[Code of Federal Regulations]
[Title 45, Volume 1]
[Revised as of October 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 45CFR160.103]
[Page 667-670]
TITLE 45--PUBLIC WELFARE
SUBTITLE A--DEPARTMENT OF HEALTH
AND HUMAN SERVICES
PART 160--GENERAL ADMINISTRATIVE REQUIREMENTS--Table of Contents
Subpart A--General Provisions
Sec. 160.103 Definitions.
Except as otherwise provided, the following definitions apply to
this subchapter:
Act means the Social Security Act.
ANSI stands for the American National Standards Institute.
Business associate: (1) Except as provided in paragraph (2) of this
definition, business associate means, with respect to a covered entity,
a person who:
(i) On behalf of such covered entity or of an organized health care
arrangement (as defined in Sec. 164.501 of this subchapter) in which the
covered entity participates, but other than in the capacity of a member
of the workforce of such covered entity or arrangement, performs, or
assists in the performance of:
(A) A function or activity involving the use or disclosure of
individually identifiable health information, including claims
processing or administration, data analysis, processing or
administration, utilization review, quality assurance, billing, benefit
management, practice management, and repricing; or
(B) Any other function or activity regulated by this subchapter; or
(ii) Provides, other than in the capacity of a member of the
workforce of such covered entity, legal, actuarial, accounting,
consulting, data aggregation (as defined in Sec. 164.501 of this
subchapter), management, administrative, accreditation, or financial
services to or for such covered entity, or to or for an organized health
care arrangement
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in which the covered entity participates, where the provision of the
service involves the disclosure of individually identifiable health
information from such covered entity or arrangement, or from another
business associate of such covered entity or arrangement, to the person.
(2) A covered entity participating in an organized health care
arrangement that performs a function or activity as described by
paragraph (1)(i) of this definition for or on behalf of such organized
health care arrangement, or that provides a service as described in
paragraph (1)(ii) of this definition to or for such organized health
care arrangement, does not, simply through the performance of such
function or activity or the provision of such service, become a business
associate of other covered entities participating in such organized
health care arrangement.
(3) A covered entity may be a business associate of another covered
entity.
CMS stands for Centers for Medicare & Medicaid Services within the
Department of Health and Human Services.
Compliance date means the date by which a covered entity must comply
with a standard, implementation specification, requirement, or
modification adopted under this subchapter.
Covered entity means:
(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 covered by this
subchapter.
Group health plan (also see definition of health plan in this
section) means an employee welfare benefit plan (as defined in section
3(1) of the Employee Retirement Income and Security Act of 1974 (ERISA),
29 U.S.C. 1002(1)), including insured and self-insured plans, to the
extent that the plan provides medical care (as defined in section
2791(a)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 300gg-
91(a)(2)), including items and services paid for as medical care, to
employees or their dependents directly or through insurance,
reimbursement, or otherwise, that:
(1) Has 50 or more participants (as defined in section 3(7) of
ERISA, 29 U.S.C. 1002(7)); or
(2) Is administered by an entity other than the employer that
established and maintains the plan.
HHS stands for the Department of Health and Human Services.
Health care means care, services, or supplies related to the health
of an individual. Health care includes, but is not limited to, the
following:
(1) Preventive, diagnostic, therapeutic, rehabilitative,
maintenance, or palliative care, and counseling, service, assessment, or
procedure with respect to the physical or mental condition, or
functional status, of an individual or that affects the structure or
function of the body; and
(2) Sale or dispensing of a drug, device, equipment, or other item
in accordance with a prescription.
Health care clearinghouse means a public or private entity,
including a billing service, repricing company, community health
management information system or community health information system,
and ``value-added'' networks and switches, that does either of the
following functions:
(1) Processes or facilitates the processing of health information
received from another entity in a nonstandard format or containing
nonstandard data content into standard data elements or a standard
transaction.
(2) Receives a standard transaction from another entity and
processes or facilitates the processing of health information into
nonstandard format or nonstandard data content for the receiving entity.
Health care provider means a provider of services (as defined in
section 1861(u) of the Act, 42 U.S.C. 1395x(u)), a provider of medical
or health services (as defined in section 1861(s) of the Act, 42 U.S.C.
1395x(s)), and any other person or organization who furnishes, bills, or
is paid for health care in the normal course of business.
Health information means any information, whether oral or recorded
in any form or medium, that:
(1) Is created or received by a health care provider, health plan,
public
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health authority, employer, life insurer, school or university, or
health care clearinghouse; and
(2) 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.
Health insurance issuer (as defined in section 2791(b)(2) of the PHS
Act, 42 U.S.C. 300gg-91(b)(2) and used in the definition of health plan
in this section) means an insurance company, insurance service, or
insurance organization (including an HMO) that is licensed to engage in
the business of insurance in a State and is subject to State law that
regulates insurance. Such term does not include a group health plan.
Health maintenance organization (HMO) (as defined in section
2791(b)(3) of the PHS Act, 42 U.S.C. 300gg-91(b)(3) and used in the
definition of health plan in this section) means a federally qualified
HMO, an organization recognized as an HMO under State law, or a similar
organization regulated for solvency under State law in the same manner
and to the same extent as such an HMO.
Health plan means an individual or group plan that provides, or pays
the cost of, medical care (as defined in section 2791(a)(2) of the PHS
Act, 42 U.S.C. 300gg-91(a)(2)).
(1) Health plan includes the following, singly or in combination:
(i) A group health plan, as defined in this section.
(ii) A health insurance issuer, as defined in this section.
(iii) An HMO, as defined in this section.
(iv) Part A or Part B of the Medicare program under title XVIII of
the Act.
(v) The Medicaid program under title XIX of the Act, 42 U.S.C. 1396,
et seq.
(vi) An issuer of a Medicare supplemental policy (as defined in
section 1882(g)(1) of the Act, 42 U.S.C. 1395ss(g)(1)).
(vii) An issuer of a long-term care policy, excluding a nursing home
fixed-indemnity policy.
(viii) An employee welfare benefit plan or any other arrangement
that is established or maintained for the purpose of offering or
providing health benefits to the employees of two or more employers.
(ix) The health care program for active military personnel under
title 10 of the United States Code.
(x) The veterans health care program under 38 U.S.C. chapter 17.
(xi) The Civilian Health and Medical Program of the Uniformed
Services (CHAMPUS) (as defined in 10 U.S.C. 1072(4)).
(xii) The Indian Health Service program under the Indian Health Care
Improvement Act, 25 U.S.C. 1601, et seq.
(xiii) The Federal Employees Health Benefits Program under 5 U.S.C.
8902, et seq.
(xiv) An approved State child health plan under title XXI of the
Act, providing benefits for child health assistance that meet the
requirements of section 2103 of the Act, 42 U.S.C. 1397, et seq.
(xv) The Medicare+Choice program under Part C of title XVIII of the
Act, 42 U.S.C. 1395w-21 through 1395w-28.
(xvi) A high risk pool that is a mechanism established under State
law to provide health insurance coverage or comparable coverage to
eligible individuals.
(xvii) Any other individual or group plan, or combination of
individual or group plans, that provides or pays for the cost of medical
care (as defined in section 2791(a)(2) of the PHS Act, 42 U.S.C. 300gg-
91(a)(2)).
(2) Health plan excludes:
(i) Any policy, plan, or program to the extent that it provides, or
pays for the cost of, excepted benefits that are listed in section
2791(c)(1) of the PHS Act, 42 U.S.C. 300gg-91(c)(1); and
(ii) A government-funded program (other than one listed in paragraph
(1)(i)-(xvi) of this definition):
(A) Whose principal purpose is other than providing, or paying the
cost of, health care; or
(B) Whose principal activity is:
(1) The direct provision of health care to persons; or
(2) The making of grants to fund the direct provision of health care
to persons.
Implementation specification means specific requirements or
instructions for implementing a standard.
[[Page 670]]
Modify or modification refers to a change adopted by the Secretary,
through regulation, to a standard or an implementation specification.
Secretary means the Secretary of Health and Human Services or any
other officer or employee of HHS to whom the authority involved has been
delegated.
Small health plan means a health plan with annual receipts of $5
million or less.
Standard means a rule, condition, or requirement:
(1) Describing the following information for products, systems,
services or practices:
(i) Classification of components.
(ii) Specification of materials, performance, or operations; or
(iii) Delineation of procedures; or
(2) With respect to the privacy of individually identifiable health
information.
Standard setting organization (SSO) means an organization accredited
by the American National Standards Institute that develops and maintains
standards for information transactions or data elements, or any other
standard that is necessary for, or will facilitate the implementation
of, this part.
State refers to one of the following:
(1) For a health plan established or regulated by Federal law, State
has the meaning set forth in the applicable section of the United States
Code for such health plan.
(2) For all other purposes, State means any of the several States,
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands, and Guam.
Trading partner agreement means an agreement related to the exchange
of information in electronic transactions, whether the agreement is
distinct or part of a larger agreement, between each party to the
agreement. (For example, a trading partner agreement may specify, among
other things, the duties and responsibilities of each party to the
agreement in conducting a standard transaction.)
Transaction means the transmission of information between two
parties to carry out financial or administrative activities related to
health care. It includes the following types of information
transmissions:
(1) Health care claims or equivalent encounter information.
(2) Health care payment and remittance advice.
(3) Coordination of benefits.
(4) Health care claim status.
(5) Enrollment and disenrollment in a health plan.
(6) Eligibility for a health plan.
(7) Health plan premium payments.
(8) Referral certification and authorization.
(9) First report of injury.
(10) Health claims attachments.
(11) Other transactions that the Secretary may prescribe by
regulation.
Workforce means employees, volunteers, trainees, and other persons
whose conduct, in the performance of work for a covered entity, is under
the direct control of such entity, whether or not they are paid by the
covered entity.