We are currently in the midst of an “information age” where the world is populated by various forms of technologies which contribute to the advancement of the global society. One of the prime multi-disciplinary segments of technology is “Digital Health” which is the integration of technologies such as robotics, artificial intelligence, blockchain and virtual reality with pharmaceuticals and healthcare.

In the recent times, Digital Health technologies have emerged as a pivotal pillar in the delivery of healthcare. The world has witnessed a boom in the health technology market for products such as wearables, telemedicine, e-pharmacies etc. The use and scale up of such digital health solutions has revolutionized how people worldwide achieve higher standards of health, and access services to promote and protect health and well-being.

India has been gearing towards Digital Health since 2015. The Government has identified digitization as the prime tool for the attainment of universal healthcare in India. In pursuance, the Government has steadily been working towards a robust regulatory mechanism for Digital Health. In 2023, this sector has seen even more progress with the announcement of pan-India implementation of National Digital Health Mission and the release of various policy documents for a prospective nationwide digital health ecosystem. This scale-up of Digital Health in India has raised legal questions in respect of regulatory approvals, data considerations, liability etc.

Keeping these developments in mind, in this research paper, we discuss the recent advances in the digital health space, the regulation of digital health interventions and the key legal considerations.

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