[My internship] was invaluable in gaining deeper real-world understanding and insights, opportunities for growth, and contacts for my future empirical research.

Tatiana Aranovich

Short bio:

Tatiana Aranovich is a PhD researcher at Macquarie Law School, where she also serves as a tutor for the Law and Technology Course. In her leadership role as a graduate representative, she represents Law graduate students, advocating for their interests. With 16 years of extensive experience, including 8 years at the Brazilian Healthcare Regulatory Agency, she has taken a multidisciplinary approach in government across diverse sectors dealing with several industry members.

Tell us about your PhD research topic in 100 words or less:

Artificial Intelligence (AI) has the potential to offer great benefits to the healthcare sector, addressing quality, cost, and personnel shortage concerns. However, it also raises various challenges, including possible bias, reliability issues, lack of transparency, and explainability of AI, all of which are important for the safe implementation and use of AI medical devices. My research addresses this problem by studying measures to be proposed for Australia to enhance transparency and explainability around AI medical devices, addressing stakeholders' needs for the safe use of these technologies.

Please tell us a bit about your internship project:

I did my internship with the Therapeutic Goods Administration (TGA). The TGA approves AI medical devices into the market, and healthcare agencies around the world are now trying to understand what they need to adjust their frameworks and address new challenges/risks of AI. My internship project was on the same topic as my PhD research.

During the internship, I wrote a research report focusing on understanding and proposing parameters for defining AI, its transparency, and its explainability to be employed in the TGA guidelines for AI medical devices in Australia. The report reviewed 78 policy documents and the relevant academic literature to determine the most suitable definition and parameters of AI transparency and explainability. It examined the relevance of AI transparency and explainability in ensuring the safety of AI devices as well as the barriers and limitations in achieving adequate transparency and explainability of AI medical devices.

The project ended up being very timely. The Australian Government recently announced a significant reform program to address AI across multiple sectors, targeting high-risk AI, with a funding of $39.9 million over five years. Under this program, the TGA will have to conduct a review of its frameworks, to ensure the safety and reliability of these technologies. My team of supervisors and I hope to keep cooperating with the TGA during this review process.

Were there any challenges you faced during your internship, and how did you approach them?

The biggest challenge was fitting a broad research project into a six-month timeline while serving as a tutor and having a leadership role (graduate student representative). This demanded unwavering dedication and time management. I owe the world to Rita Matulionyte, my supervisor, who was always in the loop and sharply orienting me (even when sick or on leave). Her mentoring was vital in devising effective research strategies, aligning the TGA research goals and our PhD research aspirations with the time constraints, and ensuring the project's success. I am also grateful to TGA experts, especially Fiona McCormack, for her outstanding dedication and leadership; my associate supervisor Farah Magrabi, for her crucial insights and feedback; and Jason Ford, MQ Strategic Programs Coordinator (Industry), and Madeline Taylor, MQ Law School Director of Research Training, for their invaluable and kind support.

How has the internship had an impact on you as a researcher? Has it changed your approach to any aspects of your PhD research?

The experience at the TGA has been key for enhancing the impact of my research and the engagement with industry. It has also been vital for better polishing and targeting the questions my research will answer. It was invaluable in gaining deeper real-world understanding and insights, opportunities for growth, and contacts for my future empirical research.

Is there anything else you’d like to share about your internship experience?

It is worth mentioning that the approach for the internship started during my presentation at the MQ Law HDR Conference last year. A TGA leader was invited as my external commentator, and the networking resulted in the internship opportunity.