Regulation and accreditation of addictive behaviour applications-navigating the landscape
Regulation and accreditation of addictive behaviour applications-navigating the landscape
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DOI：
10.1111/add.15484
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发表时间：
2021-03-26
期刊：
影响因子：
6
通讯作者：
Naughton, Felix
中科院分区：
文献类型：
--
作者：
Khadjesari, Zarnie;Brown, Tracey;Naughton, Felix
背景针对成瘾行为的mHealth应用程序(App)为成瘾行为提供了广泛的数字支持，尤其有利于受耻辱的群体和那些难以获得治疗服务的群体。监管和认证可能会鼓励基于证据的成瘾行为应用程序的采用和使用，但这是一个复杂而令人困惑的局面。我们导航国际监管和认证指南，探索一些实施挑战，并为应用程序开发人员、医疗保健专业人员和应用程序用户提供启示。分析我们探索将健康和福祉、混合支持和临床治疗应用程序按国家/地区归类为医疗设备，以帮助读者驾驭指南的复杂性。我们描述了一款被归类为医疗设备的成瘾行为应用程序，并探索了目前正在出现的创新监管方法。我们讨论如何使用经过管理的在线应用程序库，这些程序库遵守质量、用户满意度或有效性等特征的门槛，我们希望这将成为搜索合适应用程序的起点，而不是商业应用程序商店。我们还探讨了与应用程序相关的伦理问题，以及受管理的图书馆如何解决这些问题。结论对医疗器械应用的国际监管因国家而异，以简单、可用和透明的格式进行标准化将使其受益。为非医疗器械申请提供认证的努力也是多种多样的，公共机构提供关于认可的含混不清的信息。鼓励卫生保健专业人员和用户在存在成瘾行为的情况下使用经认可的应用程序，或探索其他形式的数字干预，以更有力的证据为基础。
Background mHealth applications (apps) for addictive behaviours offer widespread provision of digital support, with particular benefits for stigmatized groups and those with poor access to treatment services. Regulation and accreditation may encourage the uptake and use of evidence-based addictive behaviour apps, yet this is a complex and confusing landscape. We navigate international regulatory and accreditation guidance, explore some of the implementation challenges and provide implications for app developers, health-care professionals and app users. Analysis We explore the classification of health and wellbeing, blended support and clinical therapy apps as medical devices by country to help readers navigate the complexity of the guidance. We describe an addictive behaviour app classified as a medical device and explore the innovative approaches to regulation that are currently emerging. We discuss the use of curated on-line app libraries that adhere to thresholds for characteristics such as quality, user satisfaction or effectiveness, which we hope will become the starting-point in the search for suitable apps, rather than commercial app stores. We also explore the ethical concerns associated with apps and how curated libraries address these. Conclusions International regulation of applications as medical devices varies across countries and would benefit from standardization in a simple, usable and transparent format. Efforts to provide accreditation of non-medical device applications are also variable, and public bodies provide mixed messages concerning endorsement. Health-care professionals and users are encouraged to use accredited applications for addictive behaviours where they exist, or explore other forms of digital intervention with a stronger evidence base.