FAQs on Telemedicine Practice Guideline

Author: thinkinglegal | May 7, 2020 - 20:25 | Tags: Regulatory Advisory

On March 25, 2020, the Ministry of Health and Family Welfare, Government of India released the Telemedicine Practice Guideline (the “Guideline”). Telemedicine increases timely access to appropriate interventions including faster access and access to services that may not otherwise be available. The introduction of the Guideline is a timely intervention, since there are restrictions on movement and physical interaction in place currently. The Guideline specifically allows prescribing medications notified by Government of India on an emergency basis through telemedicine. In this piece, we answer all the frequently asked questions on how to consult doctors through telemedicine.

One of the major advantages of telemedicine can be for saving of cost and effort especially of rural patients, as they need not travel long distances for obtaining consultation and treatment. Telemedicine is also playing a critical role in improving access to medical interventions during the lockdown and pandemic. In this type of scenario, telemedicine can provide an optimal solution for providing timely and faster access. It would also reduce financial costs associated with travel. It also reduces the inconvenience/impact to family and caregivers and social factors. Telemedicine can play a particularly important role in cases where there is no need for the patient to physically see the Registered Medical Professional (“RMP”) (or other medical professional), e.g. for regular, routine check-ups or continuous monitoring. Telemedicine can reduce the burden on the secondary hospitals.

Purpose

The purpose of this Guideline is to give practical advice to doctors so that all services and models of care used by doctors and health workers are encouraged to consider the use of telemedicine as a part of normal practice. This Guideline will assist the medical practitioner in pursuing a sound course of action to provide effective and safe medical care founded on current information, available resources, and patient needs to ensure patient and provider safety.

1. What is the definition of “telemedicine”?

World Health Organization defines telemedicine as “The delivery of health-care services, where distance is a critical factor, by all health-care professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health-care workers, with the aim of advancing the health of individuals and communities.”

2. What is the definition of “telehealth”?

New England Journal of Medicine (“NEJM”) Catalyst defines telehealth as “The delivery and facilitation of health and health-related services including medical care, provider and patient education, health information services, and selfcare via telecommunications and digital communication technologies.” In general, telemedicine is used to denote clinical service delivered by a registered medical practitioner while telehealth is a broader term of use of technology for health and health related services including telemedicine.

3. What is the definition of “Registered Medical Practitioner” (“RMP”)?

A ‘Registered Medical Practitioner’ is defined as a person who is enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act, 1956 (“IMC Act”).

4. What is the scope of this Guideline?

Within the broad paradigm of telemedicine, this Guideline will be published under the IMC Act and are for privileged access only. This Guideline is designed to serve as an aid and tool to enable RMPs to effectively leverage Telemedicine to enhance healthcare service and access to all:

  • The guideline is meant for RMPs under the IMC Act
  • The guideline covers norms and standards of the RMP to consult patients via telemedicine
  • Telemedicine includes all channels of communication with the patient that leverage Information Technology platforms, including Voice, Audio, Text & Digital Data exchange

5. What are the exclusions to this Guideline?

The Guideline specifically explicitly excludes the following:

  • Specifications for hardware or software, infrastructure building & maintenance
  • Data management systems involved; standards and interoperability
  • Use of digital technology to conduct surgical or invasive procedures remotely
  • Other aspects of telehealth such as research and evaluation and continuing education of health-care workers
  • Does not provide for consultations outside the jurisdiction of India

6. What are the steps taken to enable RMPs who want to practice telemedicine?

To enable all those RMPs who would want to practice telemedicine get familiar with this Guideline as well as with the process and limitations of telemedicine practice:

  • An online program will be developed and made available by the Board of Governors in supersession of Medical Council of India.
  • All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification.
  • In the interim period, the principles mentioned in this guideline need to be followed.
  • Thereafter, undergoing and qualifying such a course, as prescribed, will be essential prior to practice of telemedicine.

7. What are the modes to facilitate telemedicine?

Telemedicine applications can be classified into four basic types, according to the mode of communication, timing of the information transmitted, the purpose of the consultation and the interaction between the individuals involved—be it RMP-to-patient / caregiver, or RMP to RMP.

According to the Mode of Communication

  • Video (Telemedicine facility, Apps, Video on chat platforms, Skype/Face time etc.)
  • Audio (Phone, VOIP, Apps etc.)
  • Text Based:
  • Telemedicine chat based applications (specialized telemedicine smartphone Apps, Websites, other internet-based systems etc.)
  • General messaging/ text/ chat platforms (WhatsApp, Google Hangouts, Facebook Messenger etc.)
  • Asynchronous (email/ Fax etc.)

There may be situations where in order to reach a diagnosis and to understand the context better; a real-time consultation may be preferable over an asynchronous exchange of information. Similarly, there would be conditions where an RMP could require hearing the patient speak, therefore, a voice interaction may be preferred than an email or text for a diagnosis. There are also situations where the RMP needs to visually examine the patient and make a diagnosis. In such a case, the RMP could recommend a video consultation. Considering the situation, using his/her best judgment, an RMP may decide the best technology to use to diagnose and treat.

8. What are the necessary requirements to be kept in mind by RMPs while prescribing telemedicine?

  1. An RMP should verify and confirm patient’s identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed to be appropriate. The RMP should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP.
  2. For issuing a prescription, the RMP needs to explicitly ask the age of the patient, and if there is any doubt, seek age proof. Where the patient is a minor, after confirming the age, tele consultation would be allowed only if the minor is consulting along-with an adult whose identity needs to be ascertained.
  3. An RMP should begin the consultation by informing the patient about his/her name and qualifications.
  4. Every RMP shall display the registration number accorded to him/her by the State Medical Council/MCI, on prescriptions, website, electronic communication (WhatsApp/ email etc.) and receipts etc. given to his/her patients

9. Is consent of the patient required for telemedicine?

Patient consent is necessary for any telemedicine consultation. The consent can be implied or explicit depending on the following situations:

  1. If the patient initiates the telemedicine consultation, then the consent is implied.
  2. An Explicit patient consent is needed if a health worker, RMP or a Caregiver initiates a Telemedicine consultation.

An Explicit consent can be recorded in any form. Patient can send an email, text or audio/video message. Patient can state his/her intent on phone/video to the RMP (e.g. “Yes, I consent to avail consultation via telemedicine” or any such communication in simple words). The RMP must record this in his patient records.

10. How many types of patient consultations are in place?

There are two types of patient consultations, namely, first consult and the follow-up consult.

  1. First Consult means
  • The patient is consulting with the RMP for the first time; or
  • The patient has consulted with the RMP earlier, but more than 6 months have lapsed since the previous consultation; or
  • The patient has consulted with the RMP earlier, but for a different health condition
  1. Follow-Up Consult(s) means

The patient is consulting with the same RMP within 6 months of his/her previous in-person consultation and this is for continuation of care of the same health condition. However, it will not be considered a follow up if:

  • There are new symptoms that are not in the spectrum of the same health condition; and/or
  • RMP does not recall the context of previous treatment and advice

11. Which type of medicines should an RMP prescribe medicine through telemedicine?

RMP may prescribe medicines via telemedicine only when RMP 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 a professional misconduct.

Specific Restrictions

The categories of medicines that can be prescribed are listed below:

  • List O: It will comprise those medicines which are safe to be prescribed through any mode of tele-consultation. In essence they would comprise of
  • Medicines which are used for common conditions and are often available ‘over the counter’. For instance, these medicines would include, paracetamol, ORS solutions, cough lozenges etc
  • Medicines that may be deemed necessary during public health emergencies.
  • List A: These medications are those which can be prescribed during the first consult which is a video consultation and are being re-prescribed for re-fill, in case of follow-up.
  • This would be an inclusion list, containing relatively safe medicines with low potential for abuse Is a list of medication which RMP can prescribe in a patient who is undergoing follow-up consult, as a refill.
  • List B: Is a list of medication which RMP can prescribe in a patient who is undergoing follow-up consultation in addition to those which have been prescribed during in-person consult for the same medical condition.
  • Prohibited List: An RMP providing consultation via telemedicine cannot prescribe medicines in this list. These medicine have a high potential of abuse and could harm the patient or the society at large if used improperly .
  • Medicines listed in Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985

12. What is the role of a health worker?

“Health worker” could be a Nurse, Allied Health Professional, Mid-Level Health Practitioner, ANM or any other health worker designated by an appropriate authority.

In all cases of emergency, the Health Worker must seek measures for immediate relief and first-aid from the RMP who is being tele-consulted. Health worker must provide the immediate relief/first aid as advised by the RMP and facilitate the referral of the patient for appropriate care. The Health Worker must ensure that patient is advised for an in-person interaction with an RMP, at the earliest.

For patients who can be suitably managed via telemedicine, the Health Worker plays a vital role of

  • Reinforcing the health education and counseling provided by the RMP
  • Providing the medicine prescribed by the RMP and providing patient counseling on his/her treatment.

For queries, please reach out to our team at admin@thinkinglegal.in.

This post has been contributed by Ms. Vaneesa Agrawal and Ms. Vasuvita Singh.

[DISCLAIMER:  This article is for academic purpose and is solely to provide readers with general information regarding developments in Indian law. The information contained herein does not constitute legal or a professional advice.]