Regulatory reform for software-based consumer health products – new regulations provide clarity but can they keep up with the technology?

Mobile health apps and devices are everywhere (“mHealth”), with Australians now the biggest consumers of health apps per capita. The TGA recently released a suite of reforms on software-based medical devices and consumer health products to better address this area. But what are the impacts on developers, and will the regulations be “future proof” as the technology continues to advance?

Key takeaways

  • mHealth is a rapidly growing sector of consumer technology. These products are able to measure increasingly complex physiological functions.
  • Recent regulatory reforms clarify that “consumer health products”, including most mHealth products, are not medical devices and therefore not regulated by the TGA.
  • The simplified regulatory landscape should allow Australian consumers faster access to the newest and most advanced mHealth technology.
  • Continual review of the regulatory framework will help the regulations keep pace with technological advancements in mHealth to ensure that the classification of “consumer health products” remains fit for purpose.

Click here to read our analysis of the reforms and their implications for the future.

Emma Iles
Emma Iles
Partner, Melbourne
+61 3 9288 1625
John Lao
John Lao
Solicitor, Melbourne