The challenge
Biomedomics' Sickle SCAN device sees use in low-resource clinical settings where the operator may not be a hematologist, and structured clinician-note output is currently a manual step. Cross-border deployments mean the data path has to satisfy both HIPAA and GDPR depending on geography.
How we approached it
Ajuni is scoping a field-trial pilot where Vaidya bridges Sickle SCAN device data into structured triage and clinician-note drafts, with Pragna handling cohort-level analysis. The pilot will run on a region-flexible Azure footprint, with HIPAA and GDPR controls switched by deployment region.
What the pilot will prove
- Pilot will prove sub-90-second clinician-note drafts
- Pilot will prove HIPAA + GDPR-grade audit posture
- In scope: device-to-agent data bridging
- In scope: cohort-level pattern analysis
- Scoping target: multi-region field-trial rollout
Stack & guardrails
Integration & deployment
- Azure · region-flexible
- Sickle SCAN device bridge
- Claude Sonnet 4 · API
- FHIR-aligned data store
- Region-switched compliance
- Clinician review surface
Compliance & audit
- HIPAA · US deployments
- GDPR · EU deployments
- ISO 13485 alignment
- Device-level audit trail
Timeline
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Week 0–2
Field-trial design
Trial geography and compliance-region split designed with clinical leads.
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Week 3–4
Device bridge build
Sickle SCAN data path validated end to end; FHIR mapping confirmed.
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Week 5–7
Clinician shadow
Vaidya drafts notes alongside clinicians; accuracy tracked per cohort.
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Week 8–10
Pilot review
Pilot reviewed with medical advisory board; multi-region rollout decision.
