There are a number of benefits of telemedicine. It increases timely access to appropriate interventions including faster access and access to services that may not otherwise be available.
In India, providing In-person healthcare is challenging, particularly given the large geographical distances and limited resources. 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. In this type of scenario, telemedicine can provide an optimal solution for not just 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 RMP (or other medical professional), e.g. for regular, routine check-ups or continuous monitoring. Telemedicine can reduce the burden on the secondary hospitals.
With telemedicine, there is higher likelihood of maintenance of records and documentation hence minimalizes the likelihood of missing out advice from the doctor other health care staff. Conversely, the doctor has an exact document of the advice provided via tele-consultation. Written documentation increases the legal protection of both parties. Telemedicine provides patient's safety, as well as health workers safety especially in situations where there is risk of contagious infections. There are a number of technologies that can be used in telemedicine, which can help patients adhere better to their medication regimens and manage their diseases better. Telemedicine can also enable the availability of vital parameters of the patient available to the physician with the help of medical devices such as blood pressure, blood glucose, etc management.
Disasters and pandemics pose unique challenges to providing health care. Though telemedicine will not solve them all, it is well suited for scenarios in which medical practitioners can evaluate and manage patients. A telemedicine visit can be conducted without exposing staff to viruses/infections in the times of such outbreaks. Telemedicine practice can prevent the transmission of infectious diseases reducing the risks to both health care workers and patients. Unnecessary and avoidable exposure of the people involved in delivery of healthcare can to be avoided using telemedicine and patients can be screened remotely. It can provide rapid access to medical practitioners who may not be immediately available in person. In addition, it makes available extra working hands to provide physical care at the respective health institutions. Thus, health systems that are invested in telemedicine are well positioned to ensure that patients with Covid-19 kind of issues receive the care they need.
The government is committed to providing equal access to quality care to all and digital health is a critical enabler for the overall transformation of the health system. Hence, mainstreaming telemedicine in health systems will minimize inequity and barriers to access. India's digital health policy advocates use of digital tools for improving the efficiency and outcome of the healthcare system and lays significant focus on the use of telemedicine services, especially in the Health and Wellness Centers at the grassroots level wherein a mid-level provider/health worker can connect the patients to the doctors through technology platforms in providing timely and best possible care.
However, there has been concern on the practice of telemedicine. Lack of clear guidelines has created significant ambiguity for registered medical professionals, raising doubts on the practice of telemedicine. The 2018 judgement of the Hon'ble High Court of Bombay had created uncertainty about the place and legitimacy of telemedicine because an appropriate framework does not exist.
In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone, Internet based platforms (web/chat/apps etc). The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002), Drugs &Cosmetics Act, 1940 and Rules 1945, Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 primarily govern the practice of medicine and information technology. Gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients.
There are some countries that have put in legislative measures and some countries, which follow non-legislative measures such as guidelines to practice telemedicine. In some countries guidelines are treated as professional norms that need to be followed by medical practitioners. We reviewed these other guidelines and consulted to put together these guidelines to enable medical practitioners to practice telemedicine.
Telemedicine will continue to grow and be adopted by more healthcare practitioners and patients in a wide variety of forms, and these practice guidelines will be a key enabler in fostering its growth.
The purpose of these guidelines 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. These guidelines 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.
These telemedicine guidelines will help realize the full potential of these advancements in technology for health care delivery. It provides norms and protocols relating to physician-patient relationship; issues of liability and negligence; evaluation, management and treatment; informed consent; continuity of care; referrals for emergency services; medical records; privacy and security of the patient records and exchange of information; prescribing; and reimbursement; health education and counseling.
These guidelines will provide information on various aspects of telemedicine including information on technology platforms and tools available to medical practitioners and how to integrate these technologies to provide health care delivery. It also spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care. Where clinically appropriate, telemedicine is a safe, effective and a valuable modality to support patient care.
Like any other technology, the technology used for telemedicine services can be abused. It has some risks, drawbacks and limitations, which can be mitigated through appropriate training, enforcement of standards, protocols and guidelines,These guidelines should be used in conjunction with the other national clinical standards, protocols, policies and procedures.
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.
Definition of Telehealth
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 self-care 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.
Definition of Registered Medical Practitioner (RMP)
For the purpose of this document a 'Registered Medical Practitioner' is defined as a person who is enrolled in the State Medical Register or the Indian Medical Register under the IMC Act 1956.
Within the broad paradigm of telemedicine, these guidelines will be published under the IMC Act and are for privileged access only. These guidelines are designed to serve as an aid and tool to enable RMPs to effectively leverage Telemedicine to enhance healthcare service and access to all
The guidelines specifically explicitly exclude the following:
A Registered Medical Practitioner is entitled to provide telemedicine consultation to patients from any part of India
RMPs using telemedicine shall uphold the same professional and ethical norms and standards as applicable to traditional in-person care, within the intrinsic limitations of telemedicine
To enable all those RMPs who would want to practice telemedicine get familiar with these Guidelines as well as with the process and limitations of telemedicine practice:
Tools for Telemedicine
RMP may use any telemedicine tool suitable for carrying out technology-based patient consultation e.g. telephone, video, devices connected over LAN, WAN, Internet, mobile or landline phones, Chat Platforms like WhatsApp, Facebook Messenger etc., or Mobile App or internet based digital platforms for telemedicine or data transmission systems like Skype/ email/ fax etc.
Irrespective of the tool of communication used, the core principles of telemedicine practice remain the same.
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
According to timing of information transmitted
|Real time Video/audio/text interaction||Asynchronous exchange of relevant information|
|Video/audio/text for exchange of relevant information for diagnosis, medication and health education and counseling||Transmission of summary of patient complaints and supplementary data including images, lab reports and/or radiological investigations between stakeholders. Such data can be forwarded to different parties at any point of time and thereafter accessed per convenience/need|
According to the purpose of the consultation
For Non-Emergency consult:
|First consult with any RMP for diagnosis/treatment/health education/ counseling||Follow-up consult with the same RMP|
|Patients may consult with an RMP for diagnosis and treatment of her condition or for health education and counseling||Patients may use this service for follow up consultation on his ongoing treatment with the same RMP who prescribed the treatment in an earlier in-person consult.|
Emergency consult for immediate assistance or first aid etc.
According to the individuals involved
|Patient to RMP||Caregiver to RMP|
|Telemedicine services may connect patients to an RMP||Telemedicine services may connect Care givers to an RMP, under certain conditions as detailed in Framework (Section 4)|
|RMP to RMP||Health worker to RMP|
|RMP may use telemedicine services to discuss with other RMPs issues of care of one or more patients, or to disseminate knowledge||A Health Worker can facilitate a consultation session for a patient with an RMP. In doing so, the former can help take history, examine the patient and convey the findings. They can also explain/reinforce the advice given by the RMP to the patient.|
Multiple technologies can be used to deliver telemedicine consultation. There are 3 primary modes: Video, Audio, or Text (chat, messaging, email, fax etc.) Each one of these technology systems has their respective strengths, weaknesses and contexts, in which, they may be appropriate or inadequate to deliver a proper diagnosis.
It is therefore important to understand the strengths, benefits as well as limitations of different technologies. Broadly, though telemedicine consultation provides safety to the RMP from contagious conditions, it cannot replace physical examination that may require palpation, percussion or auscultation; that requires physical touch and feel. Newer technologies may improve this drawback.
STRENGTHS AND LIMITATIONS OF VARIOUS MODES OF COMMUNICATION
|VIDEO: Telemedicine facility, Apps, Video on chat platforms, Facetime etc.||
|AUDIO: Phone, VOIP, Apps etc.||
|TEXT BASED: Specialized Chat based Telemedicine Smartphone Apps, SMS, Websites, messaging systems e.g. WhatsApp, Google Hangouts, FB Messenger||
|ASYNCHRONOUS: Email Fax, recordings etc.||
The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations: An RMP is well positioned to decide whether a technology-based consultation is sufficient or an in-person review is needed. Practitioner shall exercise proper discretion and not compromise on the quality of care. Seven elements need to be considered before beginning any telemedicine consultation (see panel)
|Seven Elements to be considered before any telemedicine consultation|
|2||Identification of RMP and Patient|
|3||Mode of Communication|
|5||Type of Consultation|
The Registered Medical Practitioners should exercise their professional judgment to decide whether a telemedicine consultation is appropriate in a given situation or an in-person consultation is needed in the interest of the patient. They should consider the mode/technologies available and their adequacy for a diagnosis before choosing to proceed with any health education or counseling or medication. They should be reasonably comfortable that telemedicine is in the patient's interest after taking a holistic view of the given situation.
Complexity of Patient's health condition Every patient/case/medical condition may be different, for example, a new patient may present with a simple complaint such as headache while a known patient of Diabetes may consult for a follow-up with emergencies such as Diabetic Ketoacidosis. The RMP shall uphold the same standard of care as in an in-person consultation but within the intrinsic limits of telemedicine.
Telemedicine consultation is should not be anonymous: both patient and the RMP need to know each other's identity.
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.
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.
An RMP should begin the consultation by informing the patient about his/her name and qualifications.
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
Multiple technologies can be used to deliver telemedicine consultations. All these technology systems have their respective strengths, weaknesses and contexts in which they may be appropriate or inadequate in order to deliver proper care.
Primarily there are 3 modes: Video, Audio or Text (chat, images, messaging, email, fax etc.). Their strengths, limitations and appropriateness as detailed in Section 2 need to be considered by the RMP.
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.
Patient consent is necessary for any telemedicine consultation. The consent can be Implied or explicit depending on the following situations:
If, the patient initiates the telemedicine consultation, then the consent is implied
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.
RMPs must make all efforts to gather sufficient medical information about the patient's condition before making any professional judgment.
There are two types of patient consultations, namely, first consult and the follow-up consult.
An RMP may have only a limited understanding of the patient seeking teleconsultation for the first time, when there have been no prior in-person consultation. However, if the first consult happens to be via video, RMP can make a much better judgment and hence can provide much better advice including additional medicines, if indicated.
On the other hand, if a patient has been seen in-person earlier by the RMP, then it is possible to be more comprehensive in managing the patient.
Health Education: An RMP may impart health promotion and disease prevention messages. These could be related to diet, physical activity, cessation of smoking, contagious infections and so on. Likewise, he/ she may give advice on immunizations, exercises, hygiene practices, mosquito control etc
Counseling: This is specific advice given to patients and it may, for instance, include food restrictions, do's and don't's for a patient on anticancer drugs, proper use of a hearing aid, home physiotherapy, etc to mitigate the underlying condition. This may also include advice for new investigations that need to be carried out before the next consult.
Prescribing Medicines: Prescribing medications, via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person consult. If a medical condition requires a particular protocol to diagnose and prescribe as in a case of in-person consult then same prevailing principle will be applicable to a telemedicine consult.
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
There are certain limitations on prescribing medicines on consult via telemedicine depending upon the type of consultation and mode of consultation. The categories of medicines that can be prescribed via tele-consultation will be as notified in consultation with the Central Government from time to time.
The categories of medicines that can be prescribed are listed below:
|List Group||Mode of Consultation [Video/Audio/Text]||Nature of Consultation [First-consultation/ Follow-up]||List of Medicines|
|A||Video||First Consultation Follow-up, for continuation of medications||List A2|
|Prohibited||Not to be prescribed||Not to be prescribed||Schedule X of Drug and Cosmetic Act and Rules or any Narcotic and Psychotropic substance listed in the Narcotic Drugs and Psychotropic Substances, Act, 19854|
Some examples of actions that are not permissible:
It is incumbent on RMP to maintain the following records/ documents for the period as prescribed from time to time:
Specifically, this section details with the key elements of the process of teleconsultation to be used in the First consults and Follow up consults when a patient consults with an RMP.
In these 2 situations, the patient initiates telemedicine consultation and thereby consent is implied
First Consult: Patient to Registered Medical Practitioner
The flow of the process is summarized in the Figure 1 and the steps are detailed below.
If the condition does not merit an emergency intervention, the following steps are undertaken:
If the condition can be appropriately managed via telemedicine, then the RMP may take a professional judgement to either:
Follow-up Consult: Patient to Registered Medical Practitioner
In a follow-up consultation, since the RMP-patient interaction has already taken place for the specific medical condition under follow-up, there is already an understanding of the context, with availability of previous records. This allows a more definitive and secure interaction between the RMP and the patient.
The patient is consulting with the RMP within 6 months of his/her previous in-person, and this consultation is for continuation of care of the same health condition. Follow-up can be in situations of a chronic disease or a treatment (e.g. renewal or change in medications) when a face-to-face consultation is not necessary. Examples of such chronic diseases are: asthma, diabetes, hypertension and epilepsy etc
The flow of the process is summarized in Figure 2 and the steps are detailed below:
In all of the above, the consult shall proceed as in the case of RMP and the patient.
For the purpose of these guidelines, “Health worker” could be a Nurse, Allied Health Professional, Mid-Level Health Practitioner, ANM or any other health worker designated by an appropriate authority
The flow of the process is summarized in Figure 3 and the steps are detailed below:
In case, the condition is not an emergency, the following steps would be taken:
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
In all telemedicine consultations, as per the judgment of the RMP, if it is an emergency situation, the goal and objective should be to provide in-person care at the soonest. However critical steps could be life-saving and guidance and counseling could be critical. For example, in cases involving trauma, right advice and guidance around maintaining the neck position might protect the spine in some cases. The guidelines are designed to provide a balanced approach in such conditions. The RMP, based on his/ her professional discretion may
In all cases of emergency, the patient MUST be advised for an in-person interaction with a Registered Medical Practitioner at the earliest
This specifically covers those technology platforms which work across a network of Registered medical practitioners and enable patients to consult with RMPs through the platform
Technology platforms (mobile apps, websites etc.) providing telemedicine services to consumers shall be obligated to ensure that the consumers are consulting with Registered medical practitioners duly registered with national medical councils or respective state medical council and comply with relevant provisions
Technology Platforms shall conduct their due diligence before listing any RMP on its online portal. Platform must provide the name, qualification and registration number, contact details of every RMP listed on the platform
In the event some non-compliance is noted, the technology platform shall be required to report the same to BoG, in supersession to MCI who may take appropriate action
Technology platforms based on Artificial Intelligence/Machine Learning are not allowed to counsel the patients or prescribe any medicines to a patient. Only a RMP is entitled to counsel or prescribe and has to directly communicate with the patient in this regard. While new technologies such as Artificial Intelligence, Internet of Things, advanced data science-based decision support systems etc. could assist and support a RMP on patient evaluation, diagnosis or management, the final prescription or counseling has to be directly delivered by the RMP
Technology Platform must ensure that there is a proper mechanism in place to address any queries or grievances that the end-customer may have
In case any specific technology platform is found in violation, BoG, MCI may designate the technology platform as blacklisted, and no RMP may then use that platform to provide telemedicine
Any of the drug-lists contained in Telemedicine Practice Guidelines can be modified by the Board of Governors in super-session of the Medical Council of India/Medical Council of India from time to time, as required.
The Board of Governors in super-session of the Medical Council of India may issue necessary directions or advisories or clarifications in regard to these Guidelines, as required.
The Telemedicine Practice Guidelines can be amended from time to time in larger public interest with the prior approval of Central Government [Ministry of Health and Family Welfare, Government of India].