Who is going to pay for SaMDs? Insurers’ transparency needs around AI medical devices
Tatiana Aranovich1, Macquarie University sydney 1Macquarie University, sydney, New South Wales, Australia
Abstract
AI medical devices, also known as “Software as a Medical Device” (SaMD), hold great promise for improving people’s health. These devices have the potential to perform on par with or even surpass humans in diagnosing and treating common and life-threatening diseases. Additionally, they can offer a holistic approach to patient care, focusing on maintaining good health rather than just treating illnesses. Furthermore, these devices have the potential to reduce healthcare costs significantly. However, alongside the potential benefits, there are also safety concerns, as errors in health-related AI can have severe consequences, even leading to loss of life. Therefore, establishing a secure foundation and defining regulations for the widespread adoption and investment in AI medical devices are crucial tasks for the judicial system. One aspect that requires further exploration is the level of transparency necessary for insurers concerning AI medical devices, as outlined in guidelines. Addressing this question, this research aims to identify the needs of insurers and propose policy solutions in Australia, drawing from the United Kingdom’s experiences. The study employs a combination of doctrinal, comparative, and law reform methodologies. The research has revealed that insurers primarily require transparency regarding the cost-effectiveness of these devices, an aspect not yet adequately addressed in Australian frameworks. Given insurers’ significant role as major funders, they can play a crucial part in enhancing overall transparency. Consequently, this study holds relevance for guiding regulators in drafting necessary reforms, thereby positioning Australia as a leader in the implementation of AI for medical purposes.
Biography
Tatiana de Campos Aranovich is a PhD in Law Candidate at Macquarie University in the artificial intelligence and health field.
She had also been a senior civil servant in Brazil with experience in public policy issues in a multidisciplinary approach, working at the Brazilian Healthcare Regulatory Agency for 8 years.