📜 Terms of Service & Public Offer

1. General Provisions, Regulatory Classification & Provider Details

1.1. These Terms of Service (hereinafter the "Agreement" or "Public Offer") govern the contractual relationship between the Operator / Service Provider, independent technology specialist Sofya Aleksandrovna Lelyukhina (Tax ID / INN: 781450780176, St. Petersburg, hereinafter the "Provider"), and any licensed medical practitioner, healthcare facility, or authorized entity (hereinafter the "User") accessing or utilizing the RadBot AI platform, web application, bots, and related APIs.

1.2. Regulatory Classification & Medical Device Status:

• United States (FDA 2022 CDS Guidance): In full compliance with Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA’s Guidance for Industry and Food and Drug Administration Staff on Clinical Decision Support Software (September 2022), RadBot is classified as Non-Device Clinical Decision Support (CDS) Software and an administrative drafting assistant. RadBot does not diagnose, treat, prevent, or mitigate any disease or physiological condition, nor does it provide autonomous diagnostic recommendations.
• European Union (EU AI Act & MDR): In accordance with Regulation (EU) 2024/1689 (the EU Artificial Intelligence Act), specifically Article 14 (Human Oversight), RadBot is designed and operated strictly under a human-in-the-loop paradigm. The software provides assistive draft generation that requires human verification. RadBot does not qualify as an autonomous medical diagnostic device under Regulation (EU) 2017/745 (MDR).
• United Kingdom (MHRA & GMC): RadBot operates as assistive administrative documentation software under MHRA SaMD regulatory guidance. Practicing clinicians remain subject to General Medical Council (GMC) Good Medical Practice obligations to independently verify all clinical entries.
• Latin America (Brazil CFM): Fully compliant with Conselho Federal de Medicina (CFM) resolutions governing teleradiology and assistive digital healthcare technologies.

1.3. Provider Information:

2. Service Status: Early Access / Beta & SLA

2.1. The Service is currently made available under an Early Access (Beta) operational model. New features, clinical templates, and AI integration channels are continuously deployed and calibrated based on clinical feedback from practicing radiologists.

2.2. The Provider undertakes commercially reasonable efforts to maintain a 99.5% service availability target, excluding scheduled maintenance windows announced in advance.

3. Functional Scope & Permitted Use

3.1. RadBot provides licensed clinicians with assistive automated workflow tools for diagnostic imaging (CT, MRI, X-ray, Ultrasound, Echocardiography), including:

• Speech-to-text dictation with medical terminology adaptation and phonetic correction;
• Structured reporting conforming to international standards (RSNA RadLex, ACR BI-RADS, PI-RADS, Lung-RADS, TI-RADS);
• Provisional draft generation of findings and impression sections from clinician voice inputs;
• Evidence-based clinical guidelines lookup (RAG DocMed knowledge engine);
• Auxiliary computer vision triage for DICOM studies (Vision AI);
• Desktop automation for clipboard auto-injection into local PACS, RIS, and EHR software.

4. Sole Clinical Responsibility & Limitation of Liability

4.1. Non-Delegable Physician Responsibility: The User (licensed medical specialist) retains sole, exclusive, and non-delegable clinical discretion, autonomy, and legal responsibility for validating, editing, and certifying any diagnostic report, measurement, laterality (left/right), classification score, or clinical finding generated or formatted by the Service prior to patient communication or EHR submission.

4.2. Under no circumstances shall the Provider be held liable for clinical misdiagnoses, medical malpractice claims, therapeutic decisions, or incidental damages resulting from the User's reliance on draft outputs generated by the Service.

4.3. Cap on Monetary Liability: To the maximum extent permitted by applicable law, the Provider's total aggregate liability arising out of or related to this Agreement shall be strictly limited to the actual fees paid by the User to the Provider during the twelve (12) months immediately preceding the incident giving rise to liability. For Free Tier users, total liability is exactly zero ($0.00 / 0.00 €).

5. Health Data Protection, HIPAA Safe Harbor & GDPR

5.1. HIPAA Safe Harbor Standard (45 CFR § 164.514(b)): The Service incorporates an automated client-side de-identification engine (PD Guard). All 18 direct HIPAA identifiers (including patient full names, social security numbers, insurance IDs, telephone numbers, direct addresses, and exact calendar dates) are automatically masked and stripped in-flight prior to external cloud processing.

5.2. GDPR Article 9 (Health Data): In the European Union and United Kingdom, the Service operates under zero-retention principles for processed health data. The Provider does not store unencrypted identifiable patient records. Complete data handling specifications are set forth in the Privacy Policy.

5.3. The User covenants not to knowingly transmit unmasked, unencrypted Protected Health Information (PHI) through open communication channels.

6. AI Processing Infrastructure & Zero-Model-Training Guarantee

6.1. All external model requests are routed through the Provider’s proprietary secure gateway, ensuring centralized auditability, token optimization, and rigorous pseudonymization.

7. Plans & Billing

7.1. Pricing Matrix

7.1.2. Payments are securely processed via international acquiring gateways (supporting Visa, Mastercard, American Express, UnionPay, local payment rails). Electronic fiscal invoices and VAT-exempt receipts are transmitted automatically to the User’s registered email address.

7.2. Early Adopter Program Privileges

7.3. Plan Upgrade & Pro-Rata Day Carryover

7.3.1. Standard tier subscribers may upgrade to the Pro unlimited tier at any time. Unused active days on Standard are not forfeited; they are automatically converted into bonus Pro unlimited days proportionally (Pro-rata formula: Remaining Days × 990 / 1990) and credited on top of the new 30-day billing cycle.

7.4. Refund Policy & Subscription Cancellation

7.3.1. Users may cancel their recurring subscription at any time via the account settings panel or by notifying customer support.

7.3.2. If a cancellation is requested due to software unavailability or critical technical failure, a prorated refund for the unused paid period will be issued upon written application to support@ai-protocol.ru within ten (10) business days via the original payment method.

8. Intellectual Property & Report Ownership

8.1. Ownership of Medical Reports: The User (or the User's employing healthcare facility) owns 100% of all exclusive rights, title, and copyright in and to all generated, validated, and finalized medical reports and clinical texts. The Provider claims zero ownership, license, or copyright in clinician reports.

8.2. The Provider retains all proprietary rights, trademarks, source code, and trade secrets in the RadBot platform, algorithms, and models.

9. User Rights & Complete Account Erasure

9.1. Under GDPR Article 17 ("Right to Erasure / Right to be Forgotten") and California Consumer Privacy Act (CCPA/CPRA), the User may at any time trigger complete, irrevocable deletion of their account, protocol history, and stored templates via:

• The "Delete Account" button within the Web App Settings panel;
• The /delete_account command in the Telegram Bot;
• Direct written communication to support@ai-protocol.ru.

9.2. Deletion is executed across all production databases within thirty (30) calendar days.

10. Governing Law, Binding Arbitration & Class Action Waiver

10.1. Arbitration Clause: Any dispute, controversy, or claim arising out of or relating to this Agreement, its interpretation, performance, or breach shall be resolved by binding, individual arbitration administered under the Commercial Arbitration Rules of the American Arbitration Association (AAA) or UNCITRAL Arbitration Rules, rather than in court.

10.2. Class Action Waiver: The User and the Provider agree that any dispute resolution proceedings shall be conducted solely on an individual basis and not in a class, consolidated, or representative action.

10.3. This Agreement shall be governed by and construed in accordance with generally recognized principles of international commercial law and the laws of the Provider's primary registration, without regard to conflict of laws principles.