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India’s new telemedicine guidelines
J Sagar Associates, Bengaluru
Winston Churchill is said to have remarked that a good crisis should not be wasted, and the Government of India has concurred. Following long periods without any clarity on whether the practice of telemedicine was legal, culminating in the decision of the Bombay High Court in Deepa Sanjeev Pawaskar & Anr v the State of Maharashtra, following which the legitimacy of practising telemedicine was questioned, the Ministry of Health, has issued the Telemedicine Practice Guidelines (Guidelines), and provided some legitimacy to the practice.
Telemedicine is the delivery of healthcare services, where distance is a critical factor. It is carried out by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation. It can also be conducted for the continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities. The Guidelines go on to encourage all services and models of care used by doctors and health workers to consider the use of telemedicine as a part of normal practice.
Consultations can be provided by a registered medical practitioner, who may use any tools of communication, including video, audio, text based or asynchronous. Consultations may be real-time or asynchronous. Apart from direct registered medical practitioner/patient consultation where the onus is placed on the practitioner to determine whether a teleconsultation will suffice, telemedicine consultations can be held between caregivers and practitioners (where the patient may be incapacitated), and more than one practitioner, as well as between health workers and practitioners.
Guidelines for registered medical practitioner/patient consultations
Both parties need to identify each other. The registered medical practitioner is required to collect the patient’s personal details, while the patient must be given with the means and opportunity to verify the practitioner’s credentials and registration number, which must be prominently displayed. The age of the patient has to be explicitly determined/verified along with proof of age. Teleconsultation for minors is only permitted with an identified adult family member in attendance.
The doctrine of consent is implied if the consultation is initiated by the patient. Explicit consent is required however if the practitioner initiates the consultation. Such consent can be given via email, text, video, or audio. A copy of such express consent must be retained, along with personal details collected.
A registered medical practitioner can issue prescriptions and transmit the prescription directly to a pharmacy, after obtaining the patient’s consent. A practitioner can prescribe most drugs following teleconsultation, other than those drugs listed in Schedule X to the Drugs and Cosmetics Act, 1940 or drugs under the Narcotic Drugs and Psychotropic Substances, Act, 1985.
The registered medical practitioner’s responsibilities
The registered medical practitioner is required to comply with all data protection laws, as well as any regulations relating to patient confidentiality. The practitioner will be held liable for any breach of confidentiality, provided such violation was not due to a breach on the technological platform. The registered medical practitioner is also required to comply with all principles and regulations relating to medical ethics.
Guidelines for technology platforms to enable telemedicine
Technology platforms providing telemedicine services are required to ensure that the patients are consulting with a registered medical practitioner, and are required to conduct their due diligence before listing any practitioner on their online portal. The platform must provide the name, qualification and registration number, and contact details of every registered medical practitioner listed on the platform. Any misconduct or non-compliance by the practitioner must be reported to the relevant authorities, ie, the Board of Governors, in place of the Medical Council of India.
Technology platforms based on artificial intelligence/machine learning are not permitted for consultations or the prescribing of medicines via telemedicine, although they may assist the registered medical practitioner.
In cases where a specific technology platform is found in breach of the Guidelines, the technology platform may be barred, and no registered medical practitioner may then use that platform to provide telemedicine.
Telemedicine services can increase timely access to services that may not otherwise be available and serve to address the discrepancy in accessing quality medical services in rural areas compared to urban centres. This is especially the case in a vast country such as India with limited resources for providing in-person healthcare. Although the Government of India with has focus on digitisation which has helped the growth of telemedicine, until recently, the lack of specific rules and regulations has meant that the future of the sector was uncertain.
The Guidelines have gone a long way in removing this uncertainty. While telemedicine service providers and registered medical practitioners must still comply with a excess of legislation in this field, by clearly setting out what may and may not be done in a teleconsultation, the Guidelines have established the norms for operating in this sector.
Nevertheless, in addition to obtaining a licence under existing telecommunications laws telemedicine service providers may also now have to obtain licences under India’s pharmaceutical laws. This is because they may fall under the all-encompassing definition of a ‘medical device’ and consequently, a ‘drug’, from the perspective of the registered medical practitioners, they need not worry about providing consultation over the internet or by telephone.
1. A ‘registered medical practitioner’ is a person enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act, 1956. Under the Guidelines, the registered medical practitioner intending to provide online consultations is required to have completed a compulsory online course within three years of the notification of the Guidelines ie, 25 March 2020.
2. Video applications would include Skype, Zoom, videos on chat platforms, videos through a telemedicine service provider; audio applications include phone (mobile or landline), VoIP, among others; text-based instances include general messaging through SMS, messaging on platforms such as WhatsApp and other instant messengers, messaging through telemedicine apps; and asynchronous would be e-mail, faxes, etc.