Health apps, diagnostic AI systems and the 3D printing of body parts are among the tech innovations that could soon be subject to strengthened oversight, with the Therapeutic Goods Administration planning to put forward regulatory amendments for the emerging technologies.

Within its new business plan for 2018-19, the TGA said software as a medical device – such as the recently announced Apple Watch 4, which includes an atrial fibrillation-detecting algorithm and an ECG – will soon need to jump through custom-fit hoops.

In response to the “complicated and dynamic” healthcare landscape, the TGA is chasing the health tech pioneers to put in place rules that manage risk and weed out the cowboys.

“Scientific advancements such as new cancer treatments and new technologies such as 3D bio-printing continue to bring opportunities for Australians,” the business plan said.

“They also require a regulatory framework that is contemporary, adaptable and supports innovation. Our challenge is to capitalise on advancements in technology while ensuring that regulation is appropriate to manage risk.”

The TGA said it will continue to implement regulatory reforms, including those recommended by the Expert Panel Review of Medicines and Medical Devices Regulation, and will also “implement a number of other major and necessary reforms to the regulatory system”.

Within those reforms it will propose “regulatory amendments for the emerging technologies of software as a medical device and the medical application of 3D printing (cognisant of international harmonisation)”.

Efforts to improve rigour and speed in regulatory processes to contend with the explosion in digital health innovations is a worldwide scramble.

[Read more: How FDA is evolving to keep pace with innovation in healthcare | Elizabeth Warren, colleagues pen critical letter on FDA Pre-Cert]

In the US, the Food and Drug Administration has been evolving to better vet and approve emerging technologies. It has announced plans to create a Centre for Excellence for Digital Health with the goal of modernising the regulatory approach. Its proposed Pre-Cert program is designed to focus on evaluating “standards of excellence” for companies, without each new device needing to undergo the FDA approval process, although it is currently receiving scrutiny in Congress.

Meanwhile, in June the FDA announced a ruling exempting individual genetic risk tests from 510(k) premarket approval, which means companies such as 23andMe only have to go through a one-time pre-market review of its genetic risk testing apparatus.

The TGA’s reforms will affect companies that produce software that has a role in diagnosing or managing illness, or analyses clinical data such as the results of blood tests or ECGs.

[Read more: Apple unveils Watch Series 4 with game-changing fall detection and FDA-approved ECG | Australia’s ResApp signs deal to help test the health of US military personnel for deployment]

The proliferation of mobile apps has contributed genuine health benefits but some have caused concerns.

University of Sydney researchers claimed mental health apps could lead to unnecessary diagnoses and misinformation about mental illness in an analysis published by the Annals of Family Medicine

“Mental health apps may promote medicalisation of normal mental states and imply individual responsibility for mental well-being,” the authors of the study wrote.

“Within the healthcare clinician-patient relationship, such messages should be challenged, where appropriate, to prevent over-diagnosis and ensure supportive healthcare where needed.”

The researchers looked at apps from the US, UK, Canada and Australia, and narrowed down the analysis to platforms that referenced mental health diagnoses or symptoms, offered diagnosis and guidance, or made health claims.

Out of the 61 apps selected, 34 of the addressed panic and stress, 16 targeted mood disorders, and 11 focused on wellbeing and other psychological symptoms. The study also looked at themes and messaging. 

“We identified two dominant messages about mental health: one, poor or fragile mental health is ubiquitous; and two, individuals can easily manage their own mental health problems with apps. Developers offered very limited scientific evidence for the apps’ claimed benefits.” 

The authors also found that 61 per cent of the apps “claimed vague scientific authority” for their product and claimed they could lead to the over-diagnosing of mental illness and prevent individuals who need help from reaching out. 

[Read more: Mental health apps can lead to over-diagnosis and have “limited” scientific basis | Basic drug reminder app punches above its weight in Australian heart disease trial]

But research into the benefits of a smartphone app for medication reminders for coronary heart disease patients demonstrated greater adherence to prescriptions in an Australian study.

In what was described as “exciting” news for patients, the researchers also found a basic reminder app can be just as effective as more advanced varieties.

“Currently, there are numerous smartphone applications that claim to improve adherence through programmed regular reminders but very limited evidence that such apps are effective,” the University of Sydney researchers wrote in the journal Heart.

In a randomised clinical trial, participants in the study were randomly assigned to receive either standard care, or instructions and assistance to download one of two freely available medication reminder apps.

After the three-month study period, participants using the apps had much higher adherence levels.

Earlier this year, the TGA engaged CSIRO to conduct research into Australia’s software as a medical device innovators, the regulatory environment and cybersecurity.


TAGS: TGA, FDA, apps, AI, 3D printing



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