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moirai

The evidentiary backbone for clinical AI oversight. Built around current Australian governance references.

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Monthly digest of regulatory changes and clinical AI best practices.

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AU data sovereignty·Encryption at rest & in transit·Trust Center →

Trust signals

Hash VerifiedSHA-256 sealed
Enterprise SecurityAES-256, RLS, audit
External RefsRANZCR, TGA, Ahpra
Risk ControlsMonitoring + incidents
on the record.
Mapped toRANZCRChapter 9TGASaMDAhpraAI obligationsACSQHCNSQHSDISRAI plan
© 2026 Moirai Health Pty Ltd. All rights reserved.
Privacy PolicyTerms of ServiceSecurityTrust CenterDPA
All systems operational

§ Authority layer · Source-reviewed monthly

Radiology AI intelligence.

A source-reviewed context layer for radiology follow-up status: RANZCR Chapter 9, Ahpra AI guidance, TGA AI and medical-device software guidance, ACSQHC AI guidance and clinical governance, and the National AI Centre register template. Use it as a source map; do not treat it as legal advice, certification, or a cleared-market claim.

Curated intelligenceSource-reviewed 5 June 2026; not automatically scraped

Source-reviewed by hand. Not automatically scraped.

Review overdue by 1 day · 5 July 2026

Jump to source · freshness at a glance

RANZCR AI standardsChecked 31d·Overdue 1dAhpra AI guidanceChecked 31d·Overdue 1dTGA medical software guidanceChecked 31d·Overdue 1dACSQHC AI guidanceChecked 31d·Overdue 1dNational AI Centre registerChecked 31d·Overdue 1d

Cite this page

Reviewed 5 June 2026

Moirai. (2026). Radiology AI intelligence for follow-up status. Moirai Health Pty Ltd. https://moirai.health/standards
Take the brief awayPDF · 8 pagesSubscribe to source changes
Framework alignment

Mapped to current Australian governance guidance

RANZCR Chapter 9

Standards of Practice for Clinical Radiology

Reviewed July 2026

TGA SaMD

Software as a Medical Device guidance

Reviewed July 2026

Ahpra AI obligations

Practitioner-side AI use and oversight

Reviewed July 2026

ACSQHC NSQHS

National Safety and Quality Health Service standards

Reviewed July 2026

DISR AI plan

Australia's AI Ethics Principles and Action Plan

Reviewed July 2026

Moirai maps to the above guidance. No endorsement by any regulator, college, or agency is claimed.

Public intelligence layer

What changed, what matters, what belongs in the register.

This surface is source-reviewed, not automatically scraped. The paid Tools surface remains the private system of record, and follow-up status remains the product wedge.

Signal 01

Regulatory landscape

Source map current

TGA, RANZCR, Ahpra, ACSQHC, and the National AI Centre create overlapping expectations for intended-use review, accountability, monitoring, evidence, and governance visibility.

Public intelligence layer. Moirai maps the landscape around follow-up status and tool oversight; practices still need their own legal and clinical governance review.

Source confidence

High. Official regulators and professional bodies.

Check source

Signal 02

Deployment signals

Category pressure

Follow-up orchestration is already a named category in radiology AI, with public competitors marketing closed-loop follow-up, incidental-finding tracking, EHR/RIS integration, and revenue/liability outcomes.

Market intelligence only. Moirai should not claim an open cleared market, customer outcomes, or integration parity until each public source and local buyer workflow is verified.

Source confidence

Medium. Public vendor claims and regulatory lists need source-by-source qualification.

Check source

Signal 03

RAN Score mapping

Private readiness model

Readiness, Assurance, and Navigation scores translate public obligations into concrete evidence gaps, owner actions, review cadence, and board-reportable posture.

The score is a Moirai operating model, not a regulatory certification and not legal advice.

Source confidence

Internal method, source-linked obligations.

Check source

Signal 04

AI Tool Atlas preview

Private record first

Public vendor and ARTG references can support the Atlas. Private tool records own the customer's full risk posture, incidents, evidence, and monitoring record.

Authenticated register first. A public read view remains a candidate only when rows have exact official/vendor citations, checked dates, and no implied endorsement.

Source confidence

Source-backed where public entries exist; otherwise explicitly unknown.

Check source

Source registry

Public intelligence with a visible review file.

The register below is generated from the official source registry. It shows what was checked, when it was checked, and the next review date without pretending to run automated legal monitoring or regulator-grade certification.

Last source review

5 June 2026

Official sources

5

High confidence

5

Next review

2026-07-05

Source-reviewed public intelligence; not automatically scraped

Professional standards · Australia and New Zealand

RANZCR AI standards

High. Official college standards page.

https://www.ranzcr.com/our-work/artificial-intelligence

Source status

Checked
5 June 2026
Cadence
Monthly until first 10 customers, then fortnightly.
Status
Active reference
Reviewer sign-off
2026-06-05
Public visibility
public

Professional obligations guidance · Australia

Ahpra AI guidance

High. Official regulator guidance.

https://www.ahpra.gov.au/Resources/Regulating-new-and-changing-healthcare.aspx

Source status

Checked
5 June 2026
Cadence
Monthly, or within 48 hours of a detected Ahpra update.
Status
Active reference
Reviewer sign-off
2026-06-05
Public visibility
public

Medical device regulation guidance · Australia

TGA medical software guidance

High. Official regulator guidance, with explicit scope limits.

https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/manufacturing/artificial-intelligence-ai-and-medical-device-software-regulation

Source status

Checked
5 June 2026
Cadence
Fortnightly, because TGA AI and ARTG materials are moving.
Status
Active reference
Reviewer sign-off
2026-06-05
Public visibility
public

Clinical safety guidance · Australia

ACSQHC AI guidance

High. Official safety and quality body guidance.

https://www.safetyandquality.gov.au/clinical-topics/digital-health/artificial-intelligence

Source status

Checked
5 June 2026
Cadence
Monthly, or when the digital health topic page changes.
Status
Active reference
Reviewer sign-off
2026-06-05
Public visibility
public

Whole-of-organisation AI governance guidance · Australia

National AI Centre register

High. Official government guidance.

https://www.ai.gov.au/staying-safe-and-responsible/essential-ai-practices/ai-systems-register

Source status

Checked
5 June 2026
Cadence
Monthly, with priority review after NAIC updates.
Status
Active reference
Reviewer sign-off
2026-06-05
Public visibility
public

Recent reviews

The audit trail of this source map.

Source-reviewed by hand on a fortnightly-to-monthly cadence. Every re-check lands here, dated, with a one-line summary of what actually changed in the public material.

  1. 4 Jun 2026·Founder clinical review

    TGA medical software guidance

    Re-checked TGA AI and CDSS guidance. Tightened wording around intended purpose, ARTG inclusion, CDSS exemption limits, scope creep, and off-label use.

    Scope clarified
  2. 4 Jun 2026·Founder clinical review

    ACSQHC AI guidance

    Added the 2026 National Model clinical-governance signal: board/executive oversight of digitally enabled models of care and automated systems.

    Minor update
  3. 4 Jun 2026·Founder clinical review

    National AI Centre AI register

    Updated the National AI Centre register citation to the current AI systems register page and preserved the note that registers do not replace deeper risk management.

    Minor update
  4. 5 May 2026·Clinical reviewer · RN

    National AI Centre AI register

    Confirmed the AI systems register wording still recommends accountable people per AI system. No structural change to local Tools record schema required.

    No change
  5. 5 May 2026·Clinical reviewer · RN

    ACSQHC AI guidance

    ACSQHC AI Clinical Use Guide page updated 20 March 2026. Medical Image Interpretation scenario language tightened around automation bias and post-incident review.

    Minor update
  6. 21 Apr 2026·Clinical reviewer · RN

    TGA medical software guidance

    TGA AI-enabled ARTG list expanded with two new entries in radiology category. Re-checked intended-use language; existing buyer guidance still applies.

    Scope clarified
  7. 7 Apr 2026·Clinical reviewer · RN

    Ahpra AI guidance

    Ahpra published a clarifying FAQ on practitioner accountability for AI-assisted decisions. Wording on this page already covers it; cross-link added.

    Minor update
  8. 24 Mar 2026·Clinical reviewer · RN

    RANZCR AI standards

    Confirmed RANZCR's AI-specific standards still sit inside the broader Standards of Practice. No new chapter; clarified version-change review trigger.

    No change
Document 01RANZCR AI standardsCurrent AI standards page, reviewed May 2026
Document 02Ahpra AI guidance22 August 2024, regularly updated guidance
Document 03TGA medical software guidanceAI guidance updated 5 February 2026; CDSS guidance updated 29 January 2026
Document 04ACSQHC AI guidanceAI page updated 20 March 2026; 2026 National Model released June 2026
Document 05National AI Centre registerTemplate documents published 22 April 2026

Document 01

Checked 31 days ago·Overdue by 1 day

RANZCR AI standards

Royal Australian and New Zealand College of Radiologists

Current AI standards page, reviewed May 2026

Read source

Official source citation

Source checked 5 June 2026. External reference: https://www.ranzcr.com/our-work/artificial-intelligence

Professional standards context for AI use in clinical radiology. RANZCR states that AI-specific standards for clinical radiology can be found in Chapter 9 and should be interpreted inside the broader Standards of Practice.

What the source emphasises

    01Governance structure for AI tools in clinical use
    02Training and competency evidence for deployed AI tools
    03Documented human oversight and divergence from AI outputs
    04Ongoing monitoring and review
    05Risk assessment per AI tool, including version-change review
    06Incident response evidence for AI-related events

How Moirai maps evidence

    01Tools. Every deployed tool with vendor, version, TGA classification, ARTG status, and risk profile.
    02Evidence records. Administrative follow-up and tool-governance actions with reviewer, timestamp, and source context.
    03Override audit trail. Hash-chained, retrievable by case reference.
    04Monitoring workflow. Captures concordance, overrides, incidents, and review dates.
    05Risk Assessment workflow. Triggered automatically on tool registration and version changes.
    06Incident Response module. Documented escalation pathway with evidence preservation.

Document 02

Checked 31 days ago·Overdue by 1 day

Ahpra AI guidance

Australian Health Practitioner Regulation Agency and National Boards

22 August 2024, regularly updated guidance

Read source

Official source citation

Source checked 5 June 2026. External reference: https://www.ahpra.gov.au/Resources/Regulating-new-and-changing-healthcare.aspx

Practitioner-level guidance on professional obligations when using AI in healthcare. It emphasises safe use, professional codes, human judgement, intended use, limitations, data handling, transparency, consent where relevant, local governance, and indemnity.

What the source emphasises

    01Practitioner accountability and human judgement for AI-influenced clinical decisions
    02Understanding of AI tool intended use, limitations, and inappropriate contexts
    03Documentation of AI involvement in clinical decisions
    04Awareness of data location, storage, retraining, privacy, and ethical implications
    05Local governance arrangements and indemnity coverage

How Moirai maps evidence

    01Per-user competency tracking. Linked to the private tool registry where a practice elects to maintain AI evidence.
    02Per-record attribution. Evidence records capture the reviewer or practice follow-up assignee without shifting clinical responsibility to the software.
    03Vendor Evidence Register records. Disclosure, training, vendor, and policy evidence can be mapped to tools.
    04Owner and review cadence. Every tool record has governance accountability.
    05Vendor and intended-use fields. Surfaces what the AI vendor warrants vs what the practice is actually doing.

Document 03

Checked 31 days ago·Overdue by 1 day

TGA medical software guidance

Therapeutic Goods Administration

AI guidance updated 5 February 2026; CDSS guidance updated 29 January 2026

Read source

Official source citation

Source checked 5 June 2026. External reference: https://www.tga.gov.au/products/medical-devices/software-and-artificial-intelligence-ai/manufacturing/artificial-intelligence-ai-and-medical-device-software-regulation

Australian medical device regulation is technology-neutral and based on intended purpose. Software and AI can be regulated as medical devices when intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment, investigation of anatomy or physiological processes, or related therapeutic purposes. TGA CDSS guidance also says advanced analysis of medical-device results or images is unlikely to meet the simple exemption pathway, and AI-enabled CDSS should not be treated as automatically exempt.

What the source emphasises

    01Intended-use review for each AI tool used in clinical workflows
    02ARTG entry or explicit evidence gap where status is not established
    03Vendor declaration and regulatory documents on file
    04Process for identifying scope creep and off-label use
    05Incident evidence that supports escalation and vendor/TGA reporting assessment
    06Clear boundary between administrative follow-up evidence and diagnostic or treatment recommendations

How Moirai maps evidence

    01TGA classification and status fields on every AI tool in the register.
    02ARTG number cross-reference. Linked to TGA public database.
    03Vendor evidence vault. SaMD declarations stored with expiry tracking.
    04Intended-use notes. Surfaces mismatch between vendor purpose and local deployment.
    05Incident workflow. Preserves facts needed to assess escalation or reporting.
    06Follow-up status boundary. Moirai records administrative evidence and does not interpret images, rank clinical urgency, or recommend treatment.

Document 04

Checked 31 days ago·Overdue by 1 day

ACSQHC AI guidance

Australian Commission on Safety and Quality in Health Care

AI page updated 20 March 2026; 2026 National Model released June 2026

Read source

Official source citation

Source checked 5 June 2026. External reference: https://www.safetyandquality.gov.au/clinical-topics/digital-health/artificial-intelligence

Pragmatic AI guidance for health professionals and safety scenarios for clinical AI use, including medical image interpretation. The Commission highlights that AI can introduce new patient risks if not applied thoughtfully and appropriately. The 2026 National Model also places digitally enabled models of care, privacy, security, and automated-system safety inside clinical governance oversight.

What the source emphasises

    01Review evidence for safety and efficacy before use
    02Understand limitations, automation bias, transparency, consent, and patient-information implications
    03Monitor AI tools during clinical use
    04Review AI-involved incidents and safety events
    05Keep governance oversight visible to the health service
    06Avoid siloing digital-tool responsibility inside ICT without clinical governance integration

How Moirai maps evidence

    01Pre-deployment risk module. Mapped to the Commission framework.
    02Live performance dashboards. Concordance, override rate, drift signals per tool.
    03Post-incident review records. Captures facts, corrective actions, and evidence.
    04Patient safety event tagging. AI involvement captured as a structured field.
    05Follow-Up Evidence Pack exports. Follow-up proof remains the primary board-facing artifact.

Document 05

Checked 31 days ago·Overdue by 1 day

National AI Centre register

National AI Centre / Department of Industry, Science and Resources

Template documents published 22 April 2026

Read source

Official source citation

Source checked 5 June 2026. External reference: https://www.ai.gov.au/staying-safe-and-responsible/essential-ai-practices/ai-systems-register

Whole-of-organisation AI adoption guidance. The National AI Centre recommends maintaining an AI systems register that records AI systems, use cases, accountable people, and appropriate governance level, while noting that a register does not replace deeper risk management.

What the source emphasises

    01AI systems register with key characteristics and use cases
    02Named accountable people for AI systems
    03Governance level appropriate to each system
    04Documentation that supports auditors and stakeholders
    05Recognition that registers do not replace deeper risk management

How Moirai maps evidence

    01Tools as the system of record for imaging AI deployments.
    02Owner, site, modality, use-case, vendor, version, and review fields.
    03Risk profile, evidence gaps, incident signal, and regulatory status per tool.
    04Authority layer context stays secondary to the Follow-Up Evidence Pack.
    05Risk assessment and Vendor Evidence Register workflows for deeper governance beyond the tool record.

§ Beyond regulatory

Compliance is the obligation. Evidence is the moat.

Regulatory mapping helps you prepare for review. The core Moirai product still lives in the Follow-Up Evidence Pack: source, review, practice follow-up assignee, communication, follow-up status, and verifier seal.

See security & trustOpen the follow-up preview