08 · CONFIRMATION

Decisions we ask you to confirm

Everything in this report proceeds on the recommendations below unless you direct otherwise. Approve, amend, or defer each item — then P1 kicks off against the confirmed scope.

Open decisions

#	Decision	Options	Recommendation	Needed by
C-01	Product name & brand	Keep "EKLIS" · rename · defer to branding exercise	Run a short naming/brand pass before the first external demo; "EKLIS" remains the working name	Before first demo
C-02	Scope confirmation	Plan as presented · amend segments/modules	Approve the P1–P4 scope and entry order (POL → independent labs → reference labs → specialty)	P1 kickoff
C-03	Design theme	Adopt the eklotho design system (this site) · commission a distinct theme	Theme proposal is a P1 pre-build deliverable; this report uses the house system as the starting point	P1 scaffolding
C-04	Hosting & BAA	AWS (matching existing infrastructure) · other US cloud	AWS US region; the signed HIPAA BAA is a hard gate before any real patient data (P2 pilot)	Before P2 pilot
C-05	Clearinghouse	ClaimMD · Change Healthcare · Availity	Decide at P3 kickoff — the BillingProvider adapter keeps the choice swappable	P3 kickoff
C-06	Patient portal timing	Read-only subset late-P2 · full portal P3	Full portal at P3; pull read-only results into P2 only if capacity allows	P2 planning
C-07	First analyzer targets	Named at P2 kickoff from pilot lab's bench	Choose the two P2 integration analyzers from the pilot lab's highest-volume instruments	P2 kickoff
C-08	Pilot lab	Candidate labs to be proposed	Select one POL or small independent lab as design partner for P1–P2 hero-flow verification	During P1

Risks & dispositions

Item	Level	Disposition
Analyzer interface breadth	high	Driver framework + two real analyzers in P2; evaluate instrument-middleware partnership as an accelerator
HIPAA BAA before real PHI	gate	Signed BAA with the US-region host is a hard gate before any P2 pilot data
Clearinghouse choice	medium	Hidden behind the BillingProvider adapter; decide at P3 kickoff (C-05)
Blood bank / transfusion	avoided	Out of scope — FDA-regulated device software (510(k))
FDA LDT rule	favorable	Vacated March 2025; laboratory-developed-test oversight stays under CLIA — lower burden for molecular-lab customers
ONC certification	later	Not required to sell; evaluate certifying the results-delivery module at P4

Sign-off checklist

Market & positioning approved

Target segments, entry order, and the LABGEN-benchmark strategy (Market page).

Architecture & stack approved

Next.js / FastAPI / MySQL schema-per-tenant / Redis / Docker; interface engine as a separate process; rules as versioned data (Platform page).

Workflow & quality model approved

Pipeline, specimen state machine, auto-verification, QC gating, critical-value closed loop (Workflow page).

Connectivity plan approved

ASTM + HL7 v2 first, FHIR R4 and ELR at P4; reference labs both directions (Connectivity page).

Module map & portals approved

Core → business → specialty waves; physician, patient, and DTC portals (Modules page).

Compliance posture approved

HIPAA/CLIA/CAP requirements, result immutability, audit model, phase exit gates (Compliance page).

Roadmap P1–P4 approved

Phase goals, hero flows, and exit gates (Roadmap page).

Open decisions C-01 – C-08 resolved

Each item above approved, amended, or explicitly deferred with an owner and date.

This checklist is a review aid — ticks are not saved. Formal confirmation happens in writing (email or signed minutes) referencing the item numbers above.

What happens next

Confirmation meeting

Walk through this report together; resolve C-01 – C-08 and log amendments.

P1 kickoff

Scaffolding, tenancy, auth, compendium, and the manual bench loop — against the confirmed scope.

P1 review

Hero-flow demonstration on the deployed stack: order → labels → accession → result → verify → PDF report.

P2 planning

Pilot lab and first two analyzers named (C-07/C-08); BAA in place before pilot data (C-04).