The AIDH has provided a framework for app developers, giving guidance for evaluating the quality, safety and efficacy of mobile health apps.
In the age of smartphones and wearables, digital health tools are more accessible than ever. With over 350,000 health and wellbeing apps available worldwide, Australians are increasingly turning to mobile health apps to manage everything from sleep and fitness to chronic illness and mental health.
With such a rapidly growing market, how do we know which apps are safe, effective and trustworthy?
At the Australasian Institute of Digital Health, we believe that quality, safety and trust in digital health is non-negotiable. Consumers, carers and health professionals must have confidence in the digital tools they use.
The Therapeutic Goods Administration regulates health apps which meet the definition of a regulated medical device under the therapeutic goods regulations against safety, quality and performance requirements.
Outside of these requirements, there are few specific mechanisms to assess the quality or reliability of health apps beyond the protections warranted under the Australian Consumer Law.
That leaves a gap for the vast number of other health and wellbeing apps Australians download every day. This is particularly concerning when health apps are used to support vulnerable people or those managing complex conditions.
To help address this gap, AIDH was commissioned to evaluate and propose revisions to the mHealth App Assessment Framework, originally developed by the Australian Digital Health Agency.
The suggested revised version is now available under the name Health Apps Assessment Revised Framework; it provides guidance for evaluating the quality, safety and efficacy of mobile health apps.
The revised Framework is freely available on the AIDH website and has been carefully designed for use by app developers. It outlines clear principles and evidence-based criteria across domains such as acceptability and culture; safety and trustworthiness; usability, equity and inclusion; privacy and security; and technical and quality.
We’ve already seen the impact of similar approaches overseas.
In the UK, the Organisation for the Review of Care and Health Apps, founded by NHS clinicians, provide libraries of independently assessed health apps. The libraries provide a trusted platform where apps are reviewed against a digital assessment questionnaire.
Germany’s DiGA program enables prescribed digital health apps to be reimbursed under statutory health insurance once they meet strict evidence and quality standards.
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Both programs rely on structured evaluation frameworks to ensure apps meet safety and clinical effectiveness thresholds.
We are pleased to see there is progress in Australia to strengthen digital health infrastructure through similar initiatives. Consumers and their healthcare providers want to know what apps have been reviewed and meet acceptable safety and quality standards. Health professionals need confidence when recommending apps as part of a patient’s care plan.
We are looking forward to seeing these efforts expanded to the broader health apps ecosystem. Apps supporting physical health, self-management, rehabilitation, and medication adherence should also meet appropriate standards if we are to truly embed digital tools into mainstream care.
We encourage all health app developers to put quality and safety at the centre of their design, development and deployment processes.
The Health Apps Assessment Revised Framework offers practical, evidence-based guidance to help developers build trust, meet expectations and deliver value to users and the health system. It should be used early in the design process and often throughout development, production and ongoing improvement.
As the national peak body for digital health, AIDH sees strong potential for the Framework to be adopted as part of a broader, consistent national approach.
Ultimately, building trust in digital health starts with transparency and accountability. If we expect Australians to rely on digital tools to manage their health, we must ensure those tools are worthy of that trust.
Anja Nikolic is the CEO of the Australasian Institute of Digital Health.
More Information
The revised Health Apps Assessment Framework is available here: https://digitalhealth.org.au/advocacy/mhealth/
