New regulation for software-based medical devices

Changes to the regulation of ‘software as a medical device’ (SaMD) by the Therapeutic Goods Administration (TGA) mark a coming of age for the healthcare system of the future — one which is connected, asynchronous, data-driven and patient-centric.

Under these changes, software-based products that make health claims are now subject to a medical device classification aligned to the risk level to the patient. This includes devices that:

• provide a diagnosis or screen for a disease or condition;
• monitor the state or progression of a disease or condition, or the parameters of a person with a disease or condition;
• specify or recommend a treatment or intervention; or
• provide therapy through the provision of information.
   

From 25 February, products not listed on the Australian Registry for Therapeutic Goods (ARTG) will be prevented from being sold in Australia.

The TGA has worked closely with ANDHealth and the industry over the last two years to usher in this new regulatory framework. This puts us in step with global markets like the US who already have similar regulation structures in place and is the first step to wide-scale adoption and acceptance of technologies that have the potential to significantly reduce healthcare inefficiencies while simultaneously improving patient outcomes.

The TGA has created ‘carve outs’ for certain products that are considered low risk, present a low risk to users, or are subject to other mechanisms of oversight, including an exemption for clinical decision support software (CDSS) that meets the definition of a medical device. This allows health system software providers to continue with their important work in improving connectivity within the healthcare system, but brings a regulatory oversight component into play when technologies are claiming to directly impact the diagnosis, prevention, monitoring, treatment or alleviation of diseases, injury or disability.

Overcoming the challenges of outdated regulation

Rapid innovation has driven significant changes to software function and adoption, giving rise to a larger number of software applications (with or without connected devices) able to inform, drive or replace clinical decisions, or directly provide therapy to an individual, including via sustained patient behavioural change and engagement. Patient and clinician access to patient-generated data has become much easier with personal devices such as smartphones, wearables and tablets. These rapid advances in technology have led to a large increase in the number of software-based medical devices, including digital therapeutics, available globally.

Most therapeutic and medical device regulatory frameworks were developed before the internet and smartphones, meaning existing regulatory frameworks have often lagged behind modern digital health innovations. This regulatory uncertainty has made it difficult for digital health to flourish. In a survey of over 50 digital health growth companies in Australia, undertaken by ANDHealth in 2020, only 25% felt completely confident navigating digital health regulation in Australia. At the same time, regulators and governments need to preserve the necessary quality and evidence thresholds with respect to safety, efficacy and value of healthcare products.

Regulation improves safety and access, and paves the way for reimbursement

Like any health products, software can have adverse effects. We don’t accept pharmaceuticals, vaccines or medical devices that aren’t approved by our medical regulator, so why would we treat digital interventions that make similar health claims any differently?

Digital health companies need to provide robust clinical evidence on efficacy and safety, verified by an independent regulator, to substantiate the claims they make about the impact of their products and services on patients. At the same time, patients and users should be able to trust that the product does ‘what it says on the box’ (or on the app store). If a software application claims it can help patients with type 2 diabetes reduce their HbA1c levels, or that it can provide support and management of complex medication regimes for serious illness, then the manufacturers should have robust clinical evidence to support that claim.

A strong regulatory environment increases the availability of products that benefit the health of Australians, whilst providing the right level of regulatory rigor for safety, quality and efficacy, which allows clinicians and patients to have trust in the products and their likely outcomes. This type of regulation also creates an important distinction between evidence-based digital health products, digital therapeutics and general consumer wellness products, and prevents those in the latter category making more serious health claims when they do not have sufficient data or necessary regulatory approvals.

Third-party authentication of clinical evidence, claims, product quality and patient outcomes through established regulatory mechanisms provides clinicians with trust in claims made by software and app providers. This opens the door for clinicians to use and prescribe safe, evidence-based digital health technologies to their patients (including those already approved overseas) and paves the way for reimbursement frameworks in the near future, which will make these new types of interventions cost-effective for patients and clinicians alike.

Evolution of our healthcare industry

The establishment of a clear and well-communicated regulatory pathway for digital health applications is a critical step in the evolution of our healthcare industry and recognises the role that digital health will play in the health system of the future, supporting the safety of current and emerging digital health technologies.

We welcome the introduction of these regulatory changes, which mark a critical first step in supporting the uptake of technologies that can improve the efficiency and impact of the healthcare system in Australia.

*Bronwyn Le Grice is the founder and CEO of ANDHealth, an Australian digital health accelerator and incubator.

Image credit: ©stock.adobe.com/au/Štěpán Kápl