Business associate agreement
between
Covered Entity (Name), Covered Entity (Address (one line)) ("Covered Entity")
and
Business Associate (Name), Business Associate (Address (one line)) ("Business Associate")
This Business Associate Agreement ("Agreement") is effective as of Effective date. It supplements the Service Agreement (the "Service Agreement"), under which Business Associate performs services for Covered Entity that involve protected health information.
Definitions
Catch-all definition. The following terms used in this Agreement have the same meaning as in the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required By Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use.
Business Associate. "Business Associate" generally has the same meaning as the term "business associate" at 45 CFR 160.103 and, in reference to the party to this Agreement, means the Business Associate named above.
Covered Entity. "Covered Entity" generally has the same meaning as the term "covered entity" at 45 CFR 160.103 and, in reference to the party to this Agreement, means the Covered Entity named above.
HIPAA Rules. "HIPAA Rules" means the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.
Obligations and activities of business associate
Business associate agrees to:
not use or disclose protected health information other than as permitted or required by this Agreement or as required by law;
use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information, to prevent use or disclosure of protected health information other than as provided for by this Agreement;
report to covered entity any use or disclosure of protected health information not provided for by this Agreement of which it becomes aware, including breaches of unsecured protected health information as required at 45 CFR 164.410, and any security incident of which it becomes aware. Business associate will make this report without unreasonable delay and no later than Breach reporting deadline (days) calendar days after discovery, and will give covered entity the information covered entity needs to notify affected individuals;
in accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any subcontractors that create, receive, maintain, or transmit protected health information on behalf of business associate agree in writing to the same restrictions, conditions, and requirements that apply to business associate with respect to such information;
make available protected health information in a designated record set to the Access requests go to as necessary to satisfy covered entity's obligations under 45 CFR 164.524;
make any amendment(s) to protected health information in a designated record set as directed or agreed to by covered entity pursuant to 45 CFR 164.526, or take other measures as necessary to satisfy covered entity's obligations under 45 CFR 164.526;
maintain and make available the information required to provide an accounting of disclosures to the Accounting of disclosures goes to as necessary to satisfy covered entity's obligations under 45 CFR 164.528;
forward to covered entity, within five business days of receipt, any request for access, amendment, or an accounting of disclosures that business associate receives directly from an individual, unless this Agreement provides that business associate responds to the individual directly;
to the extent business associate is to carry out one or more of covered entity's obligations under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to covered entity in the performance of such obligations; and
make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.
Permitted uses and disclosures by business associate
Business associate may only use or disclose protected health information as necessary to perform the services set forth in the Service Agreement. De-identification
Business associate may use or disclose protected health information as required by law.
Business associate agrees to make uses and disclosures and requests for protected health information consistent with covered entity's minimum necessary policies and procedures.
Business associate may not use or disclose protected health information in a manner that would violate Subpart E of 45 CFR Part 164 if done by covered entity, except for the specific uses and disclosures set forth in (3.e), (3.f) and (3.g).
Business associate may use protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of business associate.
Business associate may disclose protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of business associate, provided the disclosures are required by law, or business associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and be used or further disclosed only as required by law or for the purposes for which it was disclosed to the person, and the person notifies business associate of any instances of which it is aware in which the confidentiality of the information has been breached.
Data aggregation
Obligations of covered entity
Covered entity shall notify business associate of any limitation(s) in the notice of privacy practices of covered entity under 45 CFR 164.520, to the extent that such limitation may affect business associate's use or disclosure of protected health information.
Covered entity shall notify business associate of any changes in, or revocation of, the permission by an individual to use or disclose his or her protected health information, to the extent that such changes may affect business associate's use or disclosure of protected health information.
Covered entity shall notify business associate of any restriction on the use or disclosure of protected health information that covered entity has agreed to or is required to abide by under 45 CFR 164.522, to the extent that such restriction may affect business associate's use or disclosure of protected health information.
Term and termination
Term. This Agreement takes effect on the effective date stated above and ends when the Service Agreement terminates or expires, or on the date covered entity terminates this Agreement for cause under (5.b), whichever is sooner.
Termination for cause. Business associate authorizes termination of this Agreement by covered entity if covered entity determines that business associate has violated a material term of this AgreementCure period Covered entity may also terminate the parts of the Service Agreement that involve protected health information.
Obligations of business associate upon termination. Upon termination of this Agreement for any reason, business associate, with respect to protected health information received from covered entity, or created, maintained, or received by business associate on behalf of covered entity, shall:
retain only that protected health information which is necessary for business associate to continue its proper management and administration or to carry out its legal responsibilities;
Return or destroy the remaining protected health information that business associate still maintains in any form, including protected health information held by its subcontractors;
continue to use appropriate safeguards and comply with Subpart C of 45 CFR Part 164 with respect to electronic protected health information to prevent use or disclosure of the protected health information, other than as provided for in this section, for as long as business associate retains the protected health information;
not use or disclose the protected health information retained by business associate other than for the purposes for which it was retained and subject to the same conditions set out in (3.e) and (3.f), which applied prior to termination; and
Return or destroy the protected health information retained by business associate when it is no longer needed for its proper management and administration or to carry out its legal responsibilities.
Survival. The obligations of business associate under this section survive the termination of this Agreement.
Miscellaneous
Regulatory references. A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
Amendment. The parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for compliance with the requirements of the HIPAA Rules and any other applicable law. Any other amendment must be in writing and signed by both parties.
Interpretation. Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.
Relationship to the Service Agreement. If this Agreement conflicts with the Service Agreement on the handling of protected health information, this Agreement controls. In all other respects the Service Agreement continues to apply.
No third-party beneficiaries. Nothing in this Agreement gives any person other than the parties any rights, remedies, or obligations.
Governing law. This Agreement is governed by the laws of Governing law, to the extent not preempted by the HIPAA Rules or other federal law.
Signatures. This Agreement may be signed electronically and in counterparts, each of which is an original and all of which together are one agreement.
