Adaptive Regulation for Digital Health

This research was funded was funded by MTP Connect and supported by the Therapeutic Goods Administration, CSIRO and others.  The report was published in February 2021.

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. This report examines how digital health industry stakeholders are engaging with the Australian therapeutic goods regulatory framework.

The emergence of DHTs has seen companies unfamiliar with the regulated health environment entering the sector. They bring different work and investment practices and may delay, or even avoid, regulatory engagement. At the same time, falling manufacturing and distribution barriers have substantially boosted the number of new digital health products.

Australia’s regulatory framework for medical devices is currently risk-weighted, outcomes-based and moving towards international harmonisation. There are, however, different perspectives and understandings of DHTs within the industry that have implications for regulation.

New and some existing developers often have little understanding of regulatory requirements, including the level of clinical evidence required for market approval. In contrast, experienced developers actively build regulatory processes into their product development cycles from the outset by enacting risk-based assessments during their commercialisation process, from proof of concept to prototyping.

Using case studies, this report highlights the rapid and diverse development pathways for digital medical devices in Australia. Each device progresses from initial needs assessment and idea generation. through screening, feasibility testing, proof of concept and evidence building, to market launch, and, finally, market uptake and post-market reporting. The development process is typically iterative rather than linear, with feedback loops between stages of development for improvement, rework, enhanced functionality, enhanced cybersecurity and usability.

The need for flexible regulatory frameworks supported by education and awareness programs across the industry is clear. Policy cannot predict technological disruption – but it can be designed to deliver proactive and responsive regulation to capture and assess new data and support evidence-based decision-making. Regulation that is flexible and adaptive would better suit the rapid pace of technological change.

Australia can lead the way in the regulation of DHTs. This will require change to the existing regulatory framework. This is a challenge, not just for the Therapeutic Goods Administration (TGA) as the regulator, but for all stakeholders. In doing so, Australia will have the opportunity to take the global lead in ensuring timely consumer access to cutting-edge medical technologies.

Report