Alto is built with a safety-first architecture, ensuring clinical automation never comes at the expense of data sovereignty or regulatory compliance.
Enterprise-Grade Security for Clinical Infrastructure
We don't just meet standards. We build to them.
CE Class I Medical Device
Alto is registered with the MHRA in Northern Ireland as Software as a Medical Device. Unlike unregulated black-box AI, Alto is subject to rigorous clinical evaluation and post-market surveillance requirements.
Integrated Management System
Alto operates under a quality management system covering MDR, the EU AI Act, GDPR, and DBC Clinical requirements. Our compliance posture is documented, auditable, and reviewed continuously.
Independent validation
Alto's clinical logic has been independently validated through academic research partnerships, a clinical advisory board, and ongoing evaluation with Health Innovation Hub Ireland.
For the full picture, see our Clinical Integrity page.
How we handle data is as important as the data itself.
Zero-Training Policy
Alto does not use any customer data to train our foundational models. Your data stays yours.
GDPR and Data Sovereignty
Fully compliant with UK and EU GDPR. Alto acts as a Data Processor, ensuring your organisation retains full ownership and control of all patient information.
Data Minimisation
Alto only extracts the specific clinical markers required for vetting, appropriateness assessment, and prioritisation. Unnecessary data is never processed or stored.
Localised Cloud Hosting
Alto uses AWS Dublin regional infrastructure to ensure data remains within your jurisdiction and meets local data sovereignty requirements.
Transparency at every step.
Dual AI Human-in-the-Loop Architecture
Alto's Assistant + Judge system ensures AI never operates in isolation. Every output is independently audited before it influences a clinical recommendation.
Built-in Quality Assurance
Every clinical extraction is linked back to its source document, providing a 1:1 audit trail for the clinician in charge.
Field-Level Confidence
Alto surfaces a confidence rating at the field level for every data extraction, making uncertainty visible rather than hiding it behind a single output.
Explainable AI
Every recommendation Alto makes is accompanied by transparent reasoning drawn directly from the referral document. No black-box results.
Privacy by Design
Alto's architecture embeds data minimisation, purpose limitation, and access control at the system level.
Redundant security layers to protect the clinical workflow.
Encryption at Every Stage
Data is encrypted using AES-256 at rest and TLS 1.3 in transit.
Access Control
Role-Based Access Control (RBAC) and Multi-Factor Authentication (MFA) ensure only authorised personnel interact with clinical data.
Infrastructure
Alto runs on AWS with zero-downtime architecture and regional data hosting.
The Blackrock Protocol: Algorithmic safety before live deployment.
No referral pathway changes overnight. And every patient cohort has unique edges. So very deployment moves through the same staged validation, developed on the basis of established best practice:
Synthetic data. Our internal medics build referrals internally that mirror the real thing and test the system in a controlled environment.
Historic data. We then test against the hospital's own historic referrals, so performance is measured on real cases rather than assumptions.
Shadow mode. Alto runs concurrently alongside the existing process on live data, behind the scenes, with every field checked. Nothing is pushed live.
Supported live deployment. Only once shadow mode is signed off do we move to a live, supported deployment.