STRATEGY Overcoming uncertainties in regulatory status of digital health in India

Technology today has pervaded almost all aspects of human life. Health sector is also not untouched by the evolution of technology. Today, with the incoming of several digital technologies, healthcare delivery has become personalised and precise, and the direct intervention of a healthcare professional is limited.

The term ‘Digital Health’ is all encompassing and includes all applications resulting from the intersection of healthcare and technology. As per the World Health Organization, 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.

As per Ministry of Health and Family Welfare (MoHFW), eHealth or Digital Health is using of information and communication technology in the direction of reaching services to citizens and citizens empowerment through information dissemination.

Digital health includes the use of information and communication technologies in order to resolve the health problems and issues faced by people.

These technologies include both hardware and software solutions. It can cover everything from wearable gadgets to ingestible sensors, from mobile health apps to artificial intelligence, from robotic carriers to electronic records and from web-based analysis to remote monitoring sensors. It is basically about applying digital transformation, through disruptive technolo- gies and cultural dynamics, to the healthcare sector and services.

Post COVID-19 pandemic, there has been a great rise in the rate of adoption of the digital technology in healthcare sector. As per an estimate, 60 per cent of patients and 65 per cent of physicians now favor digital platforms over in person consultations.

With such increased acceptance of technology and growing opportunities in the healthcare industry, there is a need for regulatory intervention to ensure correct and effective usage of the technology. Due to the regular exchange of personal data, 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 India, legal framework pertaining to e-health protection is broadly governed by the following provisions:

◆ IT Act, 2000, read with, the IT (SPDI) Rules, 2011,

Intermediary Guideline Rules 2011, which provide protection to the collection, disclosure and transfer of sensitive personal data, covering medical records and history.

◆ Drugs and Cosmetics Act,1940 (D&C Act): This is the principal legislation governing manufacture, sell, and distribution of drugs, cosmeticsand Medical Devices in India.

◆ The Clinical Establishment Act, 2010: It mandates the “maintenance and provision of Electronic Medical Record for every patient” for the registration and continuation of every clinical establishment.

◆ Telemedicine Guidelines 2020: It allows medical practitioner to perform telemedicine from anywhere in the country and provides direction on the type of care that can be provided and how that care should be delivered.

Although the aforesaid provisions provide legal and regulatory framework to digital health but there exist certain uncertainties which can be overcome with effective implementation of the aforesaid provisions and by introducing fresh set of legal and regulatory framework. Some of areas of concerns are discussed below.

◆ Liability concerns: There are serious concerns regarding liability while accessing digital health enabled by technologies like Artificial Intelligence (AI). For instance, if a medical device, diagnosis or treatment is powered by AI, in such cases, the concerns arise that who is liable towards the same i.e., software developer, the manufacturer, service provider or the physician.

◆ Categorisation of “Software” as drugs: On 11 February 2020, MoHFW released two notifications concerning medical devices in India. The effect of the aforesaid notifications is that medical devices, including digital healthcare systems, will now fall within the definition of "Drugs" under the D&C Act. Some examples like - blood sugar monitor, diabetes tracker, pulse and sleep monitor applications are currently regulated as drugs. As per notification, the ambit of the term “medical devices” has been expanded to include all things that assist a human body in diagnosis, prevention, monitoring and supporting life. This can have far-reaching implications. The drugs regulators are required to be equipped with the technology to regulate the intangible nature of software and other evolving technology in the healthcare sector.

◆ IPR related issues: A flurry of innovations are expected in digital health sector. Most of these inn ovations are going to be related to method or systems implemented on a computer. Under Section 3(k) of the Patent Act, 1970, a mathematical method or a computer program per se or algorithms are not patentable. For example, a typical digital health system might involve machine learning for diagnostic analysis which will involve computer program and mathematical methods and thus careful consideration regarding their patentability is required.

In light of the above, certain measures are required to be undertaken by the government to overcome the uncertainties in legal and regulatory status of Digital health. For instance, data generated by digital healthcare needs to be protected under the specific regulatory regime. A clear categorisation is required to be put in place to ascertain which products and services fall within the healthcare sector and which fall under other categories. The Digital Information Security in Healthcare Act 2018 (‘DISHA’) provides security, standardisation, privacy, and confidentiality standards for electronic health data and the same is required to be enacted soon. Digital health is an evolving sector with huge potential therefore introduction of a unified legal and regulatory framework is need of the hour.