A COMPREHENSIVE REVIEW OF DIGITAL HEALTH TECHNOLOGY REGULATION AS PER USFDA
Authors: Chandru S , SUDHEER KUMAR T* AND KAMARAJ R

ABSTRACT
Digital health technology is revolutionizing the healthcare landscape by leveraging digital and information technologies to enhance healthcare delivery, monitoring, and management. This technology encompasses a wide range of tools, including mobile apps, wearable, telemedicine, electronic health records, and AI-driven diagnostics. While promising significant benefits, the development of digital health technology presents several challenges. Navigating complex regulatory frameworks and ensuring compliance with evolving standards is a critical aspect of development. Robust clinical validation is required to establish the safety and efficacy of these technologies, especially for those employing AI algorithms. Data privacy and security are paramount due to the sensitive nature of health information. Interoperability with existing healthcare systems, seamless user experience, and addressing ethical and legal concerns are essential for successful adoption. The ability to generate substantial clinical evidence, manage costs, and overcome resistance to change are also key factors in realizing the potential of digital health technology. Collaboration among healthcare experts, technology professionals, regulatory bodies, and patients is crucial for addressing these challenges. By striking a balance between innovation and safety, digital health technology can empower individuals, improve patient outcomes, and reshape healthcare practices. While obstacles exist, the positive impact of digital health technology on global health is undeniable, requiring ongoing dedication to innovation, regulatory compliance, and equitable access. Keywords: Mobile medical app, Cybersecurity, Software, mHealth, Wearables
Publication date: 01/09/2024
    https://ijbpas.com/pdf/2024/September/MS_IJBPAS_2024_8306.pdf
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https://doi.org/10.31032/IJBPAS/2024/13.9.8306