1. Regulatory Classification & Auxiliary Scope (SaMD Positioning)
PaedsCalc is designed and distributed as a Clinical Decision Support System (CDSS) and medical arithmetic calculator. Under the Medical Device Authority (MDA) of Malaysia guidelines on Software as a Medical Device (SaMD), PaedsCalc operates strictly as an auxiliary calculation aid for qualified clinicians.
The software does not make independent diagnostic determinations, does not initiate therapy autonomously, and does not replace the professional clinical assessment of a registered medical practitioner. Under the learned intermediary doctrine, all therapeutic decisions, prescription choices, and drug administrations remain under the direct supervision and sole professional responsibility of the attending prescriber.
2. Clinical Formula Transparency & Prescriber Verification
To prevent unchecked reliance on automated outputs, PaedsCalc provides complete formula and concentration transparency on every calculation card (e.g., displaying exact mg/kg/dose, formulation concentration in mg/mL, and the arithmetic steps utilized). Prescribers are expected to review this computation prior to signing prescriptions or administering medications.
Immediate independent clinical verification is mandatory in:
- Extreme neonatology and premature low-birth-weight infants (<2 kg).
- Patients with renal impairment, hepatic insufficiency, or severe hemodynamic instability.
- Therapeutic drug monitoring scenarios involving narrow therapeutic window agents.
- Off-label or compassionate clinical protocols.
3. Guideline Version Drift & Institutional Protocols
Clinical protocols evolve. Dosing recommendations within PaedsCalc are calibrated against published guidelines (including Malaysian Ministry of Health Paediatric Protocols 4th Edition, Malaysian CPG Neonatal Jaundice 2014, and GINA 2023).
When institutional hospital formularies, revised Ministry of Health circulars, or district health directives supersede published reference versions, clinicians must adhere to the latest approved local protocol. The software author assumes no liability for clinical practice guideline version drift occurring subsequent to published revisions.
4. Limitation of Liability & Indemnity
While every reasonable algorithmic effort is made to maintain fidelity to published Malaysian medical governance, PaedsCalc is provided on an "as-is" and "as-available" basis without warranties of any kind. To the fullest extent permitted by Malaysian law, the software author and contributors disclaim liability for any direct, indirect, incidental, or consequential damages, medication errors, adverse drug reactions, or clinical outcomes arising from the use or misuse of the calculation tools.