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数字健康的监管挑战:以南非的心理健康应用程序和个人数据为例。

Regulatory challenges of digital health: the case of mental health applications and personal data in South Africa.

作者信息

Botes Marietjie

机构信息

School of Law, University of KwaZulu Natal, Durban, South Africa.

出版信息

Front Pharmacol. 2025 Apr 30;16:1498600. doi: 10.3389/fphar.2025.1498600. eCollection 2025.

Abstract

INTRODUCTION

This study explores the regulatory challenges posed by digital mental health applications in South Africa, particularly regarding the collection and protection of personal data. It aimed to assess whether South Africa's current legal framework sufficiently protects users' sensitive mental health data amidst the rise of digital mental health solutions, especially in the context of privacy concerns.

METHODS

The research focused on the intersection of digital mental health applications, data protection laws, and user privacy in South Africa. It examined existing legal frameworks, including the Protection of Personal Information Act (POPIA), National Health Act (NHA), and Consumer Protection Act (CPA). The study reviewed relevant literature, legal texts, and case studies, focusing on mental health applications in both urban and rural contexts.

RESULTS

While South Africa has laws in place to protect personal information, these laws have significant gaps in addressing the unique risks associated with digital mental health technologies. Key findings include inadequate regulation of AI-driven mental health tools, insufficient guidelines for third-party data sharing, and challenges with cross-border data transfers.

DISCUSSION

The implications of these findings suggest that South Africa needs to modernize its legal framework to better regulate digital mental health tools and ensure user privacy. This includes improving AI regulation, strengthening consent mechanisms, and enhancing protections against third-party data misuse. Future research should focus on developing specific legal guidelines for mental health data and addressing the vulnerabilities faced by rural populations with low digital literacy. The study's conclusions align with global concerns over the ethical implications of mental health datacommodification and emphasize the need for robust, adaptable regulatory approaches.

摘要

引言

本研究探讨了南非数字心理健康应用所带来的监管挑战,特别是在个人数据收集和保护方面。其目的是评估在数字心理健康解决方案兴起的背景下,尤其是在隐私问题方面,南非现行法律框架是否足以保护用户的敏感心理健康数据。

方法

该研究聚焦于南非数字心理健康应用、数据保护法和用户隐私的交叉点。它审视了现有法律框架,包括《个人信息保护法》(POPIA)、《国家卫生法》(NHA)和《消费者保护法》(CPA)。该研究回顾了相关文献、法律文本和案例研究,重点关注城乡背景下的心理健康应用。

结果

虽然南非有保护个人信息的法律,但这些法律在应对与数字心理健康技术相关的独特风险方面存在重大差距。主要发现包括对人工智能驱动的心理健康工具监管不足、第三方数据共享的指导方针不充分以及跨境数据传输面临挑战。

讨论

这些发现的影响表明,南非需要使其法律框架现代化,以更好地监管数字心理健康工具并确保用户隐私。这包括改进人工智能监管、加强同意机制以及增强对第三方数据滥用的保护。未来的研究应专注于制定心理健康数据的具体法律指导方针,并解决数字素养较低的农村人口所面临的脆弱性问题。该研究的结论与全球对心理健康数据商品化的伦理影响的担忧一致,并强调需要强有力的、适应性强的监管方法。

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