SAFETY & QUALITY
OUR APPROACH
Clinical AI safety, built on three pillars
Regulatory compliance
Tucuvi Health Manager is CE-marked as a Class IIb medical device, developed under our ISO 13485-certified quality management system. Our ISO 27001-certified information security management system, together with GDPR compliance, supports the safe and secure operation of clinical AI.
Specialised agents within an approved scope
Specialised agents handle defined tasks within an approved scope. Deterministic rules govern the permitted actions and escalation, while conversational models support natural interactions.
Ongoing evaluation and human oversight
Scenario testing evaluates behaviour before launch. Once live, AI monitoring helps identify conversation-quality patterns, while AI Sentinel and human-in-the-loop review support the quality checks configured for each programme.
Medical device rigor
Class IIb CE-marked medical device
Tucuvi Health Manager (THM) is software as a medical device (SaMD), CE-marked as Class IIb under Regulation (EU) 2017/745 and certified by the notified body ECM (CE 1282). LOLA, Tucuvi’s AI agent, is part of THM and is covered by this marking.
THM is developed under an ISO 13485-certified quality management system, with risk management, clinical evaluation and a software lifecycle compliant with EN 62304.
This certification demonstrates that it meets the safety and performance requirements set by the MDR for use in complex care settings.
REGULATORY COMPLIANCE
Safe, clinically validated AI
Tucuvi Health Manager, including LOLA, is designed for the security reviews health systems run before go-live.
HIPAA. PHI handled under a Business Associate Agreement, with data minimization.
SOC 2. Our security controls are independently audited, with the report available to your security team on request.
Encryption and access. PHI encrypted in transit and at rest, role-based access controls and single sign-on with your identity provider.
Audit and monitoring. A full audit trail links every output to its source, with prompt injection protection and continuous monitoring.
AI governance. Accountability under BS 30440 and alignment with the EU AI Act.
Medical device certification. CE-marked as a Class IIb Software as a Medical Device (SaMD) under the EU Medical Device Regulation. An independent notified body audits the product’s clinical evaluation, risk management and quality system (ISO 13485, IEC 62304), before and after launch.
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https://vimeo.com/1239411543/5f699643b2?share=copy&fl=sv&fe=ci
MULTI-AGENT APPROACH
Specialised agents, working within a defined scope
LOLA, the agent within Tucuvi Health Manager, coordinates a network of purpose-built AI agents, from appointment booking to post-discharge care.
Each agent uses the AI model and tools best suited to its task, and together they support patients across the entire care pathway.
All of them work within a defined protocol and under human oversight.
https://vimeo.com/1239411543/5f699643b2?share=copy&fl=sv&fe=ci
MULTI-AGENT APPROACH
Specialized agents, working within a defined scope
LOLA, the AI agent within Tucuvi Health Manager, coordinates a network of purpose-built AI agents, from appointment scheduling to post-discharge care.
Each agent uses the model and tools best suited to its task, and together they support patients across the care journey.
All of them work within a defined workflow and under human oversight.
QUALITY PROCESS
Safety first, with control at every stage
Our process combines automated testing, structured feedback, controlled rollout and ongoing evaluation. Each programme defines the checks and review arrangements relevant to its scope.
Scenario-based testing
Before launch, automated scenarios test expected conversations and difficult situations. Checks cover the actions LOLA takes, the information it records, escalation behaviour and the quality of its responses. Issues lead to fixes and repeat tests.
Empathy and user experience validation
Clinicians and experts in conversation design and quality role-play different patient profiles to refine each agent’s tone, pacing and accessibility.
Controlled rollout
The first live interactions are manually audited for performance and empathy before rollout expands.
Human-in-the-loop review
AI Sentinel checks completed interactions against the programme’s configured quality criteria. Cases requiring human judgement go to Tucuvi’s review team before results are released.
Scenario-based testing
Before launch, automated scenarios test expected conversations and difficult situations. Checks cover the actions LOLA takes, the information it records, escalation behavior and the quality of its responses. Issues lead to fixes and repeat tests.
Empathy and user experience validation
Clinicians and experts in conversation design and quality role-play different patient profiles to refine each agent’s tone, pacing and accessibility.
Controlled rollout
The first live interactions are manually audited for performance and empathy before rollout expands.
Human-in-the-loop review
AI Sentinel checks completed interactions against the program’s configured quality criteria. Cases requiring human judgment go to Tucuvi’s review team before results are released.
REGULATORY COMPLIANCE
Built to protect patient data
Tucuvi Health Manager, including LOLA, is a reproducible and secure platform for managing patient data and AI-supported care tasks.
Information security. ISO 27001, ENS High category for the Spanish public sector and Cyber Essentials certifications. In the UK, compliance with the NHS Data Security and Protection Toolkit.
AI governance. Accountability under BS 30440 and alignment with the EU AI Act.
Data protection. GDPR and HIPAA compliance, with a Data Protection Officer and data minimization in practice.
https://vimeo.com/1239414558/158f49c28c?share=copy&fl=sv&fe=ci
BELOW THE WATERLINE
What clinically safe AI agents are made of
Designing the conversation and connecting it to patient data is only the visible part. Below it sit six layers of work that support the safety of every interaction within Tucuvi.
https://vimeo.com/1239283194/94e55c73a4?fl=tl&fe=ec&share=copy
https://vimeo.com/1239283194/94e55c73a4?fl=tl&fe=ec&share=copy
