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Research: Software as a Medical Device and Cyber Security for Medical Devices

8 October 2018

Globally, regulators of therapeutic goods are faced with numerous challenges concerning emerging medical device technology. The Therapeutic Goods Administration (TGA) recognises that, to continue providing a clear regulatory environment for medical devices in Australia, it is essential that we engage with the medical devices ecosystem during the development of new regulatory recommendations and guidelines.

The TGA has commenced consultation, through CSIRO Futures, in the areas of Software as a Medical Device (SaMD), and Cyber Security for Medical Devices (CSfMD). Regulation of SaMD is challenged by the emergence of new players that may not have had the opportunity to engage with the TGA, or are lacking an awareness of the regulatory requirements in Australia. CSfMD challenges arise due to the increasing impact and complexity of the cyber threat landscape, and the lack of current regulatory guidelines to effectively address this.

The TGA has engaged CSIRO to develop reports for both SaMD and CSfMD that help shape recommendations moving forward.

Opportunity to have your say

CSIRO Futures has set out how it intends to conduct the research across two key streams:

Software as a Medical Device

To assist the TGA to identify stakeholders in this environment, CSIRO will engage with industry to understand their activities and their needs for further engagement in order to appropriately support their knowledge of regulatory requirements relating to medical software innovations.

If you or your company identify with this emerging industry, go to the CSIRO projects page Mapping the emerging innovation landscape for more information on how you can be involved.

Cyber Security for Medical Devices

The TGA, through CSIRO Futures, has commenced research and consultation regarding cyber security for medical devices. This project will be critical to informing the review of the TGA's existing framework for regulation of the cybersecurity of medical devices. The research and consultation seeks to explore and capture the complexities of the Australian medical devices cyber security landscape and then develop new industry guidance.

As part of the consultation, on 14 September 2018, TGA and CSIRO Futures held an auditorium presentation in Canberra with a simultaneous live webinar stream. This webinar included two panel discussions with questions from the audience and webinar participants. The panels consisted of representatives from industry, hospitals, government, and cybersecurity experts. The webinar recording is now available on demand and can be viewed using the link below.

The next stage of the project will be a public consultation paper to further inform the guidance, which is currently under preparation.

Additional details are available at the CSIRO Projects page: Cyber security for medical devices guidelines, and from the Live Stream website.