The TGA has engaged CSIRO to conduct research to build an understanding of Australia’s innovation in ‘software as a medical device’ and to learn how and when agencies such as the TGA can support them in demonstrating the safety of their products on the global market.
The CSIRO will also develop a TGA guidance document around medical device cybersecurity to assist the medical device and digital health ecosystem to implement best-practice approaches to cybersecurity.
The CSIRO is now engaging with the medical device and digital health industries to better understand their work and how they can work together to continue developing and implementing safe technologies.
The project is in acknowledgment that digital technologies are providing the foundation for many emerging global healthcare innovations and the Australian healthcare sector has been quick to both develop and adopt these for cost-effective outcomes benefiting the clinician and the patient.
This project will also assist the medical devices ecosystem to implement best-practice approaches to cybersecurity.
A cluster of technology developers, focussed on the production of health and medical software including mobile applications, clinical decision support tools and companion apps for medical devices is emerging in Australia. In order to appropriately support this cluster in their knowledge of regulatory requirements, supports and pathways that may relate to medical software innovations CSIRO will engage with industry players to understand their needs.
The CSIRO is seeking comment from companies that identify with this emerging industry we encourage you to tell us more about your activities and support needs. The CSIRO are asking interested parties to contact the team using the link below, before close of business on 20 of August 2018.
Members of the medical device industry will be invited to engage in a national workshop and webinar on 14 September, following which a consultation paper will be released for public input.
To find out more about this project or register your interest in participating in the workshop and consultation process please contact CSIRO project team member Dr Shane Seabrook. For software as a medical device and for cybersecurity please contact CSIRO project team member Dr Jill Freyne.
More information can be found online.