computer chipsThis national research report “Adaptive Regulation for Digital Health: Enhancing Australia’s Regulation System for the Next Generation of Healthcare” built a comprehensive picture for current and future regulatory requirements. Developer case studies and stakeholder-focused interviews with developers, consumers, industry bodies, and the national regulator were used to create an overview of how Australian digital stakeholders are engaging with digital health regulation, both within Australia and across other jurisdictions.

The research was funded by the Australian Government Department of Innovation, Industry and Science (DIIS), MPTConnect and CSIRO. Key partners and Steering Committee membership included Australian Government Department of Innovation, Industry and Science (DIIS), MTPConnect, CSIRO, the Therapeutic Goods Administration (TGA), ANDHealth, AIBE, and other experts in the medical technology and health industries.

Project Benefits

The research was designed to:

  • ascertain the current state of knowledge regarding regulatory pathways and regulation compliance for digital health technologies, including key challenges in digital health regulation within the current regulatory framework;
  • identify potential alignments and misalignments between current regulatory requirements and new product development processes;
  • clarify how current regulatory policies and frameworks could be enhanced towards an adaptive approach to digital health regulation; and
  • identify areas where greater education and awareness are needed within industry.

Project members

Dr Lisette Pregelj

Research Fellow
Australian Institute for Business and Economics