How do we create a fit-for-purpose regulatory framework for digital health in New Zealand?
Over the past two decades, software has begun to permeate and transform virtually every industry, and healthcare is no exception. The digital health market globally, was valued at over US$200 billion in 2022, and it is projected to expand at a compound annual growth rate of 18% from 2023 to 2030. The COVID-19 pandemic has also accelerated interest in digital health, with an unprecedented rise in investment in and use of digital tools as medical devices to diagnose, treat, and manage a wide array of medical conditions.
The rapid uptake of such digital tools points to an area ripe with opportunity to improve and complement existing health care services and reach historically underserved populations. But to fully realise the benefits of novel digital offerings, concomitant innovation in regulatory pathways is necessary. One revolutionary development in digital health technology is software that can perform complex medical functions, software as a medical device (SaMD). SaMD can diagnose conditions, suggest treatments, and inform clinical management. SaMD offers myriad health benefits. One of the most important is that it allows patients to play a more active role in their own health care.
Global regions are approaching the challenges of digital health technologies in different ways and timelines. Some countries or regions develop bespoke legislation while others are attempting to regulate such technologies under the existing regulatory framework. The value of real-world evidence is increasingly recognised to provide its value for regulatory decision making on the development, authorisation and supervision throughout the entire product lifecycle. Four factors that might be useful to consider in unison for the successful regulation of digital health technology are: Intended user, product claims, effect on health outcomes, and data source and destination.
In NZ, the Therapeutic Products Bill 2022 addresses regulation of several different types of therapeutic products, including but not limited to medicines, natural health products, medical devices, and SaMD. There is a risk that the current definition of SaMD in the bill is too broad. It is entirely plausible that low-risk health software products might inadvertently get caught by the broad definition of SaMD, decreasing the productivity of the health software industry, affecting health services who rely on developments to health software.
Developing a new regulatory framework, let alone implementing it, is no small feat. Still, the unique characteristics of digital health suggest that a reimagined regulatory pathway could be greatly beneficial to numerous healthcare stakeholders. Clearer distinctions and more specific guidelines are needed to effectively regulate the rapidly growing digital healthcare industry.