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The technology sector, and the practical applications of technological developments, have grown exponentially over the years, and the healthcare and pharma industries have .
India Food, Drugs, Healthcare, Life Sciences
The technology sector, and the practical applications of technological developments, have grown exponentially over the years, and the healthcare and pharma industries have benefitted alongside many others. To add to this, the outbreak of Covid-19 and consequent lockdowns also accelerated the usage of digital healthcare, not only in India but also globally, thereby leading to the rapid growth of start-ups within the digital healthcare space.
As per the World Health Organisation, digital health is a broad umbrella term encompassing eHealth (which includes mHealth), as well as emerging areas, such as advanced computing sciences in 'big data', genomics, and artificial intelligence. 1
Combining technology with healthcare, the digital healthcare ecosystem encompasses different aspects of technology used for monitoring, diagnosing, preventing, and curing health. In today's world, this includes robot-assisted surgeries, fitness wearables, telemedicine, software as a medical device, mobile phone trackers, the internet of medical things, electronic health records, and artificial intelligence applications in healthcare, among others.
With the increased proliferation of technology in the healthcare industry, there is a clear need for regulatory intervention to ensure that this technology is not misused. Due to the regular exchange of personal data regarding health issues and consultation between patients and the service providers, the protection of the personal data thus generated has become a matter of concern. Today, everyone is freely using smartphones with pulse trackers, smartwatches that monitor people's heart rate even during sleep, and menstruation trackers, without being aware of the amount of data generated and stored.
In the light of the concerns cited above, there is an urgent need for regulators to pass specific laws and regulations addressing current and prospective issues relating to the digital healthcare ecosystem.
The present note deals with the current regulatory regime for digital healthcare in India and how a change in the definition of 'medical devices' by the Ministry of Health and Family Welfare might affect the digital healthcare industry in India.
In a revolutionary move on February 11, 2020, the Ministry of Health and Family Welfare released two notifications concerning medical devices in India 2 :
The effect of the said notifications is that medical devices, including digital healthcare systems, will now fall within the definition of "Drugs" under the Drugs and Cosmetics Act, 1940. Some examples like - blood sugar monitor, diabetes tracker, pulse and sleep monitor applications are currently regulated as drugs. This can have far-reaching implications, which the regulators seem to have overlooked, such as the ability of the Central Drugs and Standards Control Organisation (CDSCO) to adequately regulate medical devices and drugs.
