BUSINESS ASSOCIATE ADDENDUM

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1 BUSINESS ASSOCIATE ADDENDUM This Business Associate Addendum ( Addendum ) is entered into this day of Perry Memorial Hospital ( Covered Entity ) and [ABC Company] ( Business Associate ) referred to collectively as the Parties. WITNESSETH: WHEREAS, Perry Memorial Hospital ( Covered Entity ) and [ABC Company] ( Business Associate ) are parties to an agreement ( Agreement ) involving the disclosure of protected health information (PHI); and WHEREAS, pursuant to the Health Insurance Portability and Accountability Act of 1996 ( HIPAA ), regulations have been promulgated governing the privacy of individually identifiable health information (codified at 45 C.F.R. Parts 160 and 164) (hereinafter referred to as the HIPAA Privacy Regulations ) and WHEREAS, pursuant to the Health Information Technology and Clinical Health Act (HITECH Act) as included in the American Recovery and Renewal Act of 2009 (AARA) certain regulations have been promulgated by the Department of Health and Human Services; and, WHEREAS, the HIPAA Privacy Regulations specify requirements with respect to the contracts between an entity covered under the HIPAA Privacy Regulations, and its business associates, defined as a party which performs certain services on behalf of, or provides certain services for, a Covered Entity and, in conjunction therewith, gains access to individually identifiable health information; and WHEREAS, the nature of the existing contractual relationship between Covered Entity and Business Associate may involve the exchange of PHI as that term is defined under the HIPAA as amended by the HITECH Act; and WHEREAS, in accordance with the HIPAA Privacy Regulations and the HITECH Act, the Parties seek to enter into an agreement specifying certain of their respective obligations when acting in the capacity of a covered entity and a business associate. NOW THEREFORE, in consideration of the foregoing premises, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows: Article 1 Definitions 1.1 Breach. Breach has the same meaning as this term has in 45 CFR of the HITECH Act 1.2 Business Associate. Business Associate shall mean ABC Company 1.3 Covered Entity. Covered Entity shall mean Perry Memorial Hospital 1.4 Designated Record Set. Designated Record Set has the same meaning as this term has in 45 CFR Privacy Rule. Privacy Rule shall mean the Standards for Privacy for Individually Identifiable Information at 45 CFR Part 160 and Part 164, Subparts A and E, as amended by the HITECH Act. 1.6 Protected Health Information. Protected Health Information (or PHI) has the same meaning as this term has in 45 CFR (as Amended by the HITECH Act) limited to the information or created or received by Business Associate form or on behalf of Covered Entity. 1.7 Required by Law. Required by law has the same meaning as this term has in 45 CFR Page 1 of 7

2 Article Secretary. Secretary shall mean the Secretary of the U.S. Department of Health and Human Services or his/her designee. 1.9 Security Standards. Security Standards means the security standards for the protection of PHI promulgated by the Secretary in Title 45 CFR Unsecured Protected Health Information. Unsecured Protected Health Information shall mean Protected health Information that is not secured through the use of a technology or methodology specified by the Secretary in regulations or as otherwise defined in 13402(h) of the HITECH Act Any prospective amendments to the laws referenced in this definitional section prospectively amend this Agreement to incorporate said changes by Congressional Act or by regulation of the Secretary of HHS. Business Associate Provisions 2.1 Protected Health Information. The Parties agree that Article 2 of this Addendum shall specify the terms and conditions governing and handling of protected health information (as defined by the HIPAA Privacy Regulations) provided by, or created or received by [ABC Company] when acting as a business associate of the Covered Entity ( Protected Health Information ). 2.2 Services. Pursuant to the Agreement, Business Associate shall provide services ( Services ) for or on behalf of Covered Entity that are encompassed within the definition of business associate under the HIPAA Privacy Regulations and that involve the use and/or disclosure of the Protected Health Information. Except as otherwise provided herein, Business Associate may make: (1) any and all uses and disclosures of the Protected Health Information necessary to perform its obligations under the Agreement; and (2) any use or disclosure of the Protected Health Information permitted under applicable law, including, but not limited to, 45C.F.R Moreover, Business Associate may disclose the Protected Health Information: (1) to its subcontractors and agents in accordance with Section 2.9 below; and (2) as directed by Covered Entity. Business Associate s use and disclosure of, and requests for PHI shall be limited to a Limited Data Set, unless a greater amount of PHI is the minimum necessary to accomplish the purposes of the use, disclosure or request. 2.3 Additional Purposes for Use and Disclosure. Notwithstanding Article 2, Section 2.2 above and unless otherwise limited herein: Business Associate may use the Protected Health Information if necessary for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate provided that any such use is permitted under applicable law; and Business Associate may disclose that Protected Health Information to third parties for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate provided that: (a) the disclosure is Required by Law; or (b) Business Associate has obtained from the third party written assurance, which shall be available to Covered Entity upon request, that the Protected Health Information shall be held confidentially and used or further disclosed only as Required by Law or for the purpose for which it was disclosed to the third party and that the third party shall immediately notify Business Associate, in writing, of any instance of which it is aware in which the confidentiality of the Protected Health Information has been breached; and Page 2 of 7

3 2.3.3 Business Associate may use or disclose Protected Health Information on behalf of Covered Entity provided that such use or disclosures would not violate the Privacy Rule if done by Covered Entity Business Associate may aggregate the Protected Health Information with such information of other covered entities which Business Associate has received or created in its capacity as a business associate of such other covered entities provided that the purpose of the aggregation is to provide Covered Entity with data analysis relating to Covered Entity s health care operations. 2.4 Limitations on Use and Disclosure. Business Associate agrees not to use or further disclose the Protected Health Information other than as may be expressly permitted or required by this Addendum or as required by law. Business Associate further agrees not to use or further disclose the Protected Health Information in any manner that would violate the requirements of applicable law, including, but not limited to, the HIPAA Privacy Regulations, if done by Covered Entity. 2.5 Privacy Notice. Business Associate agrees to comply with Covered Entity s then current notice of privacy practices ( Notice ) required by applicable law, including, but not limited to, the HIPAA Privacy Regulations, upon Business Associate s receipt of a copy thereof. A current privacy notice is available at 2.6 Appropriate Safeguards. Business Associate agrees that it shall utilize physical, administrative and technical safeguards meeting required security safeguards and protect the confidentiality, integrity, and availability of the Protected Health Information that it creates, receives, maintains, or transmits, and that ensure the Protected Health Information is not used or disclosed in any manner inconsistent with this Addendum. Such safeguards shall include, but not be limited to: (1) establishing policies and procedures to ensure that any employee of Business Associate who does not have a reasonable need for the Protected Health Information in order to accomplish an authorized use or disclosure is not given access to such information and that all employees of Business Associate whose services may be used to fulfill obligations under this Agreement are appropriately informed of the terms of this Agreement; and (2) disclosing to any agent, subcontractor or other third party and requesting from covered Entity only the minimum Protected Health Information necessary to accomplish the intended purpose of the use, disclosure or request. Business Associate shall, at anytime so requested by Covered Entity, provide assurances, in whatever form requested, that it is in compliance with the requirements of this Addendum as well as the Privacy Rule. 2.7 Report of Inconsistent Use or Disclosure. Business Associate agrees to report, in writing, to covered Entity s Privacy Officer any use, disclosure, or security breach related to the Protected Health Information which is inconsistent with the terms of this Addendum and of which Business Associate becomes aware, immediately and in no case no more than one (1) calendar day of Business Associate s discovery of such inconsistent use or disclosure, including, but not limited to, any discovery of an inconsistent use or disclosure by an agent or subcontractor of Business Associate. The report of Business Associate shall include detailed information about the Breach such as contact information for all affected individuals, a description of the Breach, and the corrective actions that have been taken to mitigate the harm and prevent a recurrence. 2.8 Mitigation. Business Associate agrees to mitigate and to establish policies and procedures for mitigating, to the greatest extent practicable, any harmful effect from any inconsistent use or disclosure of the Protected Health Information which Business Associate is required to report to Covered Entity pursuant to this Addendum. Page 3 of 7

4 2.9 Agents and Subcontractors. Business Associate agrees to enter into a written contract with any agent or subcontractor to which Business Associate provides or makes available the Protected Health Information and agrees that such contract shall obligate Business Associate s agent or subcontractor, as applicable, to abide by the same terms and conditions with respect to use and disclosure of the Protected Health Information as are recited in the Addendum. Business Associate further agrees that Covered Entity shall be named an intended third party beneficiary of each such contract with respect to the enforcement and enjoyment of the benefits of such terms and conditions Protected Health Information Access. Business Associate agrees to make available and to provide access to the Protected Health Information in a Designated Record Set in a prompt commercial manner to Covered Entity, the individual to whom any such Protected Health Information relates or the individual s authorized personal representative in response to a request for access by the individual (or the individual s authorized personal representative) in accordance with applicable law, including, but not limited to, 45 C.F.R Business Associate shall immediately notify Covered Entity, in writing, upon Business Associate s receipt of any such request other than from Covered Entity and shall provide Covered Entity with a copy of any Protected Health Information so accessed Protected Health Information Amendment. Business Associate agrees to make available the Protected Health Information for amendment and to incorporate any amendment to the Protected Health Information requested by the individual to whom any such Protected Health Information relates or the individual s authorized personal representative or as directed by Covered Entity in accordance with applicable law, including, but not limited to, 45 C.F.R Business Associate shall immediately notify Covered Entity, in writing, upon Business Associate s receipt of any such request other than from Covered Entity and shall provide Covered Entity with a copy of any Protected Health Information so amended Protected Health Information Accounting. Business Associate agrees to make available the information required to provide an accounting of disclosures of the Protected Health Information to Covered Entity, the individual to whom any such Protected Health Information relates or the individual s authorized personal representative in response to a request for such accounting by the individual (or the individual s authorized personal representative) in accordance with applicable law, including, but not limited to, 45 C.F.R Business Associate shall immediately notify Covered Entity, in writing, upon Business Associate s receipt of any such request other than from Covered Entity and shall provide Covered Entity with a copy of any such accounting so provided Secretary s Access to Books and Records. Business Associate agrees to make its internal practices, books, and records relating to the implementation of security safeguards as well as the use and disclosure of the Protected Health Information available to the Secretary of Health and Human Services ( Secretary ) or the Secretary s designee in a prompt commercially reasonable manner for the purposes of determining Covered Entity s compliance with the HIPAA Privacy Regulations. Business Associate shall immediately notify Covered Entity of its receipt of such request and shall provide covered Entity with a copy of any such materials so accessed Covered Entity s Access to Books and Records. Business Associate agrees to make its books, records, agreements, policies and procedures with respect to its performance hereunder available to Covered Entity, upon prior written request during normal business hours, for the purposes of determining Business Associate s compliance with this Addendum. Page 4 of 7

5 2.15 Covered Entity s Access to Premises. Business Associate shall, upon request with reasonable notice provide Covered Entity access to its premises for a review and demonstration of its internal practices and procedures for safeguarding PHI Protected Health Information Return/Destruction. Notwithstanding anything to the contrary in the Agreement, upon the termination of this Agreement (or termination of Covered Entity s or Business Associate s participation thereunder), Business Associate shall return all Protected Health Information to covered Entity and shall retain no copies of the Protected Health Information in any form. Covered Entity may request, in writing, that Business Associate destroy all Protected Health Information, including any copies of the Protected Health Information in any form, upon termination of the Agreement rather than returning the Protected Health Information to Covered Entity. Upon Business Associate s destruction of all Protected Health Information, including any copies of the Protected Health Information in any form, Business Associate shall certify in writing to Covered Entity that it has done so. Business Associate agrees to recover any Protected Health Information in the possession of its agents or subcontractors and to return or destroy such Protected Health Information, as applicable. If the return or destruction of all Protected Health Information is not feasible upon termination of the Agreement, then Business Associate shall explain in writing, directed to Covered Entity s privacy officer, why such return or destruction is not feasible. Business Associate agrees that, in that case, it shall extend its obligations under this Addendum to protect any Protected Health Information retained after the termination of the Agreement and shall limit any further use or disclosure to the purposes which make return or destruction of the Protected Health Information infeasible Covered Entity Responsibilities. With respect to the use and disclosure of the Protected Health Information by Business Associate, Covered Entity agrees to: (1) inform Business Associate of any changes in the Notice and to provide Business Associate with a copy of the current Notice; (2) inform Business Associate of any change in or revocation of any consent or authorization provided to Covered Entity by individuals pursuant to applicable law, including, but not limited to, the HIPAA Privacy Regulations and which is applicable to Business Associate; (3) to timely notify Business Associate, in writing, of any arrangement permitted or required of Covered Entity under applicable law, including, but not limited to, the HIPAA Privacy Regulations, that may impact in any manner the use or disclosure of the Protected Health Information by Business Associate under this Agreement, including, but not limited to, any agreement by Covered Entity to restrict use or disclosure of any Protected Health Information as permitted by the HIPAA Privacy Regulations; and (4) not request Business Associate to use or disclose PHI in any manner that would not be permissible under the Privacy Rule if done by Covered Entity. Nothing in this paragraph shall restrict the ability of Business Associate to use or disclose PHI as set forth in paragraph 2.2 and 2.3. herein Remedies. Business Associate agrees that Covered Entity shall be entitled to seek immediate injunctive relief as well as to exercise all other rights and remedies which Covered Entity may have at law or in equity in the event of an unauthorized use or disclosure of Protected Health Information by Business Associate or any agent or subcontractor of Business Associate that received Protected Health Information from Business Associate Ownership. The Protected Health Information shall be and remain the property of Covered Entity. Business Associate agrees that it acquires no title or rights to the Protected Health Information as a result of this Addendum Waiver. No forbearance or neglect on the part of Covered Entity nor Business Associate to enforce or insist upon any of the applicable provisions of this Agreement shall be construed as a Page 5 of 7

6 Article 3 Article 4 Article 5 wavier of Covered Entity s or Business Associate s rights hereunder unless it is in writing and signed by a duly authorized officer of Covered Entity and business Associate. A waiver with respect to one event shall not be construed as continuing, or as a bar to or a waiver of any right or remedy as to subsequent events Covered Entity s Privacy Rule Obligations. To the extent Business Associate is to carry out one or more of Covered Entity s obligation(s) under Subpart E of 45 CFR Part 164, Business Associate shall comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligation(s). Insurance Business Associate shall obtain and maintain during the term of the Agreement liability insurance covering claims based on a violation of the HIPAA Regulations or any applicable state law or regulation concerning the privacy of patient information and claims based on its obligations pursuant to this Addendum in an amount not less than $1,000,000 per claim and $3,000,000 annual aggregate. To the extent that such insurance is purchased on a claims made basis, Business Associate agrees to purchase appropriate tail coverage upon termination of this Addendum. Business Associate shall immediately notify Covered Entity of any amendment, modification, renewal, or cancellation of the insurance coverage provided for in this Section. Indemnification Business Associate shall indemnify, hold harmless and defend (if requested by Covered Entity) Covered Entity and its officers, directors and members (all of the foregoing collectively referred to in this Article 3 as the Indemnitees ) from and against any and all liabilities, costs, expenses and damages, including attorneys fees, actually and necessary incurred by or imposed on any of the Indemnitees in connection with or resulting from a Breach or any claim, action, suit or proceeding, whether civil, criminal, administrative or investigate, or any appeal thereon, with which an Indemnitee may be or become involved or with which an Indemnitee may be threatened, as a party or otherwise, as a direct or indirect result of any actions or omissions of Business Associates, its agents or subcontractors, including failure to perform its obligations under this Agreement, or as a result of Business Associate s negligence or willful misconduct in its performance of its duties under this Agreement. General Provisions 5.1 Original Agreement. The Agreement, as amended hereby, shall remain in full force and effect. 5.2 Change of Law. The Parties agree to negotiate in good faith any modification of this Addendum that may be necessary or required to ensure consistency with any amendment to or change in applicable law, including, but not limited to, the HIPAA Privacy Regulations. 5.3 Term. This Addendum shall be effective as of 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. 5.4 Termination for Cause. Upon Covered Entity s knowledge of a material breach by Business Associate Covered Entity shall either: Provide an opportunity for Business Associate to cure the breach or end the violation and terminate this Agreement if Business Associate does not cure the breach or end the violation within the tome specified by Covered Entity; Page 6 of 7

7 5.4.2 Immediately terminate this agreement if Business Associate has breached Covered Entity s PHI during the term of this Agreement and cure is not possible; or, If neither termination nor cure is feasible, Covered Entity shall report the violation to the Secretary. 5.5 Effect of Termination Except as provided in paragraph of this Section, upon termination of this Addendum for any reason, Business Associate shall return or destroy all PHI received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to PHI that is in the possession of subcontractors or agents of Business Associate. Business Associate shall retain no copies of PHI In the event that Business Associate determines that returning or destroying the PHI is infeasible, Business Associate shall provide to Covered Entity notification of the conditions that make return or destruction infeasible. Upon notification to Covered Entity that return or destruction is infeasible, Business Associate shall extend the protections of this Addendum to such PHI and limit further uses and disclosures of such PHI to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such PHI. 5.6 Survival. Articles 2 and 3 shall survive termination of this Addendum and the underlying Agreement for any reason. 5.7 Counterparts. This Addendum may be executed in any number of counterparts, each of which shall be deemed an original, but all such counterparts together shall constitute but one and the same instrument. PERRY MEMORIAL HOSPITAL Rex Conger, President/CEO [ABC COMPANY] (BUSINESS ASSOCIATE) By: Title: (signature) (Print name) Page 7 of 7

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