On 25th march, 2020, the Ministry of Health and Family Welfare issued the Telemedicine Practice Guidelines, 2020 [1] under the Indian Medical Council Act, 1956 and which superseded the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation, 2002[2].

The guidelines, which have borrowed the definition of telemedicine from the World Health Organisation,[3] provide that telemedicine would include the delivery of healthcare services by health care professional using information and communication technologies, not just for diagnosis, prevention and treatment of diseases, but also for research purposes and education of health care providers.

The Background to the guidelines states that the purpose of issuing the guidelines is to enable delivery of timely and faster health care services so that the limitations relating to geographical distances do not hamper equal access to quality healthcare for all. The practice is in line with similar actions taken by other common law jurisdictions as well. Also, digital health care services assist in better maintenance of large volume of records and data.

The guidelines provide that the mode of delivery of tele health care services shall include any platform which enables digital data exchange, be it, audio, text video, or email/fax. While the first three modes, the guidelines provide, may be used for real time interaction and communication between either an RMP to the patient or his caregiver, or between two or more RMPs, the last one may be used for exchange of information for example, lab reports, images or data related to radiological investigations.

Also, the guidelines are applicable to telemedicine consultations in 4 scenarios:

1. When the patient initiates the consultation by first approaching the RMP
2. When the patient is under the supervision of a caregiver, either present physically with the patient or taking care virtually, the RMP may be approached by the caregiver directly. The RMP may then give instructions to the caregiver to better support the patient.
3. The RMP may be approached by a health care worker currently treating the patient. This could be a nurse, mid-level worker in the hospital etc.
4. Lastly, an RMP can approach another RMP for advice or opinion on particular case and the same may be done via telemedicine consultation.

The general points that are of relevance for Registered Medical Professionals (RMPs) are as under:

1. They shall be continued to be bound by the same degree of ethical and professional norms and standards as were applicable for conventional in-person care.
2. The guidelines cannot be used to provide consultation outside India.
3. The guidelines specifically exclude surgeries and other invasive procedures from their purview.
4. The Board of Governors (which shall supersede the Medical Council of India) shall soon develop an online training program and it shall be mandatory for all RMPs interested in continuing to provide tele health care services to undergo the course within a maximum of 3 years within its notification.
5. The delivery of tele health care services is dependent entirely on the discretion based on the Professional Judgement of the RMP. Such discretion should not compromise on the quality of the care.
6. The consultation can be of three types: (a) first-time consultation, (b) follow-up consultation and (c) consultation in emergency situations. While the consultations in the first two situations may be done if the RMP is satisfied that telehealth care services may be appropriately provided in the instant case, the third type of consultation can only be done in case when in-person services are not available to the patient. Additionally, the patient must be referred to in-person care as soon as the same becomes available.

In addition to these general obligations, there are specific obligations imposed on the RMP at different stages of the process.

1. Safeguards before the Consultation Begins
   

   1. The RMP shall display his registration number prominently on his website, email, video or chat platform.

2. The RMP shall first verify the identity of the patient including details relating to age.
3. If the patient is minor, the consultation cannot be done except when the patient is accompanied by the guardian.
4. The RMP must take necessarily take the consent of the patient and record the same in case the telemedicine consultation was initiated by the health worker, RMP or caregiver.
5. The RMP must try to gather information about the patient, his medical history etc. and must not proceed with telemedicine consultation if he is of the opinion that a physical examination is necessary.
6. RMPs cannot solicit patients for telemedicine consultation by way of advertisement or insist on telemedicine consultation when the patient has expressed willing to physically visit the facility/clinic.
    

Obligations During the Consultation

1. The RMP may either provide education counselling or prescription service to the patient. Education services relate to general guidelines for prevention of diseases, diet, exercise etc.
   
   Counselling refers to customized advice on peculiar condition of patient.
   
   The RMP may also prescribe medicines to the patient.
    
2.  In cases of first time consultation, the RMP may prescribe any medicine mentioned under List A and List O. The medicines under List O are those which are generally otherwise available over the counter without specific prescription and therefore there aren’t many restrictions on their prescriptions even for telemedicine consultation.
   For follow-up consultations, the RMP may prescribe medicines given under List A, List B and List O.
   
   The RMP is prevented from prescribing any medicine named under Schedule X of the Drugs and Cosmetics Act, 1940 and corresponding rules thereunder or under the Narcotic Drugs and Psychotropic Substances Act, 1985.
    
3. The RMP must maintain record of all or any prescription given.
    

Obligations Post the Telemedicine Consultation

1. The RMP shall maintain all patient records including case history, investigation reports, images, diagnostics etc. as appropriate.
2. The RMP should give receipt/invoice for the fee charged for the telemedicine consultation.
3. The RMP should respect the privacy and confidentiality rights of the patient under the Information Technology Act, 2000, data protection or under the Professional Conduct and Etiquette Regulations of 2002.

Though the guidelines do provide for penalties to be imposed on the RMP in case of breach of any obligations, not all responsibilities are that of the RMP. The guidelines explicitly provide that the obligation to provide accurate information lies on the patient.

Also, in cases where telemedicine consultation is facilitated by an intermediary platform, a lot of the responsibilities/burdens get shifted to the platform instead. For instance, the platform shall ensure that the RMPs on their platform are duly registered with the national or State medical councils.

They must also conduct their due diligence on the RMPs and make such information available to the patients. Any event of non-compliance must be reported to the Board of Governors and the platform must also provide their end-customers for a query related and grievance redressal mechanism. However, the platform is prohibited from counselling the patient directly and all that the technology enabled platform can do is to assist and support the RMP.

Conclusion
Telemedicine guidelines were the need of hour, considering the given that current circumstances warrant maintenance of social distancing and most services are taking to the digital platform wherever possible. While the medical industry has conventionally operated in manner where physical examination by the practitioner was deemed indispensable, with the advent of technology, many professionals are also of the opinion that rendering consultation via the digital mode is indeed possible and also efficient in certain cases.

The guidelines have taken due caution to exclude cases serious cases such as those necessitating surgery from their scope and also while imposing safeguards for emergency situations, while also ensuring that cases which may not be very serious but do require constant attention of the doctor should not suffer due to the current circumstances.

Therefore, they will prove extremely helpful in scenarios where the patient has already visited the RMP previously and the RMP is aware of medical history etc. By way of telemedicine consultation, the patient can get continued access to professional healthcare, with adequate safeguards.

End-Notes:

1. https://www.mohfw.gov.in/pdf/Telemedicine.pdf
2. https://www.mciindia.org/documents/rulesAndRegulations/Ethics%20Regulations-2002.pdf
3. https://www.ortelehealth.org/content/telemedicine-or-telehealth-definitions