Software and technologies that assist in diagnosis, treatment options, storing and sharing health records, and managing workflow can enable more efficient clinical practice. The proliferation of digital health tools, including mobile health apps and wearable sensors, holds great promise for improving human health.
By some accounts there are now over 318,000 health apps available on the top app stores worldwide, nearly double the number of apps available in 2015 – with more than 200 apps being added each day.
In today’s environment, apps can be created by anyone with a good idea and some programming skills.
When barriers to entry are low, how do you differentiate yourself? But more importantly how does the industry and regulators ensure the quality of the technology can be directly linked to clinical evidence sufficient to demonstrate an appropriate level of safety and performance when used for the intended purpose.
That’s why this week the TGA recognised that to continue providing a clear regulatory environment for medical devices in Australia, it is essential that it 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).
As with all other medical devices, the regulation of medical device software and mobile medical apps that are medical devices is risk-based. This means that the level of scrutiny and oversight by the TGA applied to a product will vary according to the level of risk that the product represents to the patient or healthcare professional using it. The potential risks arising from medical devices can be minor, or very significant indeed, depending on the nature of the device and its intended purpose.
PulseLine will be taking a keen interest in this project as it evolves. If you want to get involved contact the team using the link below, before close of business on the 20th of August 2018.