Sidharrth Shankar, Rupinder Malik, Partners, J Sagar Associates and Shivam Arora, Associate, J Sagar Associates, give an insight into the potential that telemedicine has in the Indian market
In general terms, telemedicine can be said to be delivery of medical services using information and communication technologies (ICT) for various medical aspects, including tele-consultation, delivery of medicines, and specialised services such as tele-radiology.
In 2010, recognising the tremendous potential of telemedicine, the World Health Organisation (WHO) adopted a wide definition of the term, highlighting distance as a critical factor in the delivery of health care services using ICT. Significantly, the WHO took note of the many definitions of the term and attributed this to telemedicine being an open and constantly evolving science, as it incorporates new advancements in technology and responds and adapts to the changing health needs and contexts of societies.
If we look at numbers, the scope of tele-medicine sector in India looks very exciting, and one of extreme potential with upward growth trajectory. McKinsey Global Institute has recently released a report in which it has estimated that the implementation of telemedicine technology could save $4-5 billion every year and replace half of in-person outpatient consultations in India. A study by Global Market Insights, the global telemedicine market is set to reach a valuation of $130.5 billion by 2025, with the market in India expected to grow at 2.4 per cent CAGR.
However, lack of a well-defined regulatory framework is hindering the growth of tele-medicine sector. Owing to the lack of a dedicated legislation for regulation of telemedicine services, the regulatory framework for provision of telemedicine services in India is scattered over several legislations. Depending on the nature of business and type of services offered, the service provider may be bound by the requirements prescribed under one or more legislation.
The regulations and standards prescribed by the Medical Council of India (MCI) require all medical practitioners (whether or not they are engaged in the provision of tele-medicine services) to mandatorily register themselves with the MCI and/ or the State Medical Council (SMC). In the context of telemedicine, it is unclear whether a medical practitioner registered in one state will be permitted to provide services in another state without obtaining any additional registration. In the event such practitioners operate out of a dedicated facility, the provisions of the Clinical Establishment Act may need to be complied with. Further, the ‘Other Service Provider’ (OSP) guidelines issued by the Department of Telecommunications prescribe that a company providing ‘application services’ (includes provision of telemedicine services) using the networks and/ or the telecom bandwidth provided by authorised telecom service provider, are required to be registered with the Department of Telecommunications.
In addition to having to comply with several requirements prescribed under a plethora of legislations, the ongoing debate amongst various stakeholders and judicial authorities regarding the legality of e-pharmacies, has added to the existing woes of service providers. Due to the regulatory uncertainty, both domestic and foreign investors, have been impeded from entering this space.
The practice of telemedicine routinely involves medical practitioners prescribing medicines merely based on the telephonic conversations (or discussions over any other audio-visual means) with the patient. Accordingly, the uncertainty around the legality of e-pharmacies and tele-pharmacies in India appears to be the most significant issue for the provision of telemedicine services in India. The apex court of India, in a 2009 judgment, remarked that no prescription should ordinarily be given without actual examination and that the tendency to give prescription over telephone, except in acute emergency, should be avoided. More recently, the Bombay High Court held that a prescription without diagnosis would amount to culpable negligence.
Security and data privacy
The tremendous upside in consolidating and maintaining electronic heath records (EHR) has been widely advertised. Apart from improving the quality of healthcare by ensuring easier access to patients’ medical records, EHRs can also be harnessed for medical research. However, in order to successfully implement technological tools that would facilitate the storage, processing and retrieval of patient data, the growing concerns around protecting a patient’s confidential data need to be addressed at the earliest. In this regard, the Ministry of Health and Family Welfare (MoH&FW), in March of 2018 placed the Digital Information Security in Healthcare, Act (DISHA) in the public domain, inviting comments from stakeholders. Even though it is a step in the right direction, the Act has not been passed yet. Till the time this regulatory vacuum exists, the gains from digitising patient data do not seem to be commensurate with the risk involved.
Telemedicine services can prove to be an effective tool to bridge the gap in access of quality medical services in rural areas vis-à-vis urban areas. The present government’s strong focus on digitisation has acted as a catalyst to propel the growth of the industry.
However, in the absence of express rules and regulations regarding telemedicine services in India, the fate and future of this industry is uncertain. Till such time, industry players should ensure that they comply with all existing applicable laws and are contractually protected to avoid any unforeseen liability.
The views of the authors in this article are personal.
1 McKinsey Global Institute, Digital India: Technology to transform a connected nation, March 2019, available at https://mck.co/2ZxAaGQ
3 Martin F. D’Souza v. Mohd. Ishfaq (2009) 3 SCC 1
4 Deepa Sanjeev Pawaskar and Ors. v. The State of Maharashtra, Criminal Anticipatory Bail Application No. 513 of 2018