The healthcare market functions through five segments namely hospitals, pharmaceuticals, diagnostics, medical equipment and supplies, medical insurance and, lastly, telemedicine. Telemedicine which is an important component of Telehealth, is referred as to the delivery and facilitation of health and health-related services via telecommunications and digital technologies. The WHO defines telemedicine as, “ Telemedicine has enormous potential in meeting the challenges of healthcare delivery to rural and remote areas besides several other applications in education, training and management in health sector.
It is a fastemerging sector in India; major hospitals (Apollo, AIIMS, Narayana) have adopted telemedicine services and entered into a number of PPPs. As of FY16, telemedicine market in India was valued at US$ 15 million and is expected to rise to US$ 32 million by 2020. Telemedicine can bridge the rural-urban divide in terms of medical facilities, extending low-cost consultation and diagnosis facilities to the remotest of areas via high-speed internet and telecommunication.
Why would telemedicine grow in the future?
According to a report by Industry Journal 24, India’s telemedicine market is growing immensely and is impacting the international economy in terms of growth rate, revenue, sale, market share and size, showing the market size in India. India has an extensive growth as it has broad rural-urban population and rural India is bereft of medical facilities, giving telemedicine a space for growth in India.
Innovation in the healthcare industry in country like India is complex due to various factors like geographical, demographical and landscape. Telemedicine helps in easing the clinical problems from distance especially for distant rural communities.
These services help patients save travel and wait time as they can consult a doctor at their own convenience and in the comfort of their homes. Deprived education and medical professionals in rural areas is the reason behind government’s ideology to use technology to bridge this gap. Remote areas not only present a number of challenges for the service providers but also for the families who are accessing these services.
NITI Aayog states that, the National Health Stack (NHS) is a virtual digital platform for healthcare in the country. NHS study aims to have digital health records for all citizens by 2022 to make telemedicine and E-Health easy.
Why do we require a robust regulatory and legal mechanism for Telemedicine in India?
Currently, the practice of Telemedicine in India is governed by various statutes that generally relate to the practice of medicine in India such as the Medical Council of India Act, 1956 (“MCI Act”) and the rules and regulations issued there under and state specific legislations where the business is proposed to be established.
In terms of Section 27 of the MCI Act, any person whose name is enrolled in the Indian medical register can practice as a medical practitioner in any state of India according to his qualifications. Accordingly, inter-state practice of Telemedicine by medical practitioners is permissible. Other laws applicable are Indian Medical Council (Professional Conduct, Etiquette And Ethics) Regulations 2002., Drugs And Cosmetics Act 1940 And 1945 Rules, NDPS Act, 1985, Clinical Establishment Act, 2010 and Information Technology Act 2000 and 2011 Rules and Epidemic Diseases Act, as Amended In 2020.
There are many issues of concern regarding the legal and ethical aspects of telemedicine. These broadly include:
• The responsibilities and potential liabilities of health professionals.
• The duty to maintain confidentiality and privacy of patient records.
• Jurisdictional problems with cross-border consultations.
• The issue of reimbursement for care provided using a telemedicine service.
Despite the concept being recognised and defined by WHO and its spreading influence over the past decade, there is no legislation which singularly deals with the practice of Telemedicine in India. In the absence of a codified law, all the existing laws relating to both medicine and information technology in India would apply to Telemedicine.
Lack of Regulations: How is it a bane?
Lack of clear guidelines created significant ambiguity for registered medical professionals, raising doubts on the practice of telemedicine.
The 2018 judgement of Bombay High Court in decided on 25 July 2018, created uncertainty about the place and legitimacy of Telemedicine because an appropriate framework does not exist. This case, essentially related to a doctor prescribing wrong medicines on telephone to patient, through a pharmacist, which eventually led to the death of the lady, post her delivery. The crucial part in this case was that the doctor, was never available even through follow-up care with the patient. The erring doctor was accordingly charged and punished for culpable homicide amounting to murder.
The High Court also came up with another relevant finding that in serious and technical cases, where some expertise is required, Telemedicine should be avoided. It is best applicable for general care and check-ups and followup care.
Existing Telemedicine Practice Guidelines in India?
On 25.03.2020, MCI in collaboration with the NITI Aayog released the Telemedicine guidelines enabling Registered Medical Practitioners (RMPs) to provide healthcare using Telemedicine for all medical treatments. They help physicians and encourage them to consider telemedicine as a part of their normal practice using videos, internet-based platforms like web chat, apps etc. without carrying out a physical examination.
This fulfils a major gap as until now there were no guidelines or legislations for the practice of telemedicine. The peculiar aspects of guidelines framed are, Firstly, that they emphasise on the importance of “informed consent” in case of any doctorpatient consultation. As per guidelines, the RMP is duty bound to inform the patient about this consent, before commencing any treatment. Secondly, as per the guidelines, any RMP is supposed to undertake a mandatory course for Telemedicine, from an institution within 3 years of its notification which should certified by the Ministry of Health and Family Welfare.
However, details of such courses and institutions are still awaited. Lastly, the classification of certain generic medicines has been done by way of various lists in these guidelines. In List O, only medicines which are safe to be prescribed, via tele consultation are mentioned. Subsequently, List A provides details of certain drugs, which could be prescribed during the first video consultation. Furthermore, List B enlists medicines which could be prescribed only in a follow-up session in addition to those which were prescribed in person. Then there is a Prohibited List, drugs enlisted here are Schedule X drugs, which cannot be prescribed at all.
What implementation challenges would we face in the post Covid-19 era?
The first and foremost challenge would be proximate contact with any patient, of course, in emergency cases, there is alternative to the same, but in the first or follow-up care, this mode would be beneficial. Since many doctors are not practicing, patients would have difficulty getting prescriptions for their chronic conditions, if their earlier prescriptions are already beyond 30 days? The content, format for a prescription has not been modified for decades.
There is no legal format for telemedicine in the country, there is no format or guidelines in place for sending a prescription by a doctor to the patient or the pharmacy directly, or to both. However, there are many other multiple issues and grounds which we need to level before introducing this technology formally in India. One, would obviously be thorough training and accreditation to doctors and paramedical staff through structured courses. Two, would be jurisdictional issues, especially in trans-boundary consultation. Let us suppose, a patient approached a doctor in New Delhi, who then wants to take advice from a surgeon in New York.
Post treatment, the patient suffers health issues, who would be responsible, how would our legal system make such a doctor, liable. Last, but not the least, strict data security guidelines need to be put in force, to make sure critical patient data is not leaked at any cost. In the absence of a strong data protection legislation, any data leak would turn out to be very costly for the Indian medical framework. Thus, the need of the hour, is to put in stringent provisions and ensure their implementation, in case there is critical data theft.
Aditya Jain is Advocate-on-record at the Supreme Court of India, Co-founder and Partner at J&G Advocates. Adv. Neha Gyamlani is Partner at J&G Advocates.