Standards
for Privacy of Individually Identifiable Health Information
Appendix to the Preamble--Sample Business Associate
Contract Provisions
Statement of Intent
The Department provides these sample business associate contract
provisions in response to numerous requests for guidance. This is
only sample language. These provisions are designed to help covered
entities more easily comply with the business associate contract
requirements of the Privacy Rule. However, use of these sample provisions
is not required for compliance with the Privacy Rule. The language
may be amended to more accurately reflect business arrangements
between the covered entity and the business associate.
These or similar provisions may be incorporated into an agreement
for the provision of services between the entities or they may be
incorporated into a separate business associate agreement. These provisions
only address concepts and requirements set forth in the Privacy Rule
and alone are not sufficient to result in a binding contract under
State law. They do not include many formalities and substantive provisions
that are required or typically included in a valid contract. Reliance
on this sample is not sufficient for compliance with State law and
does not replace consultation with a lawyer or negotiations between
the parties to the contract.
Furthermore, a covered entity may want to include other provisions
that are related to the Privacy Rule but that are not required by
the Privacy Rule. For example, a covered entity may want to add
provisions in a business associate contract in order for the covered
entity to be able to rely on the business associate to help the
covered entity meet its obligations under the Privacy Rule. In addition,
there may be permissible uses or disclosures by a business associate
that are not specifically addressed in these sample provisions,
for example having a business associate create a limited data set.
These and other types of issues will need to be worked out between
the parties.
Sample Business Associate Contract Provisions 3
3 Words or phrases
contained in brackets are intended as either optional language or
as instructions to the users of these sample provisions and are
not intended to be included in the contractual provisions.
Definitions (Alternative
Approaches) Catch-all definition:
Terms used, but not otherwise defined, in this Agreement shall
have the same meaning as those terms in the Privacy Rule.
Examples of specific definitions:
(a) Business Associate. "Business Associate" shall
mean [Insert Name of Business Associate].
(b) Covered Entity. "Covered Entity" shall mean [Insert
Name of Covered Entity].
(c) Individual. "Individual" shall have the same meaning
as the term "individual" in 45 CFR 164.501 and shall
include a person who qualifies as a personal representative in
accordance with 45 CFR 164.502(g).
(d) Privacy Rule. "Privacy Rule" shall mean the Standards
for Privacy of Individually Identifiable Health Information at
45 CFR part 160 and part 164, subparts A and E.
(e) Protected Health Information. "Protected Health Information"
shall have the same meaning as the term "protected health
information" in 45 CFR 164.501, limited to the information
created or received by Business Associate from or on behalf of
Covered Entity.
(f) Required By Law. "Required By Law" shall have the
same meaning as the term "required by law" in 45 CFR
164.501.
(g) Secretary. "Secretary" shall mean the Secretary
of the Department of Health and Human Services or his designee.
Obligations and Activities of Business Associate
(a) Business Associate agrees to not use or disclose Protected
Health Information other than as permitted or required by the
Agreement or as Required By Law.
(b) Business Associate agrees to use appropriate safeguards to
prevent use or disclosure of the Protected Health Information
other than as provided for by this Agreement.
(c) Business Associate agrees to mitigate, to the extent practicable,
any harmful effect that is known to Business Associate of a use
or disclosure of Protected Health Information by Business Associate
in violation of the requirements of this Agreement. [This provision
may be included if it is appropriate for the Covered Entity to
pass on its duty to mitigate damages to a Business Associate.]
(d) Business Associate agrees to report to Covered Entity any
use or disclosure of the Protected Health Information not provided
for by this Agreement of which it becomes aware.
(e) Business Associate agrees to ensure that any agent, including
a subcontractor, to whom it provides Protected Health Information
received from, or created or received by Business Associate on
behalf of Covered Entity agrees to the same restrictions and conditions
that apply through this Agreement to Business Associate with respect
to such information.
(f) Business Associate agrees to provide access, at the request
of Covered Entity, and in the time and manner [Insert negotiated
terms], to Protected Health Information in a Designated Record
Set, to Covered Entity or, as directed by Covered Entity, to an
Individual in order to meet the requirements under 45 CFR 164.524.
[Not necessary if business associate does not have protected health
information in a designated record set.]
(g) Business Associate agrees to make any amendment(s) to Protected
Health Information in a Designated Record Set that the Covered
Entity directs or agrees to pursuant to 45 CFR 164.526 at the
request of Covered Entity or an Individual, and in the time and
manner [Insert negotiated terms]. [Not necessary if business associate
does not have protected health information in a designated record
set.]
(h) Business Associate agrees to make internal practices, books,
and records, including policies and procedures and Protected Health
Information, relating to the use and disclosure of Protected Health
Information received from, or created or received by Business
Associate on behalf of, Covered Entity available [to the Covered
Entity, or] to the Secretary, in a time and manner [Insert negotiated
terms] or designated by the Secretary, for purposes of the Secretary
determining Covered Entity's compliance with the Privacy Rule.
(i) Business Associate agrees to document such disclosures of
Protected Health Information and information related to such disclosures
as would be required for Covered Entity to respond to a request
by an Individual for an accounting of disclosures of Protected
Health Information in accordance with 45 CFR 164.528.
(j) Business Associate agrees to provide to Covered Entity or
an Individual, in time and manner [Insert negotiated terms], information
collected in accordance with Section [Insert Section Number in
Contract Where Provision (i) Appears] of this Agreement, to permit
Covered Entity to respond to a request by an Individual for an
accounting of disclosures of Protected Health Information in accordance
with 45 CFR 164.528.
Permitted Uses and Disclosures by Business Associate General Use
and Disclosure Provisions [(a) and (b) are alternative approaches]
(a) Specify purposes:
Except as otherwise limited in this Agreement, Business Associate
may use or disclose Protected Health Information on behalf of,
or to provide services to, Covered Entity for the following purposes,
if such use or disclosure of Protected Health Information would
not violate the Privacy Rule if done by Covered Entity or the
minimum necessary policies and procedures of the Covered Entity:
[List Purposes].
(b) Refer to underlying services agreement:
Except as otherwise limited in this Agreement, Business Associate
may use or disclose Protected Health Information to perform functions,
activities, or services for, or on behalf of, Covered Entity as
specified in [Insert Name of Services Agreement], provided that
such use or disclosure would not violate the Privacy Rule if done
by Covered Entity or the minimum necessary policies and procedures
of the Covered Entity.
Specific Use and Disclosure Provisions [only necessary if parties
wish to allow Business Associate to engage in such activities]
(a) Except as otherwise limited in this Agreement, Business Associate
may use Protected Health Information for the proper management
and administration of the Business Associate or to carry out the
legal responsibilities of the Business Associate.
(b) Except as otherwise limited in this Agreement, Business Associate
may disclose Protected Health Information for the proper management
and administration of the Business Associate, provided that disclosures
are Required By Law, or Business Associate obtains reasonable
assurances from the person to whom the information is disclosed
that it will remain confidential and used or further disclosed
only as Required By Law or for the purpose for which it was disclosed
to the person, and the person notifies the Business Associate
of any instances of which it is aware in which the confidentiality
of the information has been breached.
(c) Except as otherwise limited in this Agreement, Business Associate
may use Protected Health Information to provide Data Aggregation
services to Covered Entity as permitted by 42 CFR 164.504(e)(2)(i)(B).
(d) Business Associate may use Protected Health Information to
report violations of law to appropriate Federal and State authorities,
consistent with Sec. 164.502(j)(1).
Obligations of Covered Entity Provisions for Covered Entity To
Inform Business Associate of Privacy Practices and Restrictions
[provisions dependent on business arrangement]
(a) Covered Entity shall notify Business Associate of any limitation(s)
in its notice of privacy practices of Covered Entity in accordance
with 45 CFR 164.520, to the extent that such limitation may affect
Business Associate's use or disclosure of Protected Health Information.
(b) Covered Entity shall notify Business Associate of any changes
in, or revocation of, permission by Individual to use or disclose
Protected Health Information, to the extent that such changes
may affect Business Associate's use or disclosure of Protected
Health Information.
(c) Covered Entity shall notify Business Associate of any restriction
to the use or disclosure of Protected Health Information that
Covered Entity has agreed to in accordance with 45 CFR 164.522,
to the extent that such restriction may affect Business Associate's
use or disclosure of Protected Health Information. Permissible
Requests by Covered Entity
Covered Entity shall not request Business Associate to use or
disclose Protected Health Information in any manner that would
not be permissible under the Privacy Rule if done by Covered Entity.
[Include an exception if the Business Associate will use or disclose
protected health information for, and the contract includes provisions
for, data aggregation or management and administrative activities
of Business Associate].
Term and Termination
(a) Term. The Term of this Agreement shall be effective as of
[Insert Effective Date], and shall terminate when all of the Protected
Health Information provided by Covered Entity to Business Associate,
or created or received by Business Associate on behalf of Covered
Entity, is destroyed or returned to Covered Entity, or, if it
is infeasible to return or destroy Protected Health Information,
protections are extended to such information, in accordance with
the termination provisions in this Section. [Term may differ.]
(b) Termination for Cause. Upon Covered Entity's knowledge of
a material breach by Business Associate, Covered Entity shall
either:
(1) Provide an opportunity for Business Associate to cure the
breach or end the violation and terminate this Agreement [and
the ___ Agreement/ sections __ of the ___ Agreement] if Business
Associate does not cure the breach or end the violation within
the time specified by Covered Entity;
(2) Immediately terminate this Agreement [and the ___ Agreement/
sections __ of the ___ Agreement] if Business Associate has
breached a material term of this Agreement and cure is not possible;
or
(3) If neither termination nor cure are feasible, Covered Entity
shall report the violation to the Secretary. [Bracketed language
in this provision may be necessary if there is an underlying
services agreement. Also, opportunity to cure is permitted,
but not required by the Privacy Rule.]
(c) Effect of Termination.
(1) Except as provided in paragraph (2) of this section, upon
termination of this Agreement, for any reason, Business Associate
shall return or destroy all Protected Health Information received
from Covered Entity, or created or received by Business Associate
on behalf of Covered Entity. This provision shall apply to Protected
Health Information that is in the possession of subcontractors
or agents of Business Associate. Business Associate shall retain
no copies of the Protected Health Information.
(2) In the event that Business Associate determines that returning
or destroying the Protected Health Information is infeasible,
Business Associate shall provide to Covered Entity notification
of the conditions that make return or destruction infeasible.
Upon [Insert negotiated terms] that return or destruction of
Protected Health Information is infeasible, Business Associate
shall extend the protections of this Agreement to such Protected
Health Information and limit further uses and disclosures of
such Protected Health Information to those purposes that make
the return or destruction infeasible, for so long as Business
Associate maintains such Protected Health Information.
Miscellaneous
(a) Regulatory References. A reference in this Agreement to a
section in the Privacy Rule means the section as in effect or
as amended.
(b) Amendment. The Parties agree to take such action as is necessary
to amend this Agreement from time to time as is necessary for
Covered Entity to comply with the requirements of the Privacy
Rule and the Health Insurance Portability and Accountability Act
of 1996, Pub. L. No. 104-191.
(c) Survival. The respective rights and obligations of Business
Associate under Section [Insert Section Number Related to "Effect
of Termination"] of this Agreement shall survive the termination
of this Agreement.
(d) Interpretation. Any ambiguity in this Agreement shall be
resolved to permit Covered Entity to comply with the Privacy Rule.
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