This Week Has Seen A Lot Of Reviews On The Issue Of Software And/As Medical Device Regulation.

First we had this:

Need a doctor? There's an app for that, but new TGA risk classification rules apply

Johnson Winter & Slattery - Christine Ecob and Stanley Yu

Australia

March 5 2021

Apps that treat, diagnose or monitor a condition are likely to be subject to more stringent pre-market requirements under newly implemented reforms.

Standalone software (which is not attached to any physical medical device), commonly in the form of a mobile app, is increasingly becoming one of the means upon which we treat, diagnose or monitor a condition.

Such an app (if its intended purpose is medical and it is not an excluded product) may constitute a medical device (Software as a Medical Device or SaMD) under the Therapeutic Goods Act 1989 (Cth) and must be registered on the Australian Register of Therapeutic Goods (ARTG) before it can be supplied in Australia.

The documentation required to register a SaMD onto the ARTG will depend on its risk classification, and there have been changes to the way SaMD is classified since 25 February 2021.

Importantly, if your SaMD has already been registered on the ARTG, you will have until 25 August 2021 to re-apply for ARTG entry (and as part of that, re-assess your SaMD under the new classification rules) or notify the Therapeutic Goods Administration to get more time to do so.

So what has changed?

New classification rules applying to SaMD have been inserted into the Therapeutic Goods (Medical Devices) Regulations 2002. SaMD covered by the amended regulations includes software that:

(a) recommends treatment or intervention (e.g. specifying exercises to treat a back pain injury);

(b) screens or diagnoses a condition (e.g. melanoma detector);

(c) provides therapy through provision of information (e.g. posture corrector providing exercise instructions); and

(d) monitors a condition (e.g. monitoring sleep to predict risk of sleep apnoea).

Lots more here:

https://www.lexology.com/library/detail.aspx?g=bf6f1690-3053-4aa8-9f9f-56b08803f238

Second we have this:

TGA implements stricter regulation of software-based medical devices

Australia March 10 2021

DLA Piper - Joanne Lim and Eliza Jane Saunders

The Australian Therapeutic Goods Administration (TGA) has implemented reforms to the regulation of software-based medical devices, including software that functions as a medical device in its own right (i.e. it is not attached to any physical medical device).

Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations) include:

• clarifying the boundary of regulated software products;
• introducing new classification rules for software based medical devices that:
• provide a diagnosis or screens 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; and
• providing updates to the essential principles to more clearly express the requirements for software-based medical devices.

The new classification rules will subject these software-based medical devices to more stringent pre-market requirements (such as external conformity assessments) depending on the function of the device, risk of harm and whether the user is a health professional or patient. Software-based medical devices are classified from Class I (low risk) to Class III (high risk).

The changes came into effect from 25 February 2021 and all applications for inclusion of software-based medical devices in the ARTG made after this date must meet the amended classification rules.

More here:

https://www.lexology.com/library/detail.aspx?g=e68db991-b4b1-4071-bacf-2a24de53a7cc

And third we have this as a release from the industry:

New regulation for software-based medical devices

By Bronwyn Le Grice*
Monday, 08 March, 2021

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.

Here is the link:

https://www.hospitalhealth.com.au/content/technology/article/new-regulation-for-software-based-medical-devices-508576514

It is going to be interesting to see how this all plays out and what the practical, real world outcomes are.

This paragraph from the third article has me a little confused.

“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.”

Surely CDSS is just the sort of system you would want to be confident that it is both reliable and fit for purpose!

I am taking a wait and see approach to all this for now!

David.