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 § 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 § 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 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.
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.
HCFA
stands for Health Care Financing Administration within the Department of
Health and Human Services.
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 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.
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.