Artificial Intelligence is rapidly transforming the healthcare sector, offering new opportunities to enhance efficiency, improve diagnostics and reduce administrative burdens. If you have already or are yet to incorporate AI into your practice, you may be wondering what is and isn’t permitted under professional regulations.

Late in 2024 the Australian Health Practitioner Regulation Agency (“AHPRA”) published guidance on the topic ‘Meeting your professional obligations when using Artificial Intelligence in healthcare’ (“Guidance”), providing specific guidance to all health professionals, including but not limited to medical practitioners, dentists, allied health professionals, pharmacists and psychologists. Recognising AI’s significant potential to improve health outcomes and create a more human-centric health system, AHPRA supports the safe use of AI in healthcare.

To ensure compliance with the Guidance, healthcare professionals must understand their obligations and existing responsibilities in the National Boards’ code of conduct when using AI in practice.

The role of AI in healthcare

AI encompasses various technologies in healthcare from AI-driven diagnostic tools to automated scribing applications. These innovations promise improved healthcare delivery, but they also raise concerns about patient privacy, informed consent, accountability and ethical considerations.

Understanding the regulatory landscape

Some AI tools in healthcare fall under the regulation of the Therapeutic Goods Administration (“TGA”), particularly if they meet the definition of a ‘medical device’ which may include screening apps or software allowing to access imaging. However, generative AI tools often used in clinical practices, such as AI scribing, are usually intended for general purposes and therefore do not have therapeutic use nor are regulated by the TGA. This means that while these tools can assist with administrative tasks, they do not undergo the same scrutiny or approval process as AI-driven medical devices, placing greater responsibility on healthcare professionals to assess their suitability and compliance with ethical and professional standards.

Meeting your professional obligations

As AI advancements are evolving, safe usage in healthcare involves practical and ethical considerations. AHPRA’s Guidance outlines key principles practitioners should follow to align with regulations and meet their professional obligations. These include accountability, understanding, transparency, informed consent and ethical and legal implications of AI. Case studies are also made available directly on AHPRA website and are updated as this area continues to develop.

1. Accountability

Regardless of AI integration and TGA approval, healthcare professionals retain full accountability for the services they provide. AHPRA’s Guidance emphasises that while AI can certainly assist practitioners, ultimate responsibility for patient care remains with the human professional. Consequently, in the event of error or an adverse outcome from AI use, the practitioner may be held accountable regardless of the AI system’s reputation or regulatory approval status. This highlights the need for continued education and due diligence in AI adoption in healthcare settings.

2. Understanding

Practices and practitioners should familiarise themselves with AI systems, including their intended use, limitations and potential biases. Understanding how AI models are trained, handle data and whether they are suitable for specific patient populations is critical. Healthcare professionals should also be aware of how the data is being used to retrain the AI, where data is located and how it is stored.

3. Transparency

Patients should be informed about the use of AI if any in their treatment and any implications it may have. For examples, when AI is used to analyse diagnostic images, detailed explanations of the underlying technology may not be necessary. However, if AI is utilised for recording or scribing consultations, explicit patient consent is required, as it involves handling personal sensitive personal data.

4. Informed consent

Obtaining informed consent before using any AI-driven tools that require patient data is a fundamental professional obligation. Patients should be made aware of how their personal data will be used, stored, and whether it contributes to any AI model training. Consent must be documented within health records to demonstrate compliance with privacy and ethical standards.

5. Ethical and legal considerations

Practitioners must ensure that their chosen AI applications align with ethical guidelines and legal frameworks in each Board’s Code of Conduct including:

Protecting patient confidentiality and adhering to privacy laws.
Complying with the relevant legislation and regulatory requirements regarding AI use in practice.
Addressing biases in AI models that may impact Aboriginal and Torres Strait Islander communities and other diverse populations and only using where appropriate.
Ensuring professional indemnity insurance covers all AI-related activities.

For more information about how to legally and ethically leverage AI in your medical practice, read one of our earlier articles here.

Next steps for practices and practitioners

As AI continues to evolve, we anticipate further growth in this space. AHPRA has committed to regularly reviewing and updating the guidelines and publishing new case studies to reflect technological advancements. Healthcare professionals should take proactive steps to stay informed and compliant including:

Update or Develop Privacy Policy & Consent forms: If you are about to start using or have been using AI in your practice, updating or developing your Privacy Policy and Consent Form is a critical step.
Develop AI Polices: Establish internal protocols within your practice to guide the responsible and compliant use of AI, one of the biggest risk with AI is your people. You Legal offers a Fast Track Solution for an Artificial Intelligence Policy available to purchase.
Stay updated: Regularly review AHPRA’s guidance and case studies on AI developments in healthcare. If you haven’t already, subscribe to the You Legal newsletter for updates on evolving regulations and guidelines in the medical sector.
Engage in training: Participate in training programs and attend webinars to enhance your knowledge. Explore recorded You Legal webinars, specifically ‘Safely Implement AI In Your Medical Practice: Legal and Ethical Guidelines for Healthcare,’ for further guidance on this topic.

AI is a powerful tool that has the potential to transform healthcare, but adoption must be carefully managed to align with AHPRA’s professional and ethical standards.

Further information

For further information on AI regulations in healthcare, visit AHPRA’s official resources and regulatory guides here.

Not sure if your practice is compliant? Download our complimentary AI Compliance Checklist for Practice Owners to ensure your AI tools and processes align with legal and ethical standards.

Need expert advice?

Our team has extensive experience in providing legal advice for medical practices. To discuss how AHPRA’s Guidance may impact you or your organisation, or if you need assistance preparing you organisations’ AI framework, contact our team here, and we will put you in touch with the best professional for your needs.

AI in healthcare: AHPRA’s guidelines and what they mean for you and your practice