Calls for precision regulation in submission to Federal Government AI consultation paper 

Digital Health Cooperative Research Centre (DHCRC) has used its response to the Australian Government Department of Industry, Science and Resources, Safe and Responsible AI in Australia discussion paper to reinforce its support of the development of a National AI in Healthcare Strategy.

First proposed by the Australian Alliance for Artificial Intelligence in Healthcare (AAAiH), a dedicated AI in healthcare roadmap would provide a unified approach to the design, development, testing and delivery of AI.

Responsibility for the strategy should rest with the Department of Health and Aged Care, Digital Health and the Therapeutic Goods Administration and include public and private healthcare stakeholders to ensure there is a common, unified approach to the ethical and safe use of AI in healthcare.

“Government-led action at the national level is required to support AI development in Australia,” said DHCRC Chief Innovation Officer Dr Stefan Harrer, who authored a recently-published world-first  comprehensive ethical framework  for the responsible design, development, and use of generative AI technology in health and medicine and an accompanying guide suggesting regulatory and governance approaches to implementing it.

This framework addresses risk identification and mitigation guidelines with respect to the core ethical principles of responsible AI development and use. While the developed framework is primarily applicable to generative AI in health and medicine its core principles can be extrapolated to a broad field of other types of AI and areas of use.

“While the scope of use cases and accessibility of Artificial Intelligence have grown exponentially over the past six months alone, it is the ethical and trustworthy use of AI that has been thrust into the spotlight,” Dr Harrer said.

“We’re seeing the entire spectrum from misguided overreactions calling for the pause in development of advanced AI systems, and invoking doomsday predictions that AI could end humanity, to AI as the panacea for every problem. What we need is a measured factual approach to regulation that efficiently addresses the very real immediate challenges and risks of using AI while not stifling innovation.”

Regulating use cases not the technology

The DHCRC submission advocates for a ‘precision regulation’ approach that establishes rules to govern the deployment of AI in specific use-cases but does not regulate the technology itself.

“Precision regulation carries a much higher level of adaptability,” Dr Harrer said. “New AI technologies and applications evolve at lightening-speed making it near impossible to generate the evidence base for risk mitigation at the same pace.

“Only regulation that focuses on outcomes rather than technology will be able to keep up and adapt to changing conditions quickly and efficiently.”
DHCRC strongly advocates for a risk-based approach to assessing and weighing AI risks against benefits for specific use case scenarios and is currently developing a risk-assessment framework for the use of AI in healthcare.

“A risk-based approach offers a clear roadmap to implement precision regulation in practice,” Dr Harrer said. “We are currently exploring a number of international risk-assessment frameworks, applying them across our AI-related projects and validating their effectiveness in a practical setting. We expect this to help us develop a best-in-class risk assessment framework.”
DHCRC CEO Annette Schmiede said the rise of AI in healthcare is an unstoppable force and welcomed the Federal Government for being proactive in engaging on a topic that will have a substantial impact on healthcare.

“AI presents such a significant opportunity for the healthcare sector, but it will not be without challenges,” Ms Schmiede said. “It will require technology providers, health industry, universities, and government to work closely together to ensure the ultimate applications of AI in health benefit all stakeholders and most importantly deliver value to patients. This is exactly the style of collaboration that the DHCRC was established to facilitate.”

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