Sample Business Associate Agreement

MODEL BUSINESS ASSOCIATE AGREEMENT
This BUSINESS ASSOCIATE AGREEMENT (the “BAA”) is made and entered into as of
by and between , a
organized under the laws of the
(“Covered Entity”) and , a
organized under the laws of
(“Business Associate”, in accordance with the meaning given to those terms at 45 CFR ง164.501). 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 1996, 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
the 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 the terms of this
Agreement, HIPAA and other applicable laws.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants 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:
Page 2 of 9
1. Definitions. For 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 not 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 ง164.402.
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 ง164.501.B.
F. “De-Identify” means to alter the PHI such that the resulting information meets the
requirements described in 45 CFR งง164.514(a) and (b).
G. “Electronic PHI” means any PHI maintained in or transmitted by electronic media as
defined in 45 CFR ง160.103.
H. “Health Care Operations” has the meaning given to that term in 45 CFR ง164.501.
I. “HHS” means the U.S. Department of Health and Human Services.
J. “HITECH Act” means the Health Information Technology for Economic and Clinical
Health 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 i in 45 CFR งง164.501 and 160.130
and includes a person who qualifies as a personal representative in accordance with 45 CFR
ง164.502(g).
L. “Privacy Rule” means that portion of HIPAA set forth in 45 CFR Part 160 and Part 164,
Subparts A and E.
Page 3 of 9
M. “Protected Health Information” or “PHI” has the meaning given to the term “protected
health information” in 45 CFR งง164.501 and 160.103, limited to the information created or
received by Business Associate from or on behalf of Covered Entity.
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 งง164.501 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 ง17932(h).
2. Use and Disclosure of PHI.
A. Except as otherwise provided in this BAA, Business Associate may use or disclose PHI as
reasonably necessary 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 required 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 at 42 USC ง17935(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 ง164.502(j)(1).
Page 4 of 9
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 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
five business days of becoming aware of the event.
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 ง164.410, but in no case later than 30 calendar days after 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 ง164 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 restrictions 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, receives, 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 receives PHI as described in section 1.M. of this BAA. Such notification shall occur within 30
(thirty) 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.
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
Page 5 of 9
designated by Covered Entity to enable Covered Entity to respond to an Individual’s request for
access to PHI under 45 CFR ง164.524.
B. In the event any Individual or personal representative requests access to the Individual’s
PHI directly from Business Associate, Business Associate within ten 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 ง164.526. 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 ten 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 ง164.528(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 ง164.528. 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 ten business days after written request by Covered Entity, to permit
Covered Entity to make an accounting of disclosures as required by 45 CFR ง164.528, 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 of 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 ten business days forward such request to
Covered Entity.
Page 6 of 9
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 ง164.520, 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 ง164.522, 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 immediately 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 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 HHS.
Page 7 of 9
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 BAA 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:
Attn:
T:
E:
B. If to Business Associate, to:
Attn:
T:
E:
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.
Page 8 of 9
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 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.
[The remainder of this page intentionally left blank; signatures on the following page]
Page 9 of 9
In light of the mutual agreement and understanding described above, the Parties execute this BAA as of
the date first written above.
By: ____________________________________
Name:
Title:
By: ____________________________________
Name:
Title: