LavieuxLabs · Health technology R&D

Decision support software for medication safety and hospital billing.

PharmaDeux shows the physician risky drug combinations in polypharmacy at the moment of prescription. Shield catches reimbursement and audit risks before a claim is submitted. In both, a qualified person makes the final decision and every step is recorded.

Medication safety checks
18
Automated tests
2,480+
Data standard
FHIR R4
MDR target class
Class IIa

Products

Two products, one way of working.

One works on prescriptions, the other on claims. In both, you can see which rule raised an alert, the same input gives the same result, and a qualified person decides.

Clinical decision support · medication safety

PharmaDeux CDSS

Clinical decision support software alerting physicians to cumulative organ burden and toxicity at the moment of prescription. Each alert is shown with the rule and threshold that triggered it.

Safety planes
18
Automated tests
2,480+
Data standard
FHIR R4
Technology readiness level
TRL 4

Revenue integrity · claim pre-check

Shield

Pre-claim revenue integrity platform identifying reimbursement and audit risks before submission. A risky line item goes to the specialist's queue together with the reason.

Risk score, sum of rule contributions
0–100
When the check runs
Pre-claim
Code systems matched
ICD-10 · SUT
Audit log
Append-only

Standards

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.

STD-01In use

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
STD-02In use

Tamper-evident audit trail

Every assessment and decision is written to an append-only log; each entry carries the digest of the one before.

Mechanism
Append-only · digest chain
Scope
Input · rule version · actor · time
Reference
ISO/IEC 27001 logging controls
STD-03In use

Human oversight

The system produces suggestions 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
STD-04In use

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
STD-05In use

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
STD-06In use

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
STD-07Design input

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
STD-08In preparation

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

Verification and decision

A suggestion becomes a decision in four steps.

No step is skipped. Each step's output is the next step's input, and each is recorded.

  1. Input

    Data is converted to a standard format

    A prescription, lab result or claim line is mapped to HL7 FHIR R4 resources. Missing fields are flagged, not silently skipped.

    Output · FHIR R4 resources

  2. Assessment

    The rules run

    A versioned rule set assesses the input. The same input and rule version always give the same result.

    Output · Finding · rule ID · threshold

  3. Approval

    A specialist decides

    The physician, pharmacist or revenue specialist sees the finding with its reason, then approves, corrects or rejects it.

    Output · Decision · reason

  4. Record

    Every step is recorded

    Input, rule version, result and decision are written to an append-only log. Months later, you can reproduce the same decision exactly.

    Output · Append-only log

Pilot programme

Write to us about a pilot.

Together we write down the scope, which data is accessed and what counts as success, in a non-binding Letter of Intent (LOI).

  • Clinical teams

    Clinical pharmacy units, medication safety committees and ward physicians.

  • Revenue cycle teams

    Units handling billing, pre-authorisation and SGK reimbursement.

  • Academic partners

    University hospitals and research groups that want to run a joint validation study.