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BUSINESS ASSOCIATE AGREEMENT

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Page 1 of 8
BUSINESS ASSOCIATE AGREEMENT
This BUSINESS ASSOCIATE AGREEMENT (the “BAA”) is made and entered into as of
________________, 20____ by and between:
Covered Entity: ________________, a(n) ☐ LLC ☐ Corporation
☐ Partnership ☐ Other: ________________ (“Covered Entity”)
Business Associate: ________________, a(n) ☐ Individual ☐ LLC
☐ Corporation ☐ Partnership ☐ Other: ________________ (“Business
Associate”, in accordance with the meaning given to those terms at 45 CFR §
164.501). In this BAA, Covered Entity and Business Associate are each a “Party”
and, collectively, are the “Parties”.
BACKGROUND
I. Covered Entity is either a “covered entity” or “business associate” of a covered entity
as each are defined under the Health Insurance Portability and Accountability Act of
1986, Public Law 104-191, as amended by the HITECH ACT (as defined below) and the
related regulations promulgated by HHS (as defined below) (collectively, “HIPAA”) and,
as such, is required to comply with HIPAA’s provisions regarding the confidentiality and
privacy of Protected Health Information (as defined below);
II. The Parties have entered into or will enter into one or more agreements under which
Business Associate provides or will provide certain specified services to Covered Entity
(collectively, the “Agreement”);
III. In providing services pursuant to the Agreement, Business Associate will have
access to Protected Health Information;
IV. By providing the services pursuant to the Agreement, Business Associate will
become a “business associate” of the Covered Entity as such term is defined under
HIPAA;
V. Both Parties are committed to complying with all federal and state laws governing
confidentiality and privacy of health information, including, but not limited to, the
Standards for Privacy of Individually Identifiable Health Information found at 45 CFR
Part 160 and Part 164, Subparts A and E (collectively, the “Privacy Rule”); and
VI. Both Parties intend to protect the privacy and provide for the security of Protected
Health Information disclosed to Business Associate pursuant to this Agreement, HIPAA
and other applicable laws.
Page 2 of 8
AGREEMENT
NOW, THEREFORE, in consideration of the mutual and conditions contained herein
and the continued provision of PHI by Covered Entity to Business Associate under the
Agreement in reliance on this BAA, the Parties agree as follows:
1. Definitions. For the purposes of this BAA, the Parties give the following meaning
to each of the terms in this Section 1 below. Any capitalized term used in this
BAA, but otherwise defined, has the meaning given to that term in the Privacy
Rule or pertinent law.
A. “Affiliate” means a subsidiary or affiliate of Covered Entity that is, or has
been, considered a covered entity, as defined by HIPAA.
B. “Breach” means the acquisition, access, use, or disclosure of PHI in a
manner not permitted under the Privacy Rule which compromises the
security or privacy of the PHI, as defined in 45 CFR § 164.402.
C. “Breach Notification Rule” means the portion of HIPAA set forth in Subpart
D of 45 CFR Part 164.
D. “Data Aggregation” means, with respect to PHI created or received by
Business Associate in its capacity as the “business associate” under
HIPAA of Covered Entity, the combining of such PHI by Business
Associate with the PHI received by Business Associate in its capacity as a
business associate of one or more other “covered entity” under HIPAA, to
permit data analyses that relate to the Health Care Operations (defined
below) of the respective covered entities. The meaning of “data
aggregation” in this BAA shall be consistent with the meaning given to that
term in the Privacy Rule.
E. “Designated Record Set” has the meaning given to such term under the
Privacy Rule including 45 CFR § 164.501.B.
F. “De-Identify” means to alter the PHI such that the resulting information
meets the requirements described in 45 CFR §§164.514(a) and (b).
G. “Electronic PHI” means any PHI maintained in or transmitted by electronic
media as defined in 45 CFR § 160.103
H. “Health Care Operations” has the meaning given to that term in 45 CFR §
164.501.
I. “HHS” means the U.S. Department of Health and Human Services.
J. “HITECH Act” means the Health Information Technology for Economic
and Clinical Act, enacted as part of the American Recovery and
Reinvestment Act of 2009, Public Law 111-005.
K. “Individual” has the same meaning given to that term in 45 CFR
§§164.501 and 160.130 and includes a person who qualifies as a personal
representative in accordance with 45 CFR § 164.502(g).
L. “Privacy Rule” means that portion of HIPAA set forth in 45 CFR Part 160
and Part 164, Subparts A and E.
M. “Protected Health Information” or “PHI” has the meaning given to the term
“protected health information” in 45 CFR §§164.501 and 160.103, limited
to the information created or received by Business Associate from or on
behalf of the Covered Entity.
Page 3 of 8
N. “Security Incident” means the attempted or successful unauthorized
access, use, disclosure, modification, or destruction of information or
interference with system operations in an information system.
O. “Security Rule” means the Security Standards for the Protection of
Electronic Health Information provided in 45 CFR Part 160 & Part 164,
Subparts A and C.
P. “Unsecured Protected Health Information” or “Unsecured PHI” means any
“protected health information” as defined in 45 CFR §§164.501 and
160.103 that is not rendered unusable, unreadable, or indecipherable to
unauthorized individuals through the use of a technology or methodology
specified by the HHS Secretary in the guidance issued pursuant to the
HITECH Act and codified at 42 USC § 17932(h).
2. Use and Disclosure of PHI.
A. Except as otherwise provided in this BAA, Business Associate may use or
disclose PHI as reasonably to provide the services described in the
Agreement to Covered Entity, and to undertake other activities of
Business Associate permitted or required of Business Associate by this
BAA or as required by law.
B. Except as otherwise limited by this BAA or federal or state law, Covered
Entity authorizes Business Associate to use the PHI in its possession for
the proper management and administration of Business Associate’s
business and to carry out its legal responsibilities. Business Associate
may disclose PHI for its proper management and administration, provided
that (i) the disclosures are by law; or (ii) Business Associate obtains, in
writing, prior to making any disclosure to a third party (a) reasonable
assurances from this third party that the PHI will be held confidential as
provided under this BAA and used or further disclosed only as required by
law or for the purpose for which it was disclosed to this third party and (b)
an agreement from this third party to notify Business Associate
immediately of any breaches of the confidentiality of the PHI, to the extent
it has knowledge of the breach.
C. Business Associate will not use or disclose PHI in a manner other than as
provided in this BAA, as permitted under the Privacy Rule, or as required
by law. Business Associate will use or disclose PHI, to the extent
practicable, as a limited data set or limited to the minimum necessary
amount of PHI to carry out the intended purpose of the use or disclosure,
in accordance with Section 13405(b) of the HITECH ACT (codified as 42
USC § 17935(b)) and any of the act’s implementing regulations adopted
by HHS, for each use or disclosure of PHI.
D. Upon request, Business Associate will make available to Covered Entity
any of Covered Entity’s PHI that Business Associate or any of its agents
or subcontractors have in their possession.
E. Business Associate may use PHI to report violations of law to appropriate
Federal and State authorities, consistent with 45 CFR §164.502(j)(1).
3. Safeguards Against Misuse of PHI. Business Associate will use appropriate
safeguards to prevent the use or disclosure of PHI other than as provided by the
Page 4 of 8
Agreement or this BAA and Business Associate agrees to implement
administrative, physical, and technical safeguards that reasonably and
appropriately protect the confidentiality, integrity and availability of the Electronic
PHI that it creates, receives, maintains or transmits on behalf of Covered Entity.
Business Associate agrees to take reasonable steps, including providing
adequate training to its employees to ensure compliance with this BAA and to
ensure that the actions or omissions of its employees or agents do not cause
Business Associate to breach the terms of this BAA.
4. Reporting Disclosures of PHI and Security Incidents. Business Associate will
report to Covered Entity in writing any use or disclosure of PHI not provided for
by this BAA of which it becomes aware and Business Associate agrees to report
to Covered Entity any Security Incident affecting Electronic PHI of Covered Entity
of which it becomes aware. Business Associate agrees to report any such event
within 30 business days.
5. Reporting Breaches of Unsecured PHI. Business Associate will notify Covered
Entity in writing promptly upon the discovery of any Breach of Unsecured PHI in
accordance with the requirements set forth in 45 CFR § 164.410, but in no case
later than 30 calendar days after the discovery of a Breach. Business Associate
will reimburse Covered Entity for any costs incurred by it in complying with the
requirements of Subpart D of 45 CFR §164 that are imposed on Covered Entity
as a result of a Breach committed by Business Associate.
6. Mitigation of Disclosures of PHI. Business Associate will take reasonable
measures to mitigate, to the extent practicable, any harmful effect that is known
to Business Associate of any use or disclosure of PHI by Business Associate or
its agents or subcontractors in violation of the requirements of this BAA.
7. Agreements with Agents or Subcontractors. Business Associate will ensure
that any of its agents or subcontractors that have access to, or to which Business
Associate provides, PHI agree in writing to the restriction and conditions
concerning uses and disclosures of PHI contained in this BAA and agree to
implement reasonable and appropriate safeguards to protect any Electronic PHI
that it creates, received, maintains or transmits on behalf of Business Associate
or, through the Business Associate, Covered Entity. Business Associate shall
notify Covered Entity, or upstream Business Associate, of all subcontracts and
agreements relating to the Agreement, where the subcontractor or agent
received PHI as described in section 1.M of this BAA. Such notification shall
occur within 30 calendar days of the execution of the subcontract by placement
of such notice on the Business Associate’s primary website. Business Associate
shall ensure that all subcontracts and agreements provide the same level of
privacy and security as this BAA.
8. Audit Report. Upon request, Business Associate will provide Covered Entity, or
upstream Business Associate, with a copy of its most recent independent HIPAA
compliance report (AT-C 315), HITRUST certification or other mutually agreed
upon independent standards based third party audit report. Covered Entity
agrees not to re-disclose Business Associate's audit report.
Page 5 of 8
9. Access to PHI by Individuals.
A. Upon request, Business Associate agrees to furnish Covered Entity with
copies of the PHI maintained by Business Associate in a Designated
Record Set in the time and manner designated by Covered Entity to
enable Covered Entity to respond to an Individual’s request for access to
PHI under 45 CFR §164.524.
B. In the event any Individual or personal representative requests access to
the Individual’s PHI directly from Business Associate, Business Associate
within 10 business days, will forward that request to Covered Entity. Any
disclosure of, or decision not to disclose, the PHI requested by an
Individual or a personal representative and compliance with the
requirements applicable to an Individual’s right to obtain access to PHI
shall be the sole responsibility of Covered Entity.
10. Amendment of PHI.
A. Upon request and instruction from Covered Entity, Business Associate will
amend PHI or a record about an Individual in a Designated Record Set
that is maintained by, or otherwise within the possession of, Business
Associate as directed by Covered Entity in accordance with procedures
established by 45 CFR §164.526. Any request by Covered Entity to
amend such information will be completed by Business Associate within
15 business days of Covered Entity’s request.
B. In the event that any Individual requests that Business Associate amend
such Individual’s PHI or record in a Designated Record Set, Business
Associate within 10 business days will forward this request to Covered
Entity. Any amendment of, or decision not to amend, the PHI or record as
requested by an Individual and compliance with the requirements
applicable to an Individual’s right to request an amendment of PHI will be
the sole responsibility of Covered Entity.
11. Accounting of Disclosures.
A. Business Associate will document any disclosures of PHI made by it to
account for such disclosures as required by 45 CFR §164.528(a).
Business Associate also will make available information related to such
disclosures as would be required for Covered Entity to respond to a
request for an accounting of disclosures in accordance with 45 CFR
§164.528. At a minimum, Business Associate will furnish Covered Entity
the following with respect to any covered disclosures by Business
Associate: (i) the date of disclosure of PHI; (ii) the name of the entity or
person who received PHI, and, if known, the address of such entity or
person; (iii) a brief description of the PHI disclosed; and (iv) a brief
statement of the purpose of the disclosure which includes the basis for
such disclosure.
B. Business Associate will furnish to Covered Entity information collected in
accordance with this Section 10, within 10 business days after written
Page 6 of 8
request by Covered Entity, to permit Covered Entity to make an
accounting of disclosures as required by 45 CFR §164.528, or in the event
that Covered Entity elects to provide an Individual with a list of its business
associates, Business Associate will provide an accounting of its
disclosures of PHI upon request if the Individual, if and to the extent that
such accounting is required under the HITECH ACT or under HHS
regulations adopted in connection with the HITECH ACT.
C. In the event an Individual delivers the initial request for an accounting
directly to Business Associate, Business Associate will within 10 business
days forward such request to Covered Entity.
12. Availability of Books and Records. Business Associate will make available its
internal practices, books, agreements, records, and policies and procedures
relating to the use and disclosure of PHI, upon request, to the Secretary of HHS
for purposes of determining Covered Entity's and Business Associate's
compliance with HIPAA, and this BAA.
13. Responsibilities of Covered Entity. With regard to the use and/or disclosure of
Protected Health Information by Business Associate, Covered Entity agrees to:
A. Notify Business Associate of any limitation(s) in its notice of privacy
practices in accordance with 45 CFR §164.520, to the extent that such
limitation may affect Business Associate’s use or disclosure of PHI.
B. Notify Business Associate of any changes in, or revocation of, permission
by an Individual to use or disclose Protected Health Information, to the
extent that such changes may affect Business Associate’s use or
disclosure of PHI.
C. Notify Business Associate of any restriction to the use or disclosure of PHI
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 PHI.
D. Except for data aggregation or management and administrative activities
of Business Associate, Covered Entity shall not request Business
Associate to use or disclose PHI in any manner that would not be
permissible under HIPAA if done by Covered Entity.
14. Data Ownership. Business Associate’s data stewardship does not confer data
ownership rights on Business Associate with respect to any data shared with it
under the Agreement, including any and all forms thereof.
15. Term and Termination.
A. This BAA will become effective on the date first written above and will
continue in effect until all obligations of the Parties have been met under
the Agreement and under this BAA.
B. Covered Entity may terminate this BAA, the Agreement, and any other
related agreements if Covered Entity makes a determination that Business
Associate has breached a material term of this BAA and Business
Associate has failed to cure that material breach, to Covered Entity’s
Page 7 of 8
reasonable satisfaction, within 30 days after written notice from Covered
Entity. Covered Entity may report the problem to the Secretary of HHS if
termination is not feasible.
C. If Business Associate determines that Covered Entity has breached a
material term of this BAA, then Business Associate will provide Covered
Entity with written notice of the existence of the breach and shall provide
Covered Entity with 30 days to cure the breach. Covered Entity’s failure to
cure the breach within the 30-day period will be grounds for immediate
termination of the Agreement and this BAA by Business Associate.
Business Associate may report the breach to the HHS.
D. Upon termination of the Agreement or this BAA for any reason, all PHI
maintained by Business Associate will be returned to Covered Entity or
destroyed by Business Associate. Business Associate will not retain any
copies of such information. This provision will apply to PHI in the
possession of Business Associate’s agents and subcontractors. If return
or destruction of the PHI is not feasible, in Business Associate’s
reasonable judgment, Business Associate will furnish Covered Entity with
notification, in writing, of the conditions that make return or destruction
infeasible. Upon mutual agreement of the Parties that return or destruction
of the PHI is infeasible, Business Associate will extend the protections of
this BAA to such information for as long as Business Associate retains
such information and will limit further uses and disclosures to those
purposes that make the return or destruction of the information not
feasible. The Parties understand that this Section 14.D. will survive any
termination of this BAA.
16. Effect of BAA.
A. This BAA is a part of and subject to the terms of the Agreement, except
that to the extent any terms of this BAA conflict with any term of the
Agreement, the terms of this BAA will govern.
B. Except as expressly stated in this BA or as provided by law, this BAA will
not create any rights in favor of any third party.
17. Regulatory References. A reference in this BAA to a section in HIPAA means
the section as in effect or as amended at the time.
18. Notices. All notices, requests and demands or other communications to be given
under this BAA to a Party will be made via either first class mail, registered or
certified or express courier, or electronic mail to the Party’s address given below:
A. If to Covered Entity, to:
Name: ________________
Attn: ________________
Mailing Address: ________________________________
Telephone: (____) ____-______
E-Mail: ________________
Page 8 of 8
B. If to Business Associate, to:
Name: ________________
Attn: ________________
Mailing Address: ________________________________
Telephone: (____) ____-______
E-Mail: ________________
19. Amendments and Waiver. This BAA may not be modified, nor will any provision
be waived or amended, except in writing duly signed by authorized
representatives of the Parties. A waiver with respect to one event shall not be
construed as continuing, or as a bar to or waiver of any right or remedy as to
subsequent events.
20. HITECH ACT Compliance. The Parties acknowledge that the HITECH Act
includes significant changes to the Privacy Rule and the Security Rule. The
privacy subtitle of the HITECH Act sets forth provisions that significantly change
the requirements for business associates and the agreements between business
associates and covered entities under HIPAA and these changes may be further
clarified in forthcoming regulations and guidance. Each Party agrees to comply
with the applicable provisions of the HITECH Act and any HHS regulations
issued with respect to the HITECH Act. The Parties also agree to negotiate in
good faith to modify this BAA as reasonably necessary to comply with the
HITECH Act and its regulations as they become effective but, in the event that
the Parties are unable to reach an agreement on such a modification, either
Party will have the right to terminate this BAA upon 30 days’ prior written notice
to the other Party.
In light of the mutual agreement and understanding described above, the Parties
execute this BAA as of the date first written above.
Covered Entity: _________________________________ Date: _____________
Print Name: _________________________________
Title: _________________________________
Business Associate: _________________________________ Date: _____________
Print Name: _________________________________
Title: _________________________________
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BUSINESS ASSOCIATE AGREEMENT

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Completed 20 April 2022

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