For CMOs, CIOs, MTB coordinators, oncologists
The safe second look on every tumor board recommendation.
POLI8 integrates into existing MTD workflows via HL7 FHIR R4. No new interface for clinicians.
Role and liability
POLI8 is a tool. Not a decision-maker.
POLI8 does not make therapy decisions. The system generates a traceable second opinion. Responsibility always remains with the treating physician.
The 3-minute bottleneck
Complexity grows. Discussion time does not.
The literature on multidisciplinary tumor boards is consistent: without structured support, discussion depth and guideline concordance decline as case complexity increases.
Clinical workflow
Three phases. Three roles.
Preparation
Structured case data is uploaded 24 to 48 hours before the board. POLI8 matches guideline recommendations with source references.
Discussion at the screen
During the board discussion, POLI8 shows source-linked evidence for each option. Deviations are documented with rationale.
Audit-grade record
The decision is documented with source, timestamp, board participants, and reasoning trace. Audit-proof at all times.
Data sovereignty
Four-stage anonymisation pipeline.
Identifying data never leaves your hospital network. POLI8 processes only anonymized clinical payloads.
Pseudonymisation
Direct identifiers are removed at the HIS interface before transmission. FHIR R4 compliant.
Structural normalisation
FHIR R4 resources are normalized to ICD-10-GM, OPS, and SNOMED CT coding standards.
Differential privacy
Quasi-identifiers are anonymized under documented epsilon-budget (differential privacy).
Audit log separation
Reasoning traces are stored separately from clinical content and cannot be re-identified.
Architecture
White Box vs Black Box.
| Dimension | POLI8 White Box | Generalist clinical chat |
|---|---|---|
| Source attribution | Every statement references guideline, section, version date, level of evidence. | Citations \"best effort\", sometimes synthetic or unverifiable. |
| Guideline currency | S3, ESMO, NCCN, EAU, AUA, version-pinned with an update pipeline. | Web crawl without version control, update lag unclear. |
| Audit log | Reasoning trace persisted, reproducible, MDR-suitable. | Stateless, not reproducible, legal liability nightmare. |
| Regulatory path | MDR Class IIa in preparation, EU AI Act high-risk conformity planned. | Consumer or general-purpose AI without medical device status. |
| Hallucination control | Constrained RAG with refusal outside the guideline corpus. | Open generation, hallucination rate documented as problematic. |
| Data residency | EU hosting (Frankfurt), DSGVO-compliant, on-premise option. | Varies by provider, often US cloud without SCC clarity. |
Clinical validation
Pilot operation since 2025 · over 90% concordance with guidelines.
POLI8 has been in prospective pilot operation at the Swiss Urology Competence Center since 2025. We measure guideline concordance, time-to-decision, and documentation completeness.
Concordance rate
Over 90% agreement with board decision in ongoing pilot evaluation.
Preparation time
Over 30% reduction in case preparation time compared with manual workflow.
Discrepancy detection
Detection of conflicts between S3 and NCCN where local recommendations differ.
Compliance
Procurement, IT, legal, data protection: one document.
POLI8 is documented so that procurement, IT security, data protection, and medical devices can evaluate it from a single document set.
- EU AI Act
- High-risk classification under Art. 6(1)(b). Conformity assessment per Annex IX planned.
- MDR Class IIa
- Registration as Class IIa medical device under EU Regulation 2017/745 in preparation.
- GDPR
- Four-stage anonymization pipeline, EU hosting Frankfurt, data processing per Art. 28.
- ISO 13485
- Quality management system for medical devices. Processes documented and audited.
- ISO 14971
- Risk management for medical devices. Systematic risk analysis and evaluation process.
- BfArM Registration
- Registration with the Federal Institute for Drugs and Medical Devices prior to market placement.