Adaptive Regulation for Digital Health: Enhancing Australia’s Regulation System

Banner Image

Digital health technologies (DHTs) have the potential to disrupt both the medical technology, biotechnology and pharmaceutical sector and the broader delivery of healthcare, creating challenges for the effective and timely regulation of new therapeutic goods.

Our new report Adaptive Regulation for Digital Health: Enhancing Australia’s Regulation System examines how digital health industry stakeholders are engaging with the Australian therapeutic goods regulatory framework, using case studies to highlight the rapid and diverse development pathways for digital medical devices in Australia.

Focusing on DHTs regulated as medical devices – including software as a medical device (SaMD) and physical medical devices with associated software – the research has sought to cover the following:

  1.  Ascertain the current state of knowledge regarding regulatory pathways and regulation compliance for DHTs;
  2. Identify key challenges in digital health regulation within the current regulatory framework;
  3. Identify potential alignments and misalignments between current regulatory requirements and new product development processes;
  4. Clarify how current regulatory policies and frameworks could accommodate an adaptive approach to digital health regulation; and
  5. Identify areas where greater education and awareness are needed within industry.

The research presented in this report was funded by MTPConnect and conducted by researchers at The University of Queensland’s (UQ) Australian Institute for Business and Economics (AIBE) with support from Steering Committee representatives from the Therapeutic Goods Administration, CSIRO, ANDHealth, University of Queensland and Allens.

Australia has an opportunity to take the global lead in ensuring timely consumer access to cutting-edge medical technologies. This report is critical reading for start-ups and innovators developing digital health technologies.