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Use Cases · Healthcare & Pharma

AI Agents for
Healthcare & Pharma

Automate the most critical processes in the healthcare sector with AI agents designed with GDPR, HIPAA and ISO 27001 built in from the ground up. Without compromising patient safety or data integrity.

Compliance: ISO 27001 HIPAA GDPR Art. 9 ENS High
95% Reduction in internal medical query time
80h+ Saved per pharmacological audit
100% Patient data traceability

Healthcare lives a paradox

Healthcare organisations manage the most sensitive data in the world and yet still rely on slow, costly, error-prone manual processes.

AI agents are not science fiction: they are the answer to that paradox. But only if they are designed with security and compliance built in from the core.

Without AI
  • Manual pharmacovigilance: 40h/month
  • ER triage: 3h average wait
  • Trial management: 60% time on paperwork
  • Audits: 80h/cycle
With Delbion AI
  • Pharmacovigilance: automated 24/7
  • Triage: real-time prioritisation
  • Trials: focus on science, not admin
  • Audits: continuous, not periodic

6 Production Use Cases

Each case includes the real problem, the agent architecture and measurable results

Pharma

Autonomous Pharmacovigilance Agent

Continuous monitoring of drug safety signals at scale, with automatic alerts and regulatory reports ready for EMA/FDA.

AI visualisation of pharmacovigilance: neural network processing pharmacological safety signals

The challenge

Pharmacovigilance teams monitor thousands of sources (scientific publications, social media, clinical records, EudraVigilance databases) manually. A team of 5 people spends more than 40 hours a month just on signal review. Regulatory deadlines are inflexible.

How the agent works

Continuous ingestionPubMed, EudraVigilance, Twitter/X, internal records
Signal analysisNLP classification + automatic causal reasoning
Prioritised alertsOnly relevant signals reach the medical team
Regulatory reportsICH E2B(R3) automatically generated for EMA/FDA

Measurable results

-75%Manual review hours
24/7Source coverage
100%Regulatory traceability
HIPAA ICH E2B(R3) ISO 27001 GDPR
Hospital

Clinical Triage and Prioritisation Assistant

Agent that assists emergency staff in prioritising patients based on clinical severity, history and available resources in real time.

AI visualisation of clinical triage: prioritisation engine with ECG signals and emergency channels

The challenge

In emergency rooms, manual triage depends on the individual judgement of the on-duty nurse, with incomplete information under pressure. A patient with a heart attack may wait if they present atypical symptoms. The margin for error has direct consequences on lives.

How the agent works

Structured data collectionSymptoms, vital signs, clinical history (EHR)
Multimodal analysisComparison with clinical guidelines + anonymised similar cases
Evidence-based recommendationPriority level + auditable reasoning for the clinician
Continuous monitoringAutomatic re-prioritisation if vital signs change

Measurable results

-40%Time to medical assessment
+30%Early detection of critical cases
0Decisions without audit trail
Human-in-the-loop: The agent assists the clinician. The final clinical decision always rests with the healthcare professional.
HIPAA GDPR Art. 9 ISO 27001 MDR 2017/745
Pharma / CRO

Clinical Trial Optimisation

Agents that automate document management, protocol tracking and regulatory reporting in clinical trials, reducing administrative burden by 60%.

AI visualisation of assisted diagnosis: brain scan with real-time pathology analysis

The challenge

More than 60% of trial coordinators' time is spent on administrative tasks: consent management, CRF updates, adverse event tracking and preparing reports for EMA/FDA. Less than 40% can be dedicated to the science.

How the agent works

Intelligent document managementCRFs, consents and protocols automatically organised
Deviation monitoringAutomatic detection of protocol deviations and adverse events
Regulatory reportsSUSARs, INDs and Clinical Study Reports generated automatically

Measurable results

-60%Coordinator administrative burden
-3 wkEMA report preparation time
0 gapsUndetected protocol deviations
ICH GCP E6(R3) 21 CFR Part 11 GDPR ISO 27001
Hospital / Clinic

24/7 Patient Care Agent

Conversational assistant that answers post-consultation queries, manages appointments, sends medication reminders and detects alarm signals requiring urgent attention.

AI visualisation of chronic care: continuous cycle of wearable data and real-time health predictions

The challenge

30% of calls to healthcare centres are post-appointment queries or appointment management that require no medical intervention. They saturate switchboards, create waiting times and frustrate patients. A chronic patient who does not receive a quick response may end up in the emergency room unnecessarily.

How the agent works

Secure omnichannelEncrypted WhatsApp, dedicated app or patient portal
Personalised clinical contextControlled access to the patient's EHR (only what is needed)
Intelligent escalationAlarm signals detected → immediate referral to doctor

Measurable results

95%Queries resolved without intervention
-35%Avoidable ER visits
4.8/5Patient satisfaction
Least privilege principle: The agent only accesses the clinical data strictly necessary for each interaction, with the patient's explicit consent.
HIPAA GDPR Art. 9 ENS High ISO 27001
Compliance

GDPR Compliance Agent for Health Data

Continuous monitoring of GDPR compliance in the processing of special category data (Art. 9), with automated rights management and security breach alerts.

AI visualisation of regulatory document management: document vault with automatic classification

The challenge

Health data is a special category under GDPR (Art. 9): non-compliance fines can reach 4% of global turnover. Hospital DPOs manually handle rights requests, with the risk of exceeding the 30-day legal deadline.

How the agent works

GDPR rights intake and classificationAccess, rectification, erasure and portability requests handled automatically
Legal deadline trackingAutomatic alerts before the 30-day deadline expires
Breach monitoringDetection and notification to the supervisory authority within 72h if required

Measurable results

0GDPR requests past deadline
-70%DPO workload on rights management
72hGuaranteed breach notification
GDPR Art. 9 LOPDGDD ISO 27001 ENS High
Hospital / Clinic

Internal Query Agent for Clinical Teams

Clinical and regulatory knowledge base accessible via secure chat: protocols, clinical guidelines, internal procedures and regulations. Answers in seconds, with sources cited.

AI visualisation of clinical knowledge base: data network connecting protocols and regulatory documentation

The challenge

An on-call doctor spends an average of 20 minutes searching intranets and PDFs for the answer to a protocol query. Multiply that by 500 doctors. That is 10,000 hours a month lost in internal searches. The documented Suzano case with Google Gemini reduced that time by 95%.

How the agent works

Internal documentation ingestionProtocols, clinical guidelines, regulations, drug datasheets
Role-based secure accessEach professional sees only information within their clinical scope
Responses with cited sourcesMinimises hallucinations: always cites the source document with page number

Measurable results

95%Reduction in internal search time
<30sAverage response time
100%Responses with cited source
Analogous case: Suzano reduced internal search time by 95% for 50,000 employees with a similar agent on Google Gemini. See case →
ISO 27001 GDPR ENS High On-Premise

Why Delbion in healthcare

Not just AI. AI designed for environments where errors have real consequences.

Human-in-the-loop by design

Our agents never make autonomous clinical decisions. They always assist, never decide. The clinician retains full control.

End-to-end patient data encryption

All clinical data is encrypted in transit and at rest. We support 100% on-premise deployments where data cannot leave the hospital perimeter.

Complete and immutable audit trail

Every agent action is logged: what data it accessed, what it reasoned, what it recommended. Audit available to regulators at any time.

Specialised regulatory expertise

We know GDPR Art. 9, HIPAA, MDR, GCP ICH E6(R3), LOPDGDD. You do not need to teach us your sector's regulatory framework: we already master it.

EHR and legacy system integration

We connect with SAP, Epic, Cerner, proprietary EHRs and hospital legacy systems. The architecture adapts to your environment, not the other way around.

24/7 post-deployment monitoring

The work does not end at production. Our team continuously monitors performance, security and regulatory compliance.

Certificaciones y marcos de cumplimiento

ISO 27001 Certified ENS Alto Compliant NIS2 Compliance HIPAA Compliant GDPR Ready

Built by experts.
Overseen by clinicians.
Protected by law.

The people behind every technical, clinical and regulatory decision.

Carlos Salgado, CEO Delbion
Involved
Carlos Salgado
CEO · Founder, Delbion

"We have spent years protecting critical infrastructures. We now apply that same security rigour to Artificial Intelligence in healthcare."

ISO 27001 · Critical infrastructures
Jacobo, AI Agentic Expert
Technical
Jacobo
AI Agentic Expert

"We design agents that act with surgical precision: every decision is anchored to real data and every action is fully traceable."

Autonomous agents · Multi-agent architecture
Bryn Bennett, Strategic Advisor GTM
Strategy
Bryn Bennett
Strategic Advisor · GTM

"Bringing AI to the healthcare market requires more than technology: it requires trust, credibility and a strategy that resonates with clinical decision-makers."

Go-to-market · Commercial strategy · Digital health
Pablo Navarro, Chief Medical Officer
Clinical
Pablo Navarro
Chief Medical Officer · Lead Clinical Advisor

"Delbion's technology understands the reality of an emergency room. Agents assist with millimetre precision, but the final clinical judgement always belongs to the specialist."

Human-in-the-loop · Patient safety
Aine Vidal, Data Protection Officer
Aine Vidal
Data Protection Officer · Compliance Lead

"We design the architecture assuming the maximum regulatory risk level. Complying with GDPR, HIPAA and ENS High is not an option: it is our standard from the very first line of code."

GDPR Art. 9 · HIPAA · ENS High
Paul Godzinski, Chief Technology Officer
Technical
Paul Godzinski
Chief Technology Officer · Head of AI

"Our RAG models are deterministic. If the AI cannot find the exact answer in your clinical or official protocols, it does not invent it. It only cites auditable truths."

RAG with source-anchored answers and full traceability · Minimal hallucinations

Frequently asked questions: AI in Healthcare

No. Our agents are designed with the human-in-the-loop principle: they assist, inform and recommend, but the final clinical decision always rests with the healthcare professional. This is a legal requirement in most cases (MDR, AI Act) and a non-negotiable ethical principle.

Completely flexible: private cloud in the EU (GDPR compliant), hybrid infrastructure, or 100% on-premise within the hospital perimeter. For special category data (GDPR Art. 9), we recommend on-premise or sovereign cloud. Patient data never leaves the defined jurisdiction.

The agent always operates within the existing legal basis (healthcare, art. 9.2.h GDPR). If the use case requires additional consent (e.g. use of data to improve the system), we integrate the collection and management of digital consent directly into the agent flow, with an auditable record.

This is the most important risk and the one we control most rigorously. We use RAG (Retrieval Augmented Generation) architecture: the agent can only respond based on official documentation you provide (protocols, clinical guidelines, datasheets). It always cites the source with document number and page. If it cannot find the answer in the authorised sources, it says so explicitly rather than inventing it.

We have a documented incident response plan specific to special category data. In the event of a breach: automatic containment within minutes, notification to your DPO within 2 hours, and support for notifying the supervisory authority within the 72-hour legal deadline. All forensic evidence is preserved in the immutable audit trail.

AI systems in the healthcare sector are classified as high-risk under the AI Act (Annex III). We design our agents complying with the requirements for high-risk systems: documented risk management, verifiable robustness and accuracy, integrated human oversight, transparency about capabilities and limitations, and registration in the EU database where applicable.

Free assessment

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1 hour of specialised healthcare consultancy. Analysis of your use case, ROI estimate and compliance gap map. No commitment.