Behavioural and Implementation Science Research Group, School of Health Sciences, University of East Anglia, Norwich, UK.
Norwich Medical School, University of East Anglia, Norwich, UK.
Addiction. 2021 Dec;116(12):3276-3283. doi: 10.1111/add.15484. Epub 2021 Mar 26.
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.
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.
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.
针对成瘾行为的移动医疗应用（apps）提供了广泛的数字支持，对于有污名化的群体和那些难以获得治疗服务的人来说，具有特别的益处。监管和认证可能会鼓励采用基于证据的成瘾行为应用，但这是一个复杂而混乱的领域。我们探讨了国际监管和认证指南，研究了一些实施挑战，并为应用开发者、医疗保健专业人员和应用用户提供了相关启示。
我们探讨了不同国家将健康和幸福、混合支持和临床治疗应用归类为医疗器械的情况，以帮助读者理解指南的复杂性。我们描述了一款被归类为医疗器械的成瘾行为应用，并探讨了目前正在出现的创新监管方法。我们讨论了使用符合质量、用户满意度或有效性等标准的精选在线应用程序库，我们希望这些库将成为寻找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，以及精选库如何解决这些问题。
应用程序作为医疗器械的国际监管在各国之间存在差异，需要以简单、易用和透明的格式进行标准化。对非医疗器械应用程序进行认证的努力也存在差异，并且公共机构在认可方面传递了混合信息。鼓励医疗保健专业人员和用户在存在认证应用程序的情况下使用它们来治疗成瘾行为，或者探索其他具有更强证据基础的数字干预形式。
