HIPAA Business Associate AgreementHIPAA Business Associate Agreement

This Business Associate Agreement (the "Agreement") is entered into between [name of covered entity] and [name of business associate] to be effective on [effective date] (the "Effective Date").

• Catch-all definitions:

  • The following terms used in this Agreement shall have the same meaning as those terms in the HIPAA Rules: Breach, Breach Notification, Data Aggregation, Designated Record Set, De-Identified Information, Disclosure (Disclose), Electronic Protected Health Information, Electronic Transactions Rule, Enforcement Rule, Genetic Information, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required By Law, Sale, Secretary, Security Incident, Security Rule, Subcontractor, Transaction, Unsecured Protected Health Information, and Use.

• Specific definitions:

  • (a)

     "Business Associate" shall generally have the same meaning as the term "Business Associate" at 45 C.F.R. § 160.103, and in reference to the party to this agreement, shall mean [name of business associate].

  • (b)

     "Covered Entity" shall generally have the same meaning as the term "Covered Entity" at 45 C.F.R. § 160.103, and in reference to the party to this Agreement, shall mean [name of covered entity].

  • (c)

     "HIPAA Rules" shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and Part 164.

  • (d)

     "HITECH Act" shall mean the Health Information Technology for Economic and Clinical Health Act.

• Business Associate agrees to:

  • (a)

     Not Use or Disclose Protected Health Information other than as permitted or required by the Agreement or as Required by Law;

  • Optional Clause

    Optional Section 2.(b):

    (b)

     Maintain a HIPAA compliance program that includes specific policies and procedures, workforce training, and documentation requirements and permit Covered Entity, upon reasonable advanced notice, to review or audit such compliance program and all documentation relating to the services contemplated by this Agreement;

    Drafting Note

    Drafting Note to Optional Section 2.(b)

    Although a business associate is required to have in place procedures that comply with the HIPAA Privacy Rule and Security Rule, to the extent applicable, there is no requirement that a business associate agreement must require the business associate to subject their HIPAA practices to a covered entity's oversight. Nevertheless, it is not uncommon for a covered entity to impose such a condition as part of its own HIPAA compliance program.

  • (b)

     Use appropriate safeguards, and comply with Subpart C of 45 C.F.R. 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;

  • (c)

     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 C.F.R. § 164.410, and any Security Incident of which it becomes aware;

    Drafting Note

    Drafting Note to Section 2.(c)

    The parties may wish to add additional specificity regarding the breach- and security incident-related notification obligations of the business associate, such as establishing a specific time frame and format for the business associate to report such incidents, any requirement to report potential breaches or security incidents, and/or whether the business associate will have a role in handling breach notifications to individuals, the HHS Office for Civil Rights (OCR), and potentially the media on behalf of the covered entity. See also the breach notification provision in Section 6..

    Note that, as a practical matter, business associates may not agree to report individually on all security incidents of which it becomes aware because the HIPAA regulations broadly define that term to include any unauthorized attempted access of the relevant information systems, whether or not successful. A more pragmatic solution is for the business associate to promptly report any successful security incidents involving covered entity PHI and to provide periodic reports of other security incidents on an aggregate basis.

  • (d)

     In accordance with 45 C.F.R. §§ 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;

    Drafting Note

    Drafting Note to Section 2.(d)

    A subcontractor of a business associate that handles the covered entity's PHI is also considered a business associate under HIPAA. 45 C.F.R. § 160.103 (definition of "business associate"). The HIPAA regulations pass along responsibility of obtaining business associate agreements with subcontractors to the business associate that retains the subcontractor. That is, a business associate must (and must represent in its business associate agreement that it will) procure a business associate agreement with any subcontractor that it retains to assure that subcontractor's compliance with HIPAA to protect the covered entity's PHI. See 45 C.F.R. §§ 164.502(e)(1), 164.504(e)(2)(ii)(D).

    This provision addresses compliance with these rules. See also First Alternate Section 2.(d), which requires the business associate to first obtain the covered entity's consent to delegate such services to a subcontractor, and Second Alternate Section 2.(d), which simply prohibits the business associate is from delegating such duties to a third party.

    Alternate Clause

    First Alternate Section 2.(d):

    (d)

     Obtain Covered Entity's prior written consent[, which shall not be unreasonably delayed or denied,] prior to retaining any Subcontractor to create, receive, maintain, or transmit Protected Health Information of the Covered Entity on behalf of Business Associate, and, if such consent is granted, ensure that any such Subcontractors agree to the same restrictions, conditions, and requirements that apply to Business Associate with respect to such Protected Health Information, in accordance with 45 C.F.R. §§ 164.502(e)(1)(ii) and 164.308(b)(2), if applicable;

    Drafting Note

    Drafting Note to First Alternate Section 2.(d)

    Use this alternate language if the business associate must obtain the covered entity's consent before delegating PHI-handling duties to a third-party subcontractor. Include the bracketed language if appropriate. Use the default language for Section 2.(d) if the business associate may freely delegate such duties to a third party so long as it complies with HIPAA requirements. Use Second Alternate Section 2.(d) if the subcontractor is prohibited from delegating such duties.

    Second Alternate Section 2.(d):

    (d)

     Not retain any third party as a Subcontractor that will create, receive, maintain, or transmit Protected Health Information of the Covered Entity on behalf of Business Associate;

    Drafting Note

    Drafting Note to Second Alternate Section 2.(d)

    Use this alternate language if the business associate is prohibited from delegating PHI-handling duties to a third-party subcontractor. Use the default language for Section 2.(d) if the business associate may freely delegate such duties to a third party so long as it complies with HIPAA requirements. Use First Alternate Section 2.(d) if the business associate must first obtain the covered entity's consent before delegating such duties.

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  • (e)

     Make available Protected Health Information in a Designated Record Set to [Covered Entity AND/OR an individual or individual's designee] as necessary to satisfy Covered Entity's obligations under 45 C.F.R. § 164.524, including furnishing upon Covered Entity's request or direction an electronic copy of Protected Health Information that is maintained in a Designated Record Set;

    Drafting Note

    Drafting Note to Section 2.(e)

    The parties may wish to add additional specificity regarding how the business associate will respond to a request for access that the business associate receives directly from an individual (such as whether, and in what time and manner, a business associate is to provide the requested access or whether the business associate will forward the individual's request to the covered entity to fulfill) and the time frame for the business associate to provide information regarding such requests to the covered entity so that it can fulfill its documentation obligations.

  • (f)

     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 C.F.R. § 164.526, or take other measures as necessary to satisfy Covered Entity's obligations under 45 C.F.R. § 164.526;

    Drafting Note

    Drafting Note to Section 2.(f)

    The parties may wish to add additional specificity regarding how the business associate will respond to a request for amendment that the business associate receives directly from the individual (such as whether and in what time and manner a business associate is to act on the request for amendment or whether the business associate will forward the individual's request to the covered entity) and the time frame for the business associate to incorporate any amendments to the information in the designated record set and to provide information regarding such requests to the covered entity so that it can fulfill its documentation obligations.

  • (g)

     Maintain and make available the information required to provide an accounting of Disclosures to [Covered Entity AND/OR an individual] as necessary to satisfy Covered Entity's obligations under 45 C.F.R. § 164.528.

    Drafting Note

    Drafting Note to Section 2.(g)

    The parties may wish to add additional specificity regarding how the business associate will respond to a request for an accounting of disclosures that the business associate receives directly from the individual (such as whether and in what time and manner the business associate is to provide the accounting of disclosures to the individual or whether the business associate will forward the request to the covered entity) and the time frame for the business associate to provide information regarding such requests to the covered entity so that it can fulfill its documentation obligations.

  • (h)

     To the extent the Business Associate is to carry out one or more of Covered Entity's obligation(s) under Subpart E of 45 C.F.R. Part 164 ("Privacy of Individually Identifiable Health Information"), comply with the requirements of such Subpart E that apply to the Covered Entity in the performance of such obligation(s);

  • (i)

     Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules;

  • (j)

     Not participate in any Sale of Protected Health Information;

  • (k)

     Not Use or Disclose Genetic Information for underwriting purposes in violation of the HIPAA Rules;

  • (l)

     Comply with the Electronic Transaction Rule and any applicable corresponding requirements adopted by HHS with respect to any Electronic Transactions conducted by Business Associate on behalf of Covered Entity in connection with the services provided under this Agreement.

• Business Associate agrees that it is directly liable under the HIPAA Rules and the HITECH Act and is subject to civil and, in some cases, criminal penalties for making Uses and Disclosures of Protected Health Information that are not authorized by this Agreement or Required by Law. Business Associate also acknowledges that it is liable and subject to civil penalties for failing to safeguard Electronic Protected Health Information in accordance with the HIPAA Security Rule.

• Business Associate shall not Use or Disclose Protected Health Information relating to Covered Entity, except as expressly permitted under and consistent with this Section 4..

  • (a)

     Business Associate may Use or Disclose Protected Health Information for the following permissible purposes: [list of permissible purposes]

    Drafting Note

    Drafting Note to Section 4.(a)

    List the specific purposes for which protected health information will be used by the business associate in its performance of services for the covered entity under the Agreement. See Alternate Section 4.(a) for language to set forth this information on a separate schedule.

    In addition to other permissible purposes, the parties should specify whether the business associate is authorized to use protected health information to de-identify the information in accordance with 45 C.F.R. 164.514(a)-(c). The parties also may wish to specify the manner in which the business associate will de-identify the information and the permitted uses and disclosures by the business associate of the de-identified information.

    Alternate Clause

    Alternate Section 4.(a):

    (a)

     Business Associate may Use or Disclose Protected Health Information as necessary to perform the services set forth in the Service Agreement attached hereto as Exhibit 1.

    Drafting Note

    Drafting Note to Alternate Section 4.(a)

    This alternate language identifies the permitted activities for which PHI may be used and disclosed (to the minimum extent necessary) by the business associate by reference to a separate services agreement attached as an exhibit to the business associate agreement, instead of enumerating the types of uses and disclosures contemplated by the services agreement as in the default language.

  • (b)

     Business Associate may Use or Disclose Protected Health Information as Required by Law.

  • (c)

     Business Associate agrees to make Uses and Disclosures and requests for Protected Health Information consistent with Covered Entity's Minimum Necessary policies and procedures, a copy of which has been furnished to Business Associate.

    Drafting Note

    Drafting Note to Section 4.(c)

    The default language for this section merely incorporates by reference a separate document setting forth the covered entity's minimum necessary standard. See First Alternate Section 4.(c) to put customized language consistent with the covered entity's minimum necessary requirements into the business associate agreement in lieu of providing a separate policy and procedures document. Second Alternate Section 4.(c) contains sample language for this purpose.

    Alternate Clause

    First Alternate Section 4.(c):

    (c)

     Business Associate agrees to make Uses and Disclosures and requests for Protected Health Information subject to the following Minimum Necessary requirements: [include specific provisions that are consistent with covered entity's minimum-necessary-use policies and procedures].

    Drafting Note

    Drafting Note to First Alternate Section

    This alternate clause is intended to provide within the business associate agreement a description of the minimum necessary standard that is appropriately tailored to reflect the covered entity's policies in lieu of providing a separate policy and procedures document. For an example of sample language, see Second Alternate Section 4.(c)

    Second Alternate Section 4.(c):

    (c)

     Business Associate agrees to make Uses and Disclosures and requests for Protected Health Information subject to the following Minimum Necessary requirements:

    In accordance with HIPAA's Minimum Necessary standard, Business Associate shall make reasonable efforts to ensure that its access to Protected Health Information in connection with its services for the Covered Entity shall be limited to the minimum necessary information to accomplish the intended purpose of any particular use, disclosure, or request. Further, Business Associate shall support any determinations it makes with respect to the Minimum Necessary standard with a rational justification that, as applicable, (i) reflects the technical capabilities of the Business Associate and (ii) factors in relevant privacy and security risks. Business Associate shall record and maintain documentation of all such determinations consistent with reasonable recordkeeping practices and the HIPAA Rules.

    Drafting Note

    Drafting Note to Second Alternate Section4.(c)

    This clause contains sample language expressing the HIPAA minimum necessary standard that covered entities and business associates must adhere to when using PHI. Make sure this language is consistent with the covered entity's HIPAA policies. Alternatively, you can incorporate a separate document or policy be reference, as in the default language for this Section 4.(c). Use First Alternate Section 4.(c) to customize the language as necessary to reflect the covered entity's policies.

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  • (d)

     Business Associate may not Use or Disclose Protected Health Information in a manner that would violate Subpart E of 45 C.F.R. Part 164 if done by Covered Entity.

    Drafting Note

    Drafting Note to Section 4.(d)

    If the agreement permits the business associate to use or disclose PHI for its own management and administration and to carry out its legal responsibilities, as set forth in Optional Section 4.(e) (PHI use), Optional Section 4.(e) (PHI disclosure), and/or for data aggregation services, as set forth in Optional Section 4.(e), then use Alternate Section 4.(d) and include the appropriate optional section(s). In such cases, a covered entity that wishes to impose specific limitations on these additional permitted uses and disclosures should modify those optional provisions accordingly. See also the optional provisions in Section 5. relating to certain covered entity disclosure obligations that may be appropriate for the business associate's use of the PHI.

    Alternate Clause

    Alternate Section 4.(d):

    (d)

     Business Associate may not Use or Disclose Protected Health Information in a manner that would violate Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except for the specific Uses and Disclosures set forth in the following provisions of this Section 4.

  • Optional Clause

    First Optional Section 4.(e):

    (e)

     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.

    Drafting Note

    Drafting Note to First Optional Section 4.(e)

    Only include this clause if the business associate will need to use PHI for its own administrative or management purposes or to fulfill its legal responsibilities. See 45 C.F.R. § 164.504(e)(4)(i). See Second Optional Section 4.(e) for language that allows the business associate to also disclose PHI for such purposes. See 45 C.F.R. § 164.504(e)(4)(ii).

    Second Optional Section 4.(e):

    (e)

     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 will notify Business Associate of any instances of which the person becomes aware in which the confidentiality of the information has been Breached.

    Drafting Note

    Drafting Note to Second Optional Section 4.(e)

    Only include this clause if the business associate will need to disclose PHI for its own administrative or management purposes or carry out legal responsibilities. The limiting conditions are required under 45 C.F.R. § 164.504(e)(4)(ii). See also First Optional Section 4.(e) for language allowing the business associate to use PHI for such purposes.

    Third Optional Section 4.(e):

    (e)

     Business Associate may Use Protected Health Information to provide Data Aggregation services relating to the Health Care Operations of Covered Entity[, but only with the prior written consent of Covered Entity].

    Drafting Note

    Drafting Note to Third optional Section 4.(e)

    Only include this clause if the business associate will need to use or disclose PHI for purposes of providing data aggregation services. PHI-related data aggregation services are defined as the combining of PHI handled by a business associate with other PHI received by the business associate in its capacity as a business associate of another covered entity to permit data analyses that relate to the health care operations of the respective covered entities. 45 C.F.R. § 164.501. Although not a HIPAA requirement, consider whether the requirement to obtain the covered entity's consent in the bracketed clause is appropriate for the arrangement.

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• Optional Clause

  First Optional Section 5.(a):

  (a)

   Covered entity shall notify Business Associate of any limitation(s) in the Notice of Privacy Practices of Covered Entity under 45 C.F.R. § 164.520, to the extent that such limitation may affect Business Associate's Use or Disclosure of Protected Health Information.

  Second Optional Section 5.(a):

  (a)

   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.

  Third Optional Section 5.(a):

  (a)

   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 C.F.R. § 164.522, to the extent that such restriction may affect Business Associate's Use or Disclosure of Protected Health Information.

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• If Business Associate discovers a Breach of Protected Health Information, the Business Associate shall, following the discovery of the Breach of Unsecured Protected Health Information, notify the Covered Entity of such Breach in accordance with this Section 6..

  • (a)

     A Breach is treated as discovered by Business Associate on the first day on which such breach is known to Business Associate or, by exercising reasonable diligence, would have been known to Business Associate. Business Associate shall be deemed to have knowledge of a Breach if the Breach is known, or by exercising reasonable diligence would have been known, to any person, other than the person committing the Breach, who is an employee, officer, or other agent of Business Associate.

  • (b)

     Business Associate shall provide the notification required under this Section 6. without unreasonable delay and in no case later than [number, e.g., 5] calendar days after discovery of the Breach.

    Drafting Note

    Drafting Note to Section 6.(b)

    There is a hard 60-day deadline under HIPAA regulations for business associates to alert covered entities of a PHI breach. 45 C.F.R. § 164.410(b). A covered entity will inevitably want to ensure more prompt notice from a business associate regarding a breach of which it becomes aware to allow the covered entity time to assess the situation and to coordinate with the business associate on remedial steps and any notification that may be required as promptly as is practicable.

  • (c)

     The notification shall include, to the extent possible, the identification of each individual whose Unsecured Protected Health Information has been, or is reasonably believed by Business Associate to have been, accessed, acquired, used, or disclosed during the Breach.

  • (d)

     Business Associate shall provide the Covered Entity with any other available information that the Covered Entity is required to include in notification to the individual under 45 C.F.R. § 164.404(c) at the time of the notification by Business Associate, and any information that is not then available promptly after such information becomes available. Information to be provided includes, to the extent possible:

    • (i)

       A brief description of what happened, including the date of the Breach and the date of the discovery of the Breach, if known;

    • (ii)

       A description of the types of Unsecured Protected Health Information that were involved in the Breach (such as whether full name, social security number, date of birth, home address, account number, diagnosis, disability code, or other types of information were involved); and

    • (iii)

       A brief description of what Business Associate is doing to investigate the Breach, to mitigate harm to Individuals, and to protect against any further Breaches.

• (a) Term.

   The term of this Agreement shall be effective as of the Effective Date and shall terminate on [termination date or event] or on the date Covered Entity terminates for cause as authorized in paragraph (b) of this Section, whichever is sooner.

• (b) Termination for Cause.

   Business Associate authorizes termination of this Agreement by Covered Entity if Covered Entity reasonably determines in good faith that Business Associate has violated a material term of the Agreement.

  Drafting Note

  Drafting Note to Section 7.(b)

  This language gives the covered entity the discretion to determine whether a violation has occurred that triggers its right to terminate the agreement for cause. This is a requirement for business associate agreements. See 45 C.F.R. § 164.502(e). Business associates will often insist on a cure period (see First Alternate Section 7.(b) for sample language). Additionally, business associates may seek a reciprocal provision giving them a termination for cause right (see Second Alternate Section 7.(b).

  Alternate Clause

  First Alternate Section 7.(b):

  (b) Termination for Cause.

   Business Associate authorizes termination of this Agreement by Covered Entity if Covered Entity reasonably determines in good faith that Business Associate has violated a material term of the Agreement and Business Associate has not cured the Breach or ended the violation to the reasonable satisfaction of Covered Entity within [time period] or such longer time period agreed to in writing by Covered Entity.

  Drafting Note

  Drafting Note to First Alternate Section 7.(b)

  This termination clause provides the business associate with an opportunity to cure a violation or breach of the contract before the covered entity has the right to terminate the agreement for cause. The Second Alternate Section 7.(b) provides language that gives the business associate a reciprocal right to terminate for cause if the covered entity breaches the agreement and provides a cure period in each case.

  Second Alternate Section 7.(b):

  (b) Termination for Cause.

   Business Associate authorizes termination of this Agreement by Covered Entity if Covered Entity reasonably determines in good faith that Business Associate has violated a material term of the Agreement and Business Associate has not cured the Breach or ended the violation to the reasonable satisfaction of Covered Entity within [time period] or such longer time period specified by Covered Entity. Covered Entity authorizes termination of this Agreement by Business Associate if Business Associate reasonably determines in good faith that Covered Entity has violated a material term of the Agreement and Covered Entity has not cured the Breach or ended the violation to the reasonable satisfaction of Business Associate within [time period] or such longer time period agreed to in writing by Business Associate.

  Drafting Note

  Drafting Note to Second Alternate Section 7.(b)

  This termination clause provides each party with a right to terminate the agreement early for a breach by the other party that is not cured within a specified time period. See the default language for Section 7.(b) for a provision that only gives this right to the covered entity (without a cure right). See First Alternate Section 7.(b) for language that gives the business associate a cure right, but does not make the provision reciprocal.

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• (c) Obligations of Business Associate Upon Termination.

   Except as set forth in Section 7.(d), upon termination of this Agreement for any reason, Business Associate shall return to Covered Entity (or, if agreed to by Covered Entity, destroy) all Protected Health Information received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, that the Business Associate still maintains in any form. Business associate shall retain no copies of the Protected Health Information.

  Drafting Note

  Drafting Note to Section 7.(c)

  Use this language if the business associate is to return or destroy all PHI upon termination of the agreement. See Alternate Section 7.(c) for language authorizing the business associate to retain certain PHI.

  Alternate Clause

  Alternate Section 7.(c):

  (c) Obligations of Business Associate Upon Termination.

   Except as set forth in Section 7.(d), 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:

  • (i)

     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;

  • (ii)

     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;

  • (iii)

     Continue to use appropriate safeguards and comply with Subpart C of 45 C.F.R. 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;

  • (iv)

     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 [Section 4(e) AND/OR Section 4(f)] which applied prior to termination; and

  • (v)

     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.

  Drafting Note

  Drafting Note to Alternate Section 7.(c)

  This language can be used if the agreement allows the business associate to use or disclose PHI for its own management and administration or to carry out its legal responsibilities and the business associate needs to retain PHI for such purposes after termination of the agreement.

• (d) Transmission of PHI

   If so directed by Covered Entity, Business Associate will transmit any Protected Health Information received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, to another Business Associate of Covered Entity at termination.

• (e) Business Associate Responsibility for Subcontractors

   Business Associate shall be responsible for compliance with the obligations regarding Covered Entity's Protected Health Information described in this Section 7. with respect to any applicable Protected Health Information created, received, or maintained by Subcontractors retained by Business Associate.

  Drafting Note

  Drafting Note to Section 7.(e)

  This clause may be omitted if the agreement prohibits the business associate from retaining subcontractors to handle the covered entity's PHI, as contemplated by Second Alternate Section 2.(d).

• (f) Survival.

   The obligations of Business Associate under this Section shall survive the termination of this Agreement.

• (a) Regulatory References.

   A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.

• (b) 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 amendment to this Agreement must be in writing and signed by both parties.

• (c) Interpretation.

   Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.

• (d) Governing Law.

   This Agreement shall be governed by the laws of [state], except to the extent preempted by federal law.

• (e) Counterparts.

   This Agreement may be executed in any number of counterparts, and may be signed via facsimile or e-mail (scan), and each such counterpart shall be deemed to be an original instrument, but all such counterparts shall constitute one agreement.

• (f) Severability.

   The provisions of this Agreement shall be severable, and the invalidity of any provision shall not affect the validity of other provisions.

• (g) Entire Agreement.

   This Agreement contains the entire agreement between the parties. This Agreement supersedes all prior agreements, understandings or writings, whether oral or written with regard to this subject matter.

• (h) Notice.

   Any notice required under this Agreement shall be in writing and shall be given by (i) delivery in person, (ii) by a nationally recognized next day courier service, (iii) by first class, registered or certified mail, postage prepaid, (iv) by electronic mail to the address of the party specified in this Agreement or such other address as either party may specify in writing.