Parker Lisa, Karliychuk Tanya, Gillies Donna, Mintzes Barbara, Raven Melissa, Grundy Quinn
Charles Perkins Centre, Faculty of Pharmacy, The University of Sydney, D17 6th floor, The Hub, Camperdown, Sydney, NSW, 2006, Australia.
Australian Communications Consumer Action Network (ACCAN), Ultimo, NSW, Australia.
BMC Med Inform Decis Mak. 2017 Oct 2;17(1):141. doi: 10.1186/s12911-017-0535-0.
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. 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.
We 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.
We 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.
We 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.
针对健康与福祉的应用程序所处的行业发展迅速，人们普遍看好其提供便捷且具成本效益的医疗保健服务的潜力。应用程序开发者可能并不知晓所有的监管要求，而最佳实践原则也刚刚出现。对健康应用程序进行监管，是为了将其潜在危害降至最低，例如个人健康隐私泄露、财务成本以及因诊断、监测和治疗延迟或不必要而导致的健康损害。我们旨在编写一份全面指南，以协助应用程序开发者开发符合法律规定且符合保护用户的高专业标准的健康应用程序。
我们对澳大利亚及相关国际心理健康应用程序的政策环境进行了案例研究分析，以确定相关部门、政策行为者和政策解决方案。
我们确定了政府和非政府组织制定的29项对健康应用程序进行监督的政策。在与利益相关者协商后，我们为应用程序开发者开发了一个交互式工具，总结了政策环境的关键特征，并突出了七个相关领域的立法、行业和专业标准：隐私、安全、内容、推广与广告、消费者财务、医疗设备功效与安全以及职业道德。我们用以下信息对这个开发者指导工具进行了注释：每个领域的相关性；现有的立法和非立法指导；对现有政策的批评；对开发者的建议；以及对其他关键利益相关者的建议。
我们预计，按照这个工具开发的心理健康应用程序更有可能符合监管要求、保护消费者隐私、保护消费者财务并带来健康益处；而不太可能受到监管处罚、冒犯消费者和社区、误导消费者或造成健康损害。我们鼓励政府、行业和消费者组织使用并宣传该工具。
