Table of Contents
This BUSINESS ASSOCIATE AGREEMENT (this “BA Agreement”) is by and between EYEFINITY, INC., a Delaware corporation (“EF”), and the Eye Care Provider (“Covered Entity”) who utilizes Eyefinity’s software products and services (the “Products and Services”). EF and Covered Entity may be referred to individually as a “Party” and collectively as the “Parties”. Capitalized terms used in this BA Agreement without definition shall have the meanings assigned to such terms by Covered by the Administrative Simplification section of the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act and their implementing regulations as amended from time to time (collectively, “HIPAA”).
WHEREAS, EF receives Protected Health Information from or on behalf of Covered Entity pursuant to Covered Entity’s use of Eyefinity’s Products and Services (“PHI”); and
WHEREAS, the Parties desire to enter into this Business Associate Agreement in order for the Parties to comply with HIPAA.
NOW THEREFORE, in consideration of the mutual premises and covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Section 1.1. Use and Disclosure of PHI. EF may use and disclose PHI as permitted or required under this BA Agreement or as Required by Law, but shall not otherwise use or disclose PHI. EF shall not use or disclose PHI received from Covered Entity in any manner that would constitute a violation of HIPAA if so used or disclosed by Covered Entity (except as set forth in Sections 1.1(b), (c), (d) and (e) of this BA Agreement). To the extent EF carries out any of Covered Entity’s obligations under the HIPAA Privacy Rule, EF shall comply with the requirements of the HIPAA Privacy Rule that apply to Covered Entity in the performance of such obligations. Without limiting the generality of the foregoing, EF is permitted to use or disclose PHI as set forth below:
- EF and its Subcontractors may use and disclose PHI to carry out EF’s duties and obligations for, or on behalf of, Covered Entity, provided that such use or disclosure would not violate the Privacy Rule if done by Covered Entity;
- EF and its Subcontractors may use PHI internally for EF’s or the Subcontractor’s proper management and administrative services or to carry out their legal responsibilities;
- EF and its Subcontractors may disclose PHI to a third party for EF’s or the Subcontractor’s proper management and administration, provided that the disclosure is Required by Law or EF or the Subcontractor, as applicable, obtains reasonable assurances from the third party to whom the PHI is to be disclosed that the third party will (1) protect the confidentially of the PHI, (2) only use or further disclose the PHI as Required by Law or for the purpose for which the PHI was disclosed to the third party and (3) notify, as applicable, EF or the Subcontractor of any instances of which the person is aware in which the confidentiality of the PHI has been breached;
- EF and its Subcontractors may use PHI to provide Data Aggregation services; and
- EF and its Subcontrators may use PHI to create de-identified health information in accordance with the HIPAA de-identification requirements. Without limiting any other rights of EF, EF may use, create, sell, disclose to third parties and otherwise exploit de-identified health information for any purposes not prohibited by law. For the avoidance of doubt, the second sentence of this Section 1.1(e) shall survive the expiration or earlier termination of this BA Agreement.
Section 1.2. Safeguards. EF shall use reasonable and appropriate safeguards to prevent the use or disclosure of PHI except as otherwise permitted or required by this BA Agreement. In addition, EF shall implement Administrative Safeguards, Physical Safeguards and Technical Safeguards that reasonably and appropriately protect the Confidentiality, Integrity and Availability of PHI transmitted or maintained in Electronic Media (“EPHI”) that it creates, receives, maintains or transmits on behalf of Covered Entity. EF shall comply with the HIPAA Security Rule with respect to EPHI.
Section 1.3. Minimum Necessary Standard. To the extent required by the "minimum necessary" requirements of HIPAA, EF shall only request, use and disclose the minimum amount of PHI necessary to accomplish the purpose of the request, use or disclosure.
Section 1.4. Mitigation. EF shall take reasonable steps to mitigate, to the extent practicable, any harmful effect (that is known to EF) of a use or disclosure of PHI by EF in violation of this BA Agreement.
Section 1.5. Subcontractors. EF shall enter into a written agreement meeting the requirements of 45 C.F.R. §§ 164.504(e) and 164.314(a)(2) with each Subcontractor that creates, receives, maintains or transmits PHI on behalf of EF. EF shall ensure that the written agreement with each Subcontractor obligates the Subcontractor to comply with restrictions and conditions that are at least as restrictive as the restrictions and conditions that apply to EF under this BA Agreement.
Section 1.6. Reporting Requirements
- If EF becomes aware of a use or disclosure of PHI in violation of this BA Agreement by EF or by a third party to which EF disclosed PHI, EF shall report any such use or disclosure to Covered Entity without unreasonable delay.
- EF shall report any Security Incident involving EPHI of which it becomes aware in the following manner: (a) any actual, successful Security Incident will be reported to Covered Entity in writing without unreasonable delay, and (b) any attempted, unsuccessful Security Incident of which EF becomes aware will be reported to Covered Entity orally or in writing on a reasonable basis, as requested by Covered Entity. If the HIPAA Security Rule is amended to remove the requirement to report any unsuccessful Security Incidents, the requirement hereunder to report such unsuccessful Security Incidents will no longer apply as of the effective date of the amendment.
- EF shall, following the discovery of a Breach of Unsecured PHI, notify Covered Entity of the Breach in accordance with 45 C.F.R. § 164.410 without unreasonable delay and in no case later than sixty (60) days after discovery of the Breach.
Section 1.7. Access to Information. EF shall make available PHI to Covered Entity for so long as EF maintains the PHI in a Designated Record Set. If EF receives a request for access to PHI directly from an Individual, EF shall forward such request to Covered Entity within ten (10) business days. Covered Entity shall have the sole responsibility for determining whether to approve a request for access to PHI and to provide such access to the Individual.
Section 1.8. Availability of PHI for Amendment. EF shall provide PHI to Covered Entity for amendment, and incorporate any such amendments in the PHI (for so long as EF maintains such information in the Designated Record Set), in accordance with this BA Agreement and as required by 45 C.F.R. § 164.526. If EF receives a request for amendment to PHI directly from an Individual, EF shall forward such request to Covered Entity within ten (10) business days. Covered Entity shall have the sole responsibility for determining whether to approve an amendment to PHI and to make such amendment.
Section 1.9. Accounting of Disclosures. Within thirty (30) business days of written notice by Covered Entity to EF that it has received a request for an accounting of disclosures of PHI (other than disclosures to which an exception to the accounting requirement applies), EF shall make available to Covered Entity such information as is in EF’s possession and is required for Covered Entity to make the accounting required by 45 C.F.R. § 164.528. If EF receives a request for an accounting directly from an Individual, EF shall forward such request to Covered Entity within ten (10) business days. Covered Entity shall have the sole responsibility for providing an accounting to the Individual.
Section 1.10. Availability of Books and Records. Following reasonable advance written notice, EF shall make its internal practices, books and records relating to the use and disclosure of PHI received from, or created or received by EF on behalf of, Covered Entity available to the Secretary for purposes of determining Covered Entity’s compliance with HIPAA.
Section 2.1. Permissible Requests. Covered Entity shall not request EF to use or disclose PHI in any manner that would not be permissible under HIPAA if done by Covered Entity.
Section 2.2. Minimum Necessary Information. When Covered Entity discloses PHI to EF, Covered Entity shall provide the minimum amount of PHI necessary for the accomplishment of Covered Entity’s purpose.
Section 2.3. Appropriate Use of PHI. Covered Entity and its employees, representatives, consultants, contractors and agents shall not submit any Protected Health Information to EF (A) outside of the Products and Services, including but not limited to submissions to any online forum made available by EF or its Subcontractors to their customers, email transmissions, and submissions through any support website, portal, or online help desk or similar service made available by EF or its Subcontractors outside of the Products and Services; or (B) directly to any third party involved in the provision of an online forum, email, support website, online help desk or other service described in (A), above.
Section 2.4. Permissions; Restrictions. Covered Entity warrants that it has obtained and will obtain any consent, authorization and/or other legal permission required under HIPAA and other applicable law for the disclosure of PHI to EF. Covered Entity shall notify EF of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes may affect EF’s use or disclosure of PHI. Covered Entity shall not agree to any restriction on the use or disclosure of PHI under 45 C.F.R. § 164.522 that restricts EF’s use or disclosure of PHI under this BA Agreement unless such restriction is Required By Law or EF grants its written consent.
Section 2.5. Notice of Privacy Practices. Except as Required By Law, with EF’s consent or as set forth in this BA Agreement, Covered Entity shall not include any limitation in Covered Entity’s notice of privacy practices that limits EF’s use or disclosure of PHI under this BA Agreement.
Section 3.1. BA Agreement Term. This BA Agreement shall continue in full force and effect for so long as EF maintains any PHI.
Section 3.2. Termination Upon Breach of this BA Agreement. This BA Agreement may be terminated by either Party (the “Non-Breaching Party”) upon ninety (90) days written notice to the other Party (the “Breaching Party”) in the event that the Breaching Party materially breaches this BA Agreement in any material respect and such breach is not cured within such ninety (90) day period. Any determination of whether a material breach has been cured shall be made by EF in its sole discretion.
Section 3.3. Return or Destruction of PHI upon Termination. Upon termination of this BA Agreement, EF shall return or destroy all PHI received from Covered Entity or created or received by EF on behalf of Covered Entity and which EF still maintains as PHI. Notwithstanding the foregoing, to the extent that EF determines, in its sole discretion, that it is not feasible to return or destroy such PHI, this BA Agreement (including, without limitation, Section 1.1(e) of this BA Agreement) shall survive termination of this BA Agreement and such PHI shall be used or disclosed solely for such purpose or purposes which prevented the return or destruction of such PHI.
Section 4.1. Applicability. This BA Agreement relates to PHI that EF or EF’s Subcontractors receive pursuant to Covered Entity’s use of Eyefinity’s Products or Services.
Section 4.2. HIPAA Amendments. The Parties acknowledge and agree that the Health Information Technology for Economic and Clinical Health Act and its implementing regulations impose requirements with respect to privacy, security and breach notification applicable to Business Associates (collectively, the “HITECH BA Provisions”). The HITECH BA Provisions and any other future amendments to HIPAA affecting Business Associate Agreements are hereby incorporated by reference into this BA Agreement as if set forth in this BA Agreement in their entirety, effective on the date as may be specified by HIPAA.
Section 4.3. Regulatory References. A reference in this BA Agreement to a section in HIPAA means the section as it may be amended from time-to-time.
Section 4.4. Relationship of the Parties. This BA Agreement does not create a partnership, franchise, joint venture, agency, fiduciary, or employment relationship between the Parties and the status of the Parties shall be independent parties to a contractual arrangement. Neither Party shall have the authority to bind the other Party by contract or otherwise.
Section 4.5. Entire Agreement. This BA Agreement constitutes the entire agreement between the Parties as to their subject matter, and supersede all previous and contemporaneous agreements, proposals or representations, written or oral, concerning such subject matter. Except as otherwise set forth therein, no modification, amendment, or waiver of any provision of this BA Agreement shall be effective unless in writing and signed by the Party against whom the modification, amendment, or waiver is to be asserted.
Section 4.6. Waiver. No failure or delay by either Party in exercising any right under this Agreement shall constitute a waiver of that right. Other than as expressly stated therein, the remedies provided herein are in addition to, and not exclusive of, any other remedies of a Party at law or in equity.
Section 4.7. Counterparts. Covered Entity’s use of the Products and Services shall constitute Covered Entity’s consent to this BA Agreement. Alternatively, this BA Agreement may be executed in one or more counterparts, which may be delivered by fax or other electronic transmission, including email, each of which shall be deemed an original and which taken together shall form one legal instrument.