Background: Australia has a seemingly robust digital health regulatory landscape. Core to this landscape a national body to develop digital health strategy, providing a strong foundation for jurisdictional policy development, and supposedly clear guidance on the regulation of digital health technologies. Despite the intentions of this regulatory regime, it has become increasingly difficult to ensure a safe, effective and equitable digital health ecosystem.
Presentation Purpose: This presentation aims to explore the ethic-legal limitations of the current Australian regulatory landscape for harnessing the full potential of digital health. The presentation will draw on findings from a comprehensive documentary analysis of the digital health regulatory landscape in Australia, and insights from interviews with key stakeholders from government and industry. Key challenges that regulators still need to be overcome to realise the potential of digital health for all Australians will be highlighted including Lack of national governance frameworks for Digital Health; Policy alignment with public expectations; and Interconnectedness of public funding and regulation processes.
Conclusion: Gaps remain in the sustained implementation of the Australian Digital Health policy. There is a notable imbalance between the portion of technologies that are regulated and funded through the public system, and those that are used by most Australians. the latter is funded by private insurers or out of pocket by members of the public. This limits equity of access but also results in a notable disconnect between the digital health technologies that undergo rigorous regulation, and those that are most widely used by the general population.