Reproducible decisions
No generative model in the decision path. The same input and rule version always give the same output.
- Mechanism
- Versioned rule engine
- Automated tests
- 2,480+
- Reference
- IEC 62304 life cycle
Standards and references
The standards the rule engine stands on.
The source of every score, formula and code in one place. Physicians can check where a formula comes from, and IT teams can check the data model.
Principles
Eight rules both products follow.
We list each standard we work against and where we stand on it. Where something is not finished yet, we say so.
Tamper-evident audit trail
Every assessment and decision is written to an append-only log. Each entry carries the digest of the previous one.
- Mechanism
- Append-only · digest chain
- Scope
- Input · rule version · actor · time
- Reference
- ISO/IEC 27001 logging controls
Human oversight
The system produces findings and risk signals. A qualified clinician or specialist makes the final decision.
- Mechanism
- Human-in-the-loop queue
- Record
- Approval · correction · reason
- Reference
- MDR Annex I · general safety requirements
Explainability
Every alert and score is shown with the rule, parameter and threshold that triggered it.
- Output
- Rule ID · value · threshold
- Score
- Σ rule contributions
- Range
- 0–100
Clinical measurement protocols
Clinical parameters are calculated with the correct method and unit. A score is never presented as a measurement.
- QTc
- Fridericia · QT / ∛RR · ms
- QT risk
- Tisdale score · 0–21 points
- Kidney
- eGFR · CKD-EPI 2021 · mL/min/1.73 m²
Interoperability
The clinical data model is built on HL7 FHIR R4 resources.
- Standard
- HL7 FHIR R4
- Resources
- MedicationRequest · Observation · Condition
- Terminology
- ATC · ICD-10 · UCUM
Data security and privacy
Role-based access and per-institution isolation; personal data is processed only as far as needed.
- Access
- RBAC · least privilege
- Isolation
- Multi-tenant
- Framework
- KVKK Art. 12 · ISO/IEC 27001
Regulatory readiness
PharmaDeux is positioned as medical device software under MDR Rule 11. It does not have a CE mark yet.
- Regulation
- MDR 2017/745 · Rule 11
- Target class
- SaMD · Class IIa
- Processes
- IEC 62304 · ISO 14971
Reference pages
Scores, formulas and data models.
Each page gives the formula or data model, the thresholds, the codes used and the original source.
- ClinicalTisdale QT risk scoreQT prolongation risk in hospitalised patients from ten risk factors; 0–21 points, ≥11 high risk.0–21 pointsQTc ≥450 msFridericiaProductPharmaDeux · QT risk engineStatusImplemented algorithmically · passes synthetic testsTisdale JE et al. Circ Cardiovasc Qual Outcomes 2013Open page
- ClinicalCKD-EPI 2021 eGFReGFR from creatinine without a race coefficient; KDIGO categories and renal dose check principles.LOINC 98979-8mL/min/1.73 m²G1–G5ProductPharmaDeux · renal dose checkStatusImplemented algorithmically · passes synthetic testsInker LA et al. N Engl J Med 2021Open page
- TechnicalHL7 FHIR R4 integrationMedicationRequest and Observation resources, code systems, example JSON and integration architecture.FHIR R4ATCLOINCUCUMProductPharmaDeux and Shield · data layerStatusData model integrated · no live HIS connectionHL7 International · FHIR R4 (v4.0.1)Open page
- Administrative / AuditSUT billing auditShield's pre-submission rule engine: four audit planes, a 0–100 risk score and the audit trail.EK-2BEK-2CICD-100–100ProductShield · billing auditStatus3 of 4 planes implemented · tested on synthetic claimsSGK · Health Implementation Communiqué (SUT)Open page
For quality and regulatory status, see Quality, information security and MDR.
This page is for information only and is not for clinical decisions. Decisions rest on the product information (SmPC/PIL), current guidelines and the physician's judgement. Last updated: 13 October 2026