印度的心理健康应用程序：监管格局与未来方向。
Mental health apps in India: regulatory landscape and future directions.
作者信息
Singh Sethi M I, Kumar Rakesh C, Manjunatha Narayana, Naveen Kumar Channaveerachari, Math Suresh Bada
机构信息
Senior Resident, Tele Medicine Centre, NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.
Assistant Professor, Tele Medicine Centre, NIMHANS Digital Academy, Department of Psychiatry, National Institute of Mental Health & Neurosciences (NIMHANS), Bangalore, India.
出版信息
BJPsych Int. 2025 Feb;22(1):2-5. doi: 10.1192/bji.2024.20.
Mental health apps (MHAs) are increasingly popular in India due to rising mental health awareness and app accessibility. Despite their benefits, like mood tracking, sleep tools and virtual therapy, MHAs lack regulatory oversight. India's framework, including the Central Drugs Standard Control Organization (CDSCO) and Medical Device Rules 2017, does not cover standalone health apps, raising concerns about data privacy and accuracy. Establishing a centralised regulatory body with guidelines for MHAs is essential for user safety and efficacy. This paper examines the current regulatory landscape, compares international approaches and proposes a tiered regulatory framework to foster responsible innovation while safeguarding user interests in digital mental health services.
由于心理健康意识的提高和应用程序的可及性，心理健康应用程序（MHA）在印度越来越受欢迎。尽管它们有诸如情绪跟踪、睡眠工具和虚拟治疗等好处，但心理健康应用程序缺乏监管。印度的框架，包括中央药品标准控制组织（CDSCO）和2017年医疗器械规则，并不涵盖独立的健康应用程序，这引发了对数据隐私和准确性的担忧。建立一个有心理健康应用程序指导方针的中央监管机构对用户安全和有效性至关重要。本文审视了当前的监管格局，比较了国际方法，并提出了一个分层监管框架，以促进负责任的创新，同时在数字心理健康服务中保护用户利益。
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