Navigate Australia's AI Regulatory Landscape with Confidence
Specialist compliance services for organisations in heavily regulated sectors. We help financial services entities, healthcare providers, and government agencies meet APRA, ASIC, TGA, AHPRA, and OAIC requirements for AI systems.
Serving APRA-regulated entities, AFS licensees, healthcare organisations, and government agencies deploying AI systems under increasing regulatory scrutiny.
AI Adoption Is Outpacing Regulatory Compliance
Australian organisations face an intensifying AI regulatory environment across multiple frameworks
Overlapping Regulations
Multiple overlapping regulators with different expectations across APRA, ASIC, OAIC, TGA, and AHPRA. Technology-neutral regulation where existing obligations apply regardless of whether you use AI. Governance frameworks not designed for AI requiring substantial adaptation.
Regulatory Requirements
APRA CPS 230 operational risk requirements apply to AI systems. Privacy Act automated decision-making requirements take effect 10 December 2026. Voluntary AI Safety Standard provides guidance on responsible AI practices. Limited detailed regulatory guidance on practical implementation.
Accountability Frameworks
Personal liability frameworks including Financial Accountability Regime for executives. AHPRA accountability for practitioners using AI in clinical decisions. Executives must take reasonable steps for AI oversight under the Financial Accountability Regime.
Sector-Specific AI Compliance Services
Financial Services
APRA CPS 230: Operational Risk Management
- Identification of AI systems supporting critical operations
- Material service provider assessment and registration
- Tolerance level definition for AI-dependent services
- Fourth-party risk assessment (AI vendors' vendors)
ASIC REP 798: AI Governance Gaps
- Assessment against ASIC's 11 questions for licensees
- Fairness and bias policy development
- Generative AI governance framework
- Consumer risk assessment implementation
Financial Accountability Regime (FAR)
- Mapping AI systems to FAR accountable persons
- Updating accountability statements and maps
- Documenting reasonable steps for AI oversight
Privacy Act 2024 Amendments
- Automated decision-making disclosure mechanisms
- Human review procedures for AI decisions
- Data quality requirements for AI inputs
Healthcare
TGA Medical Device Regulation
- Assessment of whether AI systems meet SaMD definition
- Classification determination (Class I through Class III)
- ARTG registration application preparation
- Clinical evidence compilation
AHPRA Practitioner Obligations
- Practitioner accountability framework for AI-assisted decisions
- Informed consent processes for AI use in care
- Competence assessment and training programmes
- AI output verification procedures
Government
AI Ethics Framework Implementation
- Application of eight principles to specific AI systems
- Fairness and non-discrimination testing
- Transparency and explainability mechanisms
- Contestability and appeals processes
Voluntary AI Safety Standard
- Implementation of ten voluntary guardrails
- Preparation for mandatory guardrails transition
- High-risk AI classification assessment
- Stakeholder engagement on safety and fairness
Core Compliance Services
Regulatory Compliance Assessment
We identify all AI regulations applicable to your organisation, assess current AI practices against regulatory requirements, prioritise compliance gaps by risk, and develop remediation action plans with timelines and ownership.
$25,000 - $75,000 AUD
Compliance Programme Development
Structured compliance frameworks including policies, processes, and controls mapped to specific regulations. Regulatory obligations register, compliance control framework, and horizon scanning processes.
$50,000 - $150,000 AUD
Third-Party AI Vendor Compliance
Assessment of AI vendor compliance with applicable regulations. Structured due diligence covering governance, technical, regulatory, performance, contractual, and data aspects. Ongoing vendor compliance monitoring.
$15,000 - $40,000 AUD per vendor
Ongoing Compliance Advisory
Monthly or quarterly retainer for continuous regulatory support including horizon scanning, compliance programme maintenance, regulatory relationship management, and incident notification support.
$5,000 - $25,000 AUD per month
Common Compliance Questions
Which regulations apply to our AI systems?
This depends on your sector and how you use AI. APRA-regulated entities face CPS 230 and CPS 234. AFS licensees must address ASIC expectations. Healthcare providers may face TGA medical device regulation and AHPRA obligations. Government agencies must apply the AI Ethics Framework. All organisations processing personal information face Privacy Act requirements. We conduct regulatory obligations analysis to identify all applicable requirements.
Do we need to register our healthcare AI with the TGA?
If your AI system is intended to diagnose, monitor, or treat patients, it likely meets the definition of a Software as Medical Device (SaMD) and requires TGA regulation. The TGA grace period ended in November 2024, meaning retrospective registration may be required. Classification depends on intended therapeutic purpose and risk level.
How do we protect executives from personal liability under FAR?
The Financial Accountability Regime requires mapping AI systems to accountable persons, updating accountability statements and maps to reflect AI responsibilities, documenting reasonable steps taken for AI oversight, and establishing governance processes that demonstrate proactive risk management.
What are the consequences of non-compliance?
Consequences vary by regulation but can include enforcement actions and penalties from regulators, personal liability for executives under the Financial Accountability Regime, stop-use orders for non-compliant systems, legal liability from affected individuals, reputational damage, and restrictions on business activities.
Navigate AI Regulatory Requirements with Confidence
Compliance obligations are intensifying across APRA, ASIC, TGA, and OAIC. We help you identify requirements, assess gaps, and implement defensible compliance frameworks.
Initial assessment identifies all applicable regulations and prioritises remediation by risk