Governance

Honest posture, documented.

Aescia runs two products with different regulatory postures. The Hospitals product is an investigational medical device with an intended Class IIa classification; a regulatory application has not yet been lodged. The Clinics product is a workflow tool that is not a medical device and is not represented as one. This page states what each is, and what each is not.

Aescia for Hospitals

Investigational medical device, on pathway.

Classification: Software as a Medical Device (SaMD), intended Class IIa under TGA Rule 3.4. Application not yet lodged.
Regulatory roadmap: Under development. No TGA, MDSAP, FDA, CE/UKCA, or Health Canada applications have been filed.
Software lifecycle: IEC 62304:2006+A1:2015 processes implemented and documented. No third-party conformity assessment yet undertaken.
Quality system: ISO 13485:2016 implementation underway. Certification not yet obtained; target 2026.
Information security: ISO/IEC 27001:2022 controls implemented. Certification not yet obtained.
Clinical evaluation: Through the SAFE-Discharge trial (ACTRN12625001425482).
Current engagement: Evaluation and pilot contracts only, not commercial supply.
Output posture: Advisory only. The clinician remains the decision-maker.

Aescia for Clinics

A workflow tool. Not a medical device.

Classification: Software as a Service. Not a medical device, not represented as one.
Boundary: Does not diagnose, does not treat, does not propose clinical decisions.
Posture: Propose, do not decide. The clinician remains in control.
Rule content: Delivers clinician-authored educational content and prep instructions.
Escalation: Routes exceptions to named staff, does not act autonomously.
Audit: Full record of pathway step, patient response, and clinician review.
Engagement: Per-specialty monthly subscription at the clinic level.

No conformity-assessment certifications are currently held by either product. Implementation of the listed frameworks is in progress and documented internally. A full security pack is available to prospective customers under mutual NDA.

Security and data

A documented posture, available to buyers under NDA.

Identity

SAML 2.0 and OIDC single sign-on
Role-based access control with audit trail
Tenant isolation at the database level

Data

Encryption in transit (TLS 1.3) and at rest (AES-256)
Data residency by deployment region
Documented sub-processor list on request
Minimum-necessary collection by design

Software

ISO/IEC 27001 controls implemented
IEC 62304 processes for the regulated product
OWASP secure development baseline
Independent penetration testing at each release

Integration

HL7 v2 ADT and FHIR R4 inbound
Optional flowsheet or note write-back
Designed to add a signal layer, not a new portal

Clinical oversight

Clinician-authored pathways and rules
Advisory output, clinician decides
Escalation policies configurable per institution

Regulatory

Intended Class IIa for Hospitals, application not yet lodged
Non-device posture for Clinics, documented per feature
No AI models outside clinician-authored rule sets

Corporate

Structured for multi-region operation.

Holding entity: Aescia Health Inc. (Ontario, Canada). IP and capitalisation.
R&D entity: 9550-0708 Québec inc. Canadian data residency and R&D operations. NEQ 1181312316.
Regulatory applicant: Aescia Pty Ltd (Australia). ABN 96 687 840 517.
Resident director: Shannon Kurrle, Aescia Pty Ltd. Statutory requirement under the Australian Corporations Act.
Registered office: Sydney, Australia.
Operations: Montréal, Canada. Sydney, Australia.

Need the security pack for procurement?

Request under NDA