Business Associate Agreement
This Business Associate Agreement, including the Proposal which by this reference is incorporated herein (the “Agreement”) is made by and among VoxNeuro Inc. (“VoxNeuro Canada”), VoxNeuro USA Inc. (“VoxNeuro-US”) (VoxNeuro-Canada and VoxNeuro-US are, together, “Business Associate”), and the Covered Entity (as defined below). Covered Entity and Business Associate shall collectively be known herein as the “Parties”.
BY ACCEPTING THIS AGREEMENT THROUGH (1) CHECKING A BOX INDICATING ACCEPTANCE, OR (2) EXECUTING A PROPOSAL THAT REFERENCES THIS AGREEMENT, COVERED ENTITY AGREES TO BE BOUND BY AND COMPLY WITH THE TERMS OF THIS AGREEMENT. IF THE INDIVIDUAL ACCEPTING THIS AGREEMENT IS ACCEPTING ON BEHALF OF A COMPANY OR OTHER LEGAL ENTITY, SUCH INDIVIDUAL REPRESENTS THAT THEY HAVE THE AUTHORITY TO BIND SUCH ENTITY AND ITS AFFILIATES TO THESE TERMS AND CONDITIONS, IN WHICH CASE THE TERM “COVERED ENTITY” SHALL REFER TO SUCH ENTITY AND ITS AFFILIATES. IF THE INDIVIDUAL ACCEPTING THIS AGREEMENT DOES NOT HAVE SUCH AUTHORITY, OR DOES NOT AGREE WITH THESE TERMS AND CONDITIONS, SUCH INDIVIDUAL MUST NOT ACCEPT THIS AGREEMENT.
This Agreement was last updated on April 3, 2023. It is effective between the Parties as of the date of Covered Entity’s accepting this Agreement.
WHEREAS, Covered Entity wishes to commence a business relationship with VoxNeuro-US that shall be memorialized in a separate agreement (the “Underlying Agreement”) pursuant to which Business Associate may be considered a “business associate” of Covered Entity as defined in HIPAA (as defined below) as amended by HITECH Act (as defined below); and
WHEREAS, the nature of the prospective contractual relationship between Covered Entity and Business Associate may involve the exchange of Protected Health Information (as defined below); and
WHEREAS, for good and lawful consideration as set forth in the Underlying Agreement, Covered Entity and Business Associate enter into this Agreement for the purpose of ensuring compliance with the requirements of HIPAA, its implementing regulations, and the HITECH Act;
NOW, THEREFORE, the premises having been considered and with acknowledgment of the mutual promises and of other good and valuable consideration herein contained, the Parties, intending to be legally bound, hereby agree as follows:
I. DEFINITIONS. Capitalized terms used, but not otherwise defined, in this Agreement shall have the same meaning as those terms in the Privacy Rule (as defined below), the Security Rule (as defined below), and the Breach Rules (as defined below). The following capitalized terms shall have the following meaning when used in this Agreement:
A. Breach. “Breach” shall have the same meaning as the term “breach” in §13400 of the HITECH Act and shall include the unauthorized acquisition, access, use, or disclosure of PHI that compromises the security or privacy of such information.
B. Breach Rules. “Breach Rules” shall mean the breach of notification rules at 45 CFR Part 164, subpart D as they may be amended from time to time.
C. Covered Entity. “Covered Entity” shall mean in the case of an individual accepting this Agreement on his or her own behalf, such individual, or in the case of an individual accepting this Agreement on behalf of a company or other legal entity, the company or other legal entity for which such individual is accepting this Agreement, and affiliates of that company or entity (for so long as they remain affiliates) which have entered into the Proposal.
D. Designated Record Set. “Designated Record Set” shall have the same meaning as the term “designated record set” in 45 CFR §164.501.
E. HITECH ACT. “HITECH ACT” shall mean the “Health Information Technology for Economic and Clinical Health Act” set forth within P.L. 111-5, and all relevant regulations promulgated thereunder, as amended from time to time.
F. Individual. “Individual” shall have the same meaning as the term “individual” in 45 CFR §164.501 and shall include a person who qualifies as a personal representative in accordance with 45 CFR §164.502(g).
G. Privacy Rule. “Privacy Rule” shall mean the Standards for Privacy of Individually Identifiable Health Information at 45 CFR Part 160 and Part 164, Subparts A and E, as amended by the HITECH Act and as may otherwise be amended from time to time.
H. Proposal. “Proposal” shall mean the VoxNeuro CORE agreement filled out and submitted by or on behalf of VoxNeuro-US, and accepted by Covered Entity, for Covered Entity’s engagement of VoxNeuro-US’ services under the Underlying Agreement, including any addenda and supplements thereto.
I. Protected Health Information. “Protected Health Information” or “PHI” shall have the same meaning as the term “protected health information” in 45 CFR §164.501, limited to the information accessed, created, transmitted, or received by Business Associate from or on behalf of Covered Entity.
J. Required By Law. “Required By Law” shall have the same meaning as the term “required by law” in 45 CFR §164.501.
K. Secretary. “Secretary” shall mean the Secretary of the U.S. Department of Health and Human Services or his or her designee.
L. Security Rule. “Security Rule” shall mean the Security Standards for the Protection of Electronic Protected Health Information that is codified at CFR Part 160 and Subparts A and C of Part 164.
M. Unsecured Protected Health Information. “Unsecured Protected Health Information” or “Unsecured PHI” shall mean PHI that is not secured through the use of a technology or methodology specified by the Secretary in guidance or as otherwise defined in the §13402(h) of the HITECH Act.
II. PERMITTED USE OR DISCLOSURE OF PHI BY BUSINESS ASSOCIATE.
A. Except as otherwise limited in this Agreement, Business Associate may use or disclose Protected Health Information to perform functions, activities, or services for, or on behalf of, Covered Entity as specified in the Underlying Agreement, provided that such use or disclosure is permissible under applicable law.
B. Business Associate shall only use and disclose PHI if such use or disclosure complies with each applicable requirement of 45 CFR §164.504(e), including limiting its use and disclosure of PHI to only the minimum necessary PHI required by Business Associate to furnish services on behalf of Provider.
III. DUTIES OF BUSINESS ASSOCIATE RELATIVE TO PHI.
A. Business Associate agrees to comply with those provisions of the Security Rule that are set forth at 45 CFR §§ 164.308, 164.310, 164.312, and 164.316, as amended from time to time, with respect to the security of PHI in the same manner that such regulations apply to the Covered Entity.
B. Business Associate agrees to comply with the Privacy Rule at 45 CFR §164.504(e), as amended from time to time, with respect to its use and disclosure of PHI. The additional requirements of the HITECH Act that relate to privacy and that are made applicable with respect to covered entities shall also be applicable to Business Associate and shall be and by this reference hereby are incorporated into this Agreement.
C. Business Associate shall not use or disclose PHI other than as permitted or required by this Agreement or as Required By Law.
D. Business Associate shall 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.
E. Business Associate shall immediately notify Covered Entity of any use or disclosure of PHI in violation of this Agreement.
F. Business Associate shall promptly notify Covered Entity of a Breach of Unsecured PHI or any Security Incident within ten (10) business days after Business Associate (or Business Associate’s employee, officer or agent) knows of such Breach or within ten (10) business days after Business Associate (or Business Associate’s employee, officer or agent) should have known of such Breach. Business Associate’s notification to Covered Entity hereunder shall:
1. Include the individuals whose Unsecured PHI has been, or is reasonably believed to have been, the subject of a Breach; and
2. Be in substantially the same form as Exhibit A1 hereto.
G. In the event of an unauthorized use or disclosure of PHI or a Breach of Unsecured PHI, Business Associate shall mitigate, to the extent practicable, any harmful effects of said disclosure that are known to it.
H. Business Associate agrees to use commercially reasonable efforts to cause any agent, including a subcontractor, to whom it provides Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity to agree to the same restrictions and conditions that apply through this Agreement to Business Associate with respect to such information.
I. To the extent applicable, Business Associate shall provide access to Protected Health Information in a Designated Record Set at reasonable times, at the request of Covered Entity or, as directed by Covered Entity, to an Individual in order to meet the requirements under 45 CFR §164.524.
J. To the extent applicable, Business Associate shall make any amendment(s) to Protected Health Information in a Designated Record Set that Covered Entity directs or agrees to pursuant to 45 CFR §164.526 at the request of Covered Entity or an Individual.
K. 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.
L. Business Associate agrees to document such disclosures of PHI and information related to such disclosures as would be required for a 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. Should an individual make a request to Covered Entity for an accounting of disclosures of his or her PHI pursuant to 45 C.F.R. §164.528, Business Associate agrees to promptly provide Covered Entity with information in a format and manner sufficient to respond to the individual’s request.
M. Business Associate shall, upon request with reasonable notice, provide Covered Entity with an accounting of uses and disclosures of PHI provided to it by Covered Entity.
N. Business Associate agrees to document such disclosures of PHI and information related to such disclosures as would be required by Covered Entity to respond to a request by Individual for an accounting of PHI in accordance with 45 CFR 164.528, as may be amended from time to time.
O. Business Associate shall make its internal practices, books, records, and any other material requested by the Secretary relating to the use, disclosure, and safeguarding of PHI received from Covered Entity available to the Secretary for the purpose of determining compliance with the Privacy Rule. The aforementioned information shall be made available to the Secretary in the manner and place as designated by the Secretary or the Secretary’s duly appointed delegate. Under this Agreement, Business Associate shall comply and cooperate with any request for documents or other information from the Secretary directed to Covered Entity that seeks documents or other information held by Business Associate.
P. Business Associate may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 42 C.F.R. §164.502(j)(1).
Q. Upon written request of Covered Entity, Business Associate will comply with an Individual request for restriction of certain disclosures to health plans in accordance with 45 CFR 164.522 and the HITECH Act, if the disclosure is to a health care plan for the purposes of carrying out payment or health care operations and the PHI pertains solely to a health care item or service for which the Individual has paid out of pocket in full.
IV. TERM AND TERMINATION.
A. Term. The term of this Agreement shall be effective as of the date the Underlying Agreement is effective, 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, or, if it is infeasible to return or destroy PHI, protections are extended to such information, in accordance with the termination provisions in this Section IV. This Agreement shall terminate as to VoxNeuro-Canada when all of the Protected Health Information provided by Covered Entity to VoxNeuro-Canada, or created or received by VoxNeuro-Canada 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 the termination provisions in this Section IV.
B. Termination for Cause. Upon Covered Entity’s knowledge of a material breach by Business Associate, Covered Entity shall:
1. Provide an opportunity for Business Associate to cure the breach or end the violation and, if Business Associate does not cure the breach or end the violation within a reasonable time specified by Covered Entity, terminate this Agreement;
2. Immediately terminate this Agreement if Business Associate has breached a material term of this Agreement and cure is not possible; or
3. If neither termination nor cure is feasible, report the violation to the Secretary.
C. Effect of Termination.
1. Except as provided in Section IV.C(2), upon termination of this Agreement, for any reason, Business Associate shall return or destroy all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate. Business Associate shall not retain any copies of the PHI.
2. In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall provide to Covered Entity written notification of the conditions that make return or destruction infeasible. After written notification that return or destruction of PHI is infeasible, Business Associate shall extend the protections of this Agreement to such Protected Health Information and limit further uses and disclosures of such Protected Health Information to those purposes that make the return or destruction infeasible, for so long as Business Associate maintains such Protected Health Information.
3. Should Business Associate make a disclosure of PHI in violation of this Agreement, Covered Entity shall have the right to immediately terminate any contract, other than this Agreement, then in force between the Parties, including the Underlying Agreement.
V. CONSIDERATION. Business Associate recognizes that the promises it has made in this Agreement shall, henceforth, be detrimentally relied upon by Covered Entity in choosing to continue or commence a business relationship with Business Associate.
VI. REMEDIES IN EVENT OF BREACH. Business Associate hereby recognizes that irreparable harm will result to Covered Entity, and to the business of Covered Entity, in the event of breach by Business Associate of any of the covenants and assurances contained in this Agreement. As such, in the event of breach of any of the covenants and assurances contained in Sections II or III above, Covered Entity shall be entitled to enjoin and restrain Business Associate from any continued violation of Sections II or III.
VII. MODIFICATION. This Agreement may only be modified through a writing signed by the Parties and, thus, no oral modification hereof shall be permitted. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for Covered Entity to comply with the requirements of the Privacy Rule and HIPAA.
VIII. INTERPRETATION OF THIS CONTRACT IN RELATION TO OTHER CONTRACTS BETWEEN THE PARTIES. Should there be any conflict between the language of this Agreement and any other contract entered into between the Parties (either previous or subsequent to the date of this Agreement), the language and provisions of this Agreement shall control and prevail unless the Parties specifically refer in a subsequent written agreement to this Agreement by its title and date and specifically state that the provisions of the later written agreement shall control over this Agreement.
IX. MISCELLANEOUS.
A. Ambiguity. Any ambiguity in this Agreement shall be resolved to permit Covered Entity to comply with HIPAA, Security Standards, the Privacy Rule, and the HITECH Act.
B. Regulatory References. A reference in this Agreement to a section in the Privacy Rule means the section as in effect or as amended.
C. Notice to Covered Entity. Any notice required under this Agreement to be given Covered Entity shall be made in writing to the address specified in the Proposal.
D. Notice to Business Associate. Any notice required under this Agreement to be given Business Associate shall be made in writing to:
| Address: | One Broadway, 14th Floor Kendall Square Cambridge, MA 02142 |
| Attention: | Jason Flowerday, Chief Executive Officer |
| E-mail: | [email protected] |
E. This Agreement replaces and supersedes any previous agreement with respect to the subject matter hereof.
Exhibit A1
Form of Notification to Covered Entity of
Breach of Unsecured PHI
This notification is made pursuant to Section IIIF(2) of the Business Associate Agreement among:
● Client Name __________________________________________________________________ (Covered Entity)
● VoxNeuro Inc. / VoxNeuro USA Inc. _____________________________________________ (“Business Associate”).
Business Associate hereby notifies Covered Entity that there has been a breach of unsecured (unencrypted) protected health information (PHI) that Business Associate has used or has had access to under the terms of the Business Associate Agreement.
Description of the breach: ____________________________________________________________________________
Date of the breach: __________________________________________________________________________________
Date of the discovery of the breach: ___________________________________________________________________
Number of individuals affected by the breach: __________________________________________________________
The types of unsecured PHI that were involved in the breach (such as full name, Social Security number, date of birth, home address, account number, or disability code): _________________________________________________
Description of what Business Associate is doing to investigate the breach, to mitigate losses, and to protect against any further breaches: ________________________________________________________________________
Contact information to ask questions or learn additional information:
Name: __________________________________________________________________________________
Title: ___________________________________________________________________________________
Address: _______________________________________________________________________________
Email Address: __________________________________________________________________________
Phone Number: __________________________________________________________________________