Promises, pitfalls and pressure points: Stakeholders weigh in on government’s AI healthcare report

The Department of Health and Aged Care has released the final report on the Safe and Responsible Artificial Intelligence (AI) in Health Care Legislation and Regulation Review. Stakeholders, including the Medical Technology Association of Australia (MTAA), ANDHealth, Medicines Australia and Medical Software Industry Association (MSIA), weighed in on whether the review hit the mark, spotlighted the critical gaps still left unaddressed, and laid out their expectations for what the government must do next.

Emma Hossack, CEO of MSIA, pointed to the confusion bred by multiple “AI in healthcare” reviews from the Department of Health and Aged Care, Department of Industry, Science and Resources, and the Therapeutic Goods Administration (TGA) which “show the same pain-points: overlapping laws and talk of a brand-new AI Act risk duplicating what already works and slow clinical adoption”.

Recognising the multifaceted nature of AI in healthcare, Medicines Australia noted that “this area is complex and rapidly changing. The report serves to conduct a review of the landscape, represents a point in time perspective and potential impacts of AI.”

From a digital health lens, ANDHealth described the report as a “foundation for an informed dialogue as to how to create actionable and implementable systems and guardrails for AI in healthcare.”

Despite broad support for the review, stakeholders are clear that the report does not address key blind spots.

Ian Burgess, CEO of MTAA, told Health Industry Hub, “The report goes some way in identifying the key challenges in applying AI in healthcare, but stops short of offering concrete solutions, particularly in areas like consent, data access, and confirming the TGA as the appropriate regulator of health products.”

He added, “The report doesn’t adequately address the full range of legitimate secondary uses of health data, such as for diagnosis and treatment, research, product safety monitoring, and reimbursement evaluation… The absence of clear guidance risks creating confusion for healthcare providers and slowing progress.”

The MTAA also flagged missed opportunities for international data-sharing agreements with like-minded countries.

ANDHealth’s CEO and Managing Director, Bronwyn Le Grice, stated “We need to remain cognisant this is an area of technology which is moving rapidly, and government, industry and regulators need to keep pace with it in order to ensure sufficient certainty to encourage continued investment.

“The report clearly outlines a broad range of concerns, but it falls to industry and government to now pull together to create an implementable framework that is harmonised across Australia at a State and Federal level.”

With the report now on the table, Burgess stressed that the government’s next moves are what will count. “There’s still significant work for Government to consider in its response to ensure that future regulation is both fit-for-purpose and supports innovation, including as part of related and ongoing consultation processes,” Burgess emphasised.

The MSIA advocated for a pragmatic, streamlined approach. Hossack commented, “We need to keep the TGA software-as-medical-device rules, privacy law and safety standards, but add a short, technology-agnostic AI Principles Act that tells each existing regulator what to clarify. It would not require a new regulator and complex mapping of regulatory roles and responsibilities.”

Burgess reinforced a shared sentiment among stakeholders, saying “Although the consultation process has been positive and the report identifies key challenges, ultimately what matters is how the Government acts on this consultation.

“It is essential the MedTech industry’s voice is appropriately reflected in the Government’s response to ensure that both regulatory and non-regulatory approaches to AI deliver better health outcomes for patients while supporting innovation.”

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