Business Associate Agreement

I. Definitions II. Use and Disclosure of PHI III. Safeguards Against Misuse of PHI IV. Reporting V. Mitigation of Disclosures of PHI 6. Confidential Information VII. Access to PHI by Individuals XI. Accounting of Disclosures X. Availability of Books and Records XI. Responsibilities of Covered Entity XII. Data Ownership XIII. Term and Termination XIV. Effect of BAA XV. Regulatory References XVI. Notices XVII. Amendments and Wavier XVIII. Miscellaneous

Business Associate Agreement (BAA)

This Business Associate Agreement (the "BAA") is incorporated into the Agreement entered into by and between Smilecloud (the “Business Associate”) and Customer (the “Covered Entity”), and its provisions become applicable to the Parties only upon Customers’ enabling HIPAA compliance via the Services (the “BAA Effective Date”). Capitalized terms not defined herein shall have the meanings assigned to such terms in the Contract or as defined under the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations, as may be updated from time to time (collectively, “HIPAA”).

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Applicability and Background

This BAA applies only to the extent that (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) and (ii) the Parties have entered into or will enter into one or more Agreements under which Business Associate provides or will provide certain specified Services to Covered Entity;
In providing services pursuant to the Agreement, Business Associate will have access to Protected Health Information;
By providing the Services pursuant to the Agreement, Business Associate will become a “business associate” of the Covered Entity as such term is defined under HIPAA;
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 CFR Part 160 and Part 164, Subparts A and E (collectively, the “Privacy Rule”); and
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 Agreement, HIPAA and other applicable laws.

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Agreement

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 Agreement in reliance on this BAA, the Parties agree as follows:

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I. 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.“Affiliate” means a subsidiary or affiliate of Covered Entity that is, or has been, considered a covered entity, as defined by HIPAA.

“Agreement(s)” means the written agreement(s) entered into between Covered Entity and Business Associate for provision of the Services.
“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 CFR §164.402.
“Breach Notification Rule” means the portion of HIPAA set forth in Subpart D of 45 CFR Part 164.
“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.
“Designated Record Set” has the meaning given to such term under the Privacy Rule, including 45 CFR §164.501.B.
“De-Identify” means to alter the PHI such that the resulting information meets the requirements described in 45 CFR §§164.514(a) and (b).
“Electronic PHI” means any PHI maintained in or transmitted by electronic media as defined in 45 CFR §160.103.
“Health Care Operations” has the meaning given to that term in 45 CFR §164.501.
“HHS” means the U.S. Department of Health and Human Services.
“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.
“Individual” has the same meaning given to that term i in 45 CFR §§164.501 and 160.130 and includes a person who qualifies as a personal representative in accordance with 45 CFR §164.502(g).
“Privacy Rule” means that portion of HIPAA set forth in 45 CFR Part 160 and Part 164, Subparts A and E.
“Protected Health Information” or “PHI” has the meaning given to the term “protected health information” in 45 CFR §§164.501 and 160.103, limited to the information created or received by Business Associate from or on behalf of Covered Entity.
“Security Incident” means the attempted or successful unauthorized access, use, disclosure, modification, or destruction of PHI or any interference with system operations in Business Associate’s systems or services that risks the confidentiality, integrity, or availability of PHI.
“Security Rule” means the Security Standards for the Protection of Electronic Health Information provided in 45 CFR Part 160 & Part 164, Subparts A and C.
“Services” means the Smilecloud Biometrics platform.
“Unsecured Protected Health Information” or “Unsecured PHI” means any “protected health information” as defined in 45 CFR §§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 USC §17932(h).

II. Use and Disclosure of PHI

Except as otherwise provided in this BAA, Business Associate may use or disclose PHI as reasonably necessary to provide the services described in the 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.
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.
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 USC §17935(b)) and any of the act’s implementing regulations adopted by HHS, for each use or disclosure of PHI.
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.
Business Associate may use PHI to report violations of law to appropriate Federal and State authorities, consistent with 45 CFR §164.502(j)(1).

III. 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 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.

IV. Reporting

General. Business Associate acknowledges that it neither knows nor can determine the specific contents or nature of the PHI processed via its Services. Covered Entity is solely responsible for understanding and ensuring the nature, requirements, and lawful uses of the PHI it introduces to the Services. Given this, Business Associate's obligations concerning PHI are limited to the general protections and processes outlined in the Agreement and this BAA, without regard to the exact type or nature of PHI involved. In any mandatory reporting, Business Associate will furnish details based on its overarching understanding of the data but without insights into the PHI specifics, such as the identity of individuals or a description of the type of information affected by a Breach.
Disclosures of PHI. Business Associate will report to Covered Entity any use or disclosure of PHI not provided for by this BAA of which it becomes aware.
Security Incidents. Business Associate will 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 promptly, but in no case later than 60 calendar days of becoming aware of the event. Notwithstanding the foregoing, 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. Unsuccessful Security Incidents shall include, but not be limited to, 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, or through any other mechanism so long as no such incident results in Unauthorized access, use or disclosure of PHI.
Breaches of Unsecured PHI. Business Associate will notify Covered Entity promptly upon the discovery of any Breach of Unsecured PHI in accordance with the requirements set forth in 45 CFR §164.410, but in no case later than 60 calendar days after discovery of a Breach.

V. 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.

VI. 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 restrictions and conditions concerning uses and disclosures of PHI which are no less restrictive than those 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 the Business Associate, Covered Entity.

VII. Access to PHI by Individuals

Upon request from Covered Entity for copies of the PHI maintained by Business Associate in a Designated Record Set, Business Associate agrees to make the PHI available to Covered Entity to enable Covered Entity to respond to an Individual’s request for access to PHI under 45 CFR §164.524.
In the event any Individual or personal representative requests access to the Individual’s PHI directly from Business Associate, Business Associate 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.

VIII. Amendment of PHI

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 CFR §164.526. Any request by Covered Entity to amend such information will be completed by Business Associate within a reasonable timeline as requested by Covered Entity.
In the event that any Individual requests that Business Associate amend such Individual’s PHI or record in a Designated Record Set, Business Associate 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.

XI. Accounting of Disclosures

Business Associate will document any disclosures of PHI made by it to account for such disclosures as required by 45 CFR §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 CFR §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.
Business Associate will furnish to Covered Entity information collected in accordance with this Section 10, within 30 days after written request by Covered Entity, to permit Covered Entity to make an accounting of disclosures as required by 45 CFR §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.
In the event an Individual delivers the initial request for an accounting directly to Business Associate, Business Associate will within ten business days forward such request to Covered Entity.

X. Availability of Books and Records

Business Associate will make available its internal practices, books, agreements, records, and policies and procedures relating to the use and disclosure of PHI, upon request, to the Secretary of HHS for purposes of determining Covered Entity’s and Business Associate’s compliance with HIPAA, and this BAA.

XI. Responsibilities of Covered Entity

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

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

XII. 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 Agreement, including any and all forms thereof.

XIII. Term and Termination

This BAA will become effective on the date first mentioned above, and will continue in effect until termination of the Agreement or until all obligations of the Parties have been met under the Agreement and under this BAA.
Covered Entity may terminate this BAA immediately 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 30 days after written notice from Covered Entity. Covered Entity may report the problem to the Secretary of HHS if termination is not feasible.
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 60 days to cure the breach. Covered Entity’s failure to cure the breach within the 30-day period will be grounds for immediate termination of the Agreement and this BAA by Business Associate. Business Associate may report the breach to HHS.
Upon termination of the Agreement or this BAA for any reason, all PHI maintained by Business Associate will be returned to Covered Entity or destroyed by Business Associate. Business Associate will not retain any copies of such information. This provision will apply to PHI in the possession of Business Associate’s agents and subcontractors. If return or destruction of the PHI is not feasible, in Business Associate’s reasonable judgment, Business Associate will furnish Covered Entity with notification, in writing, of the conditions that make return or destruction infeasible. Upon mutual agreement of the Parties that return or destruction of the PHI is infeasible, Business Associate will extend the protections of this BAA to such information for as long as Business Associate retains such information and will limit further uses and disclosures to those purposes that make the return or destruction of the information not feasible. The Parties understand that this Section XIII.4. will survive any termination of this BAA.

XIV. Effect of BAA

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

XV. Regulatory References

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

XVI. Notices

All notices, requests and demands or other communications to be given under this BAA to a Party will be made via either first class mail, registered or certified or express courier, or email to the Party’s address in accordance with the terms of the Agreement.

XVII. Amendments and Waiver

This BAA may not be modified, nor will any provision be waived or amended, except in writing duly signed by authorized representatives of the Parties. 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.
Amendment. Covered Entity and Business Associate agree to amend this BAA to the extent necessary to allow either Covered Entity or Business Associate to comply with HIPAA as amended by the Secretary of the Department of Health and Human Services or other related regulations or statutes. Business Associate may amend this BAA for minor edits (e.g., typos, grammatical edits and/or non-material edits) with or without notice to Covered Entity. The Parties shall mutually agree to any material edits to this BAA. In the event either of the Parties, acting reasonably, is unable to agree to new or modified terms as required to bring the BAA into compliance, either Party may terminate this BAA on thirty (30) days written notice to the other Party, or earlier if necessary to prevent non-compliance with a HIPAA requirement.

XVIII. Miscellaneous

Third-Party Services and Sharing. The Services offered by Business Associate allow for the transmission and sharing of data with other users and Third-Party Services (as outlined in the Agreement). These users and Third-Party Services might not always adhere to HIPAA standards. Should the Covered Entity decide to engage with these Third-Party Services or share data with these users, the Covered Entity assumes full responsibility for any information transfers, including any PHI, between the Business Associate’s Services and the third party. Third-Party Services are not involved in handling PHI on Smilecloud's behalf and do not act as business associates for Smilecloud. Smilecloud disclaims any responsibility for actions taken by such Third-Party Services, including any PHI exchanges, or any non-compliance by the Covered Entity to any relevant laws, regulations, or contract terms related to data sharing with these Third Party Services.
Device Configuration Requirements. The Covered Entity shall ensure that all devices used to access the Services are appropriately configured to uphold the security and confidentiality of information, consistent with the standards of this BAA and applicable legal and regulatory frameworks. This includes the implementation of mandatory security measures, such as encryption, access controls, and secure network connections. Specifically, devices must have a password-locked screensaver and startup screen, set to activate after a maximum of fifteen (15) minutes of system inactivity. Additionally, for mobile devices (like phones or tablets) utilizing mobile applications, notifications and/or notification content previews (depending on device capabilities) must be disabled. These stipulations represent minimum requirements. Failure to implement these measures will result in the Covered Entity assuming sole responsibility for any Breach arising from such non-compliance.
Governing Law. This BAA shall be governed by and construed in accordance with the laws governing the Agreement between the Parties, without regard to its conflict of laws provisions.

Last updated: 18.12.2023