Business Associate Agreement
This HIPAA Business Associate Agreement (the “Agreement”) is entered into on the date you are approved by the site (“Effective Date”) by and between stoRx, LLC (“Covered Entity”), and health care provider (“Business Associate”) (each a “Party” and collectively the “Parties”).
Business Associate performs functions, activities or services for, or on behalf of Covered Entity and Business Associate creates, receives, maintains, or transmits Protected Health Information (“PHI”), including Electronic Protected Health Information (“EPHI”), in order to perform such functions, activities or services (referred to collectively as the “Services”). The purpose of this Agreement is to set forth the terms and conditions of disclosure of PHI by Covered Entity to Business Associate, to set forth the terms and conditions of Business Associate’s use and disclosure of PHI, and to ensure the confidentiality, integrity and availability of EPHI that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity. It is the intent of Covered Entity and Business Associate that this Agreement will meet the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), the American Recovery and Reinvestment Act of 2009, Public Law 111-5 (“ARRA”), the Privacy Rule, and the Security Rule, 45 C.F.R. Parts 160 and 164.
Terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in HIPAA, ARRA, the Privacy Rule, and the Security Rule. Following are some of the key terms of this Agreement.
2.1 Electronic Protected Health Information. “Electronic Protected Health Information” or “EPHI” shall have the same meaning as the term “electronic protected health information” in 45 C.F.R. § 160.103, but shall be limited to the EPHI that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity.
2.2 Individual. “Individual” shall have the same meaning as the term “individual” in 45 C.F.R. § 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. § 164.502(g).
2.3 Minimum Necessary. “Minimum Necessary” shall have the same meaning as “minimum necessary” described in 45 C.F.R. § 164.502(b) and Section 13405(b) of ARRA.
2.4 Privacy Rule. “Privacy Rule” shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 C.F.R. Parts 160 and Part 164, subparts A and E.
2.5 Protected Health Information. “Protected Health Information” or “PHI” shall have the same meaning as the term “protected health information” in 45 C.F.R. § 160.103, but shall be limited to the information that Business Associate creates, receives, maintains, or transmits on behalf of Covered Entity.
2.6 Required by Law. “Required by Law” shall have the same meaning as the term “required by law” in 45 C.F.R. § 164.103.
2.7 Secretary. “Secretary” shall mean the Secretary of the United States Department of Health and Human Services or his designee.
2.8 Security Incident. “Security Incident” shall have the same meaning as “security incident” in 45 C.F.R. § 164.304.
2.9 Security Rule. “Security Rule” shall mean the Security Standards for the Protection of EPHI at 45 C.F.R. Parts 160 and 164, subparts A and C.
2.10 Subcontractor. “Subcontractor” shall have the same meaning as “subcontractor” in 45 C.F.R. § 160.103.
3. Obligations AND ACTIVITIES of Business Associate
3.1 Use and Disclosure. Business Associate agrees to not use or disclose PHI other than as permitted or required by this Agreement and any underlying agreement(s) related to the Services, or as Required by Law. Business Associate shall also comply, where applicable, with the Privacy Rule and the Security Rule.
3.2 Safeguards. Business Associate agrees to use appropriate safeguards and comply, where applicable, with 45 C.F.R. Part 164 Subpart C with respect to EPHI, to prevent use or disclosure of the information other than as provided for by this Agreement.
3.3 Business Associate’s Reporting Obligations.
(a) Reports of Non-Permitted Use or Disclosure. Business Associate agrees to report to Covered Entity any use or disclosure of the PHI not provided for by this Agreement without unreasonable delay and in no case longer than five (5) calendar days after discovery. Where applicable, such report shall comply with the requirements outlined in Sections 3.3(b) and 3.3(c).
(b) Reports of Breach of Unsecured PHI.
1. For purposes of this section, “Breach” and “Unsecured PHI” shall have the same meaning as “breach” and “unsecured protected health information,” respectively, as such terms are defined by 45 C.F.R. § 164.402.
2. Following the discovery of a Breach of Unsecured PHI, Business Associate shall notify Covered Entity of the Breach. Such notification shall be made as soon as reasonably practicable after discovering the Breach, but no later than five (5) calendar days after its discovery.
3. Business Associate’s notice shall include, to the extent possible, the identification of each Individual whose Unsecured PHI has been, or is reasonably believed by Business Associate to have been, accessed, acquired, used, or disclosed during or as a result of the Breach. Business Associate shall also provide Covered Entity with at least the following information: a description of the Breach, including the date of Breach and the date of discovery of the Breach, if known; a description of the types of Unsecured PHI involved in the Breach; any steps Individuals should take to protect themselves from potential harm resulting from the Breach; 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; and any other information requested by Covered Entity related to the Breach. Business Associate shall supplement such notice with additional information as it becomes available, even if such information becomes available after Individuals have been notified of the Breach.
4. Business Associate agrees to cooperate with Covered Entity in the investigation of a Breach of Unsecured PHI and to cooperate with and participate in, to the extent requested by Covered Entity, the notification of Individuals, the media, and the Secretary of any Breach of Unsecured PHI.
5. In the event that: (i) a Breach of Unsecured PHI occurs because of the action or inaction of Business Associate, its employees, agents, representatives, or Subcontractors; or (ii) a Breach occurs involving Unsecured PHI in Business Associate’s possession, or PHI created, maintained, transmitted, or received by Business Associate or its employees, agents, representatives, or Subcontractors, Business Associate agrees that Covered Entity may, in its sole discretion, require Business Associate to provide such notification as may be required of Covered Entity by 45 C.F.R. §§ 164.404, 164.406, and 164.408 at Business Associate’s sole cost and expense. Covered Entity shall have the right to review, direct, and approve or reject the contents or manner of such notification.
(c) Reports of Security Incidents. Business Associate agrees to report to Covered Entity any Security Incident of which it becomes aware without unreasonable delay and in no case longer than five (5) calendar days after discovery. Where applicable, such report shall comply with the requirements outlined in Sections 3.3(a) and 3.3(b).
3.4 Subcontractors. Business Associate agrees to ensure that any Subcontractor that creates, receives, maintains, or transmits PHI (including EPHI) on behalf of Business Associate agrees to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such information, including but not limited to, compliance with the applicable requirements of 45 C.F.R. Parts 160 and 164. Such agreement between Business Associate and the Subcontractor must be made in writing and must comply with the terms of this Agreement and the requirements outlined in 45 C.F.R. §§ 164.504(e) and 164.314.
3.5 Designated Record Set.
(a) If Business Associate maintains PHI in a Designated Record Set, Business Associate agrees to provide access, at the request of Covered Entity and in the time and manner designated by Covered Entity, to PHI 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 C.F.R. § 164.524.
(b) If Business Associate maintains PHI in a Designated Record Set, Business Associate agrees to make available such PHI for amendment and incorporate any amendment(s) to PHI in a Designated Record Set that Covered Entity directs or agrees to pursuant to 45 C.F.R. § 164.526 at the request of Covered Entity or an Individual, and in the time and manner designated by Covered Entity.
3.6 Accounting of Disclosures.
(a) Business Associate agrees to document such disclosures of PHI 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 PHI in accordance with 45 C.F.R. § 164.528.
(b) Business Associate agrees to provide to Covered Entity or an Individual, in the time and manner designated by Covered Entity, information collected in accordance with Section 3.6(a) of this Agreement, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. § 164.528.
3.7 Compliance with Law. To the extent Business Associate is to carry out Covered Entity’s obligations under the Privacy Rule, Business Associate will comply with the Privacy Rule’s requirements that apply to Covered Entity in the performance of such obligation.
3.8 Internal Practices. Business Associate agrees to make internal practices, books, and records, including policies and procedures, relating to the use and disclosure of PHI received from, or created or received by Business Associate on behalf of, Covered Entity available to Covered Entity, or to the Secretary, in a time and manner selected by Covered Entity or designated by the Secretary, for purposes of the Secretary determining Covered Entity’s and Business Associate’s compliance with the Privacy Rule and Security Rule.
3.9 Mitigation. Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of PHI by Business Associate in violation of the requirements of this Agreement.
3.10 Prohibition on the Sale of PHI. Business Associate agrees that it shall not, directly or indirectly, receive remuneration in exchange for any PHI of Covered Entity except as otherwise permitted by the Privacy Rule and as approved in writing by Covered Entity.
3.11 Conditions on Marketing and Fundraising Communications. Business Associate shall not use or disclose PHI for the purpose of making a communication about a product or service that encourages recipients of the communication to purchase or use the product or service or for fundraising communications unless such communication is permitted by the Privacy Rule and as approved in writing by Covered Entity.
4. Permitted Uses and Disclosures by Business Associate
4.1 General Use and Disclosure.
(a) Except as otherwise limited in this Agreement, Business Associate may use or disclose PHI to perform Services for, or on behalf of, Covered Entity as such services may be specified in any underlying agreement(s), provided that such use or disclosure would not violate the Privacy Rule or the Security Rule if done by Covered Entity.
(b) Business Associate must request, use, and disclose only the Minimum Necessary PHI to accomplish the intended purpose of the request, use, or disclosure. The Party disclosing PHI shall determine what constitutes the Minimum Necessary to accomplish the intended purpose of the disclosure.
4.2 Specific Use and Disclosure.
(a) Business Associate may use or disclose PHI to carry out Business Associate’s legal responsibilities and for the proper management and administration of Business Associate, provided that any such disclosures are Required by Law, or Business Associate obtains written 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 Business Associate of any instances of which it becomes aware in which the confidentiality of the information has been breached.
(b) Business Associate may use PHI to provide Data Aggregation services to Covered Entity as permitted by 45 C.F.R. § 164.504(e)(2)(i)(B).
(c) Business Associate may use and disclose PHI to report violations of law to appropriate state and federal authorities, to the extent permitted or required by 45 C.F.R. § 164.502(j)(1) and state law.
(d) Business Associate may de-identify PHI in accordance with the requirements outlined in the Privacy Rule. Data that has been de-identified will no longer be subject to the terms of this Agreement.
5. Obligations of Covered Entity
5.1 Privacy Practices. Upon request, Covered Entity shall provide Business Associate with the notice of privacy practices that Covered Entity produces in accordance with 45 C.F.R. § 164.520 and shall provide Business Associate with any changes to such notice to the extent such changes affect Business Associate’s permitted or required uses and disclosures.
5.2 Notice of Changes and Restrictions. Covered Entity shall notify Business Associate of any changes in, or revocation of, permission by Individual to use or disclose PHI, if such changes affect Business Associate’s permitted or required uses and disclosures. Such notification shall include any restriction that Covered Entity has agreed to in accordance with 45 C.F.R. § 164.522. If Business Associate receives a request to restrict the disclosure of PHI directly from an Individual, Business Associate shall promptly notify Covered Entity of such request and Covered Entity shall be responsible for making the determination, in accordance with the Privacy Rule, as to whether Business Associate shall comply with the Individual’s request.
5.3 Permissible Requests by Covered Entity. Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under the Privacy Rule or the Security Rule if done by Covered Entity, except that Business Associate may use or disclose PHI for data aggregation or management and administrative activities of Business Associate.
6. Term and Termination
6.1 Term. This Agreement shall be effective upon the Effective Date and shall remain in effect for the duration of the Services giving rise to the necessity of a Business Associate Agreement, and until all of the PHI 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 PHI, protections are extended to such information, in accordance with Section 6.3(b).
(a) Termination Resulting from the End of Services. This Agreement shall terminate in the event that the underlying agreement(s) under which Covered Entity discloses PHI to Business Associate terminates for any reason, or if the Services that give rise to the necessity of a Business Associate Agreement terminate for any reason.
(b) Termination for Cause. Upon either Party’s knowledge of a material breach of this Agreement by the other Party, the non-breaching Party must either:
1. Provide an opportunity for the breaching Party to cure the breach or end the violation, and if the breaching Party does not cure the breach or end the violation within the time specified by the non-breaching Party, the non-breaching Party shall terminate this Agreement and any underlying agreement(s); or
2. Immediately terminate this Agreement and any underlying agreement(s).
6.3 Return or Destruction of PHI.
(a) Except as provided in paragraph (b) of this section, upon termination of this Agreement 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, that Business Associate still maintains in any form. This provision shall also apply to PHI that is in the possession of Subcontractors of Business Associate. Business Associate shall retain no copies of the PHI.
(b) 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 mutual agreement of the Parties that return or destruction of PHI is unfeasible, Business Associate and its Subcontractors shall extend the protections of this Agreement 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 and/or its Subcontractors maintain such PHI.
Business Associate shall indemnify and hold harmless Covered Entity from any and all claims, causes of action, and demands whatsoever made for loss, damage, or injury to any person arising from a breach by Business Associate, or its Subcontractors, of its obligations under this Agreement.
8.1 Regulatory References. A reference in this Agreement to a section in the Privacy Rule, the Security Rule, HIPAA, or ARRA, or any other reference to a law or regulation, means the section or law as in effect as of the date of this Agreement or as subsequently amended.
8.2 Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time to comply with the requirements of the Privacy Rule, the Security Rule, HIPAA, and ARRA.
8.3 Survival. The respective rights and obligations of Business Associate under Section 6.3 and Section 7 of this Agreement shall survive the termination of this Agreement.
8.4 Interpretation. Any ambiguity in this Agreement shall be resolved in favor of a meaning that permits compliance with the Privacy Rule, the Security Rule, HIPAA, and ARRA.
8.5 Relationship to Other Agreement Provisions. In the event that a provision of this Agreement is contrary to a provision of an underlying agreement or agreements under which Covered Entity discloses PHI to Business Associate, the provision of this Agreement shall control. Otherwise, this Agreement shall be construed under, and in accordance with, the terms of such underlying agreement or agreements between the Parties.
8.6 Prior Business Associate Agreements. Consistent with Section 8.5, this Agreement shall supersede any and all prior business associate agreement(s), or terms of other agreements addressing the privacy and security of PHI, between the Parties.
8.7 Modification of Agreement. No alteration, amendment or modification of the terms of this Agreement shall be valid or effective unless in writing and signed by Business Associate and Covered Entity.
8.8 Relationship of Parties. Business Associate, in furnishing services to Covered Entity, is acting as an independent contractor, and Business Associate has the sole right and obligation to supervise, manage, contract, direct, procure, perform, or cause to be performed, all work to be performed by Business Associate under this Agreement. Business Associate is not an agent of Covered Entity, and has no authority to represent Covered Entity as to any matters, except as expressly authorized in this Agreement.
8.9 Notices. Any notices required or permitted to be given under this Agreement by either Party shall be given in writing: (a) by personal delivery; (b) by electronic facsimile with confirmation sent by United States first class mail; (c) by bonded courier or nationally recognized overnight delivery service; or (d) by United States first class registered or certified mail, postage prepaid, return receipt requested, addressed to the Parties at the addresses set forth below or to such other addresses as the Parties may request in writing by notice pursuant to this Section 8.9. Notices shall be deemed received on the earliest of personal delivery, upon the next business day after delivery by electronic facsimile with confirmation that the transmission was completed or upon receipt by any other method of delivery.
Covered Entity: stoRx, LLC
Business Associate: healthcare provider
8.10 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original and when taken together shall constitute one agreement.
8.11 Governing Law. This Agreement will be governed by and construed in accordance with the law.
8.12 No Offshore Work. In performing the Services for, or on behalf of, Covered Entity, Business Associate shall not, and shall not permit any of its Subcontractors, to transmit or make available any PHI to any entity or individual outside the United States without the prior written consent of Covered Entity.