves-
tigating complaints submitted by individ-
uals described in clause (ii) regarding a 
use or disclosure of protected health infor-
mation in violation of their Universal 
Health Privacy Declaration. 
(c) DISCLOSURES
FOR LAW ENFORCEMENT PUR-
POSES.—Subparagraph (C) of section 164.506(f)(1)(ii) of 
title 45, Code of Federal Regulations shall have no force 
or effect.
(d) DEFINITIONS.— 
(1) IN GENERAL.—For purposes of this section: 
(A) DECEMBER
2000
MEDICAL
PRIVACY 
RULE.—The term ‘‘December 2000 medical pri-
vacy rule’’ means the final rule on standards 
for privacy of individually identifiable health in-
formation published on December 28, 2000, in 
the Federal Register (65 Fed. Reg. 82462), in-
cluding the provisions of title 45, Code of Fed-
eral Regulations, revised or added by such rule. 
(B) 
AUGUST
2002
MEDICAL
PRIVACY 
RULE.—The term ‘‘August 2002 medical pri-
vacy rule’’ means the final rule, published on 
August 14, 2002, in the Federal Register (67 
Fed. Reg. 53182), that modified the December 
2000 medical privacy rule. 
(2) OTHER TERMS DEFINED.—For purposes of 
this section: 
(A) HEALTH CARE PROVIDER.—The term 
‘‘health care provider’’ shall have the meaning 
given such term in section 160.103 of title 45, 
Code of Federal Regulations, as contained in 
the December 2000 medical privacy rule. 
(B) DISCLOSURE; INDIVIDUAL; PROTECTED 
HEALTH
INFORMATION; TREATMENT; USE.—
The terms ‘‘disclosure’’, ‘‘individual’’, ‘‘pro-
tected health information’’, ‘‘treatment’’, and 
‘‘use’’ shall have the meaning given such terms 
in section 164.501 of title 45, Code of Federal 
Regulations, as contained in the December 
2000 medical privacy rule. 
TITLE III—MODIFICATIONS RE-
GARDING 
REGULATION 
OF 
DRUGS 
UNDER 
FEDERAL 
FOOD, DRUG, AND COSMETIC 
ACT 
SEC. 301. DEFINITION OF DRUG. 
Section 201(g)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(g)(1)) is amended in the 
first sentence by striking ‘‘and (B) articles intended’’ and 
all that follows and inserting the following: ‘‘and (B) arti-
cles intended for use in the diagnosis, cure, or treatment 
(but not mitigation or prevention) of disease in man or 
other animals.’’. 
SEC. 302. STRIKING OF EFFECTIVENESS REQUIREMENT; 
MODIFICATIONS REGARDING PATENT LIST-
INGS, PATENT CERTIFICATIONS, AND THIRTY- 
MONTH RULE. 
(a) STRIKING OF EFFECTIVENESS REQUIREMENT; 
PROHIBITION AGAINST LISTING OF CERTAIN PATENTS.—
(1) IN GENERAL.—Section 505(b) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
355(b)) is amended by striking ‘‘(b)(1)’’ and all that 
follows through ‘‘clinical trials required by clause 
(A).’’ and inserting the following: 
‘‘(b) APPLICATION.— 
‘‘(1) CONTENTS.— 
‘‘(A) IN GENERAL.—Any person may file 
with the Secretary an application with respect 
to any drug subject to the provisions of sub-
section (a). Such persons shall submit to the 
Secretary as a part of the application— 
‘‘(i) full reports of investigations 
which have been made to show whether or 
not such drug is safe for use; 
‘‘(ii) a full list of the articles used as 
components of such drug; 
‘‘(iii) a full statement of the composi-
tion of such drug; 
‘‘(iv) a full description of the methods 
used in, and the facilities and controls 
used for, the manufacture, processing, and 
packing of such drug;