Healthcare & Life Sciences
AI That Understands Compliance
Your competitors are cutting approval cycles from weeks to hours. The question isn't whether to adopt AI — it's how to deploy it without breaking compliance.
10 weeks → 10 min
New documentation timeline with AI
100%
Data never leaves your infrastructure
20+ years
Systems we integrate with: HL7, FHIR, legacy EHR
The Healthcare AI Challenge
Why 78% of healthcare AI projects stall at compliance review
Data Sensitivity
PHI, clinical notes, patient records — healthcare data is among the most regulated. One breach can cost millions and destroy patient trust.
Regulatory Complexity
GDPR, AI Act, MDR, national healthcare laws. Each jurisdiction adds requirements. Most AI vendors don't understand the nuances.
Accuracy Requirements
92% accuracy sounds good until you realize that's 8 wrong answers in 100. In medication dosing, the acceptable error rate is zero.
Legacy Integration
Hospital systems run on decades-old infrastructure. Connecting AI to EHR, PACS, LIS without disrupting clinical workflows is non-trivial.
European Healthcare Compliance
HIPAA is just the beginning
US-built 'HIPAA-compliant' solutions don't automatically work in Europe. Different legal basis, different technical requirements, different liability structure.
GDPR
- Lawful basis for processing health data (Art. 9)
- Data minimization and purpose limitation
- Right to explanation for automated decisions
- Data residency and transfer restrictions
AI Act
- High-risk classification for medical AI
- Mandatory conformity assessments
- Human oversight requirements
- Technical documentation obligations
MDR
- Software as Medical Device (SaMD) classification
- Clinical evaluation requirements
- Post-market surveillance
- CE marking for clinical AI
Regulatory Timeline
Now
GDPR fully enforced
Aug 2025
AI Act: Prohibited practices
Aug 2026
AI Act: High-risk requirements
2027+
Full AI Act enforcement
Healthcare AI Use Cases
Where AI delivers measurable value
Clinical Documentation
Automate note-taking, coding, and documentation. Clinicians spend 2+ hours daily on paperwork. AI can reclaim that time for patient care.
40-60% reduction in documentation time
Prior Authorization
AI reviews coverage requirements, checks clinical criteria against patient records, proposes determinations. Days become hours.
70% faster authorization processing
Literature Review
Systematic reviews of PubMed, clinical trials, regulatory submissions. What took weeks now takes hours.
10x faster literature synthesis
Drug Discovery Support
Target identification, compound screening, trial design. AI augments researchers, not replaces them.
Months saved in early discovery phases
Patient Communication
Triage incoming messages, identify urgent cases, draft responses for clinician review. Never miss a critical flag.
90% of routine queries handled automatically
Regulatory Submissions
Cross-reference documents, ensure consistency, automate formatting. Reduce submission errors and review cycles.
50% reduction in submission prep time
The Human Oversight Question
Human oversight isn't optional.
It's the product.
The best healthcare AI systems are designed around human decision-making, not to replace it. AI handles volume and pattern recognition. Humans handle judgment and accountability. We build systems where AI augments clinicians — with clear escalation paths, confidence thresholds, and audit trails.
How It Works
Three-layer architecture for compliant healthcare AI
Healthcare AI Agents
Connect to Your Data
MCP Connectors
Teach How to Operate
Agent Skills
Foundation Layer
Claude Models
Haiku / Sonnet / Opus
Human Oversight
HITL Integration
Compliance Engine
HIPAA / GDPR / AI Act
Audit Trail
Full Traceability
Kenaz builds all three layers — from MCP connectors that integrate with your existing systems, through custom Agent Skills for your specific workflows, to deployment with proper compliance controls.
How We Help
Healthcare AI infrastructure for European organizations
PHI/PII Data Preparation
Clean your clinical data for AI. Remove identifiers, maintain statistical utility, full audit trail for regulators. Your data never leaves your infrastructure.
Learn more →GDPR/AI Act Compliance
Not just checkboxes — actual compliance that survives audits. Documentation, risk assessment, technical controls designed for healthcare.
Learn more →MCP Integration
Connect AI models to your clinical systems using Model Context Protocol. EHR, PACS, LIS — secure, auditable connections.
Learn more →RAG & Knowledge Systems
Build clinical knowledge bases that actually work. Medical literature, protocols, guidelines — indexed and retrievable.
Learn more →Latest: Claude for Healthcare
Anthropic just announced HIPAA-ready Claude at J.P. Morgan Conference. What it means for European healthcare organizations.
Read the analysis →FAQ
Can we use US healthcare AI platforms in Europe?
Technically yes, legally complicated. HIPAA compliance doesn't satisfy GDPR. You need additional controls: data residency, legal basis documentation, AI Act risk assessment. We help bridge that gap.
What's the AI Act impact on medical AI?
Medical devices and clinical decision support are classified as high-risk AI. Mandatory conformity assessments, human oversight requirements, detailed technical documentation. Timeline: August 2026 for most provisions.
How long to get healthcare AI compliant?
Depends on your starting point. Clean data infrastructure: 2-3 months. Starting from scratch with legacy systems: 6-12 months. Assessment takes 2-3 weeks.
Do you handle clinical data directly?
We operate under Swiss data protection law (equivalent to GDPR). All processing on your infrastructure or Swiss-hosted systems. No clinical data leaves the EU/EEA unless explicitly authorized.
What about liability for AI-assisted decisions?
AI should augment, not replace clinical judgment. We design systems with mandatory human review for critical decisions. Liability stays with the licensed practitioner — AI is a tool, not a decision-maker.
Ready to Deploy Healthcare AI?
The regulatory clock is ticking. Companies building compliant AI infrastructure now will have years of competitive advantage. Start with an assessment — we'll show you exactly where you stand.
Request Healthcare AI Assessment