TELEMEDICINE PRACTICE GUIDELINES IN INDIA
“the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”. ~ World Health Organisation on what is Telemedicine
Amidst the outbreak of the pandemic COVID-19 and the consequent lockdown in India, when social distancing from one another is mandated, the Medical Council of India (MCI) has encouraged the doctors and health workers to practice telemedicine, whenever appropriate, to provide healthcare services, and Board of Governors (BoG) of MCI has in March 2020, issued the Telemedicine Practice Guidelines (“Guidelines”) as part of the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002 under the Indian Medical Council Act 1956 (“IMC Act”).
Overview of the Guidelines:
The Guidelines comprehensively set out the standards, norms, and procedures to be followed by any person who has enrolled in the State Medical Register or the Indian Medical Register under IMC Act ( “Registered Medical Practitioner/RMP”) while practicing telemedicine in India through any mode of communication viz video, audio or text-based communication either for exchange of information in real-time or in synchronous modes for first consults or for follow up patients. The Guidelines mandates RMPs to complete an online training session to be provided by BoG within three years of the date of notification of the Guidelines.
Professional judgment, medical ethics, and privacy:
The Guidelines underline that the core of telemedicine practice is the professional judgment skill of an RMP to decide whether the remote consultation is sufficient or in-person consultation is required. The Guidelines insists that, in general, RMP should also advise for in-person consultation in all cases of emergency. Specifically, when an alternative in personal care is available, consultation through telemedicine should be avoided in case of an emergency and should be limited to first aid, life-saving measures, advice on referral and counseling. However, if alternative care is not possible, then RMP may provide consultation to the best of their judgment. The Guidelines also highlights the need to uphold medical ethics and the practice of applicable laws and principles of privacy, confidentiality while handling the personal records of the patients during telemedicine.
The Guidelines exclude any specification to a hardware or software, infrastructure or maintenance, data management systems involved, use of digital the technology involved for remotely conducting surgeries, other aspects of telehealth such as research, evaluation, and continuing education, consultations provided outside India. Further, The guideline specifically bans technology platforms based on artificial intelligence from counseling or prescribing medicines to patients. However, such platforms could help RMP in the evaluation of a patient.
Prescription of medicines:
The Guidelines lay down the step by step procedure to be followed by an RMP starting with the identification of the appropriate mode of communication for telemedicine till the prescription of medicines to the patients. The Guidelines allows RMP to prescribe medicines to the patient through telemedicine consultation with certain restrictions depending on the type of consultation. The Guidelines categorizes the medicines to List O, List A, List B, and Prohibited List depending on the safety of the medicines, mode of communication used by the RMP for telemedicine and the prohibitions placed by the Drugs and Cosmetics Act 1940 and Narcotic Drugs and Psychotropic Substances Act 1985.
The Guidelines set out the names of the drugs categorized as per each list in Annexure -1 to the Guidelines. It is pertinent to note that prescribing medicines without an appropriate diagnosis by RMP will amount to professional misconduct. RMP must prescribe medicines as per Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002 and not in contravention with the Drugs and Cosmetics Act and Rules. According to the Guidelines, RMP can appropriately charge for the consultation provided using telemedicine and can also provide an invoice for the same to the patient
We have seen several telemedicine initiatives were taken by the government departments in collaboration with the private hospitals in India and also saw the development of several technology platforms which connected doctors and patients virtually. Prescription without a diagnosis was also questioned in Deepa Sanjeev Pawaskar And Anr vs The State Of Maharashtra (2018 SSC Online Bom. 1841). The Hon’ble High Court of Bombay held that a doctor couple was guilty of criminal negligence for the death of a patient after prescribing her medicines through telephone without a diagnosis. In this case, the negligence of the doctors was in the inability of the doctor to determine the right diagnosis for a follow-up patient of the doctor even though the patient contacted her through the phone. The judgment of the High Court was not against the practice of telemedicine. If the Guidelines were in force at the time of this incident, the act of the doctor would have amounted to misconduct for prescribing medicine without proper diagnosis and may not have been criminal negligence. This judgment also called for the standardization of the procedure to be adopted while the RMPs and the health workers adopt telemedicine practices for diagnosis. The release of the Guidelines by Indian Medical Council has created given a legal identity to the telemedicine practice in India which will help the medical fraternity in India to impart their accumulated knowledge and resource legitimately to people in need at a distance especially during the spread of a pandemic.
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