#Clinical Safety Boundary Statement: Australia

DIS-AU-028 | Version 1.0.0 | Last Modified On 01 August 2026

The Australian fork of DIS-GL-028. Read this document for an Australian deployment. The global statement covers India, the European Union and the United Arab Emirates and is not repeated here.

Written for the Director of Clinical Governance and the Quality Manager. It answers one question: is this software a medical device, and if not, prove it, with item numbers rather than assurances, and it states the product rules that keep the answer true. It is also written for Pensieve's own implementation consultants, because the person most likely to destroy this position is not a regulator; it is a well-meaning consultant configuring an observation chart.

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#Applicability

Regulatory status does not vary by deployment model. It is determined by what the software is intended to do, not by where it runs. The rules in Section 4 bind every model identically, and they bind a hospital's own configuration as much as they bind Pensieve's code.

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#Purpose

To state Pensieve's Australian therapeutic goods position, the five numbered exclusions it relies on, the testable product rules that keep it inside them, and, explicitly, the two places where the position is most likely to be lost: the clinical decision support exemption, and an implementation of National Safety and Quality Health Service Standard 8.

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#1. Regulated, exempt, excluded: three states, not two

Software meeting the definition of a medical device in section 41BD of the Therapeutic Goods Act 1989 (Cth) is regulated by the Therapeutic Goods Administration unless it is exempt or excluded. The three states are not interchangeable and the difference is commercially decisive.

Pensieve is excluded. Pensieve is not exempt. The distinction matters because an exempt product is still a medical device with a manufacturer's post-market obligations, and because "is Pensieve a medical device?" then becomes a question with a nuanced answer instead of a one-word one. Section 8 explains why Pensieve declines the exemption route deliberately rather than by oversight.

Pensieve holds no entry in the Australian Register of Therapeutic Goods and does not require one.

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#2. The five exclusions Pensieve stands on

The Therapeutic Goods (Excluded Goods) Determination 2018 was amended in 2021 to insert software exclusions into Schedule 1. Five of them cover Pensieve's functional footprint, and each is a numbered item rather than an argument.

[UNVERIFIED: the item numbers above were each corroborated from two independent retrievals of the Administration's guidance. Before this document is cited in a tender response or a clinical governance submission, verify each item number against the current text of the Determination on the Federal Register of Legislation. A wrong item number in a clinical governance artefact is a credibility event, and it is cheaper to check than to recover from.]

Storage and transmission are separately excluded from analysis. Pensieve stores and transmits images and reports; it does not analyse them. That distinction is load-bearing and appears again in Section 4.

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#3. The disqualifying condition: identical for all five

Every one of the five exclusions carries the same condition, expressed slightly differently in each. Software falls out of the exclusion if it is intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, defect or ailment, or if it is intended to replace the clinical judgement of a health professional.

Two consequences follow, and both are product constraints rather than legal opinions:

1. "Monitor" is the word that catches hospital software. A function that tracks the state or progression of a patient's condition is a monitoring function, and monitoring is outside all five exclusions. Recording an observation is not monitoring. Computing something from observations that describes the patient's clinical state is.
2. Intended purpose is determined by what the manufacturer says. A sentence in a brochure, a tooltip, a field label, a release note or a proposal can regulate a product that the code does not. Section 9 is the control that answers this.

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#4. The bright lines: testable product rules

These are binding on Pensieve engineering, on Pensieve implementation consultants, and on the hospital's own configuration. They are written so that each one can be tested by a person who is not a lawyer. They are incorporated into the Australian contract by MSA-AU-001 AU-8.

#4.1 What Pensieve will not do

#4.2 What Pensieve does, and why it stays inside the line

#4.3 The test a reviewer can run

For any feature, ask three questions in order. A "yes" to any of them means the feature is outside the exclusions and must not ship in Australia without the programme in Section 10.

1. Does the feature produce an output about an identified individual's clinical state, risk, diagnosis, prognosis or treatment that did not come from a clinician?
2. Is a clinician expected to act on that output without independently reviewing its basis?
3. Does the feature require a response within a clinically urgent timeframe?

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#5. The alarm carve-out, stated precisely

The exclusion for alert software does not apply to software that provides alarms to health professionals that must be actioned urgently. The Administration's own example is a ventilator alarm requiring an intensive care nurse to act immediately.

Product rule: Pensieve is not the delivery path for any time-critical clinical alarm. No physiological monitor alarm routing. No code-blue paging derived from device signals. No escalation triggered by a vital-sign threshold.

What Pensieve does instead: it integrates with the system that performs that function and records the event for the clinical record and for audit. It does not originate the event.

Where this belongs. This rule is in the Order Form exclusions list, not only in this document, because a hospital that asks for alarm routing at week three of an implementation must meet the answer in the contract rather than in a policy debate.

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#6. National Safety and Quality Health Service Standard 8: where the position is most likely to be lost

This section is the reason this document exists in its current form.

Every Australian hospital, public and private, must be accredited against the National Safety and Quality Health Service Standards. The second edition is operative; a third edition is in development and is anticipated later this decade. Standard 8, Recognising and Responding to Acute Deterioration, requires recognition systems and escalation processes.

The collision. A hospital implementing a new core platform will ask for a track-and-trigger observation chart with automatic escalation. That is exactly the function Section 4.1 prohibits. It is a monitoring function, it is outside all five exclusions, and configuring it would convert Pensieve into an unregistered medical device.

The rules that resolve it, and they are configuration rules, not legal ones:

The instruction to the implementation team, in one sentence: if a field, a form rule, a calculated column, a conditional format or an automation would tell a clinician something about the patient's clinical state that the clinician did not enter, stop and escalate to Legal before configuring it.

Why the risk is real. The person who breaks this will be a consultant configuring a form under time pressure at week two of a go-live, not a lawyer reading a determination. This rule therefore appears in the implementation runbook and the configuration freeze checklist, not only here. A deviation is a configuration defect with a regulatory consequence and is treated as a blocking item.

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#7. Accreditation evidence Pensieve does supply

Pensieve is not selling only software into an Australian hospital; it is selling accreditation evidence. The following is what Pensieve can evidence at survey, and, honestly, what it cannot.

Pensieve does not warrant an accreditation outcome, and MSA-AU-001 AU-8.4 says so. What it warrants is that the evidence above exists, is retrievable by the hospital without a Pensieve service request, and is accurate.

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#8. Why Pensieve does not rely on the clinical decision support exemption

The 2021 reforms created an exemption for clinical decision support software, available where the software is intended solely to provide or support a recommendation to a health professional about prevention, diagnosis, curing or alleviating a disease, ailment, defect or injury; and is not intended to directly process or analyse a medical image or a signal from another medical device; and is not intended to replace the clinical judgement of a health professional.

Pensieve does not build to it, and the reasoning is deliberate:

1. Exempt is not excluded. An exempt device is still a medical device. The manufacturer remains subject to advertising restrictions, adverse event reporting and notification, and the Administration retains oversight.
2. It imports a post-market vigilance obligation that Pensieve does not have today and would have to build, staff and evidence.
3. It converts a one-word answer into a paragraph. The most valuable sentence Pensieve can give a Director of Clinical Governance is "no, and here is the item number." Relying on the exemption replaces it with "it is a medical device, but it is relieved of registration, subject to conditions." That sentence costs days in every clinical governance committee it meets.
4. The exemption's own bright line is the same one in Section 4.1: no direct processing or analysis of an image or a device signal, so relying on it would not unlock the features that would actually require it.

Position: stay inside items 14G, 14M, 14N, 14O and 14I, where the answer is "no, and here is the item number." Exempt ≠ excluded, and the difference is not cosmetic.

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#9. Language control: the manufacturer's words regulate the product

Because intended purpose is determined by what the manufacturer says, language is a regulatory control and is treated as one.

1. The words diagnose, screen, predict, prognose, triage, monitor a condition, recommend treatment, clinical decision support, early warning, deterioration score, risk score, severity must not appear in any Pensieve marketing material, product documentation, user interface label, release note, tender response, proposal, presentation or contract in relation to an Australian offering, except in a sentence that states Pensieve does not do the thing.
2. Every Australian-facing artefact that describes a clinical capability is reviewed against this section before publication, and the review is recorded.
3. A feature name, a menu label or a column header is product documentation for this purpose. A tooltip is not too small to regulate a product.
4. Where a hospital's own configuration introduces such language into the user interface, Pensieve raises it as a configuration defect under Section 6.

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#10. If Pensieve ever crossed the line

Stated so that the cost is known in advance rather than discovered in response to a regulatory query.

• The software becomes a medical device requiring inclusion in the Australian Register of Therapeutic Goods before supply.
• Classification follows the software-specific rules: software providing information to a health professional for making a diagnosis can be Class IIa, rising to Class IIb where the disease or condition is serious; software for monitoring the state or progression of a condition sits in the corresponding monitoring rule.
• A foreign manufacturer needs an Australian sponsor, an entity resident or with a place of business in Australia, to hold the Register entry. Edsol Edtech Pvt. Ltd. would have to appoint one or establish an Australian subsidiary.
• Evidence requirements for machine learning software are explicit: the manufacturer must hold evidence transparent enough to allow evaluation of safety and performance, including what the model does, how it contributes to the intended purpose, the algorithm and model design, and information on training and testing.
• ISO 13485 and IEC 62304 become live costs, measured in quarters and lakhs, and WPR-GL-005 records that Pensieve holds neither.

Caution The decision this section forces, and it is the founder's. The exclusion position is correct, cheap and defensible today. It also permanently constrains the roadmap: no early warning score, no sepsis prediction, no imaging triage, no dose calculator, no severity-ranked interaction engine, no readmission risk score attached to an identified patient. If any of those is on the twenty-four month roadmap, the correct sequencing is a separately branded, separately regulated product line with ISO 13485 and IEC 62304 started twelve months before ship, not a retrofit after a regulatory query. The decision to record is not "buy the certificates"; it is "is a clinical-determination feature on the roadmap at all?" The answer must be written down, dated and signed, because every Australian clinical governance conversation depends on it. REG-AU-002 Section 7 carries it as an open decision with a named owner.

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#11. What the hospital must do: the boundary is shared

The exclusions depend on intended purpose, and a hospital can change intended purpose by configuration. The hospital therefore undertakes, in MSA-AU-001 AU-8.2, not to configure, extend, integrate, label or describe the Platform so that it does anything in Section 4.1.

In practice this means the hospital should:

1. Nominate a clinical safety owner for the implementation, and give that person Section 4 and Section 6 in writing.
2. Route any request for a calculated clinical field, a trigger, a score or an automatic escalation through that person before it reaches a Pensieve consultant.
3. Keep its recognition-and-response system, its alarm routing and its device integration where they are.
4. Tell its accreditation surveyor which system performs which function, using Section 7.

Pensieve will decline a change request that would put the Platform outside Section 2, will say so in writing, and will name the exclusion that would be lost. A refusal on that ground is not a breach and is not a service-level failure: MSA-AU-001 AU-8.3.

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#12. Limitations

1. This is Pensieve's own analysis. No Australian regulator has ruled on Pensieve's software. Pensieve holds no ruling, no classification decision and no legal opinion from Australian counsel on this question as at the Last Modified On date. REG-AU-002 Section 7 carries the opinion as a costed, open item.
2. Item numbers require verification against the current Determination (Section 2).
3. The position is only as true as the product. It describes the Platform as supplied and as bounded by Section 4. A configuration, an integration or a future feature that breaks Section 4 breaks the position, and nothing in this document prevents that; Section 6 and Section 11 are the controls that do.
4. This document is not clinical advice and is not legal advice to the hospital. The hospital's accreditation, its clinical governance and its recognition-and-response obligations remain its own.
5. The National Safety and Quality Health Service Standards are moving. A third edition is in development. Section 7 is mapped to the operative second edition and is re-assessed when the third is published.

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#Related documents

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#Change history