BUSINESS ASSOCIATE AGREEMENTS UNDER HIPAA

As noted in the Task List, HIPAA requires Business Associate Agreements with any entity not under your employment control to whom you release PHI for the purposes of your own operations.

160.103 Definitions.

Business associate:

(1) Except as provided in paragraph (2) of this definition, business associate means, with respect to a covered entity, a person who:

(i) On behalf of such covered entity or of an organized health care arrangement (as defined in 164.501 of this subchapter) in which the covered entity participates, but other than in the capacity of a member of the workforce of such covered entity or arrangement, performs, or assists in the performance of:

(A) A function or activity involving the use or disclosure of individually identifiable health information, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, billing, benefit management, practice management, and repricing; or

(B) Any other function or activity regulated by this subchapter; or (ii) Provides, other than in the capacity of a member of the workforce of such covered

entity, legal, actuarial, accounting, consulting, data aggregation (as defined in 164.501 of this subchapter), management, administrative, accreditation, or financial services to or for such covered entity, or to or for an organized health care arrangement in which the covered entity participates, where

the provision of the service involves the disclosure of individually identifiable health information from such covered entity or arrangement, or from another business associate of such covered entity or arrangement, to the person.

(2) A covered entity participating in an organized health care arrangement that performs a function or activity as described by paragraph (1)(i) of this definition for or on behalf of such organized health care arrangement, or that provides a service as described in paragraph (1)(ii) of this definition to or for such organized health care arrangement, does not, simply through the performance of such function or activity or the provision of such service, become a business associate of other covered entities participating in such organized health care arrangement.

 

The suggested language for such an agreement presented below has been adapted from HIPAA language which follows –  or you will find Business Associate Agreement documents for sale, or you can work with your attorney to create your own business associate agreements.

 

Business Associate Agreement:

This Agreement is entered into by and between professional/ practice group (hereafter called the Health Care Provider) and (enter name(s) of Business Associate)  (hereafter called the Business Associate) to set forth the terms and conditions under which protected health information ("PHI"), as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Regulations enacted under that act, created or received by the Business Associate on behalf of the Health Care Provider may be used or disclosed.

This Agreement shall begin on ________ and the obligations of this agreement shall continue in effect so long as the Business Associate uses, discloses, creates or otherwise possesses any PHI created or received on behalf of the Health Care Provider and until all PHI created or received by the Business Associate on behalf of the Health Care Provider is destroyed or returned to the Health Care Provider according to Section 14 of this agreement.

1)     The Health Care Provider and the Business Associate hereby agree that the Business Associate shall be permitted to use and/or disclose PHI created or received on behalf of the Health Care Provider for the following purpose(s):

[Here you should include a description of the purpose(s) for which the Business Associate may use and disclose PHI; e.g. for your billing service: "preparing statements for clients, completing and submitting health care claims to health plans and other third party payers”.  The stated purpose(s) must reflect the nature the arrangement with the Business Associate. The permitted uses and disclosures must be within the scope of, and be necessary to achieve the purposes of the Business Associate providing services to the treating professional/s.]

2)     The Business Associate may use and disclose PHI created or received by the Business Associate on behalf of the Health Care Provider if necessary for the proper management and administration of the Business Associate or to carry out the Business Associate's legal responsibilities, provided that
any disclosure is:  

a)      Required by law; or.

b)     The Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that (a) the PHI 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 person; and (b) the Business Associate will be notified of any instances of which the person is aware in which the confidentiality of the information is breached.

c)      The Business Associate hereby agrees to maintain the security and privacy of all PHI in a manner consistent with state and federal laws and regulations, including the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and Regulations pertaining to HIPAA, and all other applicable law.

3)     The Business Associate further agrees not to use or disclose PHI except as expressly permitted by this Agreement, applicable law, or for the purpose of managing Business Associate's own internal business processes consistent with Paragraph 2 herein.

4)     The Business Associate shall not disclose PHI to any member of its workforce unless the Business Associate has advised such person of the Business Associate's privacy and security obligations under this Agreement, including the consequences for violation of such obligations. The Business Associate shall take appropriate disciplinary action against any member of its workforce who uses or discloses PHI in violations of this Agreement and applicable law.

5)     The Business Associate shall not disclose PHI created or received by the Business Associate on behalf of the Health Care Provider to a person, including any agent or subcontractor of the Business Associate but not including a member of the Business Associate's own workforce, until such person agrees in writing to be bound by the provisions of this Agreement and applicable state
or federal law.

6)     The Business Associate agrees to use appropriate safeguards to prevent use or disclosure of PHI not permitted by this Agreement or applicable law.

7)     The Business Associate agrees to maintain a record of all disclosures of PHI, including disclosures not made for the purposes of this Agreement. Such record shall include the date of the disclosure, the name and, if known, the address of the recipient of the PHI, the name of the individual who is the subject of the PHI, a brief description of the PHI disclosed, and the purpose of the disclosure. Business Associate shall make such record available to an individual who is the subject of such information or the Health Care Provider within thirty (30) days
of a request and shall include disclosures made on or after the date which is six (6) years prior to the request or April 14, 2003, whichever is later.

8)     The Business Associate agrees to report to the Health Care Provider any unauthorized use or disclosure of PHI by the Business Associate or its workforce or subcontractors and the remedial action taken or proposed to be taken with respect to such use or disclosure.

9)     The Business Associate agrees to make its internal practices, books, and records relating to the use and disclosure of PHI received from the Health Care Provider, or created or received by the Business Associate on behalf of the Health Care Provider, available to the Secretary of the United States Department of Health and Human Services, for purposes of determining the Health Care Provider’s, compliance with HIPAA.

10)  Within thirty (30) days of a written request by the Health Care Provider, Business Associate shall allow a person who is the subject of PHI, such person's legal representative, or the Health Care Provider to have access to and to copy such person's PHI maintained by the Business Associate.  The Business Associate shall provide PHI in the format requested by such person, legal representative, or the Health Care Provider unless it is not readily producible in such format, in which case it shall be produced in standard hard copy format.

11)  The Business Associate agrees to amend, pursuant to a request by the Health Care Provider, PHI maintained and created or received by the Business Associate on behalf of the Health Care Provider. The Business Associate further agrees to complete such amendment within thirty (30) days of a written request by the Health Care Provider, and to make such amendment as directed by
the Health Care Provider.

12)  In the event Business Associate fails to perform the obligations under this Agreement, the Health Care Provider may, at its option:

a)      Require Business Associate to submit to a plan of compliance, including monitoring by the Health Care Provider and reporting by the Business Associate, as the Health Care Provider, in its sole discretion, determines necessary to maintain compliance with this Agreement and applicable law. Such plan shall be incorporated into this Agreement by amendment
hereto; and

b)     Require the Business Associate to mitigate any loss occasioned by the unauthorized disclosure or use of PHI.

c)       Immediately discontinue providing PHI to the Business Associate with or without written notice to the Business Associate.

 

13)  The Health Care Provider may immediately terminate this Agreement and related agreements if the Health Care Provider determines that the Business Associate has breached a material term of this Agreement. Alternatively, the Health Care Provider may choose to:

a)       provide the Business Associate with ten (10) days written notice of the existence of an alleged material breach; and

b)     afford the Business Associate an opportunity to cure said alleged material breach to the satisfaction of the Health Care Provider within ten (10) days. The Business Associate's failure to cure shall be grounds for immediate determination of this Agreement.  The Health Care Provider’s remedies under this Agreement are cumulative, and the exercise of any remedy shall not preclude the exercise of any other.

14)  Upon termination of this Agreement, Business Associate shall return or destroy all PHI received from Health Care Provider, or created or received by Business Associate on behalf of the Health Care Provider and that the Business Associate maintains in any form, and shall retain no copies of such information. If the parties mutually agree that return or destruction of PHI is not feasible, the Business Associate shall continue to maintain the security and privacy of such
PHI in a manner consistent with the obligations of this Agreement and as required by applicable law, and shall limit further use of the information to those purposes that make the return or destruction of the information infeasible. The duties hereunder to maintain the security and privacy of PHI shall survive the discontinuance of this Agreement.

15)  The Health Care Provider may amend this Agreement by providing ten (10) days prior written notice to the Business Associate in order to maintain compliance with State or Federal law. Such amendment shall be binding upon the Business Associate at the end of the ten (10) day period and shall not require the consent of the Business Associate. The Business Associate may elect to discontinue the Agreement within the ten (10) day period, but the Business Associate's duties
hereunder to maintain the security and privacy of PHI shall survive discontinuance of the Agreement.

16)  The Health Care Provider and the Business Associate may otherwise amend this Agreement by mutual written agreement.

17) The Business Associate shall, to the fullest extent permitted by law, protect, defend, indemnify and hold harmless the Health Care Provider and his/her respective employees, directors, and agents from and against any and all losses, costs, claims, penalties, fines, demands, liabilities, legal actions, judgments, and expenses of every kind (including reasonable attorneys fees, including at trial and on appeal) asserted or imposed against the Health Care Provider and his/her respective employees, directors, and agents arising out of the acts or omissions of the Business Associate or any subcontractor of or consultant of the Business Associate or any of the Business Associate's employees, directors, or agents related to the performance or nonperformance of this Agreement.

Note: End the Business Associate Agreement with Dated/Signatures of the Professional/Practice representative and Business Associate or Business Associate representative, with the authority of each signature stipulated.

 

Language from HIPAA Rule pertaining to Business Associate Contracts:

Federal Register / Vol. 67, No. 59 / Wednesday, March 27, 2002 / Proposed Rules

 

Appendix to the Preamble—Model Business Associate Contract Provisions

Introduction

The Department of Health and Human Services provides these model business associate contract provisions in response to numerous requests for guidance. This is only model language. These provisions are designed to help covered entities more easily comply with the business associate contract requirements of the Privacy Rule. However, use of these model provisions is not required for compliance with the Privacy Rule. The language may be amended to more accurately reflect business arrangements between the covered entity and the business associate.

These or similar provisions may be incorporated into an agreement for the provision of services between the entities or they may be incorporated into a separate business associate agreement. These provisions only address concepts and requirements set forth in the Privacy Rule and alone are not sufficient to result in a binding contract under State law and do not include many formalities and substantive provisions that are required or typically included in a valid contract. Reliance on this model is not sufficient for compliance with state law and does not replace consultation with a lawyer or negotiations between the parties to the contract.

Furthermore, a covered entity may want to include other provisions that are related to the Privacy Rule but that are not required by the Privacy Rule. For example, a covered entity may want to add provisions in a business associate contract in order for the covered entity to be able to rely on the business associate to help the covered entity meet its obligations under the Privacy Rule. In addition, there may be permissible uses or disclosures by a business associate that are not specifically addressed in these model provisions. For example, the Privacy Rule does not preclude a business associate from disclosing protected health information to report unlawful conduct in accordance with 164.502(j). However, there is not a specific model provision related to this permissive disclosure. These and other types of issues will need to be worked out between the parties.

 

1 Words or phrases contained in brackets are intended as either optional language or as instructions to the users of these model provisions and are not intended to be included in the contractual provisions.

Model Business Associate Contract

Provisions 1

Definitions (alternative approaches)

Catch-all definition: Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in 45 CFR 160.103 and 164.501.

Examples of specific definitions:

(a) Business Associate. ‘‘Business Associate’’ shall mean [Insert Name of Business Associate].

(b) Covered Entity. ‘‘Covered Entity’’ shall mean [Insert Name of Covered Entity].

(c) Individual. ‘‘Individual’’ shall have the same meaning as the term ‘‘individual’’ in 45 CFR 164.501 and shall include a person who qualifies as a personal representative in accordance with 45 CFR 164.502(g).

(d) Privacy Rule. ‘‘Privacy Rule’’ shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR part 160 and part 164, subparts A and E.

(e) Protected Health Information. ‘‘Protected Health Information’’ shall have the same meaning as the term ‘‘protected health information’’ in 45 CFR 164.501, limited to the information created or received by Business Associate from or on behalf of

Covered Entity.

(f) Required By Law. ‘‘Required By Law’’ shall have the same meaning as the term ‘‘required by law’’ in 45 CFR 164.501.

(g) Secretary. ‘‘Secretary’’ shall mean the Secretary of the Department of Health and Human Services or his designee.

Obligations and Activities of Business Associate

(a) Business Associate agrees to not use or further disclose Protected Health Information other than as permitted or required by the Agreement or as Required By Law.

(b) Business Associate agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this Agreement.

(c) Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of Protected Health Information by Business Associate in violation of the requirements of this Agreement. [This provision may be included if it is appropriate for the Covered Entity to pass on its duty to mitigate damages by a Business Associate.]

(d) Business Associate agrees to report to Covered Entity any use or disclosure of the Protected Health Information not provided for by this Agreement.

(e) Business Associate agrees to ensure that any agent, including a subcontractor, to whom it provides Protected Health

Information received from, or created or received by Business Associate on behalf of Covered Entity agrees to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such information.

(f) Business Associate agrees to provide access, at the request of Covered Entity, and in the time and manner designated by

Covered Entity, to Protected Health Information in a Designated Record Set, to Covered Entity or, as directed by Covered

Entity, to an Individual in order to meet the requirements under 45 CFR 164.524. [Not necessary if business associate does not have protected health information in a designated record set.]

(g) Business Associate agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that

the Covered Entity directs or agrees to pursuant to 45 CFR 164.526 at the request of Covered Entity or an Individual, and in the time and manner designated by Covered Entity. [Not necessary if business associate does not have protected health information in a designated record set.]

(h) Business Associate agrees to make internal practices, books, and records relating to the use and disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of, Covered Entity available to the Covered Entity, or at the request of the Covered Entity to the Secretary, in a time and manner designated by the Covered Entity or the Secretary, for purposes of the Secretary determining Covered Entity’s compliance with the Privacy Rule.

(i) Business Associate agrees to document such disclosures of Protected Health Information and information related to such disclosures as would be required for Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

(j) Business Associate agrees to provide to Covered Entity or an Individual, in time and manner designated by Covered Entity,

information collected in accordance with Section [Insert Section Number in Contract Where Provision (i) Appears] of this

Agreement, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR 164.528.

Permitted Uses and Disclosures by Business Associate

General Use and Disclosure Provisions (alternative approaches)

Specify purposes:

Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information on behalf of, or to provide services to, Covered Entity for the following purposes, if such use or disclosure of Protected Health Information would not violate the Privacy Rule if done by Covered Entity: [List Purposes].

Refer to underlying services agreement:

Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information to perform functions, activities, or services for, or on behalf of, Covered Entity as specified in [Insert Name of Services Agreement], provided that such use or disclosure would not violate the Privacy Rule if done by Covered Entity.

 

P 14810

Specific Use and Disclosure Provisions [only necessary if parties wish to allow Business Associate to engage in such activities]

(a) Except as otherwise limited in this Agreement, 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.

(b) Except as otherwise limited in this Agreement, Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that disclosures are required by law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that it will remain confidential and used or further disclosed only as required by law or for the purpose for which it was disclosed to the person, and the person notifies the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.

(c) Except as otherwise limited in this Agreement, Business Associate may use Protected Health Information to provide Data

Aggregation services to Covered Entity as permitted by 42 CFR 164.504(e)(2)(i)(B).

Obligations of Covered Entity

Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions [provisions dependent on business arrangement]

(a) Covered Entity shall provide Business Associate with the notice of privacy practices that Covered Entity produces in accordance with 45 CFR 164.520, as well as any changes to such notice.

(b) Covered Entity shall provide Business Associate with any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, if such changes affect Business Associate’s permitted or required uses and disclosures.

(c) Covered Entity shall notify Business Associate of any restriction to the use or disclosure of Protected Health Information that Covered Entity has agreed to in accordance with 45 CFR 164.522.

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 the Privacy Rule if done by Covered Entity. [Include an exception if the Business Associate will use or disclose protected health information for, and the contract includes provisions for, data aggregation or management and administrative activities of Business Associate].

Term and Termination

(a) Term. The Term of this Agreement shall be effective as of [Insert Effective Date], and shall terminate when all of the Protected Health Information provided by Covered Entity to Business Associate, or created or received by Business Associate on behalf of Covered Entity, is destroyed or returned to Covered Entity, or, if it is infeasible to return or destroy Protected Health Information, protections are extended to such information, in accordance with the termination provisions in this Section.

(b) Termination for Cause. Upon Covered Entity’s knowledge of a material breach by Business Associate, Covered Entity shall provide an opportunity for Business Associate to cure the breach or end the violation and terminate this Agreement [and the Agreement/sections of the Agreement] if Business Associate does not cure the breach or end the violation within the time specified by Covered Entity, or immediately terminate this Agreement [and the Agreement/sections of the Agreement] if Business Associate has breached a material term of this Agreement and cure is not possible. [Bracketed language in this provision may be necessary if there is an underlying services agreement. Also, opportunity to cure is permitted, but not required by the Privacy Rule.]

(c) Effect of Termination.

(1) Except as provided in paragraph (2) of this section, upon termination of this Agreement, for any reason, Business

Associate shall return or destroy all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies of the Protected Health Information.

(2) In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible,

Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon mutual agreement of the Parties that return or destruction of Protected Health Information is infeasible, Business Associate shall extend the protections of this Agreement to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such Protected Health Information.

Miscellaneous

(a) Regulatory References. A reference in this Agreement to a section in the Privacy Rule means the section as in effect or as amended, and for which compliance is required.

(b) Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for Covered Entity to comply with the requirements of the Privacy Rule and the Health Insurance Portability and Accountability Act, Public Law 104–191.

(c) Survival. The respective rights and obligations of Business Associate under Section [Insert Section Number Related to

‘‘Effect of Termination’’] of this Agreement shall survive the termination of this Agreement.

(d) Interpretation. Any ambiguity in this Agreement shall be resolved in favor of a meaning that permits Covered Entity to comply with the Privacy Rule.