Abstract
BackgroundApps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. App developers might not be aware of all the regulatory requirements and best practice principles are emergent. Health apps are regulated in order to minimise their potential for harm due to, for example, loss of personal health privacy, financial costs, and health harms from delayed or unnecessary diagnosis, monitoring and treatment. We aimed to produce a comprehensive guide to assist app developers in producing health apps that are legally compliant and in keeping with high professional standards of user protection.MethodsWe conducted a case study analysis of the Australian and related international policy environment for mental health apps to identify relevant sectors, policy actors, and policy solutions.ResultsWe identified 29 policies produced by governments and non-government organisations that provide oversight of health apps. In consultation with stakeholders, we developed an interactive tool targeted at app developers, summarising key features of the policy environment and highlighting legislative, industry and professional standards around seven relevant domains: privacy, security, content, promotion and advertising, consumer finances, medical device efficacy and safety, and professional ethics. We annotated this developer guidance tool with information about: the relevance of each domain; existing legislative and non-legislative guidance; critiques of existing policy; recommendations for developers; and suggestions for other key stakeholders.ConclusionsWe anticipate that mental health apps developed in accordance with this tool will be more likely to conform to regulatory requirements, protect consumer privacy, protect consumer finances, and deliver health benefit; and less likely to attract regulatory penalties, offend consumers and communities, mislead consumers, or deliver health harms. We encourage government, industry and consumer organisations to use and publicise the tool.
Highlights
Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare
This paper describes the process of developing a guidance tool to assist app developers who are producing mental health apps distributed in the Australian market
The key regulatory domains that we identified as being relevant to developers were: 1. consumer privacy 2. data security 3. content 4. promotion and advertising 5. consumer finances 6. medical device efficacy and safety 7. professional ethics
Summary
Apps targeted at health and wellbeing sit in a rapidly growing industry associated with widespread optimism about their potential to deliver accessible and cost-effective healthcare. Consumers may suffer loss of personal privacy, leading to reputational damage with subsequent financial, social, insurance or employment discrimination [9,10,11]. Symptoms of ill-health may be exacerbated [13, 14], under-diagnosed [15], or over-diagnosed [16,17,18] It is important for those involved in health app development (hereafter referred to by the umbrella term of “app developers”), regardless of whether they focus on the commercial, technical or health-related aspects, to be aware of the potential for negative outcomes, and to work towards
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