1. 📐 Scoring Method
Likelihood (5 levels)
- Rare (1): <5% · "happened once industry-wide"
- Unlikely (2): 5-20% · "rare but real precedent"
- Possible (3): 21-50% · "expect occasionally"
- Likely (4): 51-80% · "expect quarterly"
- Almost Certain (5): >80% · "monthly minimum"
Impact (5 levels)
- Negligible (1): <RM 5K · no patient harm
- Minor (2): RM 5-50K · minor inconvenience
- Moderate (3): RM 50-500K · feature delay weeks
- Major (4): RM 500K-2M · phase slip · reputation
- Catastrophic (5): >RM 2M · patient harm · legal · project halt
Risk Score = Likelihood × Impact (1-25). 1-4 GREEN · 5-9 YELLOW · 10-15 ORANGE · 16-25 RED.
2. 📊 Risk Matrix
Negligible (1)
Minor (2)
Moderate (3)
Major (4)
Catastrophic (5)
Almost Certain (5)
5
10
15
20
25
Likely (4)
4
8
12
R-12 GPU lead
R-12 GPU lead
16
20
Possible (3)
3
6
R-13 cost
R-13 cost
9
R-09 BM NLU
R-11 panel API
R-15 UX iter
R-09 BM NLU
R-11 panel API
R-15 UX iter
12
R-04 klinik pull
R-06 skill decay
R-04 klinik pull
R-06 skill decay
15
R-05 audit gap
R-05 audit gap
Unlikely (2)
2
4
6
8
R-08 jailbreak
R-08 jailbreak
10
R-01 dx miss
R-02 RX error
R-03 PDPA leak
R-01 dx miss
R-02 RX error
R-03 PDPA leak
Rare (1)
1
2
3
4
5
R-07 Doc Zam pull
R-07 Doc Zam pull
1-4 GREEN (accept)
5-9 YELLOW (monitor)
10-15 ORANGE (mitigate)
16-25 RED (active)
3. 🔴 Critical Risks (RED zone · score ≥ 10)
R-01
False-Positive Diagnosis
Score: 10 (Unlikely × Catastrophic)
- Description: AI cadang dx salah, klinisin trust tanpa challenge → patient harm.
- Trigger: Doctor over-rely AI · novel symptoms · BM rojak NLU miss
- Mitigation: HITL mandatory · citation card visible · DDx alternatives shown · Doc Zam clinical review Q3 (50 scenarios) · monitoring "doctor edit ratio" as quality signal
- Contingency: Hot-fix sprint inserted · feature flag disable CDSS suggestion · clinical incident review board
- Owner: Doc Zam (clinical review) + Founder (system fix)
- Status: 🟢 Active mitigation · Q3 gate prep ongoing
R-02
Medication Error (DDI/Dose/Allergy Miss)
Score: 10 (Unlikely × Catastrophic)
- Description: Pharmacy dispense salah ubat / dose / allergy patient terlepas.
- Trigger: NPRA DB outdated · pharmacist auto-trust AI · barcode skip · weight not captured
- Mitigation: Closed-loop verify · barcode at dispense · pharmacist final approve gate · DDI severity matrix · allergy registry global
- Contingency: Adverse Reaction Loop M6 auto-flag · clinical incident workflow · NPRA pharmacovigilance report
- Owner: Pharmacist + Doc Zam + Founder
- Status: 🟢 Active · M5 spec dah include 3-layer check
R-03
PDPA Breach (PII Leak ke Cloud LLM)
Score: 10 (Unlikely × Catastrophic)
- Description: PII (IC · nama · alamat) terhantar ke cloud LLM tanpa strip · PDP commissioner fine RM 500K · reputation damage.
- Trigger: PII filter regex miss · NER false negative · cloud burst feature flag accidentally ON · audit log gap
- Mitigation: M9 PII strip pre-LLM (regex + NER hybrid · 95% target) · per-tenant key · on-prem default · cloud burst feature flag default OFF · Q5 quarterly self-audit
- Contingency: <72h breach notify PDP · DPO trigger · audit forensic · external counsel engagement
- Owner: Founder (DPO) · Eng Lead (technical)
- Status: 🟢 M9 Sprint 1.1 priority · PII filter Day 5-6
R-12
GPU Hardware Lead Time Slip
Score: 12 (Likely × Moderate)
- Description: H100/L40S GPU lead time bertambah ke 8+ minggu · pilot delay.
- Trigger: Global supply constraint · NVIDIA allocation policy · vendor priority queue
- Mitigation: Order Mid-End L40S 4 weeks early (1 May order) · cloud burst as Plan B · alternative vendor (AMD MI300) backup spec · workstation 4090 for dev
- Contingency: Cloud burst gpt-4o-mini until hardware arrive (cost +RM 15K · pilot still go) · negotiate consumer 4090 multi-GPU rig short-term
- Owner: Founder (procurement) · DevOps (deployment)
- Status: 🟡 Monitoring · order placement decision needed by 1 May
R-04
Klinik Pilot Pull Out
Score: 12 (Possible × Major)
- Description: Klinik partner cancel agreement before pilot · phase 2 delay 4-8 weeks.
- Trigger: Klinik internal restructuring · MOH inspection scheduling · staff turnover · cold feet
- Mitigation: 2-3 backup klinik LOI signed by 1 Jun · pilot agreement dgn explicit exit clause + ALESA bear setup cost · regular weekly comm with klinik owner
- Contingency: Switch to Backup Klinik B (14-day onboarding) · adjust pilot scope · communicate transparently with Doc Zam
- Owner: Founder (BD) · Doc Zam (clinical relationships)
- Status: 🟡 BD outreach to 3 candidate klinik in May
R-06
Skill Decay (Junior Doctor Over-Rely AI)
Score: 12 (Possible × Major)
- Description: Junior klinisin terlalu bergantung pada AI scribe + CDSS · long-term competency loss · MMC concern.
- Trigger: AI used >90% encounters · doctor edit ratio <10% (signal of blind acceptance) · junior trainee usage pattern
- Mitigation: "Blind mode" toggle (AI hide recommendations · doctor work first) · periodic competency check (monthly · simulated cases) · MMC self-attestation framework · training hours guideline
- Contingency: Mandate blind mode rotation · faculty training intervention · pause feature for affected doctor · educational module deployment
- Owner: Doc Zam (clinical training) + Klinik admin
- Status: 🟢 Designed in M4 spec · "blind mode" feature flag
R-05
Audit Gap (MOH Inspection Failure)
Score: 15 (Possible × Major-leaning-Catastrophic)
- Description: MOH audit lihat audit trail gaps · clinical action tak boleh trace · klinik license risk.
- Trigger: Audit log write fail (DB outage) · log retention policy not met · access control loose · feature flag drift unaudited
- Mitigation: M9 WORM audit log · 7-yr retention · Redis stream buffer · daily reconciliation · DR drill quarterly · MOH report template
- Contingency: External compliance consultant urgent · audit gap remediation sprint · pause new klinik onboarding
- Owner: Founder (DPO) + Compliance consultant (Phase 3)
- Status: 🟢 M9 spec robust · Sprint 1.1 cross-cut foundation
4. 🩺 Clinical Safety Risks
| ID | Risk | Score | Mitigation | Owner |
|---|---|---|---|---|
| R-01 | False-positive dx | 10 | HITL · citation · DDx alt | Doc Zam |
| R-02 | Medication error | 10 | Closed-loop · barcode · pharmacist final | Pharmacist + Doc Zam |
| R-08 | HITL bypass jailbreak | 8 | Server-side enforce · 30-prompt suite · audit | Eng Lead |
| R-14 | SOAP hallucination | 9 | Doctor MUST review · edit-ratio metric · regression set | Doc Zam + Eng |
| R-16 | Whisper BM mistranscribe | 6 | Custom medical vocab biased decoding · live preview | Eng (prompt + ASR) |
| R-17 | Red-flag false negative | 6 | 50-scenario regression · over-escalate bias · monitor false-neg rate | Doc Zam + Eng |
| R-18 | Self-care advice harmful | 4 | Approved library hardcoded · LLM only paraphrase · cite source | Doc Zam |
5. 🔒 Privacy & Compliance Risks
| ID | Risk | Score | Mitigation | Owner |
|---|---|---|---|---|
| R-03 | PDPA breach (PII leak) | 10 | Strip pre-LLM · per-tenant key · on-prem default | Founder DPO |
| R-05 | Audit gap (MOH inspection) | 15 | WORM log · 7-yr retention · MOH report template | Founder + Compliance |
| R-19 | Cross-tenant leakage | 5 | Row-level RBAC · per-PR security review · matrix tests | Eng Lead |
| R-20 | DSAR/erasure miss SLA | 3 | Async batch · email notify · 30-day SLA generous | Founder |
| R-21 | Insurance API non-compliance | 6 | Manual claim fallback · MySalam first then expand | Eng + BD |
6. ⚙️ Operational Risks
| ID | Risk | Score | Mitigation | Owner |
|---|---|---|---|---|
| R-04 | Klinik pilot pull out | 12 | 2 backup klinik LOI · ALESA bear setup cost | Founder BD |
| R-12 | GPU hardware lead time | 12 | Order 4 weeks early · cloud burst Plan B · L40S fallback | Founder + DevOps |
| R-22 | Team capacity shortfall | 8 | 2-week sprint · 20% slack · contractor backup pool | Eng Lead |
| R-09 | BM rojak NLU fail | 9 | 200-sample eval · Llama fine-tune option · graceful fallback | Eng (prompt) |
| R-23 | UPS/power outage at klinik | 6 | UPS battery 15min · service worker offline mode (PWA) | DevOps |
| R-24 | Internet outage at klinik | 6 | 4G/5G modem fallback · doctor offline mode (cached SOAP) | DevOps |
| R-25 | Audit log volume cost | 4 | Compression · cold storage after 1-yr · pruning | DevOps |
7. 💰 Financial Risks
| ID | Risk | Score | Mitigation | Owner |
|---|---|---|---|---|
| R-13 | LLM API cost overrun | 6 | Tier routing · cache · per-tenant budget · gpt-4o-mini default · on-prem reduces dependency | Eng Lead |
| R-26 | Capex overrun (Hi-End upgrade) | 8 | Phase budgeting · Mid-End first option · staged GPU procurement | Founder |
| R-27 | Insurance/indemnity premium spike | 6 | Quote 3 vendors · negotiate group rate · self-insure low-impact | Founder |
| R-28 | Subscription churn >30% | 8 | Klinik success program · NPS monitoring · feature roadmap dgn klinik input | BD + Founder |
| R-29 | Currency exposure (USD GPU pricing) | 4 | Local distributor option · forex hedge · multi-vendor | Founder |
8. 🎯 Strategic Risks
| ID | Risk | Score | Mitigation | Owner |
|---|---|---|---|---|
| R-07 | Doc Zam withdraws approval | 5 | Weekly review · transparent comms · written agreement Phase 0 · co-sign major decisions | Founder |
| R-30 | Competitor launch (Adeahub MY · Halodoc enter MY) | 6 | Speed advantage · Doc Zam clinical relationship · BM/Malaysia native moat · feature flag rapid pivot | Founder + Doc Zam |
| R-31 | MOH guidelines change significantly | 4 | Compliance consultant retainer · feature flag rapid disable · 30-day adapt window built-in | Compliance |
| R-32 | MMC scope-of-practice ruling restrict AI | 4 | "AI proposes, doctor approves" architecture (already proven) · attestation ready · legal counsel review | Founder + Doc Zam |
| R-33 | Bahasa Malaysia AI quality plateau | 4 | Continuous fine-tuning · alternative model options (Qwen-Med · Sea-LION) · prompt iteration · BM-specific data acquisition | Eng (prompt) |
9. 🔄 Review Cadence
| Cadence | Trigger | Action | Owner |
|---|---|---|---|
| Weekly | Sprint review | Update R-04/R-12 status (klinik pilot · GPU lead time) | Founder |
| Bi-weekly | Steering Committee | Review all RED + ORANGE risks · adjust mitigation | Founder + Doc Zam |
| Monthly | Internal audit | Audit log volume · breach detection rules · feature flag drift | Eng Lead |
| Quarterly | Q1-Q6 gates · Q5 PDPA self-audit | Comprehensive risk register review · add new risks · close resolved · escalate emerging | All stakeholders |
| Annually | Year-end review | External pen-test · MOH-style walkthrough · risk appetite review | External consultant + Founder |
| Ad-hoc | Incident detected | Risk register update within 48h · post-mortem within 2 weeks | Eng Lead + Founder |