India’s new Telemedicine Practice Guidelines – Analysis and Do’s and Don’ts for Doctors offering teleconsultation
Summary: The Indian Government has published Telemedicine Practice Guidelines (“Telemedicine Guidelines”) on March 25, 2020. These guidelines finally clarify India’s position on the legality of teleconsultation. It is now perfectly legal to provide teleconsultation by registered medical practitioners (M.B.B.S and above) in line with the requirements of the Telemedicine Guidelines. It has been clarified that the first consultation between doctor and patient need not be an in-person consultation, and doctors in India can provide the first consultation to patients located in any State remotely through teleconsultation. However, going forward, all doctors who provide teleconsultation will have to display their registration number in all communications exchanged with the patient – for example, in emails or WhatsApp messages, on prescriptions and on fee receipts. Doctors will also have to be careful while issuing a prescription during teleconsultation. As a thumb rule, prescribing medicines for chronic diseases (such as asthma, diabetes or hypertension) should be avoided during teleconsultation, unless it is an add-on or refill of an earlier prescription obtained during an in-person consultation less than six months ago. If a prescription for chronic diseases is to be issued, then the teleconsultation should be done strictly via video. A prescription can be sent through any electronic medium such as email, WhatsApp etc. as a photo/scan / digital copy of a signed prescription or an e-prescription.
What is the new development?
On March 25, 2020, the Board of Governors (“BoG”) entasked by the Health Ministry to regulate practice and practitioners of modern medicine, published an amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (“Code of Conduct”) that gave statutory support and basis for the practice of telemedicine in India.
The relevant part of the amendment is as follows:
3.8.1. Consultation through Telemedicine by the Registered Medical Practitioner under the Indian Medical Council Act, 1956 shall be permissible in accordance with the Telemedicine Practice Guidelines contained in Appendix 5 (of Code of Conduct).
A registered medical practitioner under Indian Medical Council Act, 1956 is a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act, 1956 (or National Medical Commission Act, 2019 as and when it comes into full force and replaces the Indian Medical Council Act, 1956). Every practising doctor in India today is required by law to be enrolled in the State Medical Register or Indian Medical Register before the start of his or her medical practice. Therefore, the amendment does not add any new requirement of registration for doctors who want to practice telemedicine and provide teleconsultation to his or her patients.
Telemedicine is defined under the Telemedicine Guidelines as:
“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”
What does the amendment mean for Doctors?
Telemedicine consultation (or “teleconsultation”) has been offered by doctors in India since the year 2000. However, in the absence of statutory basis and support, it was not clear whether it was legal or not. In fact, there have been news reports that State Medical Councils had banned the practice of teleconsultation. For example, the Karnataka State Medical Council had reportedly warned doctors in the State of Karnataka against offering online consultations and threatened them with dire consequences if they did (including cancellation of registration). Despite such reports, the practice of telemedicine and teleconsultation flourished, and several major companies currently provide online teleconsultation services for a fee in India.
Now, doctors who are providing teleconsultation independently or through such companies can rest assured that such practice is lawful as long as it is done in compliance with Telemedicine Guidelines. Doctors can also provide teleconsultations to patients from any part of India.
In fact, the Telemedicine Guidelines specifically permit Doctors to provide teleconsultation for prescribing medicines, providing counselling (e.g. food restrictions, do’s and don’t’s for a patient on anticancer drugs, proper use of a hearing aid etc.) and imparting health education (e.g. advice on contagious infections, immunizations, exercises, hygiene practices, mosquito control etc.).
What does the amendment mean for patients?
India does not have a great doctor to patient ratio. This, coupled with the fact that India is a huge country and that the density of doctors is far higher in cities than in rural areas where the bulk of India’s population resides, is the reason why teleconsultation has great demand and potential in India.
Unfortunately, there were hardly any standards for doctors to follow and patients to expect during a teleconsultation. For example, Indian patients sometimes felt short-changed when a doctor was not clear or audible, or the doctor refused to issue a prescription or did not provide a report of the consultation after the consultation ended. Some patients feared whether the person on the other end was, in fact, a doctor or not. A few worried about their privacy, as electronic communications over mobile application or email, can leave a trail.
Indian patients now will be able to hold doctors accountable to provide teleconsultation as per the Telemedicine Guidelines, which provide a clear set of do’s and don’ts for doctors. A violation of the Telemedicine Guidelines will give patients avenue to complain against the doctor before appropriate State Medical Council for ‘misconduct’.
Telemedicine Guidelines – Salient features
Doctor can choose the medium of teleconsultation: A doctor may use any medium for patient consultation, e.g. telephone, mobile or landline phones, chat platforms like WhatsApp, Facebook Messenger etc., other mobile apps or internet-based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc. However, before proceeding with the teleconsultation, the doctor should exercise professional judgement to decide whether the teleconsultation is, in fact, appropriate and in the interest of the patient. If the answer is yes, then the doctor should evaluate which medium would be preferred for the teleconsultation. For example, a complaint of appendicitis may require a physical examination and teleconsultation may not be preferred. On the other hand, some common complaints may not require physical examination or even consultation in real-time. For example, a complaint of headache or fever may not always require the doctor to examine the patient physically or audio-visually through a mobile or computer application. However, in certain cases, for example, on presentation of allergy or inflammation (e.g. Conjunctivitis), the doctor may choose to examine the patient in-person or through an audio-visual teleconsultation. Thus, the decision to examine the patient physically or remotely i.e. through teleconsultation, and the medium of teleconsultation, is to be taken by the doctor himself or herself on case to case basis.
Doctor has to maintain the same standard of care during teleconsultation as during in-person consultation: The Telemedicine Guidelines require doctors to maintain the same standard of care towards a patient during a teleconsultation as they would during an in-person consultation. In other words, the fact that the teleconsultation took place over a mobile app or email or telephone cannot be taken as a defence by a doctor against an allegation of medical negligence. Every doctor is expected to know the limitation of teleconsultation and advise or prescribe accordingly.
Patient is responsible for the accuracy of information: During the course of teleconsultation, if the doctor inquires for relevant information from the patient, then the patient is supposed to disclose the right information. The Telemedicine Guidelines have clarified that is the patient who will be responsible for accuracy for the information shared with the doctor, and not the doctor. However, since the standard of care is as high in the case of teleconsultation as in-person consultation, the doctor must make all efforts to gather sufficient medical information about the patient’s condition before deciding on a diagnosis or a treatment. If a patient provides any contradictory information, or if the doctor is not convinced with the information at hand to make a professional decision, he may ask patient to provide such documents or undertake such tests as he/she may feel proper in his/her professional judgement without fear of liability.
Caregiver is deemed to be authorized on behalf of minor or incapacitated patients: If the age of the patient is 16 years or less, or if the patient is incapacitated (due to mental conditions like dementia or physical disability due to an accident), then the caregiver is deemed to be authorized to consult on behalf of the patient. The Telemedicine Guidelines clarify that in such cases, the teleconsultation can take place with the caregiver without the presence of the patient.
No fixed Format for issuing a prescription: There is no fixed format for issuing a prescription in a teleconsultation. The Telemedicine Guidelines has recommended a format, but following it is not mandatory. However, the doctor must provide photo/scan /digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform. Please note that a doctor can transfer the prescription to a pharmacy only if he/ she has the explicit consent of the patient.
Invoice for fees: Doctors can charge appropriate fees for teleconsultation. A receipt or invoice should be given to the patient against the fees.
Do’s and Don’t’s for Doctors
Patient identification is mandatory during first consultation: If the teleconsultation is, in fact, the first consultation of the patient with the doctor, then doctor should confirm the patient’s identity to his/her satisfaction by asking patient’s name or age or address or email I.D. or phone number or any other identification that may be reasonable.
Patient identity confirmation is not mandatory during follow-up consultation, but may be carried out on need basis: It is not mandatory to identify the patient during a follow-up teleconsultation with a known patient, especially if the doctor is communicating through the registered user id, email id or phone number. However, in case of doubt, the doctor should confirm patient identity as during the first consultation.
Caregiver identity and authorization should be checked: If the patient is not a minor or is not incapacitated, then a caregiver cannot consult on behalf of the patient unless he or she has a formal authorization such as a signed authority letter by the patient or his/her legal representatives (family members) or, where the caregiver is a family member himself or herself, if he or she has a document that verifies his or her relationship with the patient such as a government identity proof. The caregiver’s identity and authorization should be checked by the doctor before offering teleconsultation. In the case of minors, the identity of the caregiver should be confirmed.
Doctor should identify himself/herself to the patient before start of every teleconsultation: A doctor should begin any teleconsultation by informing the patient about his/her name and qualification. This may be uncomfortable to be done every time, especially to a known patient. However, this is the requirement of Telemedicine Guidelines at present.
Doctor should display his/her registration number at every touch-point with patient: A doctor who provides teleconsultation is required to display his/her registration number provided by respective State Medical Council on his/her prescription, website, electronic communications (WhatsApp/Message/Email etc.) and fee receipts given to his/her patients.
Doctor should not continue with teleconsultation if it not appropriate: the doctor is not satisfied with the information provided by the patient to provide specific treatment, i.e. prescription or health advice, then he/she should provide limited consultation as appropriate and refer the patient for an in-person consultation.
Doctor should maintain patient records of teleconsultation: For in-person O.P.D. consultations in India, the doctors, in general, do not maintain patient records. Appropriate patient history, observations and findings are recorded on the prescription and it is handed over to the patient. However, for teleconsultation, it is mandatory for doctors to prepare, maintain and preserve the patient’s records (e.g. case history, investigation reports, images, etc.), copy of prescription issued and proof of teleconsultation (e.g. phone call history, email records, chat/ text record, video interaction logs etc.). While no time period is prescribed for how long such records are required to be preserved, it is generally recommended to maintain these records for three years.
Patient’s personal data should not be disclosed or transferred without written consent of the patient: Since teleconsultation happens on an electronic medium, the Indian law that protects personal information, including medical and health-related information of patients, squarely applies to doctors who provide teleconsultation and receive such information from patients. This is in addition to the ethical obligation to protect patient privacy that is recognized in the Code of Conduct. The most important thing to note here is that Doctors who provide teleconsultation should not disclose or transfer any information that may identify the patient without the prior written consent of the patient.
Doctor should not deny emergency teleconsultation, but limit it for immediate assistance or first aid: Emergency teleconsultation should not be provided remotely except when it is the only way to provide timely care.Even then, such emergency teleconsultation should be limited to first aid, life-saving measures, counselling and advice on referral. Every emergency teleconsultation must end with an advise to the patient or his/her carer for in-person interaction with a Doctor at the earliest.
Limitation on prescribing medicines to patients: This is, perhaps, the most significant limitation imposed by Telemedicine Guidelines on the practice of telemedicine in India. Going forward, doctors will not be able to prescribe medicines over teleconsultation freely.
In order to prevent abuse, the Telemedicine Guidelines require every doctor to “prescribe medicines via telemedicine ONLY when (the doctor) is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescribed medicines are in the best interest of the patient.” Prescribing Medicines without an appropriate diagnosis/provisional diagnosis will amount to professional misconduct.
Before issuing a prescription through teleconsultation, every doctor is supposed to inquire about the age of the patient. If there is any doubt about the age of the patient, then the doctor should seek age proof. If the patient turns out to be a minor, then further teleconsultation should be done and prescription should be issued only in the presence of an adult, whose identity should also be ascertained by the doctor.
If the teleconsultation with the patient does not take place over video, then the concerned doctor cannot prescribe drugs to the patient other than common over-the-counter (“O.T.C.”) medications such as paracetamol, O.R.S. solutions, cough lozenges etc. Such patient also cannot be prescribed medication for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. The doctor may, however, prescribe ‘add-on’ medication to such patient to optimize the existing treatment through drugs if such existing treatment was prescribed in an in-person consultation less than six months ago. Please note that there is no bar in prescribing emergency medications, even if they are not O.T.C. medicines, as and when notified by the government, through any form of teleconsultation, whether video or not.
A list of common O.T.C. medications that can be prescribed without video teleconsultation is described in List O, Appendix 5 of the Code of Conduct. A list of ‘add-on’ medications to optimize existing treatment is described in List B, Appendix 5 of the Code of Conduct. For the purpose of this list, emergency medications would be included in the list of O.T.C. medications, i.e. List O.
If the patient is examined through video, then the doctor may prescribe medications other than O.T.C. medicines described in List A of Appendix 5 of Code of Conduct. Some examples of such medicines are:
- Ointments/Lotion for skin ailments: Ointments Clotrimazole, Mupirocin, Calamine Lotion, Benzyl Benzoate Lotion etc.
- Local Ophthalmological drops such as: Ciprofloxacillin for Conjunctivitis, etc
- Local Ear Drops such as: Clotrimazole ear drops, drops for ear wax etc.
The doctor may also prescribe a ‘refill’ of medication already prescribed during an in-person consultation for chronic illnesses (hypertension, diabetes, asthma etc.) or an ‘add-on’ medication to optimize the existing treatment (like in the case of non-video consultation).
Please note, however, that no doctor is permitted to prescribe habit forming drugs (i.e. drugs in Schedule X of Drugs and Cosmetics Rules, 1945) or narcotic or psychotropic drug (i.e. drugs regulated by Narcotic Drugs and Psychotropic Substances Act, 1985) through any medium of teleconsultation.
For details on restrictions on the ability of doctors to issue prescriptions during teleconsultation, please refer to the table below:
Type I (Non-video consultation)
| Prior in-person consultation | Scope and limitation of prescription | List of drugs that may be prescribed |
| No prior in-person consultation | + Can prescribe only O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids – Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. – Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition – Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc. – Cannot prescribe habit forming, narcotic or psychotropic drug | As provided in List O, Appendix V of Code of Conduct |
| Prior in-person consultation for same health condition in last six months | + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids + Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on. – Cannot prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. – Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc – Cannot prescribe habit forming, narcotic or psychotropic drug | As provided in List O & List B of Appendix V of Code of Conduct |
Type II (Video consultation)
| Prior in-person consultation | Scope and limitation of prescription | List of drugs that may be prescribed |
| No prior in-person consultation | + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids + Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. – Cannot prescribe ‘add-on’ medication which are used to optimize an existing condition – Cannot prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc – Cannot prescribe habit forming, narcotic or psychotropic drug | As provided in List O & List A of Appendix V of Code of Conduct |
| Prior in-person consultation for same health condition in last six months | + Can prescribe O.T.C. medication e.g. Paracetamol, Oral Rehydration Solution (O.R.S.) packets, Antacids + Can prescribe ‘add-on’ medications which are used to optimize an existing condition – e.g. if the patient is already on Atenolol for hypertension and the blood pressure is not controlled, an A.C.E. inhibitor such as Enalapril may be prescribed as an add-on. + Can prescribed medications for which diagnosis is possible only by video consultation such as antifungal medications for Tinea Cruris, Ciprofloxacillin eye drops for Conjunctivitis etc. + Can prescribe ‘refill’ medications for chronic diseases such as Diabetes, Hypertension, Asthma etc – Cannot prescribe habit forming, narcotic or psychotropic drug | As provided in List O, List A & List B of Appendix V of Code of Conduct |
Mandatory training in telemedicine
At some point of time in future, the Board of Governors in supersession of Medical Council or National Medical Commission would introduce training programs in telemedicine. It will be mandatory to participate in those training programs for all doctors who intend to offer teleconsultations to patients. However, until those training programs are developed, there is no restriction in terms of prior training or qualification for registered doctors to engage in teleconsultation.
Do Telemedicine Practice Guidelines apply to doctors who are practising Indian medicine?
The Telemedicine Guidelines do not apply to practitioners of Ayurveda, Yoga, Homeopathy, Unani or Siddha.
What happens to the Telemedicine Guidelines when the National Medical Commission is set-up?
The Board of Governors in supersession of Medical Council of India will soon make way for the National Medical Commission. However, this transition will not impact the Telemedicine Guidelines and the practice of telemedicine in India. The National Medical Commission Act, 2019 has a savings clause, which will allow the Code of Conduct and Telemedicine Guidelines to survive and remain enforceable until new regulations are made.
Impact of 2018 judgement of Deepa Sanjeev Pawaskar and Anr. v. State of Maharashtra on Telemedicine Practice Guidelines
In 2018, a judgement of High Court of Bombay caused panic amongst doctors who offered teleconsultation. In that case, two gynaecologists were denied anticipatory bail on the grounds that, prima facie, they were criminally negligent towards their patient who unfortunately died while under their care. The material facts of the case are that the deceased patient had presented herself with a complaint of fever and severe vomiting. She was admitted to the nursing home of the accused doctors by the hospital staff without examination, as the doctors were out of town. One of the doctors started treatment for the patient telephonically, by instructing the on duty nurse. Unfortunately, the patient died. The Court held that the patient died because, amongst other things, she was prescribed treatment over telephone without appropriate diagnosis, and found such practice to be an act of criminal negligence. The application of the doctors for bail in anticipation of arrest was rejected. However, the doctors were successful in receiving the bail in appeal and were not arrested.
This judgement was interpreted by some doctors as deeming the practice of telemedicine and teleconsultation itself illegal. However, such an interpretation is without basis and incorrect. The Court was only concerned failure of the doctor to diagnose the patient. The fact that the drugs for treatment of patient were communicated by the doctor through telephone is only incidental to the outcome of the judgement. It is not the basis of the judgement. In other words, had the doctor communicated the same drugs to the nurse orally while being physically present but without examining the patient, and then patient would have died, the Court would have come to the same conclusion. Thus, the judgement should not be extrapolated to state that the practice of telemedicine and teleconsultation itself is illegal.
Therefore, the above judgement of Bombay High Court does not interfere with the Telemedicine Guidelines at all. In fact, it supports it. The Telemedicine Guidelines require doctors who provide teleconsultation to start patient treatment only if the doctor is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescription of medicines which are in the best interest of the patient. Else, the doctor should not prescribe medication to the patient. If the doctor prescribes patient in violation of the Telemedicine Guidelines, he/she risks losing his/her registration with respective State Medical Council i.e. the license to practice medicine on grounds of professional misconduct.
Enforcement of the Telemedicine Guidelines
The Telemedicine Guidelines have been published in form of an amendment to the Code of Conduct. Therefore, any violation of the Telemedicine Guidelines will be looked at as a ‘misconduct’ at hands of the concerned doctor under the Code of Conduct. A patient, who suffers due to misconduct, has the right to complain to the respective State Medical Council with whom the doctor is registered about the misconduct. If the doctor is found guilty of the misconduct, he or she may be reprimanded, or his/her registration may be suspended or cancelled. A suspension or cancellation of registration would effectively stop the doctor from carrying on his/her medical practice.
Conclusion
The notification of the Telemedicine Guidelines marks the dawn of a new era in the practice of modern medicine. The law has finally caught up with the reality and necessity of modern times.
The Telemedicine Guidelines enable doctors to confidently provide teleconsultation via any medium (such as email, phone call, message, fax, WhatsApp, other mobile and computer applications such as Skype, Google Hangouts etc.) to the patients.
At the same time, they protect patient interest by mandating doctors to identify themselves before consultations, disclose their registration number, offer the same standard of care to patients as during in-person consultation and limit medicines that can be prescribed through a teleconsultation.
Indians will now be able to enjoy access to quality healthcare remotely, and doctors will be able to extend their services to many more needy patients.
Source-Arogyalegal.com
