HIPAA Business Associate Agreement

This Business Associate Agreement ("BA Agreement") is between the Customer identified in the Needletail Service Contract ("Covered Entity") and Needletail, Inc. ("Business Associate"). This BA Agreement is incorporated into and forms a part of the Needletail Service Contract upon execution of such Service Contract.

WHEREAS, Business Associate and Covered Entity have entered into, or are concurrently entering into, a Services Agreement (defined below). In connection with Business Associate's services, Business Associate and Covered Entity anticipate that Business Associate will create or receive Protected Health Information from and/or on behalf of Covered Entity, which information is subject to protection under the Federal Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, as amended by the Health Information Technology for Economic and Clinical Health Act, Title XIII of the American Recovery and Reinvestment Act of 2009 (the "HITECH Act"), and related regulations promulgated by the Secretary (together "HIPAA").

WHEREAS, in light of the foregoing and the requirements of HIPAA, Business Associate and Covered Entity agree to be bound by the following terms and conditions.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

1. Definitions

1.1 Capitalized terms used, but not otherwise defined, in this BA Agreement shall have the same meaning given to those terms (i) by HIPAA as in effect or as amended from time to time, or (ii) if (i) is not applicable, by the Services Agreement.

1.2 "Services Agreement" shall mean the Needletail Service Contract executed between Covered Entity and Business Associate, including the Terms of Service, and any present or future agreements between Covered Entity and Business Associate under which Business Associate provides services to Covered Entity which involve the use or disclosure of Protected Health Information.

2. Obligations and Activities of Business Associate

2.1 Use and Disclosure

If Protected Health Information is created by or disclosed to Business Associate, Business Associate agrees not to use or disclose Protected Health Information other than as permitted or required by the Services Agreement, this BA Agreement or as Required by Law. Business Associate shall comply with the provisions of this BA Agreement relating to privacy and security of Protected Health Information and all present and future provisions of HIPAA that relate to the privacy and security of Protected Health Information and that are applicable to "business associates," as that term is defined in HIPAA.

2.2 Appropriate Safeguards and Reporting

Business Associate agrees to use appropriate safeguards to prevent the use or disclosure of the Protected Health Information other than as provided for by this BA Agreement. Without limiting the generality of the foregoing sentence, Business Associate will:

• (a) Implement administrative, organizational, 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 as required by the Security Rule;
• (b) Report to Covered Entity any Security Incident involving Electronic Protected Health Information of which Business Associate becomes aware. Any actual, successful Security Incident will be reported to Covered Entity in writing without unreasonable delay. The parties acknowledge that unsuccessful Security Incidents (including, without limitation, 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 unauthorized access, use, or disclosure of Protected Health Information) occur in the ordinary course of operation and are deemed reported by this clause; such unsuccessful Security Incidents shall not require individual reporting, except that Business Associate shall provide aggregate reporting upon Covered Entity's reasonable written request.
• (c) Notify Covered Entity following the discovery of a Breach of Unsecured Protected Health Information in accordance with 45 C.F.R. § 164.410 without unreasonable delay and in no case later than thirty (30) calendar days (or within any shorter deadline imposed by applicable State law) after discovery of the Breach. A Breach is considered "discovered" as of the first day on which the Breach is known, or reasonably should have been known, to Business Associate or any employee, officer or agent of Business Associate, other than the individual committing the Breach. Any notice of a Security Incident or Breach of Unsecured Protected Health Information shall include the identification of each Individual whose Protected Health Information has been, or is reasonably believed by Business Associate to have been, accessed, acquired, or disclosed during such Security Incident or Breach, in each case to the extent then known to Business Associate, together with any other relevant information regarding the Security Incident or Breach. Business Associate shall promptly supplement such notice as additional information becomes available through ongoing investigation.

2.3 Minimum Necessary Standard

To the extent required by the "minimum necessary" requirements of HIPAA, Business Associate shall only request, use and disclose the minimum amount of Protected Health Information necessary to accomplish the purpose of the request, use or disclosure. Where Covered Entity operates multiple locations or Affiliated Entities, Business Associate will configure workforce access and credential scope at the level of granularity directed by Covered Entity (per-location, per-region, or organization-wide). The elected configuration shall be documented in the Services Agreement or an order form thereto. In the absence of an express written election by Covered Entity, the default configuration shall be per-location.

2.4 Mitigation

Business Associate agrees to take reasonable steps 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 BA Agreement (including, without limitation, any Security Incident or Breach of Unsecured Protected Health Information). Business Associate agrees to reasonably cooperate and coordinate with Covered Entity in the investigation of any violation of the requirements of this BA Agreement and/or any Security Incident or Breach. Business Associate shall also reasonably cooperate and coordinate with Covered Entity in the preparation of any reports or notices required to be made under HIPAA or any other Federal or State laws, rules or regulations, to any Individual (entitled to notice in connection with a Breach), regulatory body, or any third party, provided that any such reports or notices shall be subject to the prior written approval of Covered Entity. Notwithstanding the foregoing, if (i) Covered Entity does not provide approval of, or written direction regarding, any such report or notice within five (5) business days following Business Associate's written request for such approval, or (ii) Covered Entity directs Business Associate not to make any report or notice that Business Associate reasonably and in good faith determines is required by HIPAA or other applicable law, Business Associate may proceed to make such report or notice as required by law; Business Associate shall promptly inform Covered Entity of the content and recipients of any report or notice so made.

2.5 Subcontractors

Business Associate shall enter into a written agreement meeting the requirements of 45 C.F.R. §§ 164.504(e) and 164.314(a)(2) with each Subcontractor (including, without limitation, a Subcontractor that is an agent under applicable law) that creates, receives, maintains or transmits Protected Health Information on behalf of Business Associate. Business Associate shall ensure that the written agreement with each Subcontractor obligates the Subcontractor to comply with restrictions and conditions that are at least as restrictive as the restrictions and conditions that apply to Business Associate through this BA Agreement.

2.6 Access to Designated Record Sets

To the extent that Business Associate maintains Protected Health Information in a Designated Record Set, Business Associate agrees to provide access, at the request of Covered Entity, and in the time and manner designated by the Covered Entity, to Protected Health Information in a Designated Record Set created or received by Business Associate solely on behalf of Covered Entity only, to Covered Entity or, as directed by Covered Entity, to an Individual in order to meet the requirements under HIPAA Regulations. If an Individual makes a request for access to Protected Health Information directly to Business Associate, Business Associate shall notify Covered Entity of the request within ten (10) business days of such request. Covered Entity shall have the sole responsibility to make decisions regarding whether to approve a request for access to Protected Health Information.

2.7 Amendments to Designated Record Sets

To the extent that Business Associate maintains Protected Health Information in a Designated Record Set, within thirty (30) days of a receipt of a request from Covered Entity for the amendment of an Individual's Protected Health Information contained in such Designated Record Set, Business Associate agrees to provide such Protected Health Information to Covered Entity for amendment and to incorporate any such amendment(s) to Protected Health Information in the Designated Record Set maintained by the Business Associate pursuant to HIPAA Regulations and in the time and manner designated by the Covered Entity. If an Individual makes a request for an amendment to Protected Health Information directly to Business Associate, Business Associate shall notify Covered Entity of the request within ten (10) business days of such request. Covered Entity will have the sole responsibility to make decisions regarding whether to approve a request for amendment to Protected Health Information.

2.8 Access to Books and Records

Business Associate agrees to make its internal practices, books, and records relating to the 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 for purposes of the Secretary determining Covered Entity's and Business Associate's compliance with the Privacy Rule.

2.9 Credentials and Authentication Materials

Where Covered Entity provides Business Associate with credentials, tokens, or other authentication materials for access to third-party systems (including insurance portals, practice management systems, and clearinghouses) ("Access Credentials"), Business Associate shall:

• (a) Store all Access Credentials in encrypted form within an access-controlled credential management system;
• (b) Restrict access to Access Credentials to workforce members and subcontractors performing Services under the Services Agreement on a need-to-know basis;
• (c) Employ multi-factor authentication consistent with then-current industry standards where supported and enabled by the third-party system;
• (d) Use each Access Credential only to access Protected Health Information for the location, practice, or Affiliated Entity to which the credential pertains, except as expressly elected by Covered Entity under Section 4.5; and
• (e) Notify Covered Entity without unreasonable delay if Access Credentials are believed to be compromised.

2.10 Audit Logs and Activity Monitoring

Consistent with 45 C.F.R. § 164.312(b), Business Associate shall maintain audit logs sufficient to enable identification of (a) the workforce member, subcontractor, or automated system accessing Protected Health Information, (b) the date and time of such access, and (c) the action taken with respect to such Protected Health Information. Business Associate shall retain such audit logs for a period of not less than six (6) years from the date of creation, and shall make relevant audit logs available to Covered Entity upon reasonable written request in connection with a Security Incident, Breach investigation, regulatory inquiry, or audit by the Secretary.

3. Permitted Uses and Disclosures by Business Associate

3.1 Services Agreement

Except as otherwise limited in this BA 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 Services Agreement, provided that such use or disclosure would not violate HIPAA if done by Covered Entity or the minimum necessary policies and procedures of the Covered Entity.

3.2 Use for Administration of Business Associate

Except as otherwise limited in this BA Agreement, 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. Covered Entity acknowledges and agrees that proper management and administration of Business Associate includes, without limitation, modifications or upgrades to its software or services, and development of new features or functionality thereof, or new related product or services.

3.3 Disclosure for Administration of Business Associate

Except as otherwise limited in this BA Agreement, Business Associate may disclose Protected Health Information for the proper management and administration of the Business Associate, provided that (i) disclosures are Required by Law, or (ii) Business Associate obtains reasonable assurances from the third party to whom the information is disclosed that the third party will (a) protect the confidentiality of the Protected Health Information, and (b) use or further disclose the Protected Health Information only as Required by Law or for the purpose for which it was disclosed to the third party.

3.4 Data Aggregation

Business Associate may use Protected Health Information to provide Data Aggregation services relating to the Health Care Operations of Covered Entity.

3.5 De-Identified Information

Business Associate may use Protected Health Information to create de-identified health information in accordance with the HIPAA de-identification requirements. Business Associate may use or disclose de-identified health information for any purpose permitted by law.

3.6 Model Training and Improvement

Business Associate may use Protected Health Information to train, evaluate, validate, and improve machine learning models, algorithms, and other artificial intelligence systems that support the Services provided to Covered Entity, and to develop new features or functionality of the Services. Any such use shall constitute proper management and administration of Business Associate under Section 3.2. Where Business Associate trains or improves models that are intended to be used to provide services to parties other than Covered Entity, such training shall be performed only on de-identified health information created in accordance with Section 3.5. Business Associate shall not sell, license, or otherwise disclose Protected Health Information for the purpose of training third-party models.

4. Obligations of the Covered Entity

4.1 Permissible Requests by Covered Entity

Except as set forth in Section 3 of this BA Agreement, Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under the Privacy Rule if done by Covered Entity.

4.2 Minimum Necessary PHI

When Covered Entity discloses Protected Health Information to Business Associate, Covered Entity shall provide the minimum amount of Protected Health Information necessary for the accomplishment of Business Associate's purpose.

4.3 Permissions; Restrictions

Covered Entity warrants that it has obtained and will obtain any consents, authorizations and/or other legal permissions required under HIPAA and other applicable law for the disclosure of Protected Health Information to Business Associate. Covered Entity shall notify Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her Protected Health Information, to the extent that such changes may affect Business Associate's use or disclosure of Protected Health Information. Covered Entity shall not agree to any restriction on the use or disclosure of Protected Health Information under 45 C.F.R. § 164.522 that restricts Business Associate's use or disclosure of Protected Health Information under this BA Agreement unless Business Associate grants its written consent; provided, however, that this sentence shall not apply to restrictions that Covered Entity is required by HIPAA to honor (including, without limitation, restrictions on disclosures to a health plan for services paid out-of-pocket in full under 45 C.F.R. § 164.522(a)(1)(vi)), and Covered Entity shall promptly notify Business Associate of any such mandatory restriction that affects Business Associate's use or disclosure of Protected Health Information.

4.4 Notice of Privacy Practices

Except as required under HIPAA or other applicable law, with Business Associate's consent or as set forth in the Services Agreement, Covered Entity shall not include any limitation in the Covered Entity's notice of privacy practices that limits Business Associate's use or disclosure of Protected Health Information under this BA Agreement.

4.5 Affiliated Entities

If the Covered Entity includes one or more affiliates, subsidiaries, or other related legal entities ("Affiliated Entities," meaning any entity that directly or indirectly controls, is controlled by, or is under common control with Covered Entity, where "control" means ownership of more than fifty percent (50%) of the voting securities or equivalent ownership interests; for the avoidance of doubt, internal divisions or business units of Covered Entity that are not separate legal entities are treated as part of Covered Entity itself and not as Affiliated Entities), all such Affiliated Entities represented by the Covered Entity shall be deemed to have access to the Protected Health Information shared with the Business Associate. The Covered Entity represents and warrants that it has obtained all necessary consents and authorizations from each such Affiliated Entity for such access and sharing, and that reciprocal Protected Health Information access and sharing among them is permitted. Covered Entity further represents and warrants that it has full power and authority to bind each Affiliated Entity to these terms and to grant the rights granted to the Business Associate under this BA Agreement. Covered Entity shall defend, indemnify, and hold harmless the Business Associate from and against any loss, cost, liability, damage, settlement, or expense (including reasonable attorneys' fees) arising out of (a) a breach of the foregoing, or (b) any third-party claim that, if true, would constitute a breach of the foregoing.

Covered Entity acknowledges that, to the extent it elects organization-wide credential scope under Section 2.3, Protected Health Information from multiple Affiliated Entities may be processed using shared Access Credentials and may co-exist within Business Associate's logs and processing systems. Covered Entity represents that this configuration is consistent with its own HIPAA Security Rule risk analysis under 45 C.F.R. § 164.308(a)(1)(ii)(A).

5. Term and Termination

5.1 Term

This BA Agreement shall be effective as of the effective date of the Services Agreement (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 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.

5.2 Termination Upon Breach

Any other provision of this BA Agreement notwithstanding, either party (the "Non-Breaching Party"), upon knowledge of a material breach by the other party (the "Breaching Party"), shall provide an opportunity for the Breaching Party to cure the breach or end the violation. If Breaching Party does not cure the breach or end the violation within thirty (30) calendar days, the Non-Breaching Party may terminate: (a) this BA Agreement; and (b) all of the provisions of the Services Agreement that involve the use or disclosure of Protected Health Information. In the event that termination of this BA Agreement is not feasible, in the Non-Breaching Party's sole discretion, the Non-Breaching Party has the right to report the breach to the Secretary.

5.3 Effect of Termination

(a) Except as provided in Section 5.3(b), upon termination of this BA 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 retain no copies of the Protected Health Information.

(b) In the event that Business Associate reasonably determines that returning or destroying the Protected Health Information is infeasible, Business Associate shall extend the protections of this BA 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. Covered Entity acknowledges and agrees that (i) it is infeasible for Business Associate to delete Protected Health Information from its backup tapes or other backup systems and (ii) it is infeasible for Business Associate to delete all Protected Health Information during an ongoing investigation in connection with a Security Incident or Breach of Unsecured Protected Health Information, and that temporarily retaining certain Protected Health Information may be necessary for such investigation. Protected Health Information retained on backup tapes or other backup systems shall be deleted in the ordinary course of Business Associate's standard backup rotation cycle, which shall not exceed ninety (90) days from the termination of this BA Agreement, except where retention is required by a litigation hold, subpoena, regulatory investigation, or other legal preservation obligation, in which case Business Associate shall continue to protect such retained Protected Health Information in accordance with this BA Agreement for the duration of such obligation.

6. Compliance with HIPAA Transaction Standards

When providing its services and/or products, Business Associate shall comply with all applicable HIPAA standards and requirements (including, without limitation, those specified in 45 CFR Part 162) with respect to the transmission of health information in electronic form in connection with any transaction for which the Secretary has adopted a standard under HIPAA ("Covered Transactions"). Business Associate will make its services and/or products compliant with HIPAA's standards and requirements no less than thirty (30) days prior to the applicable compliance dates under HIPAA. Business Associate represents and warrants that it is aware of all current HIPAA standards and requirements regarding Covered Transactions, and Business Associate shall comply with any modifications to HIPAA standards and requirements which become effective from time to time. Business Associate shall require all of its agents and subcontractors (if any) who assist Business Associate in providing its services and/or products to comply with the terms of this Section 6.

7. Miscellaneous

7.1 Regulatory References

A reference in this BA Agreement to a section in HIPAA, means the section as in effect or as amended or modified from time to time, including any corresponding provisions of subsequent superseding laws or regulations.

7.2 Amendment

The Parties agree to take such action as is necessary to amend this BA Agreement and/or the Services Agreement from time to time as is necessary for the parties to comply with the requirements of HIPAA. If either party proposes an amendment in writing to bring the BA Agreement or Services Agreement into compliance with HIPAA, the other party shall negotiate the proposed amendment in good faith and shall not unreasonably withhold, condition, or delay execution of such amendment.

7.3 Survival

The respective rights and obligations of Business Associate under Section 5.3(b) of this BA Agreement shall survive the termination of the Services Agreement or this BA Agreement.

7.4 Interpretation

Any ambiguity in this Agreement shall be resolved to permit the parties to comply with HIPAA.

7.5 Miscellaneous

The terms of this BA Agreement are hereby incorporated into the Services Agreement, including the Needletail Service Contract and the Terms of Service. To the extent that Business Associate receives Protected Health Information from or on behalf of Covered Entity, in the event of a conflict between the terms of this BA Agreement and the terms of the Services Agreement, the terms of this BA Agreement shall prevail. In any case of conflict between the Service Contract and the Terms of Service, the Service Contract shall prevail. The terms of the Services Agreement which are not modified by this BA Agreement shall remain in full force and effect in accordance with the terms thereof. This BA Agreement shall be governed by, and construed in accordance with, the laws of the State of Delaware, exclusive of conflict of law rules. Each party to this BA Agreement hereby agrees and consents that any legal action or proceeding with respect to this BA Agreement shall only be brought in the state and federal courts located in the State of Delaware. The Services Agreement together with this BA Agreement constitutes the entire agreement between the parties with respect to the subject matter contained herein, and this BA Agreement supersedes and replaces any former business associate agreement or addendum entered into by the parties. No amendments or modifications to the BA Agreement shall be effected unless executed by both parties in writing. This BA Agreement may be executed in counterparts, each of which when taken together shall constitute one original. Any PDF or facsimile signatures to this BA Agreement shall be deemed original signatures to this BA Agreement.

7.6 Indemnification by Business Associate

Business Associate shall defend, indemnify, and hold harmless Covered Entity, its Affiliated Entities, and their respective officers, directors, and employees from and against third-party claims, regulatory fines and penalties, and reasonable expenses (including reasonable attorneys' fees) to the extent arising out of (a) Business Associate's material breach of this BA Agreement, or (b) Business Associate's violation of HIPAA, in each case caused by Business Associate's gross negligence or willful misconduct. Business Associate's aggregate liability under this Section 7.6, together with all other liability under the Services Agreement, shall be subject to the limitations of liability set forth in the Services Agreement, except to the extent such limitations are prohibited by applicable law. The indemnification obligations in this Section 7.6 are in addition to, and not in limitation of, the Covered Entity indemnification obligations set forth in Section 4.5.

How This BAA Is Executed

This Business Associate Agreement is automatically incorporated when you execute a Needletail Service Contract. If you are a Covered Entity or otherwise provide Protected Health Information via the Services, execution of the Service Contract incorporates the terms of this BAA into your agreement with Needletail.

For questions about this BAA or to request a copy, please contact us at legal@needletailai.com.