Revised Telemedicine Guidelines

TELEMEDICINE
By Venkata Raghavan
Escalade Legal Services,
Bangalore
Escalade Legal Services
© All Rights Reserved

What is 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.”
In other words, it means giving information for
diagnosis, treatment and prevention of diseases, etc.
from distance using any kind of technology.

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 self-care via
telecommunications and digital communication technologies.”
In general, telemedicine is used to denote clinical service
delivered by a Registered Medical Practitioner (RMP) while
telehealth is a broader term of use of technology for health and
health related services including telemedicine.
Definition of Registered Medical Practitioner
‘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.

Scope and Exclusions
The guidelines published by Ministry of Health gives a very narrow and limited
scope with specific exclusions.
Scope of the Guidelines are as follows:
• Guidelines are for Registered Medical Practitioners under Indian Medical
Council Act, 1956.
• Cover norms and standards of RMP to consult via Telemedicine.
• Includes all kinds of technological communications such as, email, video
conferencing, audio, text and digital data exchange.
Exclusions:
• Specification of hardware, software, infrastructure building and
maintenance.
• Data Management systems involved; standards and interoperability.
• Conduct surgery using digital technology or invasive procedures.
• Research and evaluation and continuing education of health care
workers.
• Consultations outside jurisdiction of India.

 RMP has to follow same professional and ethical norms and standards applicable to the traditional in-person care.
 Every Medical Practitioner willing to consult through telemedicine has to complete a mandatory online course
within 3 years of its notification.
 This course is sine qua non for practicing telemedicine.
 A Registered Medical Practitioner is entitled to provide telemedicine consultation from any part of India.
Rules to be followed while practicing Telemedicine
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 divided into 4 types
Sl. No. Type Description Example
1 Asynchronous Medical information
transmitted and interpreted later
A patient sharing test
reports and a doctor
sharing feedback
2 Synchronous Real-time interaction A video or a voice call
with a patient
3 Remote patient
monitoring
Health information is gathered
and sent for evaluation
Keeping a close eye on a
patient’s glucometer
readings
4 mHealth
Mobile based
Appointment booking app
In all cases of emergency, in-person interaction with an RMP shall be advised to patient.
Therefore, the guidelines have been limited to consultation only. However, it can be applied
where alternative care is not present, and the case is time-sensitive. For this the guidelines have
advised the RMP to use its best judgement to provide consultation.

GUIDELINES
FOR
TELEMEDICINE
7 ELEMENTS

Guidelines have provided 7 elements which are
needed to be considered before beginning any
telemedicine consultation:
Sl. No. Elements
1 Context – Deciding between Telemedicine or In-person
Consultation
2 Identification – Both parties should be able to identify and verify
each other
3 Mode of Telemedicine – Audio, Video or Text
4 Consent of Patient – Implied or Explicit
5 Type of Consultation – First Consultation or Follow-up
Consultation
6 Patient Evaluation – Gather sufficient information of the Patient’s
medical records.
7 Patient Management – Health Education, counselling and
medication

• The basic connotation on which Guidelines for Telemedicine is based is that,
the RMP shall first decide that a telemedicine consultation is sufficient, or a in-
person examination is required. For this, RMP shall decide based on their
professional judgement, discretion and shall not compromise on the quality of
care.
• An RMP should be reasonably comfortable that telemedicine is in the patient’s
interest after taking a holistic view of the given situation.
• An RMP should understand that every patient/ case/ medical condition may be
different, for example a patient of headache and a patient of Type IV-Diabetes.
The RMP shall uphold the same standard of care as in an in-person
consultation but within the intrinsic limits of telemedicine.
CONTEXT –DECIDING BETWEEN TELEMEDICINE
CONSULTATION & IN-PERSON CONSULTATIONNote:
 The RMP can
choose not to
proceed with the
consultation at any
time. At any step,
the RMP may refer
or request for an
in-person
consultation.
 At any stage, the
patient has the
right to choose to
discontinue the
teleconsultation.

IDENTIFICATION – BOTH PARTIES SHOULD BE ABLE
TO IDENTIFY AND VERIFY EACH OTHER
• The RMP and the Patient need to know each other’s identity. In order to know
each other and for the purposes of verification, RMP shall ask the name, age,
address, email ID, phone number and any registered ID of the patient. The RMP
should ensure that there is a mechanism for a patient to verify the credentials and
contact details of the RMP.
• For issuing prescription, the RMP needs to explicitly ask the age of the patient
and must seek proof, in case of any doubt. An adult shall always accompany the
patient, in case the patient is a minor and identities of both shall be ascertained.
• An RMP should begin the consultation by informing the patient about his/ her
name and qualification. Every RMP shall display its Registration Number
accorded by the State Medical Council/ Medical Council of India on prescription,
electronic communication, and receipts.

MODE OF TELEMEDICINE – AUDIO, VIDEO
OR TEXT
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 can 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.

CONSENT OF
PATIENT –
IMPLIED OR
EXPLICIT
– The guidelines have directed to mandatorily take the consent of
patient. Patients can give consent in two ways:
 Implied Consent – Where patient himself/ herself initiates the
telemedicine consultation.
 Explicit Consent: is required if-
• Healthcare worker, RMP initiated a telemedicine consultation.
• An explicit consent of a patient should be recorded in a form which
is text, audio, video message, The same must be recorded in the
patient’s records.

 First Consult –
• First time consultation with RMP
• Consulted before, but 6 months have elapsed since the previous
consultation.
• Consulted earlier but for a different health condition.
 Follow-up Consultation-
• Patient has been consulting the same RMP and 6 months have not
elapsed since the previous consultation.
• The consultation is for the same health condition and the treatment
is in continuation.
The following situations shall not fall under the follow up
consultation-
• 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.
TYPES OF CONSULTATION - FIRST
CONSULTATION OR FOLLOW-UP
CONSULTATION

 It is the duty of the RMP to gather all medical records such as history, examination findings,
investigation reports, past records etc. before making any professional judgement. Such
information can be supplemented through conversation with a health care worker/ provider
and by any information supported by technology-based tools.
 RMP may ask for any additional information from the patient, for making a professional
judgement.
 For example, an RMP may advise some laboratory or/and radiological tests to the patient. In
such instances, the consultation may be paused and can be resumed at the rescheduled time.
 If the RMP is of the opinion that a physical examination is required and that such information
is critical for consultation, the RMP shall not proceed with the telemedicine consultation
until a physical examination can be arranged for face to face consultation.
The information required may vary from one RMP to another based on his/her professional
experience and discretion and for different medical conditions based on the defined clinical
standards and standard treatment guidelines.
PATIENT EVALUATION – GATHER SUFFICIENT
INFORMATION OF THE PATIENT’S MEDICAL
RECORDS

After consulting the patient the RMP shall make his/ her professional judgement for the
following –
 Provide Health Education - An RMP may impart health promotion and disease prevention
messages. These could be related to diet, physical activity, stop smoking, contagious
infections and so on. Likewise, he/ she may give advice on immunizations, exercises,
hygiene practices, mosquito control etc.
 Provide Counselling - This includes giving specific advises to the patients including food
restrictions, do’s and don'ts, proper use of hearing etc. This may also include advice for new
investigations that need to be carried out before the next consult.
 Prescribing Medicines – RMP’s are required to take the same professional accountability as
in the traditional in-person consult while prescribing medicines. 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 shall
prescribe medicine only if he/she is fully satisfied that all the adequate and relevant
information has been gathered about the patient’s medical condition and the prescribed
medicines are in the best interest of the Patient.
PATIENT MANAGEMENT – HEALTH EDUCATION,
COUNSELLING AND MEDICATION

NOTE: Prescribing
Medicines without an
appropriate
diagnosis/provisional
diagnosis will amount to a
professional misconduct.
Certain limitations and restrictions have been mentioned in the
Guidelines for prescribing medicines by RMP.
For this the medicines are divided into four (4) lists-
LIST O – It comprises of medicines that are safe to be prescribed
through any mode of tele-consultation. For E.g. Paracetamol, ORS
solutions, cough syrups etc.
Medicines which may be deemed necessary during public health
emergencies.
LIST A – These medicines are prescribed for a re-fill during the first
consultation through a video .
Medicines prescribed under this list are safe with low potential of abuse
and prescribed to a patient who is undergoing a follow-up consultation.
LIST B – These medicines include the prescribed medicine in addition to
the previous medicine in a follow up consultation and to the persons who
are advised for a in-person consultation.
PROHIBITED LIST – These medicines cannot be prescribed in a
telemedicine consultation as these medicines contain a high potential of
abuse and could harm the patient if used improperly.
These medicines are listed under Schedule X of Drug and Cosmetic Act,
1940 and Rules, 1945 or any Narcotic and Psychotropic Substances
listed in the Narcotic Drugs and Psychotropic Substances, Act, 1985.
LISTS OF
MEDICINES

Issue a Prescription
and Transmit
• If the RMP has prescribed medicines, RMP shall
issue a prescription as per the Indian Medical
Council (Professional Conduct, Etiquette and
Ethics) Regulations, 2002 and shall not contravene
the provisions of the Drugs and Cosmetics Act,
1940 and Rules, 1945.
• RMP shall provide photo, scan, digital copy of a
signed prescription or e-Prescription to the patient
via email or any messaging platform
• In case the RMP is transmitting the prescription
directly to a pharmacy, he/ she must ensure explicit
consent of the patient that entitles him/her to get
the medicines dispensed from any pharmacy of his/
her choice.
Sample Format for a Prescription
given in GuidelinesEscalade Legal Services

DUTIES AND
RESPONSIBILITIES OF
AN RMP

Medical Ethics,
Data Privacy and
Confidentiality
– RMP shall uphold and practice Principles of Medical Ethics,
including professional norms for protecting patient’s privacy
and confidentiality as per Indian Medical Council Act, 1956.
– Abide by Indian Medical Council (Professional Conduct,
Etiquette and Ethics) Regulations, 2002, IT Act, Data
Protection and Privacy laws.
– RMP’s shall not be held responsible for breach of patient’s
privacy due to technical glitch or breach by any other person.

Misconduct
RMP’s shall not willfully compromise patient’s care or privacy and
confidentiality or violate prevailing law while telemedicine consultation. Some
examples of actions that are not permissible:
– RMPs insisting on Telemedicine, when the patient is willing to travel to a
facility and/or requests an in-person consultation
– RMPs misusing patient images and data, especially private and sensitive in
nature (e.g. RMP uploads an explicit picture of patient on social media etc.)
– RMPs who use telemedicine to prescribe medicines from the specific
restricted list
– RMPs are not permitted to solicit patients for telemedicine through any
advertisements or inducements.
Note: The penalties for
any professional
misconduct, violation of
data protection privacy
law and confidentiality
shall be in accordance
with the relevant
provisions under IMC
Act, IT Act, ethics and
other prevailing laws.

Maintain Digital Trail/
Documentation of Consultation
 RMP shall maintain the following records/ documents:
– Log or record of Telemedicine interaction (text, email, call).
– Patient records, reports, documents, images, diagnostics, data etc. (digital or
non-digital) utilized in the telemedicine consultation should be retained by the
RMP.
– Specifically, in case a prescription is shared with the patient, the RMP is
required to maintain the prescription records as required for in-person
consultations.
 Fee for Telemedicine Consultation
– Telemedicine consultation is on an equal footing with an in-person consultation
in terms of fees., therefore, RMP’s should charge appropriate fee.
– An RMP is required to give invoice for the fee charged.

FRAMEWORK

CONSULTATION BETWEEN
PATIENT AND RMP
 PROCESS
– Initiated by patient through email, call or text with a health query. RMP accepts to
undertake the consultation.
– Identification of Patient and taking the consent of the Patient – in case of first/ follow
up consultation it is assumed that the patient has given consent through his actions
(by interacting with the RMP).
– RMP shall assess the patient’s condition and use his professional judgement to decide
if emergency care is needed.
– If the condition of the patient merits emergency intervention, then advice for first aid/
immediate relief is provided and guidance is provided for referral, as appropriate.

Exchange of
Information
for Patient
Evaluation
 In case, emergency condition is not opined by RMP:
– RMP may ask the patient to provide relevant information (previous
consultation with other RMP’s)
– RMP may ask for additional information (Radiological Test or laboratory
test)
– Meanwhile, RMP may provide health advise as appropriate.
– If the RMP is satisfied that he/she has adequate patient information for
offering a professional opinion, then he/she shall exercise one’s
professional judgment for its suitability for management via
telemedicine.
– If the situation is NOT appropriate for further telemedicine consultation,
then the RMP should provide Health advice/ Education as appropriate;
and/or refer for in-person consultation.
– If RMP is satisfied then, RMP shall take a professional judgement for
Patient management.

Follow-up
Consultation
between RMP
and Patient
– RMP shall continue to proceed with treatment provided previously.
– RMP shall apply his/ her professional judgement.
– RMP may seek additional information before proceeding and resuming
tele-consultation for later point in time.
– RMP shall assess the situation of the Patient and may advise for
emergency care, if required. RMP after careful evaluation of the patient
and his condition shall proceed with Patient management (education,
counselling, prescribing medicines)
– If the follow up is for continuation of care for the same medical
condition, the RMP would re-prescribe original set of medications for a
refill (List A of medications, which has been previously prescribed for
the patient).
– RMP may add a new drug listed under list B.
– If the follow-up consultation, reveals new symptom pertaining to a
different spectrum of disease, then the RMP would proceed with the
condition as enunciated in the scenario for a first-time consultation.

Consultation of
Patient via A
Caregiver on
directions given
by RMP
– If the patient is a minor or is incapacitated (such as in dementia or
physical disability), the RMP will proceed with consultation to the
caregiver. The caregiver needs to have a formal authorization
establishing their relationship with the patient, and this has to be
verified by the patient in an earlier in-person consultation.
– “Caregiver” could be a family member, or any person authorized by
the patient to represent the patient.

CONSULTATION BETWEEN
HEALTH WORKER AND RMP
– For the purpose of these guidelines, “Health worker” could be a Nurse, Allied Health
Professional, Mid-Level Health Practitioner, Auxiliary Nurse Midwife (ANM) or any
other health worker designated by an appropriate authority.
 INITIAL PROCEDURE
– The health care worker has checked the patient and required a professional consultation
by the RMP. Identification, consent of the patient shall be verified and obtained
respectively by the health care worker.
– The worker should explain the potential use and limitations of a telemedicine consultation
to the patient.
 ROLE OF HEALTH CARE WORKER -
– The health worker can help take history, examine the patient, and convey the findings.
They can also explain/reinforce the advice given by the doctor to the patient.
– The health worker must ensure that the patient gets immediate relief and first aid from the
doctor, and that the patient is advised for an in-person consultation at the earliest.

RMP TO ANOTHER RMP/
SPECIALIST
– At times, an RMP may take opinion, recommendation, suggestion and advise from
another RMP/ specialist in any general case or in case the RMP treating the patient is
of the opinion that, the condition the patient is a special one.
– The RMP asking for another RMP’s advice remains the treating RMP and shall be
responsible for treatment and other recommendations given to the patient.
– Guidelines support and encourage interaction between RMPs/ specialists using
information technology for diagnosis, management and prevention of disease.
 Tele-radiology is the ability to send radiographic images (x-rays, CT, MRI, PET/CT,
SPECT/CT, MG, Ultrasound) from one location to another.
 Tele-pathology is use of technology to transfer image-rich pathology data between
distant locations for the purposes of diagnosis, education, and research.
 Tele-ophthalmology access to eye specialists for patients in remote areas, ophthalmic
disease screening, diagnosis and monitoring.

EMERGENCY SITUATIONS
 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
o Advise first aid
o Counselling
o Facilitate referral
 In all cases of emergency, the patient MUST be advised for an in-person interaction
with a Registered Medical Practitioner at the earliest.

Guidelines for Technology Platforms
enabling Telemedicine
 Platforms such as Mobile Applications, Websites providing Telemedicine Consultation shall be required to
comply with the following
 Ensure that the consumers are consulting with Registered Medical Practitioner duly registered with
National Medical Council or State Medical Council.
 Conduct due diligence before listing any RMP. The Platform shall provide details like Name, Qualification
and Registration Number and Contact Details of every RMP listed.
 In the event some non-compliance is noted, the technology platform shall be required to report the same to
Board of Governors (BoG), in supersession to MCI who may take appropriate action.
 Technology platforms based on AI and machine learning are not allowed to counsel the patients or
prescribe any medicines; only a doctor can counsel and prescribe medicines. AI, IoT, data science-based
decision support systems etc. can assist and support a doctor on patient evaluation, diagnosis or
management, but the final prescription or counseling has to be directly delivered by the doctor.
 Proper mechanism to address any queries of the end-customer.
 In case any specific technology platform is found in violation, BoG, Medical Council of India (MCI) may
designate the technology platform as blacklisted, and no RMP may then use that platform to provide
telemedicine.

Special responsibilities of Board of
Governors in supersession to
Medical Council of India
 List of drugs may be modified by BoG from time to time as required.
 BoG may issue necessary directions or advisories in regard to these Guidelines.
 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].

Insurance in
Telemedicine
Introduction, Objective &
Initiative

Insurance in Telemedicine
– Insurance Regulatory and Development Authority of India (IRDAI) has advised
insurers to allow telemedicine wherever consultation with a medical practitioner
is allowed in the terms and conditions of policy contract.
– Provision of allowing telemedicine shall be part of claim settlement of policy of
the insurers and need not be filed separately with the Authority for any
modification. However, the norms of sub limits, monthly/ annual limits etc. of
the product shall apply without any relaxation

Objective
This move brings relief to health insurance policy holders who may prefer to consult
medical practitioners online or telephonically to avoid going out of their homes or if
they are in quarantine themselves due to the coronavirus infection. Some hospitals have
even started offering some nursing services at the homes of patients in order to reduce
patients visits for safety and better social distancing.
This relaxation becomes particularly relevant as often patients with mild coronavirus
symptoms are advised to just take treatment at home and quarantine themselves. This is
aimed at preventing the spread of the disease as well as to prevent overcrowding of
hospitals.
Anyone taking telemedicine consultation from a doctor will be allowed to claim the
expenses under a health insurance policy provided your policy covers for OPD expenses.

Initiative SWASTH:
In the times of Covid-19 Pandemic
A group of 100 organizations including India’s largest hospital chains like Apollo and
Manipal, diagnostic chains like Metropolis and SRL along with technology startups
Practo, 1MG, Mfine, and Curefit have come together to set up a not for profit
telemedicine initiative called Swasth to tackle the Covid-19 pandemic.
Swasth plans to help patients reach nearest test centers and train them in home
quarantine.
Individuals can call a helpline to speak with a doctor for free or get information about
the nearest testing center and hospitals. More than 1,000 doctors on the platform will
offer free consultations, share advice on emotional wellness and dispense instant
prescriptions by text. Those with mild symptoms can access monitoring services for
home isolation or quarantine.

Contact Us
Escalade Legal Services, DBS House,
Cunningham Road, Near Indian Express
Circle, Bangalore, Karnataka.
Email ID: escalade@escaladelegal.com
Landline: 080 - 40509200
Mobile: +91 96110-57021

Thank You !!

Revised Telemedicine Guidelines

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