Introduction

The Indian government is actively promoting ‘digital India’ to empower its citizens in the field of technology. A slew of recent technological changes have dramatically improved the quality of life in India. The Indian government has been open to introduction of emerging technologies into public life, especially those in the domain of healthcare such e-pharmacy and drone delivery.

Most important laws

• The Clinical Establishment Act, 2010 (and equivalent state-level legislations) set out basic standards for medical treatment required to be followed by various healthcare professionals.
• The Information Technology Act, 2000 lays down the data protection requirements for personal and sensitive personal data. Health related data is deemed to ‘sensitive’ in nature.
• The Drugs and Cosmetics Act, 1940 regulates the process of dispensation of drugs.
• The Consumer Protection Act, 1986 / the Consumer Protection Act, 2019 makes manufacturers and service providers liable for any defect in goods deficiency in service respectively.
• The New Telecom Policy of 1999 makes it mandatory to obtain a license to provide services of nature of telemedicine over telephone or internet.
• Different registration laws regulate healthcare professionals such as doctors, dentists, pharmacists and nurses, as well as professionals providing allied healthcare services such as physiotherapists, psychologists and phlebotomists.

Key things to remember

• Emerging technologies often face one of the following two challenges – that there is no clear regulation that applies to their business or that there are several overlapping and confusing regulations. Most entrepreneurs venture into regulatory entrepreneurship and prefer it that way.
• It usually takes a number of years before any specific regulation is put in place to regulate emerging technologies. Example: Drones.
• Many government institutes issue guidance documents to regulate emerging technologies that fall within their domain. Though informal and non-binding on the face of it, these documents sometime gain legal force by imposing ethical and commercial standards on businesses. Example: Stem Cell Technology.
• It is possible in India to approach Courts to block emerging technologies on grounds of public interest, should there be unwarranted effects of the emerging technology on Indian society. The Courts always objectively assess the actual public interest in use of the emerging technology, and interfere only if necessary by issuing orders to the government to frame regulations. Example: Electronic Nicotine Delivery Systems (ENDS) or e-cigarettes.

Important sub-segments and related industries

• E-consultations
• E-pharmacy
• Drones
• Artificial Intelligence
• Block-chain
• Patient Registry