Cutting-edge digital health and regulation

23 Feb 2021

illustration of smart phone with health icons

Australia has an opportunity to take the global lead in ensuring timely consumer access to cutting-edge medical technologies.

The Adaptive Regulation for Digital Health report is a national study by the Australian Institute for Business and Economics, Therapeutic Goods Administration, CSIRO and others. It builds a comprehensive picture of how Australian digital stakeholders are engaging with health regulation, both within Australia and across other jurisdictions, in the pursuit of cutting-edge medical technologies.

Key points

  • Regulation has an important role to play in enabling evidence-based decision-making and clinical pathways
  • Australia's regulatory design enables flexibility which is important to  breakthrough digital health technology, and could be better leveraged by industry, particularly new entrants. 
  • Australia's harmonisation with EU and other international regimes is highly valued by industry,  increasing alignment with other international frameworks may make Australia more attractive as a point of entry.
  • Product development and commercialisation would be assisted by tailored guidance, greater collaboration and better online communication by Australian regulators. 

Download the Adaptive Regulation for Digital Health report (PDF, 8.3 MB)


Dr Haitham Tuffaha

Dr Lisette Pregelj, Australan Institute for Business and Economics

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