Pre-Deployment Ethics Review GDPR Compliant EU AI Act Aligned 100% European Infrastructure

Legal · Ethics & Safety

Ethics Statement

ANBORELA is designed with ethics at its core — not as a compliance exercise, but as a founding commitment. This document describes our ethical principles, oversight mechanisms and responsibilities before any public deployment.

Last updated May 2026

System status Pre-deployment · Under ethics review

Applicable frameworks GDPR · EU AI Act · Helsinki Declaration

Purpose and Scope of This Statement

This Ethics Statement applies to the ANBORELA conversational AI system, all research activities conducted under the ANBORELA research programme, and any institutional partnerships developed during pilot study phases. It covers the website (anborela.ee and anborela.com) and any future deployments of the AI system.

The ANBORELA system is currently in a pre-deployment research phase. No real users are involved at this stage. This statement is published before any public access, consistent with our ethics-first commitment and voluntary submission to national and university ethics committees across Europe.

ANBORELA does not constitute medical or psychological treatment. It is a non-clinical research tool designed to provide conversational support as a complement to — never a substitute for — professional clinical care.

Core Ethical Principles

The ANBORELA project is guided by the following principles, drawn from the European research ethics framework, the Declaration of Helsinki, and EU AI Act requirements for health-adjacent AI systems.

Non-maleficence The system is designed to cause no harm. Safety rules are hardcoded. Emergency referrals are always visible. No harmful, coercive or manipulative responses are permitted by design.

Beneficence ANBORELA exists to provide accessible, non-judgmental support to people in recovery — reaching populations that existing services do not reach, particularly women and marginalised groups across Europe.

Autonomy Participation is fully voluntary. Users may stop at any time with no consequence. Informed consent is obtained before any research interaction. No data is linked to personal identity.

Justice The project prioritises populations systematically underserved by existing addiction services: women, LGBTIQ+ individuals, migrants, and ethnic minorities across 27 EU member states and the UK.

Transparency Users are always informed they are interacting with an AI system, not a human. The system's non-clinical nature is stated clearly at every interaction. No deception is permitted.

Accountability ANBORELA OÜ maintains full responsibility for the system's behaviour. Academic and regulatory partners may request full architecture review and model behaviour audits at any time.

Pre-Deployment Ethics Review

ANBORELA was voluntarily submitted to ethics review before any public deployment or real-user testing. This reflects our commitment to institutional oversight as a founding principle, not an afterthought.

EU Level European Union Drug Agency (EUDA) · Alignment with EUDA standards for research involving addiction and behavioural health data across EU member states.

National National ethics committees · Seeking approval at ministerial or agency level in target pilot countries, including Spain and Estonia. Process ongoing.

University University and hospital research ethics boards · Open to formal review by any European or UK academic institution interested in co-designing the pilot study protocol.

Regulatory Estonian Data Protection Inspectorate (AKI) · GDPR compliance supervised by the Estonian supervisory authority. DPO registered: Francisco Moreno · ai@anborela.ee

No real-user deployment will proceed without prior ethics committee approval. This commitment is unconditional.

Clinical Safety Boundaries

ANBORELA operates within strictly defined non-clinical boundaries. These are architectural constraints built into the system, not configurable settings.

Safety architecture

What ANBORELA does not do

The system does not diagnose any medical or psychological condition. It does not prescribe or recommend any medication or treatment. It does not replace any form of professional clinical care. It does not retain any information that could identify a user. Emergency referral information is always visible during interactions and cannot be disabled.

In the event of any interaction suggesting a user is at risk, the system immediately surfaces emergency referral information and encourages the user to contact professional or emergency services in their country.

Independence from Big Tech and Conflicts of Interest

ANBORELA is not hosted on Amazon Web Services, Microsoft Azure or Google Cloud. The conversational model is built and controlled by Anborela OÜ — not licensed from OpenAI, Anthropic, Meta or any US-based AI provider.

Why this matters ethically: Independence from Big Tech infrastructure ensures that sensitive health-adjacent data remains entirely within EU jurisdiction, that no commercial third party has access to interaction data, and that the system's behaviour can be fully audited by institutional partners without contractual barriers.

Anborela OÜ has no financial relationship with pharmaceutical companies, clinical providers or insurance companies. The project does not accept funding that would create conflicts of interest with the welfare of the populations it serves.

EU AI Act Compliance

ANBORELA's architecture is designed in alignment with EU AI Act requirements applicable to AI systems used in health-adjacent domains.

Art. 9 Risk management system · ANBORELA maintains a documented risk management process covering identification, analysis, and mitigation of risks throughout the system lifecycle.

Art. 13 Transparency and information · Users are always informed they are interacting with an AI system. The system's purpose, limitations, and non-clinical scope are disclosed at every interaction.

Art. 14 Human oversight · Human oversight is maintained at all stages of the research programme. No autonomous clinical decisions are made. Academic partners may request full audit access.

Art. 17 Quality management · Documentation, monitoring, and corrective procedures are in place. Full architecture documentation available to approved institutional partners on request.

The Lived Experience Dimension

Founder · Francisco Moreno

The perspective no institution can replicate

"I know from the inside what people in recovery need: continuous, non-judgmental support — available at any moment and adapted to each individual's journey."

Francisco Moreno brings 30+ years of lived experience with alcohol and cocaine addiction, treated through Spain's UCA clinical units. This is not a credential — it is the ethical core of the project. It ensures that design decisions are grounded in the reality of what people in recovery experience, not only in what institutions observe from the outside.

The inclusion of lived experience in the design and governance of ANBORELA is consistent with European best practice guidelines from EUDA and the Pompidou Group, which recognise the unique value of survivor perspectives in addiction support systems.

Research Ethics and Participant Rights

All research conducted under the ANBORELA programme follows the principles of the Declaration of Helsinki and applicable EU research ethics standards.

Informed Consent Full informed consent documentation is provided before any research participation. Participants are told clearly what the system is, what data is collected, and how it is used.

Right to Withdraw Participants may withdraw at any time, with no consequence and no explanation required. All data associated with the withdrawal request is deleted immediately.

Anonymisation All research data is anonymised at the point of collection. No link is maintained between data and any individual identity. No names, IDs or medical records are requested or stored.

Vulnerable Populations Participants in addiction recovery are a sensitive population. Extra safeguards apply: clinical referral pathways, crisis support visibility, and mandatory researcher oversight during all pilot phases.

Commitments and Guarantees

🔒 No deployment without approval No real-user deployment will occur without prior ethics committee approval. Unconditional.

⚕ Non-clinical by design Clinical boundaries are architectural constraints — not configurable settings. They cannot be overridden.

🇪🇺 European data sovereignty All data stays within EU jurisdiction at all times. No US-based cloud provider is used.

Contact — Ethics Enquiries

For ethics review requests, institutional audit access, or research partnership enquiries:

DPO / Ethics Francisco Moreno · Founder & Data Protection Officer
Anborela OÜ · Pärnu mnt 139c, Tallinn, Estonia
ai@anborela.ee

Ethics documentation, the full research proposal and architecture review requests are available to approved institutional partners upon request.

Ready to co-design the evidence? We are inviting European universities, public health institutes and research bodies to join the scientific steering group.

Start the conversation → Read the proposal

Anborela OÜ · Registration 14746683 · Estonia · GDPR (EU) 2016/679 · EU AI Act 2024
Ethics Statement v1.0 · May 2026 · Subject to revision following ethics committee feedback

Ethics statement