Tx-Rails — Health & Medical Pricing Sheet
The auditable underlay for Health & Medical — hospitals, day-surgery centres, aged-care providers, pathology + imaging providers, biomedical-equipment vendors, payers, regulators, accreditation surveyors, coronial inquiries. Cryptographic continuous audit + equipment-and-cold-chain provenance + multi-party outcomes-attestation, sitting underneath your existing EMR, biomedical-asset register, cold-chain-monitoring, sterile-processing, infusion-pump fleet, MRI/CT/ultrasound calibration, medical-gas alarm, and pharmacy-dispensing systems. We don’t replace any of them — and crucially, we do not touch the EMR or store patient-identifiable information. We bind to the equipment-facing systems via a published integration mode and produce tamper-evident, jurisdiction-independent records of everything they emit. See iiot-health-medical.md and smart-contracts-health-medical.md for the full underlay positioning.
What you get
Three integrated capabilities, one platform:
- Continuous cryptographic audit infrastructure
Every device-registration event, every firmware update, every sterile-processing cycle, every cold-chain temperature deviation, every biomedical calibration, every medical-gas-alarm event, every device-batch handover, every recall-execution committed to a Byzantine-fault-tolerant ledger and Merkle-anchored to the Hedera public DLT. Continuous evidence stream is the structural answer to “the accreditation surveyor will be back next month” and to coronial-inquiry record-production demands.
Aligned with: TGA Conformity Assessment + Australian Register of Therapeutic Goods (ARTG); FDA 21 CFR Part 820 (Quality System Regulation) + 21 CFR Part 11 (electronic records); EU MDR (Medical Devices Regulation) + IVDR; UDI (Unique Device Identification); GS1 healthcare standards; ISO 13485 (medical-device QMS); ISO 17025 (calibration); ISO 14971 (medical-device risk); NSQHS Standards (AU hospital accreditation); ACSQHC clinical care standards; ACHS / ACQSC aged-care quality + safety; HFA hospital-facility standards; HCCC / ACSQHC complaint frameworks. - Multi-party clinical + supply-chain outcomes-attestation with smart-contract-equivalents
Outcomes-based payment release co-signed by treating clinician + radiologist + pathologist on attested clinical-response evidence; device-recall execution co-signed by manufacturer + TGA + implant-centre + insurer with batch-tracking driving payment-release automation; cold-chain breach co-signed by 3PL + receiving facility with stock-disposal-and-reorder workflow auto-firing on the attested breach event. Unlimited data capacity (database-backed, not on-chain). Your existing biomedical / cold-chain / pharmacy / sterile-processing systems feed events via change-data-capture or atomic dual-write. - Regulator, accreditation-surveyor, coronial & payer-grade evidence pipeline
Live data access for TGA / FDA / EU notified-body / state Department-of-Health inspectors; ACHS / ACQSC accreditation surveyors; coronial inquiries; private health insurer + Medicare audit; medical-device class-action plaintiff lawyers (where the evidence works in your favour); insurer claims for medical-malpractice + product-liability + business-interruption.
What we sell — and what we don’t
What we don’t sell at any price: full transaction-front-end replacement. We don’t build your EMR, your clinical workflow, your patient-facing portal, your appointment scheduler, your e-prescribing system, your clinician-facing biomedical-asset UI. Critically, we do not touch patient-identifiable information — that stays in your EMR + clinical systems where the privacy and clinical-governance frameworks live. Your clinical and patient screens stay put. If you need a new clinician-facing screen, your engineering team builds it against our published SDK with our reference connectors.
What we do sell falls into two groups:
A. Operator utilities (bundled — Items 2 + 4 in the pricing table)
- Evidence-retrieval portal — your accreditation + biomedical + risk team pulls cryptographic proofs in response to accreditation-surveyor, regulator, coronial-inquiry, insurer-claim, or class-action questions. Generates evidence packs in formats acceptable to NSQHS / ACHS / ACQSC accreditation surveys, TGA + FDA + EU MDR inspections, coronial inquiry evidence-production orders, and HIPAA / GDPR-equivalent record-of-processing inquiries.
- Compliance + accreditation dashboard — live view of biomedical calibration-due aging, sterile-processing-cycle compliance, cold-chain breach exposure, medical-device-recall execution status, NSQHS standard-of-care evidence freshness, ACSQHC clinical-care-standard attestation freshness.
- Trust-management UI — operator-side controls for your enterprise PKI: certificate issuance for biomedical engineers / clinicians (limited to attestation roles — clinical credentials remain with your EMR) / sterile-processing techs / cold-chain operators / equipment-vendor reps, revocation, partner-org onboarding (3PLs, device manufacturers, accreditation bodies), kill-switch.
B. Supplier / counterparty attestation UI (optional — Item 5 in the pricing table)
Thin signature surface for external counterparties — medical-device manufacturers (device-registration + recall + adverse-event signoffs), pharmaceutical wholesalers (cold-chain handover signoffs), pathology + imaging service providers (when they’re external to the facility), calibration + sterile-processing labs (when outsourced), implant-centre coordinators (for cross-facility implant-tracking), insurer surveyors. This is explicitly in scope for us to develop, distinct from the “no EMR replacement” line above.
What it does:
– DID / certificate-based authentication (with limited claim scope — equipment + supply-chain only, never clinical)
– Per-tenant queue of pending attestations (device-batch-receipt acknowledgements, cold-chain-handover signoffs, calibration-certificate co-signs, recall-execution attestation, outcomes-based contract milestone signoffs, sterile-processing batch-release signoffs)
– Sign + submit with cryptographic proof landing in the BFT mesh
– Multi-tenant via entnum — each counterparty sees only their own queue
What it explicitly is NOT:
– An EMR / clinical-information-system / patient-portal replacement
– A pharmacy or e-prescribing system
– A clinical-credentialing or clinician-onboarding tool
– Any system that stores patient-identifiable information
When you’d buy this: outcomes-based payer contracts where multi-party clinical attestation must drive payment release; device-recall execution where manufacturer + regulator + implant-centres + insurer all need cryptographic co-signature; cross-facility implant-tracking; cold-chain pharmaceutical supply where 3PL handovers must be auditable.
Pricing — five line items, four budget homes (Item 5 optional)
| # | Item | Type | Indicative price (AUD) |
|---|---|---|---|
| 1 | One-off integration & onboarding — integration-mode selection, wiring against your biomedical-asset register / cold-chain-monitoring / sterile-processing / infusion-pump-fleet / calibration-LIMS / medical-gas-alarm systems (not EMR), certificate-authority setup, UAT, launch | One-off CapEx — capitalisable over 3–5 years | A$140,000 – A$300,000 |
| 2 | One-off operator-UI configuration — evidence-retrieval portal skinned to your brand; regulator-export templates (NSQHS / ACHS / ACQSC accreditation packs, TGA / FDA / EU MDR inspection packs, coronial-inquiry evidence packs, insurer-claim packs); compliance dashboard customised; SSO with your IdP | One-off CapEx — capitalisable over 3–5 years | A$70,000 – A$150,000 |
| 3 | Annual support & maintenance (security patches, OS/library upgrades, 24×7 help desk for clinical-safety-adjacent operations, 99.95% uptime SLA for cold-chain + sterile-processing-linked deployments, integration-mode adjustments, operator-UI updates for new regulator templates) | OpEx — renewable annually | A$120,000 / year |
| 4 | Tx-Rails platform access — BFT infrastructure, audit attestation, Hedera anchoring, dual-DC redundancy, regulator + accreditation pipeline. Includes the three operator utilities. Tiered by facility size — see range governance below. | OpEx — annual platform subscription, facility-tiered | A$70,000 – A$1,800,000 / year |
| 5 | Supplier / counterparty attestation UI (optional) — thin signature surface for device manufacturers, pharma wholesalers, pathology/imaging providers, calibration + sterile-processing outsourced services, implant-centre coordinators, insurer surveyors. NOT an EMR or clinical-system replacement. Never stores PII. | One-off CapEx — capitalisable over 3–5 years | A$90,000 – A$220,000 |
| Year 1 total (Tier-3 example: regional acute-care hospital, Items 1+2 mid-points, Item 5 excluded) | A$720,000 | ||
| Year 1 total with Item 5 mid-point | A$875,000 | ||
| Year 2+ ongoing (Tier-3 example) | A$420,000 / year |
Item 4 — facility-tier pricing:
Health pricing is facility-size-tiered. Each acute-care or aged-care facility runs its own pyramid; large health-system customers (LHDs in NSW, statewide aged-care providers, national private-hospital chains) aggregate to higher tiers via Shape 2 grouped pyramids.
| Tier | Facility / customer profile | Annual platform fee (Item 4) |
|---|---|---|
| Tier 4 | Day-surgery centre, single-site primary-care GP-group, single residential-aged-care facility, single specialist clinic — Shape 3 single pyramid or pilot | A$70,000 |
| Tier 3 | Regional or sub-tertiary acute-care hospital (50–300 beds), multi-site primary-care group, regional aged-care operator (5–20 facilities), regional pathology / imaging provider — 1–2 pyramids | A$300,000 |
| Tier 2 | Tertiary or major-metropolitan hospital (300–800 beds), Tier-1 private-hospital operator (NSW LHD scale, single-state major), national aged-care operator (50+ facilities), national pathology / imaging primary — Shape 2 grouped (3–6 pyramids) | A$800,000 |
| Tier 1 | Statewide health-system primary (e.g. NSW Health, VIC Health), major national private-hospital chain (Ramsay / Healthscope / Healthe Care equivalent), major national aged-care primary, federal Department of Health / equivalent — Shape 1 sovereign across multiple federations | A$1,500,000+ |
Tier-4 floor is deliberately low to keep the platform accessible to day-surgery centres and small aged-care operators, which face the same accreditation evidentiary burden as larger facilities but without proportional IT budget. Statewide-health-system Tier-1 customers (NSW Health, VIC DFFH-Health, QLD Health) typically deploy Shape 2 grouped covering multiple LHDs / equivalent.
Item 1 — what governs the range:
– A$140k floor — hash-only attestation (Mode A): your biomedical / cold-chain systems commit as normal; we receive only content hashes. Lowest integration cost; no clinical workflow change.
– A$300k ceiling — atomic dual-write (Mode B): biomedical / cold-chain and Tx-Rails commit in the same transaction. Highest integrity guarantee; suits facilities with recent accreditation-survey findings.
– Most facilities land mid-range with change-data-capture observation (Mode C) at ~A$190–250k.
Item 5 — what governs the range:
– A$90k floor — single-flow attestation kiosk (e.g. just device-recall acknowledgement from one manufacturer), single role.
– A$220k ceiling — multi-flow hub (device-batch + cold-chain handover + calibration + recall + outcomes-based contract + sterile-processing batch-release), multiple role tiers, DID auth, deep brand alignment.
Payback and ROI
For a Tier-3 regional or sub-tertiary acute-care hospital (200 beds, ~A$200M annual operating budget) with ~A$40M in directly counterparty-touching flow (biomedical-equipment contracts, device + consumable supply chain, outsourced pathology / imaging / sterile-processing, recall-reserve management).
| Annual benefit | Conservative | Realistic |
|---|---|---|
| Audit IT-controls displacement (external auditor + NSQHS accreditation-survey work reduction + TGA / equivalent inspection prep) | A$100,000 | A$300,000 |
| Biomedical + supply-chain reconciliation & dispute overhead reduction (equipment-vendor warranty disputes, recall-batch-location queries, cold-chain-breach disposal-and-reorder costs) | A$150,000 | A$500,000 |
| Reduced exposure to accreditation-survey findings (a major NSQHS or ACQSC finding triggers re-survey costs, conditional registration, and management restructure — typical cost A$200k–A$2M depending on severity) | A$150,000 | A$1,200,000 |
| Insurance-premium reduction tied to telemetry-backed risk evidence (medical-malpractice cover, product-liability, business-interruption, recall coverage) | A$200,000 | A$700,000 |
| Coronial-inquiry + complaint-response cost reduction (cryptographic evidence packs replace months of manual record reconstruction; HCCC + state-equivalent complaint responses faster) | A$100,000 | A$500,000 |
| Outcomes-based payer-contract margin uplift (multi-party clinical attestation on outcomes enables outcomes-based contracts that pay 5–15% higher than fee-for-service; on a A$10M outcomes-contract portfolio, that’s significant) | A$150,000 | A$700,000 |
| Total annual value delivered | A$850,000 | A$3,900,000 |
| Tx-Rails Year 2+ cost (Tier-3 example) | A$420,000 | A$420,000 |
| Net annual return | A$430,000 | A$3,480,000 |
| ROI multiple | 2.0× | 9.3× |
The realistic-end ROI for Tier-1 statewide health-systems is substantially higher because medical-device-recall coordination costs and coronial-inquiry-driven legal-defence costs scale superlinearly with facility count.
Pilot terms — non-binding, parallel-run, zero operational risk
- 3 months running Tx-Rails alongside your existing systems. No production switchover.
- Mode A (hash-only) integration with one chosen federation (typically
tx-rails-health-biomedical,tx-rails-health-cold-chain, ortx-rails-health-sterile-processing) for the pilot. - No EMR contact — the pilot does not touch your EMR or any clinical-information system; only equipment-and-supply-chain.
- Walk-away clause: if at month 3 the metrics don’t meet agreed targets, the engagement ends.
- Accreditation-body pre-validation: before signing, we’ll meet with your ACHS / ACQSC / TGA-equivalent contact to confirm evidence-pack acceptability.
- Data ownership: cryptographic exports are open-format, re-readable indefinitely — outlives clinical-system migrations, facility ownership changes, and accreditation-body framework updates.
Why now
- NSQHS Standards intensification (AU) + ACSQHC clinical-care standards + ACQSC aged-care reforms post-Royal Commission — accreditation evidentiary burden materially higher than 5 years ago.
- FDA pre-market cybersecurity guidance (2023) + EU MDR evolving cyber requirements — medical-device firmware-provenance + recall + adverse-event evidence increasingly demanded.
- Recent medical-device class actions (Allergan textured breast implants, transvaginal mesh, hip-resurfacing devices) — evidence trails that can survive 15-year litigation cycles are now competitively required.
- Coronial-inquiry pipeline — high-profile sentinel events continuing to drive evidence-chain investment.
- Outcomes-based payer contracts scaling — multi-party clinical attestation infrastructure becomes the differentiator vs fee-for-service.
- Cold-chain pharma supply — biologics + cell + gene-therapy products demand cryptographic cold-chain provenance that paper / spreadsheet evidence cannot meet.
Next steps
- 30-minute discovery call with your CEO / DON + Director of Biomedical Engineering + Risk + Compliance lead.
- Letter of Intent — non-binding, signals pilot interest.
- Pilot kick-off within 8 weeks of LOI.
Contact: John Olsen · john@itotchaincloud.com.au · +61 490 114 879
Reference data sources: ACHS + ACQSC + ACSQHC accreditation-survey methodology; NSQHS Standards (2nd edition) + ACSQHC clinical-care standards; TGA + FDA + EU MDR adverse-event reporting + recall benchmarks; AIHW Hospital Statistics (Cat. 4390.0); AHPRA notification-and-complaint pipeline; HCCC + state-equivalent complaint-handling cost data; medical-malpractice + medical-device-product-liability insurance market loss-development triangles; published Royal Commission into Aged Care Quality and Safety cost-of-implementation data; medical-device-recall benchmarks (Stericycle Recall Index, FDA enforcement reports). Full citations available on request.
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