AI-Features Addendum

This Addendum supplements and is incorporated into the Master Subscription Agreement and the Business Associate Agreement between Sefton Health, Inc. ("Sefton," operator of the Sefton platform) and the Customer (the provider or practice). It governs the platform's AI/ML-assisted features. In case of conflict regarding PHI, the BAA controls; regarding AI-feature behavior and allocation of clinical/coding responsibility, this Addendum controls over the Master Subscription Agreement.

In plain language (summary only; the terms below control). These terms cover Sefton's AI-assisted features: draft notes, code suggestions, transcription and translation. The AI helps draft and suggest. It never makes clinical or billing decisions: your clinician reviews and is responsible for everything that is signed or submitted. We do not sell your data, and we do not use PHI to train any AI model.

Terms not defined here have the meaning in the BAA or the HIPAA Rules (45 CFR Parts 160 and 164).

1.1 "AI Features" means any machine-learning-assisted capability of the platform, including without limitation as of the effective date of this Addendum: (a) Quick Dictate Coding — suggestion of ICD-10 and CPT®/HCPCS codes from clinical documentation; (b) Transcription — automated speech-to-text of clinical/telehealth audio (via Amazon Transcribe); (c) Translation — automated translation of communications/captions (via Amazon Translate); and (d) Documentation drafting — draft notes and summaries generated from the clinician's dictation or session transcript (via Amazon Bedrock). This definition automatically captures future AI/ML capabilities; any feature that exceeds "administrative support" (e.g., autonomous diagnosis, triage, or treatment recommendation) is subject to the gating process in §12.5 before release.

1.2 "AI Output" means any text, code suggestion, transcript, translation, summary, or other artifact generated by an AI Feature.

1.3 "Clinician of Record" means the licensed provider responsible for the patient's care, the clinical record, and any claim submitted.

1.4 "Input Data" means data submitted to or processed by an AI Feature, including PHI.

1.5 "Subprocessor" means a third party that processes Input Data to deliver an AI Feature (currently Amazon Web Services HIPAA-eligible services; see BAA Part 2 inventory).

2.1 The AI Features provide administrative documentation and coding support only. They generate suggestions and drafts to be reviewed by the Clinician of Record.

2.2 The AI Features do not practice medicine, do not make clinical or coding decisions, and do not replace professional judgment. Every AI Output is a draft subject to the Clinician of Record's independent review and adoption.

2.3 AI Output may contain errors, omissions, mistranscriptions, or mistranslations. Speech recognition, code suggestion, and machine translation are probabilistic and not guaranteed accurate or complete.

3.1 Customer/Clinician responsibility. The Clinician of Record is solely responsible for: reviewing, correcting, and adopting (or rejecting) every AI Output before clinical or billing use; the accuracy and medical necessity of all documentation and codes; and all clinical decisions.

3.2 Coding is suggestion, not determination. Quick Dictate Coding proposes codes; it does not assign, certify, or submit them. The Clinician of Record (or the practice's billing staff) must independently verify each code against the documentation and payer rules before submission.

3.3 No clinician-substitution. Nothing in the platform is designed or permitted to be used as a substitute for a licensed clinician's review.

4.1 The parties intend the AI Features to qualify as non-device Clinical Decision Support (CDS) software, or as administrative/transcription software outside FDA device regulation.

4.2 To support that position, the AI Features are designed so that the Clinician of Record can independently review the basis for a suggestion and is not intended to rely primarily on the software (the Cures Act / FDA criteria).

4.3 Sefton makes no representation that the AI Features are FDA-cleared or FDA-approved, because they are positioned as non-device; if a regulator determines otherwise, the parties will cooperate to achieve compliance.

5.1 AI OUTPUT IS PROVIDED "AS IS." TO THE MAXIMUM EXTENT PERMITTED BY LAW, SEFTON DISCLAIMS ALL WARRANTIES AS TO THE ACCURACY, COMPLETENESS, CODING CORRECTNESS, OR FITNESS OF ANY AI OUTPUT FOR CLINICAL OR BILLING USE.

5.2 Marketing/representation discipline. Sefton will not represent the AI Features as more accurate, autonomous, or capable than substantiated.

6.1 Input Data that is PHI is processed only to provide the AI Feature to Customer, under the BAA and the HIPAA Security Rule.

6.2 No model training on PHI. Sefton and its Subprocessors will not use PHI to develop, train, fine-tune, or improve any AI or ML model — whether first-party or third-party, general-purpose or special-purpose — except solely to provide the contracted AI Feature to the Customer that supplied the PHI, and never to build or improve a model offered to other customers. This is consistent with the BAA.

6.2.1 Subprocessor service-improvement opt-out. Sefton's AWS account applies an AWS AI services opt-out policy covering all supported services, including Amazon Transcribe and Amazon Translate, so AWS does not use Input Data to improve its own services. Amazon Bedrock does not use Input Data to train models.

6.3 Subprocessors. Transcription uses Amazon Transcribe, translation uses Amazon Translate, and documentation drafting uses Amazon Bedrock, each a HIPAA-eligible service used under the AWS BAA.

7.1 False Claims Act allocation. Customer is solely responsible for the accuracy, medical necessity, and supportability of every claim it submits (including through its clearinghouse, Claim.MD). AI code suggestions do not transfer that responsibility to Sefton.

7.2 CPT® / AMA licensing. CPT is a registered trademark of the American Medical Association, and CPT content is copyrighted by the AMA. Sefton provides CPT content under its license from the AMA, and Customer's use of it is subject to the CPT End-User Terms, which Customer accepts before CPT content is first shown. HCPCS and ICD-10 codes are public-domain code sets.

7.3 Sefton does not guarantee reimbursement, payer acceptance, or coding compliance for any claim.

8.1 Transcription. Automated transcripts are drafts; the Clinician of Record must verify accuracy before relying on a transcript for the record.

8.2 Translation / interpreter rights. Machine translation may be inaccurate and is not a certified medical interpreter. Where federal or state law requires qualified-interpreter access (e.g., Section 1557 of the ACA, 42 U.S.C. §18116, and its language-access requirements; Title VI), Customer remains responsible for providing a qualified human interpreter; the platform's translation does not satisfy that obligation.

9.1 The platform maintains audit logging of PHI access consistent with the BAA and 45 CFR 164.312(b). AI Output adoption/rejection by the Clinician of Record is recorded to support the human-in-the-loop record.

10.1 To the maximum extent permitted by law, Sefton is not liable for clinical, coding, billing, or care decisions made by the Clinician of Record, including where informed by AI Output, given the mandatory human-review design (§3) and Customer's covenants (§11.1).

10.2 Limitation of liability (cap). EXCEPT FOR THE EXCLUDED CLAIMS BELOW, EACH PARTY'S TOTAL AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THE AI FEATURES WILL NOT EXCEED THE FEES PAID BY CUSTOMER FOR THE SERVICE IN THE TWELVE (12) MONTHS PRECEDING THE EVENT, AND NEITHER PARTY WILL BE LIABLE FOR INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES OR LOST PROFITS/DATA. Excluded claims (uncapped): a party's indemnification obligations, breach of the BAA/HIPAA obligations, a party's fraud, willful misconduct or gross negligence, and Customer's payment obligations.

10.3 Indemnification. Customer will defend and indemnify Sefton against third-party claims arising from (a) Customer's clinical, coding, or billing decisions; (b) Customer's failure to perform the human review required by §11.1; or (c) Customer's breach of §11. To the extent the parties intend this indemnity to extend to Sefton's own negligence, it does so only as expressly stated here and only to the maximum extent permitted by law. Indemnification is subject to prompt notice, Sefton's right to participate in defense, and Customer's control of settlement only with Sefton's consent.

10.4 Savings clause (scoped). Nothing limits liability that cannot be limited under applicable law, or Sefton's HIPAA/BAA obligations; this clause does not otherwise vacate the allocations in §§10.1–10.3, which apply to the fullest extent permitted.

11.1 Mandatory human review (covenant). Customer covenants that the Clinician of Record will independently review every AI Output before clinical or billing use and will not rely on AI Output without such review. This covenant is a condition of the liability allocation in §10.

11.2 Customer representations. Customer represents and warrants that it is a licensed healthcare provider (or authorized agent), is the Covered Entity (or its BA) and Clinician of Record, holds all patient consents/authorizations required for its use of the AI Features, and is solely responsible for claim submission (including through its clearinghouse, Claim.MD).

11.3 CPT® End-User Terms. Customer will comply with the CPT End-User Terms for its use of CPT content (see §7.2).

11.4 Insurance. Customer will maintain professional liability (malpractice) and general liability insurance adequate to its practice.

12.1 Order of precedence. For PHI, the BAA controls; for AI-feature behavior and clinical/coding responsibility, this Addendum controls over the Master Subscription Agreement.

12.2 Severability. If any provision is held unenforceable, it is modified to the minimum extent necessary or severed, and the remainder stays in effect.

12.3 Survival. §§3, 5, 6, 7, 10, and 11.2 survive termination.

12.4 Subprocessor changes. Sefton will flow down the §6.2 no-training commitment to any new Subprocessor and maintain the current inventory in the BAA.

12.5 New-feature gating. Before releasing any AI Feature that exceeds administrative support (§1.1), Sefton will assess FDA device status (§4), patient-notice obligations, and update this Addendum.