LEY HIPAA
-HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996
Public
Law 104-191
104th Congress
To amend the Internal
Revenue Code of 1986 to improve portability and continuity of health insurance
coverage in the group and individual markets, to combat waste, fraud, and abuse
in health insurance and health care delivery, to promote the use of medical
savings accounts, to improve access to long-term care services and coverage, to
simplify the administration of health insurance, and for other purposes.
Be it enacted by the Senate
and House of Representatives of the United States of America in Congress assembled,
(a) SHORT TITLE.--This
Act may be cited as the "Health Insurance Portability and Accountability
Act of 1996".
(b) TABLE OF
CONTENTS.--The table of contents of this Act is as follows:
Sec. 1. Short title; table
of contents.
TITLE I--HEALTH
CARE ACCESS, PORTABILITY, AND RENEWABILITY
...
TITLE
II--PREVENTING HEALTH CARE FRAUD AND ABUSE; ADMINISTRATIVE SIMPLIFICATION;
MEDICAL LIABILITY REFORM
...
Subtitle F--Administrative Simplification
· Sec. 262.
Administrative simplification.
"Part C--Administrative Simplification
· "Sec.
1172. General requirements for adoption of standards.
· "Sec.
1173. Standards for information transactions and data elements.
· "Sec.
1174. Timetables for adoption of standards.
· "Sec.
1176. General penalty for failure to comply with requirements and standards.
· "Sec.
1177. Wrongful disclosure of individually identifiable health information.
· "Sec.
1178. Effect on State law.
· "Sec.
1179. Processing payment transactions.".
Sec. 263. Changes in membership and duties of
National Committee on Vital and Health Statistics.
Sec. 264. Recommendations with respect to privacy of
certain health information.
...
It is the purpose of this
subtitle to improve the Medicare program under title XVIII of the Social
Security Act, the medicaid program under title XIX of such Act, and the
efficiency and effectiveness of the health care system, by encouraging the
development of a health information system through the establishment of
standards and requirements for the electronic transmission of certain health
information.
(a) IN GENERAL.--Title XI
(42 U.S.C. 1301 et seq.) is amended by adding at the end the following:
"PART C--ADMINISTRATIVE SIMPLIFICATION
"DEFINITIONS
"SEC. 1171. For
purposes of this part:
"(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) HEALTH CARE
CLEARINGHOUSE.--The term 'health care clearinghouse' means a public or private
entity that processes or facilitates the processing of nonstandard data
elements of health information into standard data elements.
"(3) HEALTH CARE
PROVIDER.--The term 'health care provider' includes a provider of services (as
defined in section 1861(u)), a provider of medical or other health services (as
defined in section 1861(s)), and any other person furnishing health care
services or supplies.
"(4) HEALTH
INFORMATION.--The term 'health information' means any information, whether oral
or recorded in any form or medium, that--
"(A) is created or
received by a health care provider, health plan, public health authority,
employer, life insurer, school or university, or health care clearinghouse; and
"(B) relates to the
past, present, or future physical or mental health or condition of an individual,
the provision of health care to an individual, or the past, present, or future
payment for the provision of health care to an individual.
"(5) HEALTH PLAN.--The
term 'health plan' means an individual or group plan that provides, or pays the
cost of, medical care (as such term is defined in section 2791 of the Public
Health Service Act). Such term includes the following, and any combination
thereof:
"(A) A group health
plan (as defined in section 2791(a) of the Public Health Service Act), but only
if the plan--
"(i) has 50 or more
participants (as defined in section 3(7) of the Employee Retirement Income
Security Act of 1974); or
"(ii) is administered
by an entity other than the employer who established and maintains the plan.
"(B) A health
insurance issuer (as defined in section 2791(b) of the Public Health Service
Act).
"(C) A health
maintenance organization (as defined in section 2791(b) of the Public Health
Service Act).
"(D) Part A or part B
of the Medicare program under title XVIII.
"(E) The medicaid
program under title XIX.
"(F) A Medicare
supplemental policy (as defined in section 1882(g)(1)).
"(G) A long-term care
policy, including a nursing home fixed indemnity policy (unless the Secretary
determines that such a policy does not provide sufficiently comprehensive
coverage of a benefit so that the policy should be treated as a health plan).
"(H) An employee
welfare benefit plan or any other arrangement which is established or
maintained for the purpose of offering or providing health benefits to the
employees of 2 or more employers.
"(I) The health care
program for active military personnel under title 10, United States Code.
"(J) The veterans
health care program under chapter 17 of title 38, United States Code.
"(K) The Civilian
Health and Medical Program of the Uniformed Services (CHAMPUS), as defined in
section 1072(4) of title 10, United States Code.
"(L) The Indian health
service program under the Indian Health Care Improvement Act (25 U.S.C. 1601 et
seq.).
"(M) The Federal
Employees Health Benefit Plan under chapter 89 of title 5, United States Code.
"(6) INDIVIDUALLY
IDENTIFIABLE HEALTH INFORMATION.--The term 'individually identifiable health
information' means any information, including demographic information collected
from an individual, that--
"(A) is created or
received by a health care provider, health plan, employer, or health care
clearinghouse; and
"(B) relates to the
past, present, or future physical or mental health or condition of an
individual, the provision of health care to an individual, or the past,
present, or future payment for the provision of health care to an individual,
and--
"(i) identifies the
individual; or
"(ii) with respect to
which there is a reasonable basis to believe that the information can be used
to identify the individual.
"(7) STANDARD.--The
term 'standard', when used with reference to a data element of health
information or a transaction referred to in section 1173(a)(1), means any such
data element or transaction that meets each of the standards and implementation
specifications adopted or established by the Secretary with respect to the data
element or transaction under sections 1172 through 1174.
"(8) STANDARD SETTING
ORGANIZATION.--The term 'standard setting organization' means a standard
setting organization accredited by the American National Standards Institute,
including the National Council for Prescription Drug Programs, that develops
standards for information transactions, data elements, or any other standard
that is necessary to, or will facilitate, the implementation of this part.
"GENERAL REQUIREMENTS FOR ADOPTION OF
STANDARDS
"SEC. 1172. (a)
APPLICABILITY.--Any standard adopted under this part shall apply, in whole or
in part, to the following persons:
"(1) A health plan.
"(2) A health care
clearinghouse.
"(3) A health care
provider who transmits any health information in electronic form in connection
with a transaction referred to in section 1173(a)(1).
"(b) REDUCTION OF
COSTS.--Any standard adopted under this part shall be consistent with the
objective of reducing the administrative costs of providing and paying for
health care.
"(c) ROLE OF STANDARD
SETTING ORGANIZATIONS.--
"(1) IN
GENERAL.--Except as provided in paragraph (2), any standard adopted under this
part shall be a standard that has been developed, adopted, or modified by a
standard setting organization.
"(2) SPECIAL RULES.--
"(A) DIFFERENT
STANDARDS.--The Secretary may adopt a standard that is different from any
standard developed, adopted, or modified by a standard setting organization,
if--
"(i) the different
standard will substantially reduce administrative costs to health care
providers and health plans compared to the alternatives; and
"(ii) the standard is
promulgated in accordance with the rulemaking procedures of subchapter III of
chapter 5 of title 5, United States Code.
"(B) NO STANDARD BY
STANDARD SETTING ORGANIZATION.--If no standard setting organization has
developed, adopted, or modified any standard relating to a standard that the
Secretary is authorized or required to adopt under this part--
"(i) paragraph (1)
shall not apply; and
"(ii) subsection (f)
shall apply.
(3) CONSULTATION
REQUIREMENT.--
"(A) IN GENERAL.--A
standard may not be adopted under this part unless--
"(i) in the case of a
standard that has been developed, adopted, or modified by a standard setting
organization, the organization consulted with each of the organizations
described in subparagraph (B) in the course of such development, adoption, or
modification; and
"(ii) in the case of
any other standard, the Secretary, in complying with the requirements of
subsection (f), consulted with each of the organizations described in
subparagraph (B) before adopting the standard.
"(B) ORGANIZATIONS
DESCRIBED.--The organizations referred to in subparagraph (A) are the
following:
"(i) The National
Uniform Billing Committee.
"(ii) The National
Uniform Claim Committee.
"(iii) The Workgroup
for Electronic Data Interchange.
"(iv) The American
Dental Association.
"(d) IMPLEMENTATION
SPECIFICATIONS.--The Secretary shall establish
specifications for
implementing each of the standards adopted under this
part.
"(e) PROTECTION OF
TRADE SECRETS.--Except as otherwise required by law, a standard adopted under
this part shall not require disclosure of trade secrets or confidential
commercial information by a person required to comply with this part.
"(f) ASSISTANCE TO THE
SECRETARY.--In complying with the requirements of this part, the Secretary
shall rely on the recommendations of the National Committee on Vital and Health
Statistics established under section 306(k) of the Public Health Service Act
(42 U.S.C. 242k(k)), and shall consult with appropriate Federal and State
agencies and private organizations. The Secretary shall publish in the Federal
Register any recommendation of the National Committee on Vital and Health
Statistics regarding the adoption of a standard under this part.
(g) APPLICATION TO
MODIFICATIONS OF STANDARDS.--This section shall apply to a modification to a
standard (including an addition to a standard) adopted under section 1174(b) in
the same manner as it applies to an initial standard adopted under section
1174(a).
"STANDARDS FOR INFORMATION TRANSACTIONS
AND DATA ELEMENTS
"SEC. 1173. (a)
STANDARDS TO ENABLE ELECTRONIC EXCHANGE.--
"(1) IN GENERAL.--The
Secretary shall adopt standards for transactions, and data elements for such
transactions, to enable health information to be exchanged electronically, that
are appropriate for--
"(A) the financial and
administrative transactions described in paragraph (2); and
"(B) other financial
and administrative transactions determined appropriate by the Secretary,
consistent with the goals of improving the operation of the health care system
and reducing administrative costs.
"(2)
TRANSACTIONS.--The transactions referred to in paragraph (1)(A) are
transactions with respect to the following:
"(A) Health claims or
equivalent encounter information.
"(B) Health claims
attachments.
"(C) Enrollment and
disenrollment in a health plan.
"(D) Eligibility for a
health plan.
"(E) Health care
payment and remittance advice.
"(F) Health plan
premium payments.
"(G) First report of
injury.
"(H) Health claim
status.
"(I) Referral
certification and authorization.
"(3) ACCOMMODATION OF
SPECIFIC PROVIDERS.--The standards adopted by the Secretary under paragraph (1)
shall accommodate the needs of different types of health care providers.
(b) UNIQUE HEALTH
IDENTIFIERS.--
"(1) IN GENERAL.--The
Secretary shall adopt standards providing for a standard unique health
identifier for each individual, employer, health plan, and health care provider
for use in the health care system. In carrying out the preceding sentence for
each health plan and health care provider, the Secretary shall take into
account multiple uses for identifiers and multiple locations and specialty
classifications for health care providers.
"(2) USE OF
IDENTIFIERS.--The standards adopted under paragraph (1) shall specify the
purposes for which a unique health identifier may be used.
(c) CODE SETS.--
"(1) IN GENERAL.--The
Secretary shall adopt standards that--
"(A) select code sets
for appropriate data elements for the transactions referred to in subsection
(a)(1) from among the code sets that have been developed by private and public
entities; or
"(B) establish code
sets for such data elements if no code sets for the data elements have been
developed.
"(2)
DISTRIBUTION.--The Secretary shall establish efficient and low-cost procedures
for distribution (including electronic distribution) of code sets and
modifications made to such code sets under section 1174(b).
(d) SECURITY STANDARDS FOR
HEALTH INFORMATION.--
"(1) SECURITY
STANDARDS.--The Secretary shall adopt security standards that--
"(A) take into
account--
"(i) the technical
capabilities of record systems used to maintain health information;
"(ii) the costs of
security measures;
"(iii) the need for
training persons who have access to health information;
"(iv) the value of
audit trails in computerized record systems; and
"(v) the needs and
capabilities of small health care providers and rural health care providers (as
such providers are defined by the Secretary); and
"(B) ensure that a
health care clearinghouse, if it is part of a larger organization, has policies
and security procedures which isolate the activities of the health care
clearinghouse with respect to processing information in a manner that prevents
unauthorized access to such information by such larger organization.
"(2) SAFEGUARDS.--Each
person described in section 1172(a) who maintains or transmits health
information shall maintain reasonable and appropriate administrative,
technical, and physical safeguards--
"(A) to ensure the
integrity and confidentiality of the information;
"(B) to protect
against any reasonably anticipated--
"(i) threats or
hazards to the security or integrity of the information; and
"(ii) unauthorized
uses or disclosures of the information; and
"(C) otherwise to
ensure compliance with this part by the officers and employees of such person.
(e) ELECTRONIC SIGNATURE.--
"(1) STANDARDS.--The
Secretary, in coordination with the Secretary of Commerce, shall adopt
standards specifying procedures for the electronic transmission and
authentication of signatures with respect to the transactions referred to in
subsection (a)(1).
"(2) EFFECT OF
COMPLIANCE.--Compliance with the standards adopted under paragraph (1) shall be
deemed to satisfy Federal and State statutory requirements for written
signatures with respect to the transactions referred to in subsection (a)(1).
(f) TRANSFER OF INFORMATION
AMONG HEALTH PLANS.--The Secretary shall adopt standards for transferring among
health plans appropriate standard data elements needed for the coordination of
benefits, the sequential processing of claims, and other data elements for
individuals who have more than one health plan.
"TIMETABLES FOR ADOPTION OF STANDARDS
"SEC. 1174. (a)
INITIAL STANDARDS.--The Secretary shall carry out section 1173 not later than
18 months after the date of the enactment of the Health Insurance Portability
and Accountability Act of 1996, except that standards relating to claims
attachments shall be adopted not later than 30 months after such date.
"(b) ADDITIONS AND
MODIFICATIONS TO STANDARDS.--
"(1) IN
GENERAL.--Except as provided in paragraph (2), the Secretary shall review the
standards adopted under section 1173, and shall adopt modifications to the
standards (including additions to the standards), as determined appropriate,
but not more frequently than once every 12 months. Any addition or modification
to a standard shall be completed in a manner which minimizes the disruption and
cost of compliance.
"(2) SPECIAL RULES.--
"(A) FIRST 12-MONTH
PERIOD.--Except with respect to additions and modifications to code sets under
subparagraph (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 initially adopted, unless the Secretary determines that the
modification is necessary in order to permit compliance with the standard.
"(B) ADDITIONS AND
MODIFICATIONS TO CODE SETS.--
"(i) IN GENERAL.--The
Secretary shall ensure that procedures exist for the routine 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 of health information that were
encoded prior to the modification may be converted or translated so as to
preserve the informational value of the data elements that existed before the
modification. Any modification to a code set under this subsection shall be
implemented in a manner that minimizes the disruption and cost of complying
with such modification.
"SEC. 1175. (a)
CONDUCT OF TRANSACTIONS BY PLANS.--
"(1) IN GENERAL.--If a
person desires to conduct a transaction referred to in section 1173(a)(1) with
a health plan as a standard transaction--
"(A) the health plan
may not refuse to conduct such transaction as a standard transaction;
"(B) the insurance
plan may not delay such transaction, or otherwise adversely affect, or attempt
to adversely affect, the person or the transaction on the ground that the
transaction is a standard transaction; and
"(C) the information
transmitted and received in connection with the transaction shall be in the
form of standard data elements of health information.
"(2) SATISFACTION OF
REQUIREMENTS.--A health plan may satisfy the requirements under paragraph (1)
by--
"(A) directly
transmitting and receiving standard data elements of health information; or
"(B) submitting
nonstandard data elements to a health care clearinghouse for processing into
standard data elements and transmission by the health care clearinghouse, and
receiving standard data elements through the health care clearinghouse.
"(3) TIMETABLE FOR
COMPLIANCE.--Paragraph (1) shall not be construed to require a health plan to
comply with any standard, implementation specification, or modification to a
standard or specification adopted or established by the Secretary under
sections 1172 through 1174 at any time prior to the date on which the plan is
required to comply with the standard or specification under subsection (b).
"(b) COMPLIANCE WITH
STANDARDS.--
"(1) INITIAL
COMPLIANCE.--
"(A) IN GENERAL.--Not
later than 24 months after the date on which an initial standard or
implementation specification is adopted or established under sections 1172 and
1173, each person to whom the standard or implementation specification applies
shall comply with the standard or specification.
"(B) SPECIAL RULE FOR
SMALL HEALTH PLANS.--In the case of a small health plan, paragraph (1) shall be
applied by substituting '36 months' for '24 months'. For purposes of this
subsection, the Secretary shall determine the plans that qualify as small
health plans.
"(2) COMPLIANCE WITH
MODIFIED STANDARDS.--If the Secretary adopts a modification to a standard or
implementation specification under this part, each person to whom the standard
or implementation specification applies shall comply with the modified standard
or implementation specification at such time as the Secretary determines
appropriate, taking into account the time needed to comply due to the nature
and extent of the modification. The time determined appropriate under the
preceding sentence may not be earlier than the last day of the 180-day period
beginning on the date such modification is adopted. The Secretary may extend
the time for compliance for small health plans, if the Secretary determines
that such extension is appropriate.
"(3)
CONSTRUCTION.--Nothing in this subsection shall be construed to prohibit any
person from complying with a standard or specification by--
"(A) submitting
nonstandard data elements to a health care clearinghouse for processing into
standard data elements and transmission by the health care clearinghouse; or
"(B) receiving standard
data elements through a health care clearinghouse.
"GENERAL PENALTY FOR FAILURE TO COMPLY
WITH REQUIREMENTS AND STANDARDS
"SEC. 1176. (a)
GENERAL PENALTY.--
"(1) IN
GENERAL.--Except as provided in subsection (b), the Secretary shall impose on
any person who violates a provision of this part a penalty of not more than
$100 for each such violation, except that the total amount imposed on the
person for all violations of an identical requirement or prohibition during a
calendar year may not exceed $25,000.
"(2) PROCEDURES.--The
provisions of section 1128A (other than subsections (a) and (b) and the second
sentence of subsection (f)) shall apply to the imposition of a civil money
penalty under this subsection in the same manner as such provisions apply to
the imposition of a penalty under such section 1128A.
"(b) LIMITATIONS.--
"(1) OFFENSES
OTHERWISE PUNISHABLE.--A penalty may not be imposed under subsection (a) with
respect to an act if the act constitutes an offense punishable under section
1177.
"(2) NONCOMPLIANCE NOT
DISCOVERED.--A penalty may not be imposed under subsection (a) with respect to
a provision of this part if it is established to the satisfaction of the
Secretary that the person liable for the penalty did not know, and by
exercising reasonable diligence would not have known, that such person violated
the provision.
"(3) FAILURES DUE TO
REASONABLE CAUSE.--
"(A) IN
GENERAL.--Except as provided in subparagraph (B), a penalty may not be imposed
under subsection (a) if--
"(i) the failure to
comply was due to reasonable cause and not to willful neglect; and
"(ii) the failure to
comply is corrected during the 30-day period beginning on the first date the
person liable for the penalty knew, or by exercising reasonable diligence would
have known, that the failure to comply occurred.
"(B) EXTENSION OF
PERIOD.--
"(i) NO PENALTY.--The
period referred to in subparagraph (A)(ii) may be extended as determined
appropriate by the Secretary based on the nature and extent of the failure to
comply.
"(ii) ASSISTANCE.--If
the Secretary determines that a person failed to comply because the person was
unable to comply, the Secretary may provide technical assistance to the person
during the period described in subparagraph (A)(ii). Such assistance shall be
provided in any manner determined appropriate by the Secretary.
"(4) REDUCTION.--In
the case of a failure to comply which is due to reasonable cause and not to
willful neglect, any penalty under subsection (a) that is not entirely waived
under paragraph (3) may be waived to the extent that the payment of such
penalty would be excessive relative to the compliance failure involved.
"WRONGFUL DISCLOSURE OF INDIVIDUALLY
IDENTIFIABLE HEALTH INFORMATION
"SEC. 1177. (a)
OFFENSE.--A person who knowingly and in violation of this part--
"(1) uses or causes to
be used a unique health identifier;
"(2) obtains
individually identifiable health information relating to an individual; or
"(3) discloses
individually identifiable health information to another person,
shall be punished as
provided in subsection (b).
"(b) PENALTIES.--A
person described in subsection (a) shall--
"(1) be fined not more
than $50,000, imprisoned not more than 1 year, or both;
"(2) if the offense is
committed under false pretenses, be fined not more than $100,000, imprisoned
not more than 5 years, or both; and
"(3) if the offense is
committed with intent to sell, transfer, or use individually identifiable
health information for commercial advantage, personal gain, or malicious harm,
be fined not more than $250,000, imprisoned not more than 10 years, or both.
"SEC. 1178. (a)
GENERAL EFFECT.--
"(1) GENERAL
RULE.--Except as provided in paragraph (2), a provision or requirement under
this part, or a standard or implementation specification adopted or established
under sections 1172 through 1174, shall supersede any contrary provision of
State law, including a provision of State law that requires medical or health
plan records (including billing information) to be maintained or transmitted in
written rather than electronic form.
"(2) EXCEPTIONS.--A
provision or requirement under this part, or a standard or implementation
specification adopted or established under sections 1172 through 1174, shall
not supersede a contrary provision of State law, if the provision of State
law--
"(A) is a provision
the Secretary determines--
"(i) is necessary--
"(I) to prevent fraud
and abuse;
"(II) to ensure
appropriate State regulation of insurance and health plans;
"(III) for State
reporting on health care delivery or costs; or
"(IV) for other
purposes; or
"(ii) addresses
controlled substances; or
"(B) subject to
section 264(c)(2) of the Health Insurance Portability and Accountability Act of
1996, relates to the privacy of individually identifiable health information.
"(b) PUBLIC
HEALTH.--Nothing in this part shall be construed to invalidate or limit the
authority, 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.
"(c) STATE REGULATORY
REPORTING.--Nothing in this part shall limit the ability of a State to require
a health plan to report, or to provide access to, information for management
audits, financial audits, program monitoring and evaluation, facility licensure
or certification, or individual licensure or certification.
"PROCESSING PAYMENT TRANSACTIONS BY
FINANCIAL INSTITUTIONS
"SEC. 1179. To
the extent that an entity is engaged in activities of a financial institution
(as defined in section 1101 of the Right to Financial Privacy Act of 1978), or
is engaged in authorizing, processing, clearing, settling, billing,
transferring, reconciling,
or collecting payments, for a financial institution, this part, and any
standard adopted under this part, shall not apply to the entity with respect to
such activities, including the following:
"(1) The use or
disclosure of information by the entity for authorizing, processing, clearing,
settling, billing, transferring, reconciling or collecting, a payment for, or
related to, health plan premiums or health care, where such payment is made by
any means, including a credit, debit, or other payment card, an account, check,
or electronic funds transfer.
"(2) The request for,
or the use or disclosure of, information by the entity with respect to a
payment described in paragraph (1)--
"(A) for transferring
receivables;
"(B) for auditing;
"(C) in connection
with--
"(i) a customer
dispute; or
"(ii) an inquiry from,
or to, a customer;
"(D) in a
communication to a customer of the entity regarding the customer's
transactions, payment card, account, check, or electronic funds transfer;
"(E) for reporting to
consumer reporting agencies; or
"(F) for complying
with--
"(i) a civil or
criminal subpoena; or
"(ii) a Federal or
State law regulating the entity.".
(b) CONFORMING
AMENDMENTS.--
(1) REQUIREMENT FOR
MEDICARE PROVIDERS.--Section 1866(a)(1) (42 U.S.C. 1395cc(a)(1)) is amended--
(A) by striking ``and"
at the end of subparagraph (P);
(B) by striking the period
at the end of subparagraph (Q) and inserting "; and"; and
(C) by inserting
immediately after subparagraph (Q) the following new subparagraph:
"(R) to contract only
with a health care clearinghouse (as defined in section 1171) that meets each
standard and implementation specification adopted or established under part C
of title XI on or after the date on which the health care clearinghouse is
required to comply with the standard or specification.".
(2) TITLE HEADING.--Title
XI (42 U.S.C. 1301 et seq.) is amended by striking the title heading and
inserting the following:
"TITLE XI--GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE
SIMPLIFICATION".
Section 306(k) of the
Public Health Service Act (42 U.S.C. 242k(k))
is amended--
(1) in paragraph (1), by
striking "16" and inserting "18";
(2) by amending paragraph
(2) to read as follows:
"(2) The members of
the Committee shall be appointed from among persons who have distinguished
themselves in the fields of health statistics, electronic interchange of health
care information, privacy and security of electronic information,
population-based public health, purchasing or financing health care services,
integrated computerized health information systems, health services research,
consumer interests in health information, health data standards, epidemiology,
and the provision of health services. Members of the Committee shall be
appointed for terms of 4 years.";
(3) by redesignating
paragraphs (3) through (5) as paragraphs (4) through (6), respectively, and
inserting after paragraph (2) the following:
"(3) Of the members of
the Committee--
"(A) 1 shall be appointed,
not later than 60 days after the date of the enactment of the Health Insurance
Portability and Accountability Act of 1996, by the Speaker of the House of
Representatives after consultation with the Minority Leader of the House of
Representatives;
"(B) 1 shall be
appointed, not later than 60 days after the date of the enactment of the Health
Insurance Portability and Accountability Act of 1996, by the President pro
tempore of the Senate after consultation with the Minority Leader of the Senate;
and
"(C) 16 shall be
appointed by the Secretary.";
(4) by amending paragraph
(5) (as so redesignated) to read as follows:
"(5) The Committee--
"(A) shall assist and
advise the Secretary--
"(i) to delineate
statistical problems bearing on health and health services which are of
national or international interest;
"(ii) to stimulate
studies of such problems by other organizations and agencies whenever possible
or to make investigations of such problems through subcommittees;
"(iii) to determine,
approve, and revise the terms, definitions, classifications, and guidelines for
assessing health status and health services, their distribution and costs, for
use (I) within the Department of Health and Human Services, (II) by all
programs administered or funded by the Secretary, including the
Federal-State-local cooperative health statistics system referred to in
subsection (e), and (III) to the extent possible as determined by the head of
the agency involved, by the Department of Veterans Affairs, the Department of
Defense, and other Federal agencies concerned with health and health services;
"(iv) with respect to
the design of and approval of health statistical and health information systems
concerned with the collection, processing, and tabulation of health statistics within
the Department of Health and Human Services, with respect to the Cooperative
Health Statistics System established under subsection (e), and with respect to
the standardized means for the collection of health information and statistics
to be established by the Secretary under subsection (j)(1);
"(v) to review and
comment on findings and proposals developed by other organizations and agencies
and to make recommendations for their adoption or implementation by local,
State, national, or international agencies;
"(vi) to cooperate
with national committees of other countries and with the World Health
Organization and other national agencies in the studies of problems of mutual
interest;
"(vii) to issue an
annual report on the state of the Nation's health, its health services, their
costs and distributions, and to make proposals for improvement of the Nation's
health statistics and health information systems; and
"(viii) in complying
with the requirements imposed on the Secretary under part C of title XI of the
Social Security Act;
"(B) shall study the
issues related to the adoption of uniform data standards for patient medical
record information and the electronic exchange of such information;
"(C) shall report to
the Secretary not later than 4 years after the date of the enactment of the
Health Insurance Portability and Accountability Act of 1996 recommendations and
legislative proposals for such standards and electronic exchange; and
"(D) shall be
responsible generally for advising the Secretary and the Congress on the status
of the implementation of part C of title XI of the Social Security Act.";
and
(5) by adding at the end
the following:
"(7) Not later than 1
year after the date of the enactment of the Health Insurance Portability and
Accountability Act of 1996, and annually thereafter, the Committee shall submit
to the Congress, and make public, a report regarding the implementation of part
C of title XI of the Social Security Act. Such report shall address the
following subjects, to the extent that the Committee determines appropriate:
"(A) The extent to
which persons required to comply with part C of title XI of the Social Security
Act are cooperating in implementing the standards adopted under such part.
"(B) The extent to
which such entities are meeting the security standards adopted under such part
and the types of penalties assessed for noncompliance with such standards.
"(C) Whether the
Federal and State Governments are receiving information of sufficient quality
to meet their responsibilities under such part.
"(D) Any problems that
exist with respect to implementation of such part.
"(E) The extent to
which timetables under such part are being met.".
(a) IN GENERAL.--Not later
than the date that is 12 months after the date of the enactment of this Act,
the Secretary of Health and Human Services shall submit to the Committee on
Labor and Human Resources and the Committee on Finance of the Senate and the
Committee on Commerce and the Committee on Ways and Means of the House of
Representatives detailed recommendations on standards with respect to the
privacy of individually identifiable health information.
(b) SUBJECTS FOR
RECOMMENDATIONS.--The recommendations under subsection (a) shall address at
least the following:
(1) The rights that an
individual who is a subject of individually identifiable health information
should have.
(2) The procedures that
should be established for the exercise of such rights.
(3) The uses and
disclosures of such information that should be authorized or required.
(c) REGULATIONS.--
(1) IN GENERAL.--If
legislation governing standards with respect to the privacy of individually
identifiable health information transmitted in connection with the transactions
described in section 1173(a) of the Social Security Act (as added by section
262) is not enacted by the date that is 36 months after the date of the enactment
of this Act, the Secretary of Health and Human Services shall promulgate final
regulations containing such standards not later than the date that is 42 months
after the date of the enactment of this Act. Such regulations shall address at
least the subjects described in subsection (b).
(2) PREEMPTION.--A
regulation promulgated under paragraph (1) shall not supercede a contrary
provision of State law, if the provision of State law imposes requirements,
standards, or implementation specifications that are more stringent than the
requirements, standards, or implementation specifications imposed under the
regulation.
(d) CONSULTATION.--In
carrying out this section, the Secretary of Health and Human Services shall
consult with--
(1) the National Committee
on Vital and Health Statistics established under section 306(k) of the Public
Health Service Act (42 U.S.C. 242k(k)); and
(2) the Attorney General.
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