Domain 2: Safety & Trustworthiness
Considers users’ exposures to risks and harms as well as reliability and trustworthiness of information provided. Trustworthiness of information sources and safety against misinformation are fundamental to the intended health and wellbeing purposes of Health Apps and this domain is intended to help guide developers to have clarity about what they should by way of documented evidence for their apps.
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Are all restrictions, contraindications, limitations and risks clearly communicated to the intended users including e.g., age, requirement for internet access, time commitments or durations, user qualifications or other restrictions, including situations where the App may not be suitable or recommended?
If the App is intended for the consumer without clinical supervision, the developer shall have documented evidence demonstrating that the App, or associated website, clearly declares that the information or services provided do not replace a recommendation, opinion or diagnosis made by a healthcare professional. If the App is intended for use in consultation with a healthcare professional, the developer shall have documented evidence that the App clearly declares this: e.g., this App is intended for use in consultation with a healthcare professional.
Is there any evidence that the App conforms to healthcare safety-by-design principles in relation to the design and operation of the App?
The developer shall have documented evidence: • That the App has adopted safety-by-design principles for build and operation. • That the App has been subjected to an appropriate ethical review process with respect to safety.
Where the App purports to provide a specific health benefit or make a specific health claim, does the developer offer any evidence from authoritative sources such as certificates of registration, published peer reviewed references, relevant public health authorities, recommendations from scientifically conducted medical trials, or scientific literature to support those claims?
Where the App purports to provide a specific health benefit, or make a specific health claim the developer shall have documented evidence of relevant authoritative sources within the App, or documentation available for the user including whether such evidentiary information has been subsequently withdrawn or disputed within the relevant scientific literature.
If health information is provided by the App, is the health information displayed in the App current?
If health information is provided by the App the developer shall document evidence: • that the App has been continually updated with respect to sources of information, or that real-time links to authoritative sources are current and working. • that the information has been reviewed and (where necessary) updated in the last 18 months? (whether that information is behind paywalls or not). “Not Applicable” indicates that the App does not display or make use of health information that would be expected to need to be current.
If the App is not already part of a formal human ethics evaluation process (which will have a formal ethics review process) is there any evidence of compliance with an industry or government ethical code of practice?
The developer shall document evidence of how safety or privacy breaches are reported and managed and how it complies with any relevant code of ethics. Where AI is used within the App, or where any data is sent back to AI engines for training or other purposes, the developer is encouraged to document compliance with the voluntary Australian AI ethics principles.
Does the App claim safe operation?
The developer shall document evidence: • that it provides clear support channels and mechanisms for users or clinical advisors to report safety issues or operational problems. • that safety breaches (minor or major) have a clear process for review, follow up and corrective action. • that if it requires integration with health records such as My Health Record or electronic medical records in clinical settings, then it shall be conformant with relevant health integration, terminology, imaging and/or exchange standards for Australian healthcare settings.