Ensuring Digital Health Standards

The use of digital health (DH) has grown rapidly over the last couple of years - accelerating even more during the COVID-19 pandemic. As DH becomes part of the traditional healthcare system, it's important to have stringent regulations and higher levels of scrutiny. Regulators around the world and in Asia are realising this fact and changing regulations accordingly. Let's look at the regulatory landscape in APAC.

- Ayesha Siddiqui

Digital health devices and applications pose unique challenges to regulators, and the agencies are getting serious about meeting them. Within a region as diverse as APAC, with different levels of both healthcare provision and regulatory expertise, there is inevitably a wide variation in how DH solutions are brought to market. Let's look at how countries - Australia, Singapore, Japan, China, Korea, most active in enacting such laws, are establishing regulatory frameworks.

Australia

There is no single legislation which governs digital health technology in Australia. her, different laws govern different aspects of digital health technology. In Australia, the main legislation in relation to digital health technology falls into three categories: therapeutic goods law (TGA), consumer protection law and privacy law. The TGA regulates medical devices, including software as a medical device, such as software that uses information about symptoms to make a diagnosis, and mobile apps coupled with devices for calculating medication dosages.

The TGA Act was updated in August 2021 to address the increase in medical related software-based products being developed. The TGA Act includes new classification rules for software-based medical devices, including for those that provide a diagnosis for health conditions, monitor the state of health conditions, specify a treatment or provide therapy. The reforms also amend the "Essential Principles" - the requirements relating to the safety and performance of medical devices - in relation to cyber security, the management of data and information, and requirements relating to development, product and maintenance of medical devices. Digital health technologies that collect personal information also need to comply with Australia's privacy laws as set out in the Privacy Act.