Business Associate Agreement

Background

I. Covered Entity is either a “covered entity” or “business associate” of a covered entity as each are defined under the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the HITECH Act (as defined below) and the related regulations promulgated by HHS (as defined below) (collectively, “HIPAA”) and, as such, is required to comply with HIPAA’s provisions regarding the confidentiality and privacy of Protected Health Information (as defined below);

II. The Parties have entered into the Xaia Terms of Service, together with any order form, subscription, or other written agreement under which Business Associate provides services to Covered Entity (collectively, the “Services Agreement”);

III. In providing services pursuant to the Services Agreement, Business Associate will have access to Protected Health Information;

IV. By providing the services pursuant to the Services Agreement, Business Associate will become a “business associate” of Covered Entity as such term is defined under HIPAA;

V. Both Parties are committed to complying with all federal and state laws governing the confidentiality and privacy of health information, including, but not limited to, the Standards for Privacy of Individually Identifiable Health Information found at 45 C.F.R. Part 160 and Part 164, Subparts A and E (collectively, the “Privacy Rule”); and

VI. Both Parties intend to protect the privacy and provide for the security of Protected Health Information disclosed to Business Associate pursuant to the terms of this BAA, HIPAA, and other applicable laws.

NOW, THEREFORE, in consideration of the mutual covenants and conditions contained herein and the continued provision of PHI by Covered Entity to Business Associate under the Services Agreement in reliance on this BAA, the Parties agree as follows.

1. Definitions

For purposes of this BAA, the Parties give the following meaning to each of the terms in this Section 1 below. Any capitalized term used in this BAA, but not otherwise defined, has the meaning given to that term in the Privacy Rule or pertinent law.

A. “Breach” means the acquisition, access, use, or disclosure of PHI in a manner not permitted under the Privacy Rule which compromises the security or privacy of the PHI, as defined in 45 C.F.R. §164.402.

B. “Breach Notification Rule” means the portion of HIPAA set forth in Subpart D of 45 C.F.R. Part 164.

C. “Data Aggregation” means, with respect to PHI created or received by Business Associate in its capacity as the “business associate” under HIPAA of Covered Entity, the combining of such PHI by Business Associate with the PHI received by Business Associate in its capacity as a business associate of one or more other “covered entity” under HIPAA, to permit data analyses that relate to the Health Care Operations (defined below) of the respective covered entities. The meaning of “data aggregation” in this BAA shall be consistent with the meaning given to that term in the Privacy Rule.

D. “Designated Record Set” has the meaning given to such term under the Privacy Rule, including 45 C.F.R. §164.501.

E. “De-Identify” means to alter the PHI such that the resulting information meets the requirements described in 45 C.F.R. §§164.514(a) and (b).

F. “Electronic PHI” means any PHI maintained in or transmitted by electronic media as defined in 45 C.F.R. §160.103.

G. “Health Care Operations” has the meaning given to that term in 45 C.F.R. §164.501.

H. “HHS” means the U.S. Department of Health and Human Services.

I. “HITECH Act” means the Health Information Technology for Economic and Clinical Health Act, enacted as part of the American Recovery and Reinvestment Act of 2009, Public Law 111-005.

J. “Individual” has the same meaning given to that term in 45 C.F.R. §§164.501 and 160.130 and includes a person who qualifies as a personal representative in accordance with 45 C.F.R. §164.502(g).

K. “Privacy Rule” means that portion of HIPAA set forth in 45 C.F.R. Part 160 and Part 164, Subparts A and E.

L. “Protected Health Information” or “PHI” has the meaning given to the term “protected health information” in 45 C.F.R. §§164.501 and 160.103, limited to the information created or received by Business Associate from or on behalf of Covered Entity.

M. “Security Incident” means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.

N. “Security Rule” means the Security Standards for the Protection of Electronic Health Information provided in 45 C.F.R. Part 160 and Part 164, Subparts A and C.

O. “Unsecured Protected Health Information” or “Unsecured PHI” means any “protected health information” as defined in 45 C.F.R. §§164.501 and 160.103 that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the HHS Secretary in the guidance issued pursuant to the HITECH Act and codified at 42 U.S.C. §17932(h).

2. Use and Disclosure of PHI

A. Except as otherwise provided in this BAA, Business Associate may use or disclose PHI as reasonably necessary to provide the services described in the Services Agreement to Covered Entity, and to undertake other activities of Business Associate permitted or required of Business Associate by this BAA or as required by law.

B. Except as otherwise limited by this BAA or federal or state law, Covered Entity authorizes Business Associate to use the PHI in its possession for the proper management and administration of Business Associate’s business and to carry out its legal responsibilities. Business Associate may disclose PHI for its proper management and administration, provided that (i) the disclosures are required by law; or (ii) Business Associate obtains, in writing, prior to making any disclosure to a third party (a) reasonable assurances from this third party that the PHI will be held confidential as provided under this BAA and used or further disclosed only as required by law or for the purpose for which it was disclosed to this third party, and (b) an agreement from this third party to notify Business Associate immediately of any breaches of the confidentiality of the PHI, to the extent it has knowledge of the breach.

C. Business Associate will not use or disclose PHI in a manner other than as provided in this BAA, as permitted under the Privacy Rule, or as required by law. Business Associate will use or disclose PHI, to the extent practicable, as a limited data set or limited to the minimum necessary amount of PHI to carry out the intended purpose of the use or disclosure, in accordance with Section 13405(b) of the HITECH Act (codified at 42 U.S.C. §17935(b)) and any of the act’s implementing regulations adopted by HHS, for each use or disclosure of PHI.

D. Upon request, Business Associate will make available to Covered Entity any of Covered Entity’s PHI that Business Associate or any of its agents or subcontractors have in their possession.

E. Business Associate may use PHI to report violations of law to appropriate Federal and State authorities, consistent with 45 C.F.R. §164.502(j)(1).

3. Safeguards Against Misuse of PHI

Business Associate will use appropriate safeguards to prevent the use or disclosure of PHI other than as provided by the Services Agreement or this BAA, and Business Associate agrees to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the Electronic PHI that it creates, receives, maintains, or transmits on behalf of Covered Entity. Business Associate agrees to take reasonable steps, including providing adequate training to its employees, to ensure compliance with this BAA and to ensure that the actions or omissions of its employees or agents do not cause Business Associate to breach the terms of this BAA.

4. Reporting Disclosures of PHI and Security Incidents

Business Associate will report to Covered Entity in writing any use or disclosure of PHI not provided for by this BAA of which it becomes aware, and Business Associate agrees to report to Covered Entity any Security Incident affecting Electronic PHI of Covered Entity of which it becomes aware. Business Associate agrees to report any such event within five (5) business days of becoming aware of the event.

5. Reporting Breaches of Unsecured PHI

Business Associate will notify Covered Entity in writing promptly upon the discovery of any Breach of Unsecured PHI in accordance with the requirements set forth in 45 C.F.R. §164.410, but in no case later than thirty (30) calendar days after discovery of a Breach.

6. Mitigation of Disclosures of PHI

Business Associate will take reasonable measures to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of any use or disclosure of PHI by Business Associate or its agents or subcontractors in violation of the requirements of this BAA.

7. Agreements with Agents or Subcontractors

Business Associate will ensure that any of its agents or subcontractors that have access to, or to which Business Associate provides, PHI agree in writing to the restrictions and conditions concerning uses and disclosures of PHI contained in this BAA and agree to implement reasonable and appropriate safeguards to protect any Electronic PHI that they create, receive, maintain, or transmit on behalf of Business Associate or, through Business Associate, Covered Entity. Upon written request from Covered Entity, Business Associate will provide Covered Entity with a current list of subcontractors and agents that receive PHI in connection with the Services Agreement. Business Associate shall ensure that all subcontracts and agreements provide the same level of privacy and security as this BAA.

8. Audit Report

Upon written request, Business Associate will provide Covered Entity with a copy of its most recent independent HIPAA compliance report, HITRUST certification, or other mutually agreed upon independent standards-based third-party audit report, to the extent Business Associate has obtained such a report. Covered Entity agrees not to re-disclose Business Associate’s audit report.

9. Access to PHI by Individuals

A. Upon request, Business Associate agrees to furnish Covered Entity with copies of the PHI maintained by Business Associate in a Designated Record Set in the time and manner designated by Covered Entity to enable Covered Entity to respond to an Individual’s request for access to PHI under 45 C.F.R. §164.524.

B. In the event any Individual or personal representative requests access to the Individual’s PHI directly from Business Associate, Business Associate, within ten (10) business days, will forward that request to Covered Entity. Any disclosure of, or decision not to disclose, the PHI requested by an Individual or a personal representative, and compliance with the requirements applicable to an Individual’s right to obtain access to PHI, shall be the sole responsibility of Covered Entity.

10. Amendment of PHI

A. Upon request and instruction from Covered Entity, Business Associate will amend PHI or a record about an Individual in a Designated Record Set that is maintained by, or otherwise within the possession of, Business Associate as directed by Covered Entity in accordance with procedures established by 45 C.F.R. §164.526. Any request by Covered Entity to amend such information will be completed by Business Associate within fifteen (15) business days of Covered Entity’s request.

B. In the event that any Individual requests that Business Associate amend such Individual’s PHI or record in a Designated Record Set, Business Associate, within ten (10) business days, will forward this request to Covered Entity. Any amendment of, or decision not to amend, the PHI or record as requested by an Individual, and compliance with the requirements applicable to an Individual’s right to request an amendment of PHI, will be the sole responsibility of Covered Entity.

11. Accounting of Disclosures

A. Business Associate will document any disclosures of PHI made by it to account for such disclosures as required by 45 C.F.R. §164.528(a). Business Associate also will make available information related to such disclosures as would be required for Covered Entity to respond to a request for an accounting of disclosures in accordance with 45 C.F.R. §164.528. At a minimum, Business Associate will furnish Covered Entity the following with respect to any covered disclosures by Business Associate: (i) the date of disclosure of PHI; (ii) the name of the entity or person who received PHI, and, if known, the address of such entity or person; (iii) a brief description of the PHI disclosed; and (iv) a brief statement of the purpose of the disclosure which includes the basis for such disclosure.

B. Business Associate will furnish to Covered Entity information collected in accordance with this Section 11, within ten (10) business days after written request by Covered Entity, to permit Covered Entity to make an accounting of disclosures as required by 45 C.F.R. §164.528, or in the event that Covered Entity elects to provide an Individual with a list of its business associates, Business Associate will provide an accounting of its disclosures of PHI upon request of the Individual, if and to the extent that such accounting is required under the HITECH Act or under HHS regulations adopted in connection with the HITECH Act.

C. In the event an Individual delivers the initial request for an accounting directly to Business Associate, Business Associate will, within ten (10) business days, forward such request to Covered Entity.

12. Responsibilities of Covered Entity

With regard to the use and/or disclosure of Protected Health Information by Business Associate, Covered Entity agrees to:

A. Notify Business Associate of any limitation(s) in its notice of privacy practices in accordance with 45 C.F.R. §164.520, to the extent that such limitation may affect Business Associate’s use or disclosure of PHI.

B. Notify Business Associate of any changes in, or revocation of, permission by an Individual to use or disclose Protected Health Information, to the extent that such changes may affect Business Associate’s use or disclosure of PHI.

C. Notify Business Associate of any restriction to the use or disclosure of PHI that Covered Entity has agreed to in accordance with 45 C.F.R. §164.522, to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.

D. Except for data aggregation or management and administrative activities of Business Associate, Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under HIPAA if done by Covered Entity.

13. Data Ownership

Business Associate’s data stewardship does not confer data ownership rights on Business Associate with respect to any data shared with it under the Services Agreement, including any and all forms thereof.

14. Term and Termination

A. This BAA will become effective on the Effective Date, and will continue in effect until all obligations of the Parties have been met under the Services Agreement and under this BAA.

B. Covered Entity may terminate this BAA, the Services Agreement, and any other related agreements if Covered Entity makes a determination that Business Associate has breached a material term of this BAA and Business Associate has failed to cure that material breach, to Covered Entity’s reasonable satisfaction, within thirty (30) days after written notice from Covered Entity. Covered Entity may report the problem to the Secretary of HHS if termination is not feasible.

C. If Business Associate determines that Covered Entity has breached a material term of this BAA, then Business Associate will provide Covered Entity with written notice of the existence of the breach and shall provide Covered Entity with thirty (30) days to cure the breach. Covered Entity’s failure to cure the breach within the thirty-day period will be grounds for termination of the Services Agreement and this BAA by Business Associate. Business Associate may report the breach to HHS.

D. Upon termination of the Services Agreement or this BAA for any reason, Business Associate will return to Covered Entity or destroy all PHI maintained by Business Associate, and Business Associate will not retain any copies of such information, except as provided below. Notwithstanding the foregoing, Business Associate may retain PHI (i) to the extent required by applicable law, or (ii) in routine backup systems or archives that Business Associate cannot reasonably purge on termination, provided in each case that such retained PHI remains subject to the protections of this BAA for as long as Business Associate retains it, and Business Associate will not make any further use or disclosure of such retained PHI except as required by law. This Section 14.D will apply to PHI in the possession of Business Associate’s agents and subcontractors. If return or destruction of PHI is not feasible for reasons other than those described above, Business Associate will furnish Covered Entity with written notification of the conditions that make return or destruction infeasible, and upon mutual agreement of the Parties that return or destruction is infeasible, Business Associate will extend the protections of this BAA to such information for as long as Business Associate retains it and will limit further uses and disclosures to those purposes that make the return or destruction not feasible. This Section 14.D will survive any termination of this BAA.

15. Effect of BAA

A. This BAA is a part of and subject to the terms of the Services Agreement, except that to the extent any terms of this BAA conflict with any term of the Services Agreement, the terms of this BAA will govern with respect to the subject matter of this BAA.

B. Except as expressly stated in this BAA or as provided by law, this BAA will not create any rights in favor of any third party.

16. Regulatory References

A reference in this BAA to a section in HIPAA means the section as in effect or as amended at the time.

17. Notices

All notices, requests, demands, or other communications to be given under this BAA to a Party will be made via either first class mail, registered or certified mail, express courier, or electronic mail to the Party’s address given below:

A. If to Covered Entity: the postal address (if any) and administrator email address associated with Covered Entity’s Xaia organization account.

B. If to Business Associate: VRx Health, Inc., Attn: Chief Executive Officer, 4123 Saint Clair Ave., Studio City, CA 91604; Email: support@xaia.health.

18. Amendments and Waiver

This BAA may not be modified, nor will any provision be waived or amended, except in a writing agreed to by both Parties, provided that Business Associate may amend this BAA as reasonably necessary to comply with changes in law or regulation by giving Covered Entity at least thirty (30) days’ prior written notice (including by email to the administrator address on file). If Covered Entity does not agree to such an amendment, Covered Entity may terminate the Services Agreement and this BAA by written notice before the amendment takes effect; Covered Entity’s continued use of the services after the effective date of the amendment constitutes acceptance of it. A waiver with respect to one event shall not be construed as continuing, or as a bar to or waiver of any right or remedy as to subsequent events.

19. HITECH Act Compliance

The Parties acknowledge that the HITECH Act includes significant changes to the Privacy Rule and the Security Rule. The privacy subtitle of the HITECH Act sets forth provisions that significantly change the requirements for business associates and the agreements between business associates and covered entities under HIPAA, and these changes may be further clarified in forthcoming regulations and guidance. Each Party agrees to comply with the applicable provisions of the HITECH Act and any HHS regulations issued with respect to the HITECH Act. The Parties also agree to negotiate in good faith to modify this BAA as reasonably necessary to comply with the HITECH Act and its regulations as they become effective, but in the event that the Parties are unable to reach agreement on such a modification, either Party will have the right to terminate this BAA upon thirty (30) days’ prior written notice to the other Party.

20. Electronic Acceptance

This BAA is accepted electronically. By checking the box presented during account creation (or otherwise indicating acceptance through the services), the individual accepting this BAA represents and warrants that he or she (i) is an authorized representative of Covered Entity with the legal authority to bind Covered Entity to this BAA, and (ii) accepts this BAA on Covered Entity’s behalf. The Parties agree that this electronic acceptance constitutes execution of this BAA and that this BAA is legally binding on both Parties as of the Effective Date. Business Associate maintains a record of each acceptance, including the version of this BAA accepted and the date and time of acceptance. IN WITNESS WHEREOF, the Parties have executed this Business Associate Agreement as of the Effective Date by electronic acceptance.