Development phase notice
BioAnalytiX products are in development and limited release. Orasis AI is not certified as a medical device and is not approved for clinical use. Gnosis AI is a study aid offered through a university pilot. These terms apply to our beta, pilot, and development activities.
Acceptance of terms
By accessing any BioAnalytiX product — Orasis AI or Gnosis AI — or participating in our beta or pilot programs (the “Service”), you acknowledge that:
- You have read and understood these Terms and Conditions (the “Terms”)
- You understand our products are under development and that Orasis AI is not certified for clinical use
- You agree to be bound by these Terms
- You are participating voluntarily in testing, pilot, and development activities
If you disagree with any part of these Terms, you must not access or use the Service.
Who can use the Service
Currently, access is limited to:
- Approved beta and pilot participants
- Development team members
- Academic and research partners
- Healthcare professionals evaluating Orasis AI (non-clinical use only)
- Students and faculty taking part in the Gnosis AI pilot
Development status & limitations
Critical warning: Orasis AI is not a certified medical device
- The platform is for research and development purposes only
- Not approved by the FDA, CE, or any regulatory body
- Not intended for clinical decision-making
- Not suitable for patient diagnosis or treatment
- Results are experimental and should not be relied upon
Gnosis AI is a study aid
Gnosis AI supports your learning using your official course material. It is not a substitute for your courses, instructors, or official assessments, and its answers may contain errors — always verify against your course materials.
Current platform status
- Development phase: pre-certification beta testing
- Regulatory status: no medical-device certifications
- Intended use: testing, feedback, and development only
- Data processing: test data and anonymized samples only
Future plans
We are working toward:
- HIPAA compliance for US healthcare markets
- CE marking under the Medical Device Regulation (MDR)
- FDA clearance consideration
- ISO certifications for quality management
Beta & pilot program terms
Nature of the service
By participating in our beta or pilot programs, you understand and accept that the Service is experimental and may contain bugs or errors, that features may change or be removed without notice, that the Service may experience downtime or data loss, and that all results are for testing and learning purposes only.
Participant responsibilities
- Orasis AI:use only anonymized or synthetic data — never upload real patient data or identifiable health information
- Gnosis AI:use it as a study aid and follow your institution’s academic-integrity rules; do not use it to complete graded work dishonestly
- Provide constructive feedback through designated channels
- Report bugs, errors, and security concerns promptly
- Maintain confidentiality about unreleased features
Prohibited uses
Participants must not:
- Use Orasis AI for actual patient diagnosis or treatment
- Make clinical decisions based on Orasis AI output
- Represent Orasis AI as a certified medical device
- Use Gnosis AI to violate academic-integrity or examination policies
- Charge others for access to the Service
Disclaimers & warnings
Not medical advice
Orasis AI does not provide medical advice. All content, including AI-generated analysis, is for informational and testing purposes only. Always seek the advice of qualified healthcare providers for medical decisions.
Not academic or professional advice
Gnosis AI is a learning aid, not academic, professional, or medical advice. It does not guarantee any grade or exam outcome — always rely on your official course materials and instructors.
No warranties
The Service is provided “as is” and “as available” without any warranties, including warranties of accuracy, reliability, or completeness of results; fitness for any particular purpose; merchantability or non-infringement; or uninterrupted, error-free operation.
Technology limitations
- AI technology has inherent limitations and may produce errors
- Results may vary significantly from final product performance
- The platform requires stable internet connectivity
- Compatibility with all systems is not guaranteed
Acceptable use policy
Permitted uses
You may use the Service only for:
- Testing and evaluating platform functionality
- Providing feedback on the user experience
- Academic research (with proper approval)
- Studying with Gnosis AI as a learning aid
- Learning about AI in medical imaging
- Demonstration purposes (clearly marked as a development version)
Prohibited activities
- Uploading real patient data or PHI to Orasis AI
- Using Orasis AI for clinical diagnosis
- Using Gnosis AI to cheat or violate academic-integrity policies
- Attempting to reverse engineer our algorithms
- Sharing login credentials or creating unauthorized accounts
- Introducing malicious code or attempting system breaches
- Misrepresenting the Service’s capabilities or regulatory status
- Violating any applicable laws or regulations
Account security
You are responsible for maintaining the confidentiality of your credentials, all activities under your account, notifying us immediately of unauthorized access, and using strong, unique passwords.
Intellectual property rights
Our intellectual property
All rights in the Service are owned by BioAnalytiX, including our AI algorithms and models, software code and architecture, user-interface and experience design, documentation and training materials, and trademarks, logos, and branding.
Beta tester contributions
By providing feedback, suggestions, or ideas, you grant us a perpetual, worldwide, royalty-free license to use your contributions, waive any claims to compensation or attribution, and represent that your contributions are original.
Test data
- You retain ownership of your original data
- You grant us a license to process it for testing purposes
- You confirm it contains no real patient information
- We may use anonymized insights to improve our algorithms
Limitation of liability
No liability for medical or academic outcomes
Under no circumstances shall BioAnalytiX be liable for any medical outcomes, misdiagnosis, health-related damages, or academic and exam outcomes arising from use of these development products.
To the maximum extent permitted by law, BioAnalytiX shall not be liable for any indirect, incidental, special, or consequential damages; loss of profits, data, or business opportunities; personal injury or property damage; errors or inaccuracies in the Service; unauthorized access or data breaches despite security measures; or service interruptions and system failures.
Indemnification
You agree to indemnify and hold harmless BioAnalytiX from claims arising from your use or misuse of the Service, violation of these Terms, use of the Service for clinical purposes, upload of real patient data, or any breach of applicable laws or regulations.
Total liability cap
Our total liability shall not exceed the amount you have paid us (currently $0 for beta and pilot participants) in the twelve months preceding any claim.
Privacy and data protection
We are committed to protecting your data. Please see our Privacy Policy for detailed information. We implement security best practices even during development, keep beta tester data separate from any future clinical data, and do not sell or share personal information. We are working toward GDPR compliance for EU users, HIPAA readiness for US healthcare, and international data-protection standards.
Current limitations
As we are not yet certified, we cannot guarantee full regulatory compliance. Do not upload sensitive personal or health information.
Termination
Your right to terminate
You may stop using the Service at any time by contacting us to close your beta or pilot account, uninstalling any test or pilot applications, and requesting deletion of your data.
Our right to terminate
We may terminate your access if you violate these Terms, upload real patient data, attempt unauthorized access, misuse the platform, or remain inactive for extended periods.
Effect of termination
- Your access will be revoked immediately
- Test data may be deleted or anonymized
- Confidentiality obligations survive termination
- You must cease representing any association with BioAnalytiX
General provisions
Governing law
These Terms are governed by the laws of Greece and the European Union, without regard to conflict-of-law principles.
Changes to terms
We may update these Terms as we develop the platform. We will notify beta testers of material changes via email.
Severability
If any provision is found unenforceable, the remaining provisions continue in effect.
No waiver
Our failure to enforce any right or provision is not a waiver of that right.
Entire agreement
These Terms constitute the entire agreement between you and BioAnalytiX regarding the Service.
Your agreement
By using the BioAnalytiX development platform or participating in our beta program, you acknowledge that you have read, understood, and agree to these Terms and Conditions. Remember: this platform is not approved for clinical use.
Contact information
For questions about these Terms or our beta and pilot programs, email us at info@bioanalytix.info. Our team is based in Greece (EU).