Effective Date: June 1, 2026

Welcome to MyClavis.AI, operated by Pharmacy Associates, LLC (“Pharmacy Associates,” “ClavisAI,” “we,” “us,” or “our”). These Terms of Use (“Terms”) govern your access to and use of our website, platform, dashboards, reports, communications, and any services we provide (collectively, the “Services”). By accessing or using the Services, you agree to be bound by these Terms.

Eligibility and Acceptance

By using the Services, you represent and warrant that:

  • You are at least 18 years old and legally able to enter into a binding agreement.
  • If you are using the Services on behalf of an organization, you are authorized to accept these Terms on its behalf.
  • You will comply with all applicable federal, state, and local laws, including those governing healthcare, laboratory services, and genetic information.

If you do not agree to these Terms, you must not use the Services.

Description of Services

Pharmacy Associates provides:

  • Genetic testing interpretation and laboratory‑related analytics
  • Clinical and pharmaceutical data analysis
  • Access to test results, reports, dashboards, and educational content
  • AI‑enabled insights, risk assessments, and decision‑support tools
  • Communications regarding orders, testing, and health‑related services

The Services do not provide medical, pharmacy, or clinical care. All outputs are informational and intended to support—not replace—professional judgment.

Account Registration and Security

You agree to:

  • Provide accurate, current, and complete information
  • Maintain the confidentiality of your login credentials
  • Notify us immediately of any unauthorized access or suspected breach
  • Accept responsibility for all activities conducted under your account

We may suspend or terminate accounts that violate these Terms or pose security risks.

User Responsibilities and Acceptable Use

You agree not to:

  1. Violate any applicable law, regulation, or industry standard
  2. Upload, transmit, or store any Protected Health Information (“PHI”) unless permitted under a signed Business Associate Agreement (BAA)
  3. Misuse, copy, scrape, harvest, or extract data from the Services
  4. Reverse engineer, decompile, disassemble, or attempt to derive source code, algorithms, models, or scoring logic
  5. Use the Services to train, improve, or benchmark any external AI or machine‑learning system
  6. Interfere with or disrupt the integrity or performance of the Services
  7. Misrepresent your identity or affiliation
  8. Attempt to gain unauthorized access to any system, account, or network

We reserve the right to investigate and pursue legal remedies for violations.

Privacy and Data Practices

Your use of the Services is subject to our Privacy Policy, which describes how we collect, use, disclose, and safeguard information.

You acknowledge and agree that:

  • De‑identified or aggregated data may be used to improve the Services, analytics, and AI models
  • We may monitor usage for security, compliance, and quality improvement
  • We do not guarantee HIPAA compliance unless a separate BAA is executed

Intellectual Property Rights

All content, algorithms, models, scoring logic, dashboards, trademarks, service marks, graphics, and other materials available through the Services are the exclusive property of Pharmacy Associates or its licensors.

You may not, without prior written consent:

  • Copy, reproduce, modify, distribute, or create derivative works
  • Use any content for commercial purposes outside the Services
  • Train or develop competing AI, ML, or analytics systems using our content
  • Remove or alter any copyright, trademark, or proprietary notices

All rights not expressly granted are reserved.

Disclaimers; No Medical Advice; Limitation of Liability

No Medical or Clinical Advice

The Services, including genetic interpretations that are based on published guidelines, risk assessments, and AI‑generated insights, are informational only. They:

  • Do not constitute medical, pharmacy, genetic counseling, or clinical advice
  • Do not create a provider‑patient or pharmacist‑patient relationship
  • Must not be used as a substitute for professional medical judgment

Always consult a qualified healthcare provider for diagnosis, treatment, or medical decisions.

General Disclaimer

The Services are provided “AS IS” and “AS AVAILABLE” without warranties of any kind, express or implied, including:

  • Accuracy
  • Completeness
  • Reliability
  • Fitness for a particular purpose
  • Non‑infringement

We do not guarantee that the Services will be error‑free, uninterrupted, secure, or up to date.

Limitation of Liability

To the fullest extent permitted by law:

  • Pharmacy Associates is not liable for any indirect, incidental, consequential, punitive, or special damages
  • We are not responsible for clinical outcomes, adverse events, medication errors, or decisions made based on the Services
  • Our total liability for any claim shall not exceed the amount paid for the Services in the 12 months preceding the claim, or $100 if no fees were paid

Some jurisdictions do not allow certain limitations; in those cases, limitations apply to the maximum extent permitted.

Indemnification

You agree to indemnify, defend, and hold harmless Pharmacy Associates, its affiliates, officers, employees, contractors, and partners from any claims, damages, liabilities, losses, or expenses arising out of:

  • Your use or misuse of the Services
  • Your violation of these Terms
  • Your breach of applicable laws or regulations
  • Any clinical or operational decisions you make based on the Services

Governing Law; Dispute Resolution

These Terms are governed by the laws of the State of Illinois, without regard to conflict‑of‑law principles.

You agree that:

  • Any dispute shall be resolved exclusively through binding arbitration in Cook County, Illinois
  • Class actions and class arbitration are waived
  • You may only bring claims in your individual capacity

(If you prefer litigation instead of arbitration, I can adjust this section.)

Changes to Terms

We may update these Terms at any time. The updated version will be posted with a revised Effective Date. Continued use of the Services constitutes acceptance of the updated Terms.

Machine Learning Transparency & Explainability Notice

(ClavisAI — Pharmacy Associates, LLC)

ClavisAI uses machine‑learning (“ML”) models and rule‑based analytics to support medication safety, pharmacogenomic interpretation, and clinical decision‑support. We believe transparency is essential for responsible AI use in healthcare. This Notice explains how our models operate, the types of data they use, and the safeguards in place to ensure responsible deployment.

Purpose of the Models

ClavisAI’s ML models are designed to:

  • Identify potential medication risks, interactions, duplications, and optimization opportunities
  • Interpret pharmacogenomic results using established scientific guidelines
  • Highlight patterns that may warrant clinical review
  • Support clinicians, pharmacists, and payers in making informed decisions

The models do not diagnose, treat, or prescribe. All outputs are informational and require professional judgment.

Data Sources Used

ClavisAI models may use:

  • Laboratory data and pharmacogenomic markers
  • Medication claims and pharmacy dispensing history
  • Clinical guidelines (e.g., CPIC, FDA labeling, evidence‑based literature)
  • De‑identified or aggregated population‑level data
  • User‑provided information

We do not use identifiable patient data for model training unless explicitly permitted under a signed agreement.

How the Models Generate Insights

ClavisAI combines:

  • Rule‑based clinical logic
  • Statistical pattern recognition
  • Machine‑learning algorithms
  • Evidence‑based pharmacogenomic interpretation frameworks

Where possible, the platform provides explainable outputs, including:

  • The factors contributing to a recommendation
  • Relevant clinical guidelines
  • Evidence citations
  • Model confidence indicators (where applicable)

Human Oversight and Clinical Judgment

All insights require review by a qualified healthcare professional.
Users remain responsible for:

  • Verifying accuracy
  • Applying clinical context
  • Making final decisions

ClavisAI does not replace clinical expertise.

Model Limitations

ML models have inherent limitations, including:

  • Potential for incomplete or outdated data
  • Variability in scientific evidence
  • Risk of false positives or false negatives
  • Sensitivity to data quality

We continuously monitor and update models to improve performance.

Bias Mitigation and Fairness

ClavisAI employs safeguards to reduce algorithmic bias, including:

  • Use of diverse training datasets
  • Regular performance audits
  • Monitoring for disparate impact across populations
  • Alignment with CMS AI principles for fairness and equity

Continuous Monitoring and Updates

Models are periodically updated to reflect:

  • New clinical evidence
  • Updated pharmacogenomic guidelines
  • Regulatory changes
  • Performance monitoring results

Updates may change how insights are generated.

User Responsibilities

By using the platform, you acknowledge that:

  • AI‑generated insights are advisory
  • You will not rely solely on the platform for clinical decisions
  • You will review all outputs for accuracy and appropriateness

CMS‑Aligned AI Governance Statement

(ClavisAI — Pharmacy Associates, LLC)

ClavisAI is committed to responsible, transparent, and compliant use of artificial intelligence in healthcare. Our governance framework aligns with CMS’s Principles for Responsible AI, including safety, transparency, nondiscrimination, accountability, and patient‑centeredness.

Safety and Effectiveness

We design and deploy AI systems with a focus on:

  • Medication safety
  • Reduction of preventable harm
  • Identification of high‑risk therapies
  • Support for vulnerable populations (Medicare, Medicaid, dual‑eligible, and complex‑care members)

All models undergo validation, quality checks, and continuous monitoring.

Transparency and Explainability

ClavisAI provides:

  • Clear explanations of how insights are generated
  • Evidence citations and guideline references
  • Disclosure of model limitations
  • Documentation suitable for audit and oversight

We support CMS’s emphasis on traceability and auditability.

Fairness, Equity, and Bias Mitigation

ClavisAI incorporates CMS’s equity priorities by:

  • Evaluating model performance across demographic groups
  • Monitoring for disparate impact
  • Using diverse datasets where available
  • Prioritizing fairness in medication safety and access

We strive to ensure AI benefits all populations equitably.

Accountability and Human Oversight

ClavisAI maintains:

  • Clear lines of responsibility for model development and deployment
  • Human‑in‑the‑loop review for all clinical insights
  • Governance committees overseeing AI performance, safety, and compliance
  • Documentation for CMS, state Medicaid agencies, and payer audits

Users retain full responsibility for clinical decisions.

Privacy, Security, and Data Protection

We follow industry standards for:

  • Data encryption
  • Access controls
  • Secure model development
  • De‑identification and minimization practices

ClavisAI supports HIPAA‑aligned operations and executes BAAs when required.

Continuous Improvement and Monitoring

We regularly:

  • Update models based on new evidence
  • Conduct performance audits
  • Review user feedback
  • Monitor for unintended consequences

This ensures alignment with CMS’s expectations for ongoing oversight.

Responsible Deployment Across Government Programs

ClavisAI is designed to support:

  • Medicare Advantage
  • Medicaid
  • Dual‑eligible populations
  • Value‑based care programs
  • Medication therapy management (MTM)
  • High‑risk drug class oversight

Our platform helps organizations meet CMS goals for safety, quality, equity, and cost stewardship.