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This Business Associate Agreement (“BAA”) is entered into by and between the Customer (the “Covered Entity”) and RhythmScience Inc. (the “Business Associate”), as of June 1, 2024 (hereinafter, the “Effective Date”) (collectively, the “Parties”).
WHEREAS, the Parties are contemplating entering into or have entered into one or more arrangements (“Underlying Services Agreement(s)”) pursuant to which Business Associate provides certain services to or on behalf of Covered Entity.
WHEREAS, Business Associate may receive, use and/or disclose Protected Health Information (as defined below) in order to fulfill its obligations under the Underlying Services Agreement;
WHEREAS, both Parties are committed to complying with the Privacy Regulations and the Security Regulations (as such terms are defined below) under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations and guidance issued by the Secretary (as defined below), all as amended from time to time (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act, as incorporated in the American Recovery and Reinvestment Act of 2009, and its implementing regulations and guidance issued by the Secretary, all as amended from time to time (“HITECH Act”) (hereinafter the “HIPAA Standards”); and
WHEREAS, this BAA sets forth the terms and conditions pursuant to which Protected Health Information that is provided, created or received by Business Associate from or on behalf of Covered Entity will be handled between Business Associate and Covered Entity, and with third parties, during the term of the Underlying Services Agreement and after its/their termination;
Capitalized terms used but not otherwise defined in this BAA shall have the same meaning as those terms in 45 CFR Part 160 and Part 164, including, but not limited to, sections 160.103, 164.103, 164.304, 164.402 and 164.501. In the event of an inconsistency between the provisions of this BAA and mandatory provisions of the HIPAA Standards, the HIPAA Standards in effect at the time shall control. Where provisions of this BAA are different than those mandated by the HIPAA Standards, but are nonetheless permitted by such regulations, the provisions of this BAA shall control. Any reference herein to the HIPAA Standards or other federal or state regulation shall be a reference to such rule or regulation as in effect or as subsequently updated, amended or modified:
a. Breach. “Breach” shall mean the acquisition, access, use, or disclosure of unsecured Protected Health Information in a manner not permitted under 45 CFR Part 164 Subpart E which compromises the security or privacy of the Protected Health Information.
b. Individual. "Individual" shall have the same meaning as the term "individual" in 45 CFR § 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 CFR §164.502(g).
c. 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.
d. Protected Health Information. "Protected Health Information" shall have the same meaning as the term "protected health information" in 45 CFR §160.103, but shall be limited to the information created or received by Business Associate from or on behalf of Covered Entity.
e. Required By Law. "Required By Law" shall have the same meaning as the term "required by law" in 45 CFR §164.103.
f. Secretary. "Secretary" shall mean the Secretary of the Department of Health and Human Services or his/her designee.
g. Security Incident. “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.
a. Business Associate agrees to not use or disclose Protected Health Information other than as permitted or required by this BAA or as Required by Law.
b. To the extent the Business Associate is to carry out, pursuant to the Underlying Services Agreement, a Covered Entity's obligation under this subpart, the Business Associate shall comply with the requirements of 45 CFR Part 164 Subpart E that apply to the Covered Entity in the performance of such obligation.
c. Business Associate agrees to use appropriate safeguards to prevent use or disclosure of the Protected Health Information other than as provided for by this BAA.
d. Business Associate agrees to implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of electronic Protected Health Information that it creates, receives, maintains, or transmits on behalf of the Covered Entity, in accordance with the requirements of 45 CFR Part 164 Subpart C, to the extent applicable to Business Associate.
e. Business Associate is hereby authorized to de-identify Protected Health Information in accordance with 45 CFR §164.514(a)-(c).
f. Business Associate agrees to mitigate, to the extent practicable, any harmful effect that is known to Business Associate of a use or disclosure of Protected Health Information by Business Associate in violation of the requirements of this BAA.
g. Business Associate agrees to report to Covered Entity any use or disclosure of the Protected Health Information not provided for by this BAA of which it becomes aware, or any Security Incident of which it becomes aware, including Breaches of unsecured Protected Health Information as required by 45 CFR §164.410.
h. Business Associate will take appropriate measures to ensure that any agents and subcontractors used by Business Associate to perform its obligations under the Underlying Services Agreement that require access to Protected Health Information on behalf of Business Associate are bound by written obligations that provide the same material level of protection for Protected Health Information as this BAA. To the extent Business Associate uses agents and subcontractors in its performance of obligations hereunder, Business Associate will remain responsible for their performance as if performed by Business Associate.
i. Business Associate agrees to provide reasonable access, at the request of Covered Entity, to Protected Health Information 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 CFR §164.524.
j. Business Associate agrees to make any amendment(s) to Protected Health Information in a Designated Record Set that the Covered Entity directs or agrees to pursuant to 45 CFR §164.526 at the request of Covered Entity or an Individual.
k. Business Associate agrees to make its internal practices, books, and records, including policies and procedures, relating to its use and disclosure of Protected Health Information received from, or created or received by Business Associate on behalf of Covered Entity available to the Secretary, in a time and manner designated by the Secretary, for purposes of the Secretary determining Covered Entity's compliance with 45 CFR Parts 160 and 164.
l. Business Associate agrees to document such disclosures of Protected Health Information 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 Protected Health Information in accordance with 45 CFR §164.528.
m. Business Associate agrees to reasonably provide to Covered Entity or an Individual information collected in accordance with Section 2(l) of this BAA, to permit Covered Entity to respond to a request by an Individual for an accounting of disclosures of Protected Health Information in accordance with 45 CFR §164.528.
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 Services Agreement, provided that such use or disclosure would not violate the Privacy Rule if done by Covered Entity or the minimum necessary policies and procedures of the Covered Entity.
a. Business Associate may use Protected Health Information for the proper management and administration of the Business Associate or to carry out the legal responsibilities of the Business Associate.
b. Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that disclosures are Required By Law, or Business Associate obtains reasonable 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 the Business Associate of any instances of which it is aware in which the confidentiality of the information has been breached.
c. Business Associate may use Protected Health Information to provide Data Aggregation services to Covered Entity as permitted by 45 CFR §164.504(e)(2)(i)(B).
d. Business Associate may use Protected Health Information to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR §164.502(j)(1).
a. Covered Entity shall notify Business Associate of any limitation(s) or changes in its notice of privacy practices of Covered Entity in accordance with 45 CFR §164.520, to the extent that such limitation may affect Business Associate's use or disclosure of Protected Health Information.
b. Covered Entity shall notify Business Associate of any changes in, or revocation of, permission by Individual to use or disclose Protected Health Information, to the extent that such changes or revocation may affect Business Associate's use or disclosure of Protected Health Information.
c. Covered Entity shall notify Business Associate of any restriction to the use or disclosure of Protected Health Information that Covered Entity has agreed to in accordance with 45 CFR §164.522, to the extent that such restriction may affect Business Associate's use or disclosure of Protected Health Information.
d. Covered Entity shall bear any incremental costs of Business Associate’s compliance with the any limitations, changes, revocations, or restrictions described in this Section 5 of this BAA.
e. Covered Entity shall obtain any consent, authorization, or permission that may be required by the HIPAA Standards or applicable state laws and regulations before disclosing to Business Associate the Protected Health Information pertaining to an Individual.
Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under the HIPAA Standards if done by Covered Entity except that this shall not preclude Business Associate from performing data aggregation services as defined at 45 CFR 164.501.
NOTWITHSTANDING ANYTHING ELSE TO THE CONTRARY CONTAINED IN THIS BAA OR THE UNDERLYING SERVICES AGREEMENT AND TO THE FULLEST EXTENT PERMITTED BY LAW, BUSINESS ASSOCIATE’S MAXIMUM AGGREGATE LIABILITY TO COVERED ENTITY FOR ANY AND ALL CLAIMS RELATED TO, OR IN CONNECTION WITH THIS BAA, WHETHER IN CONTRACT, TORT, OR OTHERWISE, SHALL NOT EXCEED BUSINESS ASSOCIATE’S CYBER LIABILITY POLICY THEN IN EFFECT AT THE TIME THE CLAIM ARISES AND SUCH LIMITATION SHALL APPLY FOR ALL CLAIMS IN THE AGGREGATE IN CONNECTION WITH THIS BAA.
a. Term. The Term of this BAA shall commence upon the Effective Date 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 Business Associate determines it is infeasible to return or destroy Protected Health Information, protections are extended to such information, in accordance with the termination provisions in this Section.
b. Covered Entity Termination for Cause. Upon Covered Entity's knowledge of a material breach by Business Associate, Covered Entity shall either:
1. Provide an opportunity for Business Associate to cure the breach or end the violation and terminate this BAA and the Underlying Services Agreement if Business Associate does not cure the breach or end the violation within thirty (30) days or such shorter or longer period of time as may be prescribed at law;
2. Immediately terminate this BAA and the Underlying Services Agreement if Business Associate has breached a material term of this BAA and cure is not possible; or
3. If neither termination nor cure is feasible, Covered Entity may report the violation to the Secretary.
c. Business Associate Termination for Cause. Business Associate may terminate this BAA on thirty (30) days written notice if Covered Entity agrees to restrictions that materially affect Business Associate’s ability to carry out its obligations, or materially increases the costs to carry out its obligations under this BAA.
d. Effect of Termination.
1. Except as provided in subparagraph (2) of this paragraph (d), upon termination of this BAA, for any reason, Business Associate shall, to the extent feasible, return or destroy all Protected Health Information received from Covered Entity, or created or received by Business Associate on behalf of Covered Entity, and Business Associate shall retain no copies of Protected Health Information, except that Business Associate may retain Protected Health Information for its own management and administration purposes, to carry out its legal responsibilities or included in data backups maintained in the ordinary course of business. This provision shall apply to Protected Health Information that is in the possession of subcontractors or agents of Business Associate.
2. In the event that Business Associate determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall extend the protections of this BAA 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.
a. Regulatory References. A reference in this BAA to a section in the HIPAA Standards means the section as in effect or as amended.
b. Amendment. The Parties agree to take such action as is necessary to amend this BAA from time to time as is necessary for Covered Entity to comply with the requirements of the HIPAA Standards.
c. Reporting of Security Incidents. Consistent with Section 2(g) of this BAA, the Parties acknowledge and agree that this section constitutes notice by Business Associate to Covered Entity of the ongoing existence and occurrence of attempted but Unsuccessful Security Incidents (as defined below) for which no additional notice to Covered Entity shall be required. “Unsuccessful Security Incidents” shall include pings and other broadcast attacks on Business Associate’s firewall, port scans, unsuccessful log-on attempts, denials of service and any combination of the above, so long as no such incident results in any defeat or circumvention of Business Associate’s IT security infrastructure or in any unauthorized access to, or use or disclosure of, Protected Health Information.
d. Survival. The respective rights and obligations of Business Associate under Section 8(d) of this BAA shall survive the termination of this BAA.
e. Interpretation. With respect to each Parties obligations under 45 CFR Parts 160 and 164, the provisions of this BAA shall prevail over any provisions in the Underlying Services Agreement or any related agreement between the Parties that may conflict or appear inconsistent. Any ambiguity in this BAA shall be resolved to facilitate the Parties’ compliance with their respective obligations under 45 CFR Parts 160 and 164.
