Business Associate Agreement Template

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THIS IS A TEMPLATE ONLY. CERTAIN STATES MAY NOT
PERMIT THE TYPES OF ACTIVITIES ALLOWED HEREUNDER RELATING
TO PROTECTED HEALTH INFORMATION. THUS THIS AGREEMENT MAY
NEED TO BE MODIFIED IN ORDER TO COMPLY WITH MORE
RESTRICTIVE, APPLICABLE STATE LAW.
Where indicated below, Option 1 provisions are for use when this business
associate agreement will be an amendment, addendum or rider to an existing services
agreement and Option 2 provisions are for use when this business associate agreement will be
the only written agreement between the parties regarding the business associate services to be
provided. All other provisions of the agreement can be included in both options.
BUSINESS ASSOCIATE AGREEMENT
This Business Associate Agreement (this “B.A. Agreement”), dated
______________, 200_, is entered into by and between _________________, with an
address at _______________ (the “Business Associate”) and ________________, with an
address at _____________________ (the “Covered Entity”) (each a “Party” and
collectively the “Parties”).
[Required: Choose one option as appropriate.]
[OPTION 1 The Parties have entered into a prior agreement entitled
_________ dated _________ (the “Underlying Agreement”). Performance of the
Underlying Agreement may involve Protected Health Information (as defined in 45
C.F.R. § 164.501) that is subject to the federal privacy regulations issued pursuant to
the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and
codified at 45 C.F.R. parts 160 and 164 (the “Privacy Rule”). The purpose of this B.A.
Agreement is to amend the Underlying Agreement to the extent and only to the extent
necessary to allow for Covered Entity’s compliance with the Privacy Rule with respect
to this Underlying Agreement.]
[OPTION 2 The Parties have agreed that Business Associate will
perform the following functions and provide the following services for or on behalf of
the Covered Entity: __________ [list functions or services which are permitted
by the Privacy Rule and require a Business Associate Agreement under
the Privacy Rule (see 45 C.F.R. § 164.501)]. Performance of such functions and
provision of such services by the Business Associate may involve Protected Health
Information (as defined in 45 C.F.R. § 164.501) that is subject to the federal privacy
regulations issued pursuant to the Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”) and codified at 45 C.F.R. parts 160 and 164 (the “Privacy Rule”).
The purpose of this B.A. Agreement is to set forth the obligations of the Parties with
respect to such Protected Health Information.]
The Parties hereby agrees as follows:
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THIS IS A TEMPLATE ONLY. CERTAIN STATES MAY NOT
PERMIT THE TYPES OF ACTIVITIES ALLOWED HEREUNDER RELATING
TO PROTECTED HEALTH INFORMATION. THUS THIS AGREEMENT MAY
NEED TO BE MODIFIED IN ORDER TO COMPLY WITH MORE
RESTRICTIVE, APPLICABLE STATE LAW.
Where indicated below, Option 1 provisions are for use when this business
associate agreement will be an amendment, addendum or rider to an existing services
agreement and Option 2 provisions are for use when this business associate agreement will be
the only written agreement between the parties regarding the business associate services to be
provided. All other provisions of the agreement can be included in both options.
BUSINESS ASSOCIATE AGREEMENT
This Business Associate Agreement (this “B.A. Agreement”), dated
______________, 200_, is entered into by and between _________________, with an
address at _______________ (the “Business Associate”) and ________________, with an
address at _____________________ (the “Covered Entity”) (each a “Party” and
collectively the “Parties”).
[Required: Choose one option as appropriate.]
[OPTION 1 The Parties have entered into a prior agreement entitled
_________ dated _________ (the “Underlying Agreement”). Performance of the
Underlying Agreement may involve Protected Health Information (as defined in 45
C.F.R. § 164.501) that is subject to the federal privacy regulations issued pursuant to
the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and
codified at 45 C.F.R. parts 160 and 164 (the “Privacy Rule”). The purpose of this B.A.
Agreement is to amend the Underlying Agreement to the extent and only to the extent
necessary to allow for Covered Entity’s compliance with the Privacy Rule with respect
to this Underlying Agreement.]
[OPTION 2 The Parties have agreed that Business Associate will
perform the following functions and provide the following services for or on behalf of
the Covered Entity: __________ [list functions or services which are permitted
by the Privacy Rule and require a Business Associate Agreement under
the Privacy Rule (see 45 C.F.R. § 164.501)]. Performance of such functions and
provision of such services by the Business Associate may involve Protected Health
Information (as defined in 45 C.F.R. § 164.501) that is subject to the federal privacy
regulations issued pursuant to the Health Insurance Portability and Accountability
Act of 1996 (“HIPAA”) and codified at 45 C.F.R. parts 160 and 164 (the “Privacy Rule”).
The purpose of this B.A. Agreement is to set forth the obligations of the Parties with
respect to such Protected Health Information.]
The Parties hereby agrees as follows:
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1.
DEFINITIONS [Required provisions]
1.1
Unless otherwise specified in this B.A. Agreement, all capitalized terms
used in this B.A. Agreement not otherwise defined have the meaning
established for purposes of Title 45 parts 160 and 164 of the United States Code
of Federal Regulations, as amended from time to time.
1.2
“PHI” shall mean Protected Health Information, as defined in 45 C.F.R.
§ 164.501, limited to the information received from or created or received on
behalf of Covered Entity.
2.
RESPONSIBILITIES OF BUSINESS ASSOCIATE [Required
provisions]
2.1
Except as otherwise specified herein, Business Associate may make any
and all uses and disclosures of PHI necessary to perform [OPTION 1 its
obligations under the Underlying Agreement.] [OPTION 2 the functions and
provide the services set forth above.] With regard to its use and/or disclosure of
PHI, Business Associate agrees to:
(a)
use and/or disclose PHI only as permitted or required by this B.A.
Agreement or required by law;
(b)
use appropriate safeguards to prevent use or disclosure of PHI
other than as permitted or required by this B.A. Agreement;
(c)
report to Covered Entity any use or disclosure of PHI of which it
becomes aware that is not permitted or required by this B.A.
Agreement;
(d)
require all its subcontractors and agents that create, receive, use,
disclose or have access to PHI to agree, in writing, to the same
restrictions and conditions on the use and/or disclosure of PHI that
apply to Business Associate;
(e)
make available its internal practices, books, and records relating
to the use and disclosure of PHI to the Secretary of the Department of
Health and Human Services (“HHS”) for purposes of determining
Covered Entity’s compliance with the Privacy Rule;
(f)
within __ days [Must be less than 60 days] of receiving a
written request from Covered Entity, make available information
necessary for Covered Entity to make an accounting of disclosures of
PHI about an individual; and
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(g)
mitigate, to the extent practicable, any harmful effect that is
known to Business Associate of a use or disclosure of PHI by Business
Associate in violation of the requirements of this B.A. Agreement.
[Required: choose one as appropriate.]
2.2
[Option A: The Parties agree that the information in Business
Associate’s possession does not constitute a Designated Record Set.]
[Option B: The Parties agree that the PHI in Business Associate’s
possession constitutes a Designated Record Set. With regard to PHI
maintained in a Designated Record Set, Business Associate agrees to:
(a)
within __ days [Must be less than 30 days] of receiving a
written request from Covered Entity, make available PHI necessary
for Covered Entity to respond to individuals’ requests for access to PHI
about them; and
(b)
within __ days [Must be less than 60 days] of receiving a
written request from Covered Entity, incorporate any amendments or
corrections to the PHI in accordance with the Privacy Regulation.]
3.
PERMITTED USES AND DISCLOSURES OF PHI [Optional: as
appropriate to the relationship.]
3.1
Unless otherwise limited herein, in addition to any other uses and/or
disclosures permitted or required by this B.A. Agreement or required by law,
Business Associate may:
(a)
use the PHI in its possession for its proper management and
administration and to fulfill any legal responsibilities of Business
Associate;
(b)
disclose the PHI in its possession to a third party for the purpose
of Business Associate’s proper management and administration or to
fulfill any legal responsibilities of Business Associate; provided,
however, that the disclosures are required by law or Business
Associate has received from the third party written assurances that (i)
the information will be held confidentially and used or further
disclosed only as required by law or for the purpose for which it was
disclosed to the third party; and (ii) the third party will notify Business
Associate of any instances of which it becomes aware in which the
confidentiality of the information has been breached;
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(c)
perform Data Aggregation for the Health Care Operations of
Covered Entity;
(d)
de-identify any and all PHI created or received by Business
Associate under this B.A. Agreement; provided, however, that the de-
identification conforms to the requirements of the Privacy Rule. Such
resulting de-identified information would not be subject to the terms of
this B.A. Agreement; and
(e)
create a Limited Data Set and use such Limited Data Set
pursuant to a Data Use Agreement that meets the requirements of the
Privacy Rule.
4.
RESPONSIBILITIES OF COVERED ENTITY [Important to
comply with HIPAA]
4.1
With regard to the use and/or disclosure of PHI by Business Associate,
Covered Entity agrees:
(a)
to obtain any consent, authorization or permission that may be
required by the Privacy Rule or applicable state laws and/or regulations
prior to furnishing Business Associate the PHI pertaining to an
individual; and
(b)
that it will inform Business Associate of any PHI that is subject to
any arrangements permitted or required of Covered Entity under the
Privacy Rule that may materially impact in any manner the use and/or
disclosure of PHI by Business Associate under this B.A. Agreement,
including, but not limited to, restrictions on the use and/or disclosure of
PHI as provided for in 45 C.F.R. § 164.522 and agreed to by Covered
Entity.
5.
B.A. AGREEMENT EFFECTIVE DATE
5.1
Each term and condition of this B.A. Agreement shall be effective on the
compliance date applicable to Covered Entity under the Privacy Rule (“B.A.
Effective Date”).
6.
TERM AND TERMINATION [Required provisions]
6.1
Termination by the Covered Entity. Upon Covered Entity’s
determination of a breach of a material term of this B.A. Agreement by
Business Associate, Covered Entity shall provide Business Associate written
notice of that breach in sufficient detail to enable Business Associate to
understand the specific nature of that breach and afford Business Associate
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an opportunity to cure the breach; provided, however, that if Business
Associate fails to cure the breach within a reasonable time specified by
Covered Entity, Covered Entity may terminate this B.A. Agreement
[OPTION 1 and the Underlying Agreement to the extent that the
Underlying Agreement requires Business Associate to create or receive PHI].
6.2
Effect of Termination or Expiration. Within __ days of the termination
or expiration of this B.A. Agreement, Business Associate agrees to return or
destroy all PHI, including such information in possession of Business
Associate’s subcontractors, if feasible to do so. If return or destruction of said
PHI is not feasible, Business Associate agrees to extend any and all
protections, limitations and restrictions contained in this B.A. Agreement to
Business Associate’s use and/or disclosure of any PHI retained after the
termination or expiration of this B.A. Agreement, and to limit any further
uses and/or disclosures to the purposes that make return or destruction of the
PHI infeasible. This Section 6.2 shall survive any termination or expiration
of this B.A. Agreement.
7.
MISCELLANEOUS [Important for legal purposes and clarity]
7.1
Change in Law. The Parties agree to negotiate to amend this B.A.
Agreement as necessary to comply with any amendment to any provision of
HIPAA or its implementing regulations set forth at 45 C.F.R. parts 160 and
164, including, but not limited to, the Privacy Regulation, which materially
alters either Party or both Parties’ obligations under this B.A. Agreement.
7.2
Construction of Terms. The terms of this B.A. Agreement shall be
construed in light of any applicable interpretation or guidance on HIPAA
and/or the Privacy Regulation issued by HHS or the Office of Civil Rights
(“OCR”) from time to time.
7.3
No Third Party Beneficiaries. Nothing in this B.A. Agreement shall
confer upon any person other than the parties and their respective successors
or assigns, any rights, remedies, obligations, or liabilities whatsoever.
[OPTION 1 7.4
Contradictory Terms. Any provision of the Underlying
Agreement that is directly contradictory to one or more terms of this B.A.
Agreement (“Contradictory Term”) shall be superceded by the terms of this
B.A. Agreement as of the Amendment Effective Date to the extent and only to
the extent of the contradiction, only for the purpose of Covered Entity’s
compliance with the Privacy Rule and only to the extent that it is reasonably
impossible to comply with both the Contradictory Term and the terms of this
B.A. Agreement.]
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