Digital Health and Artificial Intelligence
Navigating ethical review for digital health and artificial intelligence research, from innovative technologies to real-world healthcare applications.
What is Artificial Intelligence?
Digital health and AI are rapidly transforming research, offering new opportunities, but also complex ethical and regulatory considerations. Researchers must ensure that studies are designed, conducted and overseen in line with evolving guidance and appropriate ethical standards.
Artificial Intelligence (AI) refers to intelligent technologies and algorithms that can support decision-making by identifying patterns in data. AI-related projects may be classified as a medical device if they meet the regulatory criteria for the medical-device definition.
When is AI classed as a Medical Device?
AI is classed as a medical device if it is intended to be used for a therapeutic or diagnostic purpose such as;
• diagnosis, screening, prevention, monitoring, prediction, prognosis, or treatment of a disease, injury or disability
• alleviation of or compensation for an injury or disability
• investigation of the anatomy or of a physiological process
• control or support of conception.
TGA Software and Artificial Intelligence
AI that meets any of these criteria is regulated as a medical device regardless of its form. This includes any app, website, software program, internet-based service or software package. It could operate on a watch, phone, tablet, laptop, or other computer, be embedded in medical-device hardware, or function as part of a cloud-based ecosystem or as a standalone product.
Software incorporating generative AI – such as large language models (LLMs), text-generation systems, or multimodal generative-AI tools, is also regulated as a medical device if it performs a function that meets the above criteria.
Other AI products submitted for HREC review may not meet the definition of a medical device because they do not diagnose, treat, or inform clinical care. These tools typically support social, behavioural, or operational research without influencing health-related decisions.
Bellberry HRECs review medical device trials. Find out more about medical device trials, how medical devices are classified and what the stages of device review are.
Learn MoreApplication Guidance
Researchers should provide clear information about the nature, purpose, and use of AI tools to support accurate classification and ethical review. The HREC will consider the intended purpose, risk profile, data governance, and participant impacts when evaluating applications.
Researchers developing AI tools should ensure their application provides the following:
• A clear explanation of what the AI tool does
• The purpose of the tool (research, educational, operational, or clinical)
• Whether the intended use meets medical device criteria
• Description of training, validation, and test datasets
• Whether any personal or sensitive information is used
• Data governance arrangements (collection, storage, retention, destruction)
• Any de-identification or anonymisation processes
• Overview of the AI model type (e.g., machine learning, LLM, predictive model)
• How the model will be trained, fine-tuned, or modified
• Any third-party platforms, cloud services, or APIs used
• Potential participant risks (data breaches, algorithmic bias, misclassification)
• Measures to mitigate these risks
• Any limitations in model accuracy and how these are communicated
• Whether participants will interact with the AI tool directly
• What participants will be told about the AI system and its limitations
• Any opt-out or withdrawal processes
• Explanation of any transfer of information across borders or storage of information in another jurisdiction (Refer Bellberry documents Researcher Data Storage & Retention Guidance Confidentiality & Privacy Standard Clauses).
Ongoing oversight and governance
• Monitoring processes for model performance and safety
• Procedures for handling errors, unexpected outputs, or adverse events
• Responsibilities of the research team and any external collaborators
Get answers to common queries
Whether you’re preparing your first submission or managing amendments, these answers cover the most common scenarios and link to detailed guidance when needed.
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Not all projects require HREC review. Studies with more than a low level of risk must be reviewed by an HREC. Some low-risk or quality assurance activities may follow other pathways or be exempt. Refer to the National Statement on Ethical Conduct in Human Research for details, or see our Review Pathways guide.
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How to Apply
Understand the full application process from start to finish. This step-by-step guide shows you how to register, prepare documents, and submit your study for review.
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Guidance & Resources
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