Privacy policy
v2.0.0
Jan 1, 2026
1. Introduction
Ilana Protocol Intelligence ("we," "our," or "Ilana") provides AI-powered clinical trial protocol analysis and compliance checking through a Microsoft Word add-in. This Privacy Policy describes how we collect, use, disclose, and safeguard information when you use our services.
**By using Ilana Protocol Intelligence, you agree to the collection and use of information in accordance with this policy.**
2. Information We Collect
2.1 Protocol Content
When you use Ilana to analyze protocol text:
- **Selected Text**: Text you select in Microsoft Word for analysis
- **Document Context**: Surrounding context needed for accurate analysis
- **Analysis Results**: Suggestions, compliance issues, and recommendations generated by our AI
**Important**: We do NOT store complete protocol documents. Only the text segments you actively submit for analysis are processed.
2.2 Usage Data
We automatically collect:
- **Request Metadata**: Timestamps, analysis types requested, suggestion categories
- **Performance Metrics**: Response times, error rates, cache hit rates
- **User Interactions**: Accepts, rejects, and dismissals of suggestions (anonymized)
2.3 Technical Data
- **Session Identifiers**: Temporary session IDs for request correlation (not linked to personal identity)
- **Error Logs**: Stack traces and error messages for debugging (scrubbed of sensitive content)
2.4 Information We Do NOT Collect
- Personal health information (PHI)
- Personally identifiable information (PII) of trial participants
- Complete protocol documents
- Microsoft account credentials
- Email addresses or contact information (unless you contact support)
3. How We Use Your Information
3.1 Primary Purposes
- **Protocol Analysis**: Process your text using AI models to identify compliance issues and generate suggestions
- **Service Improvement**: Analyze usage patterns to improve suggestion quality and system performance
- **Compliance Monitoring**: Ensure regulatory alignment with ICH-GCP E6/E9 guidelines
3.2 Feedback-Based Learning
- Anonymized user feedback (accept/reject/dismiss) is used to adjust suggestion confidence scores
- No protocol content is stored in feedback data—only category and action metadata
- Feedback data is aggregated and cannot be traced to specific users or organizations
3.3 Caching
- Analysis results are temporarily cached (15 minutes) to improve performance for repeated queries
- Cached data is stored in-memory only and is never persisted to disk
- Cache is automatically purged when the service restarts
4. Third-Party Services
4.1 Azure OpenAI (Microsoft)
- **Purpose**: Natural language processing for suggestion generation
- **Data Shared**: Selected protocol text and analysis context
- **Data Retention**: Microsoft does NOT store protocol content sent to Azure OpenAI API for model training ([Azure OpenAI Data Privacy](https://learn.microsoft.com/en-us/legal/cognitive-services/openai/data-privacy))
- **Location**: United States (East US region)
4.2 Pinecone Vector Database
- **Purpose**: Semantic search for regulatory knowledge base
- **Data Shared**: Embeddings (numerical representations) of protocol text—NOT raw text
- **Data Retention**: Embeddings are stored for the duration of your subscription
- **Location**: United States (Azure East US 2)
4.3 HuggingFace Inference API
- **Purpose**: PubMedBERT model for biomedical entity recognition
- **Data Shared**: Selected protocol text segments
- **Data Retention**: HuggingFace does NOT store inference requests ([HuggingFace Privacy](https://huggingface.co/privacy))
- **Location**: United States (AWS US-East-1)
4.4 Render (Hosting Provider)
- **Purpose**: Backend service hosting
- **Data Shared**: All data processed by Ilana passes through Render infrastructure
- **Data Retention**: Logs retained for 7 days, then automatically deleted
- **Location**: United States
5. Data Storage and Retention
5.1 Operational Data
- **Analysis Requests**: NOT stored permanently
- **In-Memory Cache**: Retained for 15 minutes, then purged
- **Error Logs**: Retained for 30 days for debugging, then deleted
- **Feedback Statistics**: Anonymized category-level metrics retained indefinitely
5.2 No Long-Term Protocol Storage
We do NOT maintain a database of protocol documents or analysis history. Each analysis request is processed independently and ephemerally.
6. Data Security
6.1 Encryption
- **In Transit**: All data transmitted via HTTPS/TLS 1.3
- **At Rest**: Not applicable—no persistent storage of protocol content
- **API Keys**: Stored in environment variables, never in code or logs
6.2 Access Controls
- Production backend hosted on Render with role-based access control (RBAC)
- Azure OpenAI API keys rotated every 90 days
- Logs scrubbed of sensitive content before retention
6.3 Compliance
- **HIPAA**: Ilana does NOT process or store PHI. Users are responsible for de-identifying protocol text containing participant data
- **GDPR**: No personal data is collected from EU residents using the service
- **SOC 2**: Hosting provider (Render) is SOC 2 Type II certified
7. Your Rights and Choices
7.1 Data Access
Since we do not store protocol content or personal information, there is no data to access or download.
7.2 Data Deletion
- **Cached Data**: Automatically purged after 15 minutes
- **Feedback Data**: Contact support@ilanaimmersive.com to request deletion of aggregated feedback statistics
7.3 Opt-Out
- **Telemetry**: Set `TELEMETRY_ENABLED=false` in your deployment (enterprise deployments only)
- **Feedback Learning**: Contact support to exclude your usage from feedback-based learning
8. Children's Privacy
Ilana Protocol Intelligence is intended for professional use by clinical researchers and regulatory professionals. We do not knowingly collect information from individuals under 18 years of age.
9. International Data Transfers
All data processing occurs in United States data centers. By using Ilana, you consent to the transfer and processing of data in the U.S.
**For EU Users**: Standard Contractual Clauses (SCCs) are in place with Azure OpenAI and other U.S.-based processors to comply with GDPR Article 46.
10. Changes to This Privacy Policy
We may update this Privacy Policy to reflect changes in our practices or legal requirements. Material changes will be communicated via:
- In-app notification in the Word add-in
- Email to registered enterprise customers
- Updated "Last Updated" date at the top of this document
Continued use of Ilana after changes constitutes acceptance of the updated policy.
## 11. Contact Information
**Ilana Immersive**
501 Union St Ste 545 PMB 696328, Nashville, Tennessee 37219-1876
Email: support@ilanaimmersive.com
Privacy Officer: privacy@ilanaimmersive.com
For data protection inquiries or to exercise your rights, contact us at privacy@ilanaimmersive.com.
12. Regulatory Disclosures
12.1 AI-Generated Content
Ilana uses large language models (LLMs) to generate protocol suggestions. All AI-generated content should be reviewed by qualified clinical research professionals before use. Ilana is a decision-support tool, not a substitute for human judgment.
12.2 Liability
Ilana provides compliance suggestions based on ICH-GCP E6/E9 guidelines but does NOT constitute legal or regulatory advice. Users are responsible for verifying all suggestions before submission to regulatory authorities.
12.3 No Medical Device Classification
Ilana Protocol Intelligence is a document editing tool and is NOT classified as a medical device under FDA 21 CFR Part 11 or EU MDR. It does not directly impact patient safety or clinical outcomes.
13. California Privacy Rights (CCPA)
If you are a California resident, you have the right to:
- Know what personal information we collect about you
- Request deletion of your personal information
- Opt-out of sale of personal information (**Note**: We do NOT sell personal information)
- Request disclosure of categories and specific pieces of personal information collected
To exercise these rights, contact privacy@ilanaimmersive.com.
14. GDPR Compliance (EU Users)
If you are located in the European Economic Area (EEA):
- **Legal Basis**: Processing is based on legitimate interests (service provision) and consent
- **Data Controller**: Ilana Immersive, LLC is the data controller
- **Data Transfers**: Data may be processed in the US under Standard Contractual Clauses (SCCs)
- **Right to Complaint**: You may file a complaint with your local data protection authority
- **Data Protection Officer**: privacy@ilanaimmersive.com
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**Document Version**: 2.0
**Applicable Jurisdictions**: United States, European Union, United Kingdom
**Governing Law**: Tennessee, United States