Business associate agreement

This Business Associate Agreement ("Agreement") is between the clinic that accepts it during sign-up ("Covered Entity") and [Org Data Solutions legal entity name] ("Business Associate"), and is part of the Terms of Service for Tracker for SPRAVATO® (the "Service"). It takes effect when Covered Entity accepts it, before any protected health information is entered into the Service.

1. Definitions

Terms used but not defined here — including breach, data aggregation, designated record set, disclosure, health care operations, individual, minimum necessary, notice of privacy practices, protected health information ("PHI"), required by law, Secretary, security incident, subcontractor, unsecured protected health information and use — have the meanings given in the HIPAA Rules (the Privacy, Security, Breach Notification and Enforcement Rules at 45 CFR Parts 160 and 164). PHI here means PHI that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity through the Service.

2. Obligations of Business Associate

Business Associate will:

1. not use or disclose PHI other than as permitted or required by this Agreement or as required by law;
2. use appropriate safeguards, and comply with Subpart C of 45 CFR Part 164 with respect to electronic PHI, to prevent use or disclosure of PHI other than as provided for by this Agreement;
3. report to Covered Entity any use or disclosure of PHI not provided for by this Agreement of which it becomes aware, including breaches of unsecured PHI as required by 45 CFR 164.410, and any security incident of which it becomes aware, without unreasonable delay and no later than [10 business days] after discovery. Unsuccessful attempts that do not result in unauthorized access, use or disclosure (such as pings, port scans or blocked sign-in attempts) are reported in aggregate on request and need no individual notice;
4. in accordance with 45 CFR 164.502(e)(1)(ii) and 164.308(b)(2), ensure that any subcontractor that creates, receives, maintains or transmits PHI on its behalf agrees in writing to the same restrictions, conditions and requirements that apply to Business Associate;
5. make PHI in a designated record set available to Covered Entity as necessary to satisfy Covered Entity's obligations under 45 CFR 164.524 — the Service lets Covered Entity's administrators view and export it directly;
6. make amendments to PHI in a designated record set as directed by Covered Entity under 45 CFR 164.526 — the Service lets Covered Entity's users make and record them directly;
7. maintain and make available the information required for Covered Entity to provide an accounting of disclosures under 45 CFR 164.528;
8. to the extent Business Associate carries out an obligation of Covered Entity under Subpart E of 45 CFR Part 164, comply with the requirements of Subpart E that apply to Covered Entity in performing that obligation; and
9. make its internal practices, books and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.

3. Permitted uses and disclosures

1. Business Associate may use and disclose PHI only as necessary to provide the Service to Covered Entity under the Terms of Service, including hosting, backing up, supporting and maintaining it, and exchanging information with the systems Covered Entity connects (for example its EMR or fax account) at Covered Entity's direction.
2. Business Associate will make uses, disclosures and requests for PHI consistent with Covered Entity's minimum-necessary policies and procedures.
3. Business Associate will not use or disclose PHI in a manner that would violate Subpart E of 45 CFR Part 164 if done by Covered Entity, except for the specific uses and disclosures in 3.4 and 3.5.
4. Business Associate may use PHI for its proper management and administration or to carry out its legal responsibilities.
5. Business Associate may disclose PHI for its proper management and administration or to carry out its legal responsibilities, provided the disclosure is required by law, or Business Associate obtains reasonable assurances from the recipient that the information will remain confidential, be used or further disclosed only as required by law or for the purposes for which it was disclosed, and that the recipient will notify Business Associate of any instance in which the confidentiality of the information has been breached.
6. Business Associate will not sell PHI, use it for marketing, or use it to train any artificial-intelligence model.

4. Obligations of Covered Entity

1. Covered Entity will notify Business Associate of any limitation in its notice of privacy practices, any change in or revocation of an individual's permission, and any restriction on use or disclosure it has agreed to, to the extent it may affect Business Associate's use or disclosure of PHI.
2. Covered Entity will not ask Business Associate to use or disclose PHI in any manner that would not be permissible under Subpart E of 45 CFR Part 164 if done by Covered Entity.
3. Covered Entity is responsible for the users it admits to the Service, the roles and programs it grants them, and the systems it connects.

5. Term and termination

1. This Agreement lasts as long as Business Associate maintains PHI for Covered Entity, including any read-only period after the subscription ends.
2. Covered Entity may terminate this Agreement and the Terms of Service if it determines that Business Associate has violated a material term of this Agreement and Business Associate has not cured the violation within [30] days of written notice.
3. On termination, Business Associate will, at Covered Entity's written direction, return (by making the full export available) and then destroy all PHI it still maintains in any form, keeping no copies — except copies held in backups, which remain protected by this Agreement until they expire under the backup schedule of [35] days. Where return or destruction is infeasible, Business Associate will extend the protections of this Agreement to that PHI and limit further uses and disclosures to the purposes that make return or destruction infeasible.
4. Business Associate's obligations under this section survive termination.

6. Miscellaneous

1. A reference to a section of the HIPAA Rules means the section as in effect or as amended.
2. The parties will amend this Agreement as necessary for compliance with the HIPAA Rules and other applicable law.
3. Any ambiguity in this Agreement will be resolved to permit compliance with the HIPAA Rules.
4. If this Agreement conflicts with the Terms of Service, this Agreement controls as to PHI.
5. Notices to Business Associate go to support@orgdatasolutions.com [and postal address]; notices to Covered Entity go to the administrator e-mail on its account.

Acceptance during sign-up is recorded with the name and title of the person accepting, the date and time, their network address and this version (2026-10-31-draft), and has the same effect as a signature.