Abstract
Introduction: Wearable health devices have transformed personal health management by providing real-time monitoring and personalized care. However, the vast amounts of sensitive data collected by these devices pose significant privacy risks, particularly in compliance with the General Data Protection Regulation (GDPR). The GDPR enforces strict requirements around consent, data minimization, and the right to be forgotten. Ensuring GDPR compliance is a major challenge for developers and manufacturers of wearable health devices. Methods: This study employs a systematic review to analyze current literature on GDPR compliance challenges in wearable health devices. Data were extracted from peer-reviewed studies, industry reports, and legal analyses published between 2010 and 2024. Key themes were identified through thematic analysis, focusing on consent management, data minimization, encryption, and privacy-by-design strategies. Results: The review found that security breaches and informed consent are the most significant challenges in ensuring GDPR compliance. Many wearable devices collect excessive amounts of data, conflicting with GDPR's data minimization principle. Privacy-by-design and encryption were identified as critical solutions, though these approaches introduce trade-offs in device functionality and user experience. Conclusion: Addressing GDPR compliance in wearable health devices requires a balance between robust data protection and usability. Solutions like privacy-by-design and encryption are essential but require careful implementation to avoid performance impacts. Future efforts should focus on improving user consent management and developing more efficient data governance frameworks.
Published Version
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