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Sam Nichols for Life Matters

Mental health apps are largely unregulated in Australia. Some experts fear vulnerable users could be harmed

Mental health apps are a growing industry, but there's no way to ensure that their contents are safe in Australia. (Reuters: Issei Kato)

Australians have begun increasingly relying on technology for mental health care — ranging from diagnostic and self-help tools, to online platforms that connect users with real or AI therapists.

It comes at a time when mental illness is growing in Australia. It's estimated nearly nine million Australian adults have experienced a mental disorder. However, mental health care is simultaneously becoming less accessible.

These figures also come at a time of increased use of smartphone apps designed for mental health treatment. According to UK telecommunications company Uswitch, Australia is a leading consumer of apps for mental wellbeing.

Mental health apps offer the promise of reduced costs compared to traditional therapy.

But, in Australia, they are largely unregulated.

The popularity of mental health apps comes in the wake of reduced access to more traditional mental health treatments. (ABC News: Nick Baker)

Lisa Parker, who researches public health ethics and digital health technologies at the University of Sydney, believes some mental health apps offer real benefits, but she's concerned about the impact of those which don't.

"Almost certainly, the vast majority of apps have no evidence behind them whatsoever," Dr Parker says.

"I think the risks of harm are definitely present."

Questions of safety

Over recent years, mental health apps have raised red flags over user safety.

On October 15, 2018, YouTube personality Philip DeFranco published a statement on Twitter regarding his sponsorship by BetterHelp.

The US-based mental health platform provides global digital access to therapists and psychologists for a weekly fee, including via a smartphone app.

In 2018, DeFranco was one of the many BetterHelp-sponsored YouTubers and online creators who uploaded content about their mental health struggles alongside discounted subscriptions.

But as BetterHelp's name begun to spread more online, complaints against the company began to increase.

Vox Media tech outlet Polygon published growing criticisms of BetterHelp, including the company's inability to guarantee its listed therapists were licensed professionals.

In October 2018, Philip DeFranco began addressing the criticism around BetterHelp and its terms of service in a now-deleted video. (YouTube: Phillip DeFranco)

Both BetterHelp founder Alon Matas and DeFranco publicly addressed these accusations days after the article's release, with the latter stating he would be investigating the controversy.

In the now deleted tweet, DeFranco said, although he couldn't find anything that could be deemed a scam, he "still believe[d] [BetterHelp] need to do a lot of work on their terms and conditions". He ended the BetterHelp sponsorship.

Despite these concerns, mental health apps have continued to grow into a multi-million dollar industry.

In 2018, Olympic gold medallist Michael Phelps partnered with US mental health app Talkspace. (YouTube: Talkspace)

In 2021, BetterHelp partnered with pop star Ariana Grande to provide $US2 million worth of one-month trials to users.

Deloitte has also previously estimated the global spend of mental health apps would reach almost $US500 million ($745 million) in 2022. In 2019, this figure was $US203 million ($312 million).

'Undertaking deceptive practices'

One risk of harm from mental health apps is breached data security.

Earlier this year, BetterHelp made headlines again when the US Federal Trade Commission fined it $US7.8 million ($11.6 million) for illegally sharing user data with third parties.

BetterHelp did not reply to the ABC's request for comments.

Piers Gooding, a senior research fellow at Melbourne Law School, tells ABC RN's Life Matters there should be "additional protections in law" to ensure consumers' data is protected.

"There's general agreement that current privacy laws don't adequately protect the kind of data that is being shared online in the current data-based society that we live in," Dr Gooding says.

"I do think there's a long way to go. And there are companies who are actively — it would seem — undertaking deceptive practices."

In 2019, Dr Parker's research revealed that, of 61 mental health apps surveyed, half did not have privacy policies.

The Federal Trade Commission filed a complaint against BetterHelp over its sharing of user data with third parties, and its lack of transparency. (Federal Trade Commission)

Dr Parker describes the app industry's protection of privacy as "insufficient", and says she'd like to see increased monitoring and "enforcement of privacy principles and practices" in mental health apps and beyond.

'User beware'

Alongside privacy concerns, there are also questions of the quality of service that mental health apps are providing users.

Like all products, mental health apps range in effectiveness.

One 2018 analysis reported that, while more research was needed, the apps did improve "the monitoring and management of mental health symptoms or disorders".

Dr Lisa Parker says the mental health app market is currently a "user beware" environment. (Getty Images: NurPhoto)

But Dr Parker says some apps could be harmful to users.

She describes the current environment of mental health apps as "user beware".

Her research has concluded that some apps "imply individual responsibility" for mental wellbeing, while being silent on any external influences.

"These apps just ignore all the actual reasons why people legitimately feel anxious or depressed," she says.

Lacking information

In 2015, Australian researchers found that, despite their popularity, there were "only a limited number of empirically supported" mental health apps at that time.

Then in 2020, a paper from the University of New England reported that, of 293 mental health apps reviewed, only about half mentioned they followed evidence-based frameworks.

Some studies have suggested that many mental health apps may not be providing research-backed treatments. (Pexels: Charlotte May)

Clinical psychologist Jamie Marshall agrees there are questions over the effectiveness of some mental health apps.

He's an advisor for the Australian Digital Health Agency, and while he's in favour of mental health apps, arguing they could play a large role in filling a gap in current mental health services, he agrees there's little research on how effective they are.

Dr Marshall says testing for effectiveness is possible — but it's also expensive, something that could be dissuading app creators.

For example, a randomised control trial — what Dr Marshall calls the "gold standard" — would be the ideal way to determine effectiveness, but this could take longer than 18 months to complete.

"If someone develops an app, there's a financial imperative to get it onto the app store as quick as possible," he says.

"That [18-month] time frame may not be acceptable for many developers or investors."

For smaller companies and start-ups, the cost of research itself could be another limitation, Dr Marshall says.

There are also questions over the existing mental health app efficacy research.

Dr Marshall says that while there are quite a few existing reviews, with more coming out all the time, they're often conducted by those who developed the apps themselves.

Dr Jamie Marshall says some app creators, such as a start-ups, may not have incentives or the capacity to run scientific trials on their products. (Unsplash: Israel Andrade)

"Another way to think about this, for example, is if a brand new drug was developed by a drug company and they said, 'Look, we've done the research, and this is the only research that's been done'.

"We would all have some doubts about that until some independent researchers came along and clarified by getting the same results," he says.

In the absence of independent data, the effectiveness of the apps is determined by user ratings in app stores — platforms that "don't necessarily monitor" for user safety, Dr Marshall says.

"If someone's just surfing an app store for a mental health app, what they're likely going to be looking at are the star ratings [but] the research tells us that star ratings don't equate to effectiveness."

In 2020, the New York Times reported accusations that Talkspace employees were publishing fake positive reviews of the app at that time.

Little oversight

Mental health app Talkspace made headlines for being willing to work around healthcare rules and underdelivering on promised services.

So who is ensuring these apps are safe to use?

In Australia, the Therapeutic Goods Administration (TGA) regulates all medical devices in Australia, ensuring they work as intended and don't harm users.

In 2019, an amendment was made to the Therapeutic Goods Act to better ensure that "medical software", which includes health apps and mental health apps, was better regulated for potential risks. This mirrored similar regulations that came into force in the European Union in 2017.

"Most medical devices that consist of software are currently classified as Class I medical devices, the lowest risk classification of device," then-Health Minister Greg Hunt said in an explanatory statement in 2019.

But in February 2021 — the same month the amendment to the Act came into effect — a separate amendment came into effect that excluded software-based digital mental health tools like mental health apps from the Therapeutic Goods Act.

In 2019, then-federal health minister Greg Hunt confirmed there would be changes to the way medical apps would be classified. (ABC News: Rebecca Trigger)

Lee Walsh, technical lead for digital health with the TGA from 2018-19, describes this sequence of events as a "very strange situation".

"I'm not privy to the decision-making or the reason why that choice has been made, but it does seem like a strange one," Dr Walsh says.

"Especially given the potential risk related to making an error in delivering therapy to a person with a mental health condition."

There are now guidelines for best practice in Australia. Since 2020, the Australian Commission on Safety and Quality in Healthcare (ACSQHC) has offered a framework for mental health apps, with accreditation to these standards available since November 2022.

In a statement to the ABC, the ACSQHC said that accreditation "confirms that a digital mental health service has the required systems and processes in place to deliver safe, effective and high-quality digital mental health care".

It added that the federal government, depending on the scheme's uptake, "may require digital mental health services to be accredited as part of licensing policy for any future funding agreements".

In a separate statement, a spokesperson from the Department of Health and Aged Care said these standards "aim to improve the quality of services and protect service users and their support people from harm".

However, both the standards and the accreditation remain voluntary.

The ABC also requested comment from federal health minister Mark Butler about whether there are future plans for mental health apps to be placed under stronger regulations, but did not receive a reply.

Dr Walsh says that because of the way the Act's amendments have been worded, there may be no required assurance that mental health apps are working properly or delivering the intended therapy.

"People like to think software can't cause harm, but that's just simply not true," he says.

"If somebody gets a misdiagnosis, or they get the wrong information, and they act on it, or they get false positives, it can have a huge impact on them. And it can cause a lot of harm."

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