Current Regulatory framework of Digital Health in India

Ridhima Sandal; Sonal Setya

doi:10.22270/ijdra.v12i4.719

Ridhima Sandal Centre of excellence in pharmaceutical sciences(CEPS)
Sonal Setya Professor , SGT University, Gurgaon

DOI https://doi.org/10.22270/ijdra.v12i4.719

Abstract

India’s healthcare system is experiencing a significant transformation with the increasing adoption of digital technologies. The rise of digital health has brought remarkable improvements in the availability, affordability, and patient-centeredness of healthcare services. This article reviews the evolving regulatory landscape governing digital health in India, highlighting existing frameworks, significant initiatives, and ongoing challenges such as fragmented regulations and data protection concerns. It emphasizes the importance of establishing robust regulatory structures to safeguard patient rights and data privacy, thereby fostering sustainable growth in the digital healthcare sector. Additionally, global perspectives on digital health regulations from organizations could provide a context for India's efforts. A balanced approach to regulation will be crucial for the sustainable growth of digital health in India. By strategically addressing digital health challenges, India has the potential to enhance healthcare delivery and achieve universal health coverage, underscoring the necessity of collaboration and innovation in the digital health domain. This article aims to offer meaningful perspectives for policymakers, healthcare providers, and technology developers, delivering a comprehensive overview of the existing landscape and potential future developments in the regulation of digital healthcare in India.

Keywords: Telemedicine, regulatory framework, digital therapeutics, electronic health records, mobile health, medical devices, NDHM, CDSCO, digital health

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