• Security & clinical safety

Clinical-grade software demands clinical-grade accountability.

HALO Sphere users document patient care and account for Schedule 8 medicines, so security isn’t a layer added afterwards. The platform’s core features are accountability controls, documented and measured against recognised frameworks.

ISO/IEC 27001-aligned ISMS Essential Eight ML1 self-assessed Australian Privacy Principles Hosted in Australia

• Certifications & assurance

Where each credential stands today.

Each item below says what is operating, what is self-assessed and what is planned. We update this page when a status changes.

ISO/IEC 27001:2022

Aligned

Annex A control inventory maintained with evidence; nine approved policies. Independent certification planned as customer demand requires.

ACSC Essential Eight

ML1 self-assessed

Self-assessed at Maturity Level One (2026) with a maintained register; the assessment is available in our security pack.

Australian Privacy Principles & NDB

In place

Privacy handling structured on the APPs with health information at the highest tier, and a Notifiable Data Breaches incident plan.

TGA regulatory position

Documented

Written software self-assessment (2026): no component is a medical device, with explicit re-assessment triggers held against the roadmap.

External penetration testing

Planned

Internal hardening reviews run today; an independent external penetration test is planned and this page will carry its date once complete.

My Health Record (ADHA)

Intended pathway

Connection via the ADHA conformance pathway, including its mandatory Security Conformance Profile, is on our roadmap.

Framework-aligned

Controls mapped to ISO/IEC 27001:2022 with evidence, self-assessed at ACSC Essential Eight Maturity Level One, the bar Australian health buyers ask about first. Certification planned as customer demand requires.

ISO 27001:2022 Annex A control inventory
Essential Eight ML1 self-assessment
Nine approved security policies

Identity, done properly

Passkeys (Face ID / Touch ID) and authenticator MFA are first-class. The controlled-drug register requires fresh multi-factor step-up, and witnessed actions require the witness’s own credential, minting single-use cryptographic proof.

WebAuthn passkeys, cross-device
Mandatory step-up on the drug register
Two-person integrity with cryptographic proof

Everything on the record

Append-only audit ledgers cover logins, clinical actions, drug movements and admin activity, including who read or printed a record. Edits to patient care records are amendment-tracked field-by-field: old value, new value, who, why. Never silently overwritten.

Append-only signed drug register
Field-level amendment history
Org-scoped audit visibility

Recovery, rehearsed

Three independent backup layers: continuous point-in-time recovery, daily snapshots, and hourly complete copies to separate, write-locked storage. Restores are tested and timed, not assumed.

Restore to any moment (PITR)
Hourly write-locked copies
Documented quarterly restore tests

Shipped safely

Every change goes branch → review → CI gates: type-safety plus a blocking vulnerability audit on production dependencies, with weekly automated patching. Destructive migrations fail the deploy; failed deploys never replace the running version.

Human review on every change
CI blocks high/critical advisories
Crash & deploy-failure alerting, verified

Australian privacy, first-class

Privacy handling structured on the Australian Privacy Principles with health information at the highest sensitivity tier. Clinical data custodianship stays with the healthcare organisation; 7-year clinical retention; AI features organise the user’s own text and never invent clinical content.

APP-aligned, NDB-scheme incident plan
Custodianship with your organisation
Written AI guardrails: no fabricated clinical content

• Uptime, watched from outside

We don’t ask you to trust our uptime. We publish it.

An independent monitor checks every environment each five minutes from outside our infrastructure and alerts our directors on any failure. A release that fails its health check never replaces the running version. Live status and full uptime history are public.

Live system status → Uptime history →

• Data residency

Your data lives in Australia.

All platform data, including clinical records and every backup, is hosted onshore in Sydney. Some supporting services run offshore; each is listed below with what it receives.

AUSTRALIA

Application hosting and every database run in AWS Sydney, encrypted in transit and at rest, with no public database exposure. Consult-call transcription is processed entirely in-country, and clinical terminology comes from Australia’s National Clinical Terminology Service.

UNITED STATES

AI text processing, which can include clinical content such as care record notes, medication label photos and consult summaries. Also consult-call connectivity, email and SMS delivery (recipient details and notification text), and lookups that send coordinates or reference numbers only: aviation weather, map place names, vessel positions and parcel tracking.

EUROPE

Address search, which sends what is typed into an address field and so can include a patient’s home address. Weather, terrain and place-name lookups, which send coordinates only. No records or clinical content.

• Clinical safety

It documents care. It never directs it.

HALO Sphere is a tool that assists trained clinicians who retain full responsibility for clinical judgement. It does not diagnose, calculate doses autonomously or assign triage categories, a position we hold in writing and re-assess against Australian therapeutic-goods regulation.

Named Clinical Safety Officer

A practising clinician owns clinical safety, with a live hazard log and review before every release.

Documented regulatory position

A written TGA software self-assessment concludes no component is a medical device, with explicit re-assessment triggers.

Honest about maturity

ISO-aligned, not yet certified. External penetration testing is planned; internal hardening reviews run today. We only claim what’s live.

• Information security statement

What we hold ourselves to.

HALO Sphere Operations Pty Ltd operates an information security management system aligned to ISO/IEC 27001:2022, covering the platform, its supporting infrastructure and everyone with access to customer data. Under it we commit to:

Identifying, assessing and treating security risks on a documented, recurring cadence.
Meeting our legal, regulatory and contractual obligations, including the Australian Privacy Principles and the Notifiable Data Breaches scheme.
Maintaining security awareness and accountability for every person with access to the platform or its data.
Verifying our controls rather than assuming they work: restore tests, deploy gates, dependency audits, external monitoring.
Claiming only what is live. Where a control is planned rather than operating, we say so, here and in our documentation.

Want the detail?

The full documentation pack (control inventory, Essential Eight self-assessment, policies, TGA self-assessment) is available on request, NDA where required.

Request the pack →

Security contact: hello@halosphere.com.au