Business Associate Agreement

Adapted from Office for Civil Rights (OCR)  HHS.gov document

Introduction

    A “business associate” is a person or entity, other than a member of the workforce of a covered entity, who performs functions or activities on behalf of, or provides certain services to, a covered entity that involve access by the business associate to protected health information.  A “business associate” also is a subcontractor that creates, receives, maintains, or transmits protected health information on behalf of another business associate.  The HIPAA Rules generally require that covered entities and business associates enter into contracts with their business associates to ensure that the business associates will appropriately safeguard protected health information.  The business associate contract also serves to clarify and limit, as appropriate, the permissible uses and disclosures of protected health information by the business associate, based on the relationship between the parties and the activities or services being performed by the business associate.  A business associate may use or disclose protected health information only as permitted or required by its business associate contract or as required by law.  A business associate is directly liable under the HIPAA Rules and subject to civil and, in some cases, criminal penalties for making uses and disclosures of protected health information that are not authorized by its contract or required by law. A business associate also is directly liable and subject to civil penalties for failing to safeguard electronic protected health information in accordance with the HIPAA Security Rule.

    A written contract between a covered entity and a business associate must:

(1) establish the permitted and required uses and disclosures of protected health information by the business associate;

(2) provide that the business associate will not use or further disclose the information other than as permitted or required by the contract or as required by law;

(3) require the business associate to implement appropriate safeguards to prevent unauthorized use or disclosure of the information, including implementing requirements of the HIPAA Security Rule with regard to electronic protected health information;

(4) require the business associate to report to the covered entity any use or disclosure of the information not provided for by its contract, including incidents that constitute breaches of unsecured protected health information;

(5) require the business associate to disclose protected health information as specified in its contract to satisfy a covered entity’s obligation with respect to individuals’ requests for copies of their protected health information, as well as make available protected health information for amendments (and incorporate any amendments, if required) and accountings;

(6) to the extent the business associate is to carry out a covered entity’s obligation under the Privacy Rule, require the business associate to comply with the requirements applicable to the obligation;

(7) require the business associate to make available to HHS its internal practices, books, and records relating to the use and disclosure of protected health information received from, or created or received by the business associate on behalf of, the covered entity for purposes of HHS determining the covered entity’s compliance with the HIPAA Privacy Rule;

(8) at termination of the contract, if feasible, require the business associate to return or destroy all protected health information received from, or created or received by the business associate on behalf of, the covered entity;

(9) require the business associate to ensure that any subcontractors it may engage on its behalf that will have access to protected health information agree to the same restrictions and conditions that apply to the business associate with respect to such information; and

(10) authorize termination of the contract by the covered entity if the business associate violates a material term of the contract.  Contracts between business associates and business associates that are subcontractors are subject to these same requirements.

Definitions

Catch­all definition:

    The following terms used in this Agreement shall have the same meaning as those terms 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.

Specific definitions:

  • Business Associate. “Business Associate” shall generally have the same meaning as the term “business associate” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean [Insert Name of Business Associate].
  • Covered Entity. “Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 CFR 160.103, and in reference to the party to this agreement, shall mean [Insert Name of Covered Entity].
  • HIPAA Rules. “HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.


Obligations and Activities of Business Associate

In short: Business Associate agrees to follow HIPAA and HITECH regulations.

Business Associate agrees to:

  1. Not use or disclose protected health information other than as permitted or required by the Agreement or as required by law;
  2. 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 the Agreement;
  3. Report to covered entity any use or disclosure of protected health information not provided for by the 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;
  4. 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 the business associate agree to the same restrictions, conditions, and requirements that apply to the business associate with respect to such information;
  5. Make available protected health information in a designated record set to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.524;
  6. Make any amendment(s) to protected health information in a designated record set as directed or agreed to by the 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;
  7. Maintain and make available the information required to provide an accounting of disclosures to the covered entity as necessary to satisfy covered entity’s obligations under 45 CFR 164.528;
  8. To the extent the business associate is to carry out one or more of covered entity’s obligation(s) under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to the covered entity in the performance of such obligation(s); and
  9. 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

  1. Business associate may only use or disclose protected health information
    1. To evaluate the clinical performance of the covered entity (medical practice) as a Patient-Centered (or Person-Centered) Medical Home as variously described by the 
      1. Joint Principles of the Patient-Centered Medical Home published in March 2007 by the AAFP, AAP, ACP and AOA and subsequent revisions
      2. Scholarly articles by Barbara Starfield, D., M.P.H., and coauthors
      3. evidence in the medical literature. Note the caveats published by Dr. Starfield in Fam Pract Manag. 2009 Jul­Aug;16(4):6­7 regarding the unproven value of teams, and Dr. Wasson’s JAMA article: 1984 Nov 2;252(17):2413-7 re: Continuity
    2. Or Clinical Research.
  2. Because the clinical summaries supplied by HowsYourHealth are abstracted, and do not contain patient identifiers, it is not anticipated Business associate will receive ANY PHI, although, since HowsYourHealth retains zip code information, their data is not fully deidentified to the standard in 45 CFR 164.514(a)­(c).
  3. In addition to other permissible purposes, Business associate is authorized to use protected health information to de­identify the information in accordance with 45 CFR 164.514(a)­(c). The deidentified information may be used for PCMH evaluation or research.
    1. Business associate may use or disclose protected health information as required by law.
    2. Business associate agrees to make uses and disclosures and requests for protected health information subject to the following minimum necessary requirements: for evaluation of PCMH activities, and as much as reasonably possible, consistent with covered entity’s minimum necessary policies and procedures.
    3. 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 below.”]
    4. 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.
    5. Business associate may disclose protected health information for the proper management and administration of business associate or to carry out the legal responsibilities of the 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 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.
    6. Business associate may provide data aggregation services relating to the health care operations of the covered entity.

Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions:  If Covered Entity has any unusual features in their Privacy Practices and Restrictions (not anticipated if Covered Entity’s policies primarily relate to providing health care),

  1. 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.
  2. 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.
  3. 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.

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 Subpart E of 45 CFR Part 164 if done by covered entity.

Term and Termination

  1. Term. The Term of this Agreement shall be effective as of receipt of PHI by Business Associate and shall terminate when Business Associate destroys Covered entity’s PHI, or on the date covered entity terminates for cause as authorized in paragraph (b) of this Section, whichever is sooner.
  2. Termination for Cause. Business associate authorizes termination of this Agreement by covered entity, if covered entity determines business associate has violated a material term of the Agreement and business associate has not cured the breach or ended the violation within the time specified by covered entity. Covered entity shall provide the business associate with an opportunity to cure a violation or breach of the contract before termination for cause.
  3. 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:

  1. 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;
  2. Return to covered entity [or, if agreed to by covered entity, destroy] the remaining protected health information that the business associate still maintains in any form;
  3. 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;
  4. Not use or disclose the protected health information retained by business associate other than for the purposes for which such protected health information was retained and subject to the same conditions set out at paragraphs (e) and (f) above under “Permitted Uses and Disclosures By Business Associate” which applied prior to termination; and
  5. Return to covered entity [or, if agreed to by covered entity, destroy] the protected health information retained by business associate when it is no longer needed by business associate for its proper management and administration or to carry out its legal responsibilities.

 (d) Survival.  The obligations of business associate under this Section shall survive the termination of this Agreement.

Miscellaneous

  1. Regulatory References. A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
  2. 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.
  3. Interpretation. Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.