Oct 5, 2025
6
min read
Medically Reviewed
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Understanding the TGA Framework: Software as a Medical Device (SaMD)
The TGA does not regulate "AI" as a concept; it regulates specific products that meet the definition of a medical device. Much of the AI-powered CDS software available today falls under the regulatory category of Software as a Medical Device (SaMD). The core principle of the TGA's framework is that the level of regulation applied to a piece of software is directly proportional to the risk it poses to a patient if it were to fail or provide incorrect information.
The TGA classifies SaMD into different classes, from the lowest-risk Class I to the highest-risk Class III. The classification depends heavily on the software's intended use. A simple app that reminds a patient to take their medication might be a Class I device. However, software that uses patient data to provide a specific diagnosis or recommend a specific dose of a high-risk medication would be classified much higher and would be subject to a far more rigorous assessment of its safety, quality, and clinical efficacy before it could be legally supplied in Australia.
A crucial distinction within this framework is the difference between software that is intended to inform a clinical decision versus software that is intended to drive or replace it. A tool that simply presents a clinician with organised data or suggests a range of possibilities for their consideration is generally considered lower risk than a "black box" AI that provides a single, definitive diagnostic or therapeutic output. This is where the concept of the "clinician-in-the-loop" becomes a critical regulatory and safety principle.
The Compliance Nightmare of "Point Solutions"
Now, consider the position of a practice manager who decides to adopt multiple, standalone AI tools from different, perhaps international, vendors. They might find a clever AI scribe from one company, a diagnostic suggestion tool from another, and a pathology analysis app from a third. In doing so, they are unwittingly taking on the role of a systems integrator and, to a large extent, a compliance officer. For each of these individual point solutions, the practice manager would need to perform significant due diligence:
Regulatory Status: Is this software included in the Australian Register of Therapeutic Goods (ARTG)? What is its classification? Has the vendor provided evidence of TGA conformity assessment?
Clinical Evidence: What clinical validation studies have been performed to support the software's claims? Are these studies relevant to the Australian clinical context and your patient population?
Risk Management: How does the vendor manage the risk of software bugs or algorithm errors? What is their process for post-market surveillance and reporting of adverse events?
Data Security and Privacy: Where is the patient data being processed and stored? Does the vendor comply with the Australian Privacy Principles and data sovereignty requirements?
Conducting this level of due diligence for a single piece of software is a major undertaking. Doing it for a dozen different, disconnected apps is a compliance nightmare and a recipe for significant clinical and legal risk.
Expert Tips
"In the age of AI, choosing a technology partner is as much a compliance decision as it is a technical one. The safest strategy is to partner with a unified platform vendor who builds Australian regulatory compliance into the very architecture of their system, shifting the burden of due diligence from your clinic to your technology partner." - Arash Zohuri, CEO, MediQo
The Unified Platform: Compliance, Security, and Governance "Under One Roof"
This is where the strategic choice of a unified platform becomes a powerful act of risk mitigation. When a clinic partners with a reputable Australian platform vendor like MediQo, they are not just buying a piece of software; they are entering into a partnership with a company whose entire business model depends on understanding and adhering to the complex Australian regulatory landscape. This provides several key advantages.
First, the vendor takes on the primary responsibility for TGA compliance. A platform like MediQo is designed with these regulations in mind. The clinical decision support features, such as the Augmented Differential Analysis, are deliberately engineered to be augmentative tools. They are designed to support and broaden the clinician's judgment by providing data-driven suggestions, not to replace it with a definitive diagnosis. This "clinician-in-the-loop" design is a core safety and regulatory principle. The vendor is responsible for maintaining the necessary documentation, conducting the risk assessments, and ensuring the platform meets its regulatory obligations.
Second, a unified platform provides a single, robust security posture. Instead of having patient data fragmented across multiple apps with varying levels of security, all data within the MediQo ecosystem is managed under a single, comprehensive security framework. With data encrypted, hosted in Australia, and compliant with the highest international standards like ISO 27001 and SOC2, the clinic can be confident that it is meeting its privacy and data protection obligations. It is far easier to verify the security credentials of one trusted partner than to try and manage the risk of a dozen different vendors.
Third, a platform approach simplifies governance and accountability. If an issue arises, there is a single point of contact. The platform vendor is responsible for the entire, end-to-end workflow, from the first call handled by CALLA to the generation of a note by the Clinical Assistant. This clear line of accountability is essential for good clinical governance and is impossible to achieve in a fragmented ecosystem where multiple vendors could all point the finger at each other.
In conclusion, the TGA is indeed actively regulating AI-based clinical decision support software through its robust Software as a Medical Device framework. While this is a positive and necessary step for patient safety, it places a significant compliance burden on any clinic looking to adopt this technology. The attempt to navigate this complex landscape by assembling a collection of individual point solutions is a high-risk, high-effort strategy. The far wiser and safer path is to embrace the "Platform Advantage." By choosing a single, unified platform from a trusted vendor, a practice manager can ensure they are adopting technology that is not only powerful and efficient but is also built on a solid foundation of regulatory compliance, security, and good clinical governance.
Discover how MediQo's single, AI-powered platform can unify your clinic from the first call to the final bill. Request a Demo.
Key Takeaways
Prioritizing Ethical AI Implementation
Optimizing Practice Efficiency and Revenue
The Power of Unified Platforms
Strategic Innovation for Sustainable Growth
The rapid integration of Artificial Intelligence into Australian healthcare is ushering in a new era of clinical capability. AI-powered tools that can assist with differential diagnosis, suggest treatment plans, and analyse patient data are no longer the stuff of science fiction; they are becoming increasingly available to clinicians in general practice. This wave of innovation brings with it immense promise, but it also raises a set of critical, high-stakes questions for clinic owners and practice managers around safety, efficacy, and accountability. Chief among these is the question of regulation: is Australia's Therapeutic Goods Administration (TGA) actively regulating this new class of software, and what are a clinic's responsibilities when choosing to adopt these powerful tools?
The answer is a definitive yes. The TGA is not only aware of AI-based Clinical Decision Support (CDS) software but has a clear and evolving framework for its regulation. However, understanding and navigating this regulatory landscape can be a daunting task for a busy practice manager. The level of scrutiny a tool is under depends heavily on its intended use and the level of risk it poses to a patient. This complexity creates a significant hidden burden for any clinic attempting to build its own technology stack from a collection of disparate, unverified "point solutions." The far safer, more robust, and more strategically sound approach is to partner with a single, unified clinical automation platform from a vendor who has built their entire system on a foundation of regulatory compliance. This is the "Platform Advantage" from a governance, risk, and compliance perspective: it shifts the primary burden of regulatory adherence from the clinic to the technology partner.
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