Telemedicine Guidelines

Telemedicine Now Possible in India: Guidelines for Practice Released by Ministry of Health
Author – Dr.Sunil Shroff, MS, FRCS(UK, D.Urol (Lond.)
President, Telemedicine Society of India – Tamil Nadu Chapter

Learning Objective

Provides a brief overview of the guidelines released by Ministry of Health

Highlights:

  • Telemedicine and Tele-health practice now possible in India
  • Registered Medical Practitioner are empowered to decide which mode of consultation is appropriate for the patient
  • Diagnosis and treatment can be administered using telemedicine in India

25th March was a historic day, a day to celebrate despite the grim reality of COVID19 crisis. The Ministry of Health released a much awaited 51 page document spelling out the guidelines for the practice of telemedicine in India.
Many stalwarts in India have been pushing for these guidelines for over two decades, however it required an invasion from an invisible enemy – the COVID-19 corona virus to give this a push. This was done after the Epidemic Act of 1897 was invoked in India. Tele-consults particularly make sense at a time when the COVID-19 virus is spreading exponentially. This important step will ensure the safety of both the patients and physicians. Interestingly a day earlier, on the 24th of March, ‘Telemedicine day’ was celebrated in India.
These guidelines will be a giant leap in making access to healthcare possible for one and all. India has 597,464 villages as of 2018 census and each village has several hamlets. Many are in very remote locations with no road access. Our Prime Minister in 2018 said that nearly 600,000 villages had been given electricity connection.
According to a report from market research firm TechARC over 77 per cent of Indians are now able to access wireless broadband through smartphones and the 3G/4G connectivity can be used by 502.2 million smartphone users. The online payment gateways also seem to be maturing and are becoming easier to use and can be seamlessly integrated into tele-health applications.
With having both the connectivity and online ecosystem for financial transactions in place, it will certainly help telemedicine to get integrated with the traditional practice of medicine. These regulations will change the way patients and public interact with doctors, internet technology will at last change healthcare in India just like travel, banking and so many other sectors.

What is Telemedicine & Tele-heath ?

The guidelines define telemedicine as follows:
‘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.’
It 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.’

What are the Telemedicine Practice Guidelines?

The guidelines were prepared in partnership with NITI Aayog and available on
Ministry of Health website.
Who can practice telemedicine and tele-health- It can be practiced by ‘A
Registered Medical Practitioner [RMP] who is enrolled in the State Register or the
National Register under the IMC Act 1956.’
The guidelines recognise the gaps in legislation and the uncertainty of rules pose a
risk for both the doctors and their patients and quote the 2018 judgement of the
Hon’ble High Court of Bombay that had created uncertainty about the place and
legitimacy of telemedicine because an appropriate framework or legislation did not
exist.
Purpose of Guidelines -To provide practical advice to doctors so that all services
and models of care used by doctors and health workers integrate with the practice of
telemedicine.
The purpose of these guidelines is to 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’s needs and interests while ensuring
the safety of both the patient and the RMP.
The guidelines do not provide for –
a. Consultations outside the jurisdiction of India.
b. It does not cover hardware or software, infrastructure building &
maintenance, data management systems; standards and inter-operability,
c. Use of digital technology to conduct surgical or invasive procedures
remotely
d. To use it for Research and evaluation

Requirements to Practice Telemedicine

 RMPs should be familiar with the guidelines as well as with the process and
limitations of telemedicine practice
 All RMPs (presently registered) to take a mandatory online course within 3
years of notification of the guidelines – this is to be developed by MCI
 All qualifying RMPs will need to undergo and qualify such a course before they
are given license to practice
In all cases of emergency, the patient must be advised for an in-person interaction
with an RMP at the earliest. However if this is not possible emergency consult for
immediate assistance, focusing on life saving measures, or, first aid maybe offered.
Even with the dispensation of immediate advice, the RMP must advise the patient to
proceed with an in-person consult with an RMP who may be accessible to such
patient.
Type of Telemedicine applications allowed: Four types are to be
allowed according to the Mode of Communication –
 Video (Telemedicine facility, Apps, Video on chat platforms, Skype/Facetime )
 Audio (Phone, VOIP, Apps etc.)
 Text Based:
o chat based applications (specialized telemedicine smartphone Apps,
Websites, other internet-based systems etc.)
o General messaging/ text/ chat platforms (WhatsApp, Google Hangouts,
Facebook Messenger etc.)
 Asynchronous (email/ Fax etc.)
How to Do a Telemedicine Consult in India
The guideline gives the RMP the discretion to determine which type of consultation is
best suited for and favors the patient. The practitioner should exercise proper
discretion and not compromise on the quality of care. They should follow ‘Seven
elements’ before considering any telemedicine consultation –

  1. Context
  2. Identification of RMP and Patient
  3. Mode of Communication
  4. Consent
  5. Type of Consultation
    4
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
  6. Patient Evaluation
  7. Patient Management
  8. Context –
    Depending on the complexity of diagnosis RMP should decide on the mode and
    suitability of such consults and decide –
    • If they need health education
    • or counselling
    • or medication.
    As every case or medical condition maybe different – it maybe a simple complaint
    such as headache or complicated like Diabetic Ketoacidosis .
    The RMP shall uphold the same standard of care as in an in-person consultation but
    within the intrinsic limits of telemedicine.
  9. Identification of RMP and Patient -Telemedicine consultation should not be
    anonymous: both the patient and the RMP need to know each other’s identity.
     Patient’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.
     RMP’s Identity -The RMP should ensure that there is a mechanism for a patient
    to verify the credentials and contact details of the RMP. The RMP should
    introduce themselves and their qualification before starting the consultation.
    They should display the registration number accorded by the State Medical
    Council/National Medical Commission, on prescriptions, website, electronic
    communication (WhatsApp/ email etc.) and receipts etc. given to the patients.
     Check age when prescribing medication – through proof. If minor, then they
    should be accompanied by an adult whose proof identity and proof of such
    relationship with the minor must also be sought.
  10. Mode of Telemedicine – RMP should decide what is best suitable for the patient
    and if face to face consult would be better for diagnosis and treatment then they
    should advise the patient accordingly
    • Multiple technologies can be used to deliver telemedicine consultation
    • 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
    • Video consults have certain intrinsic advantage compared to other types of
    consults especially if it is the first consult being undertaken by the patient
    • During a consultation, the RMP may require, request the patient to change the
    mode of communication, for example, the RMP may ask the patient to switch
    to a video-based consultation, if there is a requirement for the a video
    consultation.
    5
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
  11. Consent – Patient consent is necessary for any telemedicine consultation. The
    RMP must record this in his patient records.
    • Implied Consent – If the patient initiates the telemedicine consultation, then
    the consent is implied.
    • For an in-person consultation, it is assumed the patient has consented
    to the consult by their actions.
    • When the patient walks in an OPD, the consent for the consultation is
    taken as implied as he is seeking help and this is the reason he has
    travelled to the OPD.
    • Like an in-person consultation, for most of the tele-consultations the
    consent can be assumed to be implied where the patient has initiated
    it.
    • Explicit Consent – 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).
  12. Exchange of Information for Patient Evaluation –
    This is critical for arriving to the point of diagnosis and initiating treatment –
    • All possible information should be obtained including history, examination
    findings, investigation reports, past records, supplemented further through
    conversation with a healthcare worker or provider and by any information
    supported by technology-based tools.
    • If such information is inadequate the RMP can request for additional
    information from the patient and pause the consult and restart when such info
    is available or suggest a face to face consultation.
    • If physical examination is critical judgement, he should suggest such an
    examination by another RMP or in-person consult.
    • Safety for patient is of utmost importance in making a judgment to proceed
    with tele-consult or not.
  13. Types of Consultation: First Consult/ Follow-Up Consult – There are two types
    of patient consultations, namely, first consult and the follow-up consult.
    First Consult – In first consults video consults is better as RMP can make a
    much better judgment and hence can provide much better advice including
    the prescription of limited medicines. These include –
    • The patient is consulting with the RMP for the first time
    6
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    • 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 or if new symptoms appear
    • or the RMP cannot recall earlier consult.
    Follow-Up Consult(s) means-
     The patient is consulting with the same RMP within 6 months of
    previous in person consultation and this is for the continuation of care
    of the same health condition.
     In this type consults other than video should be possible
  14. Patient Management: Health Education, Counselling & Medication
    If the condition can be appropriately managed via telemedicine, based on the type of
    consultation, then the RMP may proceed with professional judgment to:
     Provide Health Education as appropriate in the case; and/or
     Provide Counselling related to specific clinical condition; and/or Prescribe
    Medicines
    Prescribing medications, via telemedicine consultation is left to the professional
    discretion of the RMP. This is one area where utmost discretion on part of RMP is
    required at least when it is the first time the patient is doing a remote consult. 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 the same prevailing principle will be applicable to a
    telemedicine consult. The rule says –
    ‘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
    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 notified in consultation
    with the Central Government from time to time. 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 ‘over the
    7
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    counter’ medications. For instance, these medicines would include,
    paracetamol, ORS solutions, cough lozenges etc
     List A: These medications are those which can be prescribed during the first
    consult which is a video consultation and is 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 as these medicines have a high potential of
    abuse and could harm the patient or the society at large if used improperly.
    These include 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
    How to Issue a Prescription and Transmit
    RMP shall issue a prescription as per the Indian Medical Council (Professional
    Conduct, Etiquette and Ethics)Regulations and shall not contravene the provisions of
    the Drugs and Cosmetics Act and Rules thereunder.
    A sample format has been suggested and can be referred on the ministry website.
    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, they must
    ensure explicit consent of the patient that entitles him/her to get the medicines
    dispensed from any pharmacy of his/ her choice.
    Duties and Responsibilities of a RMP in GENERAL
    Medical Ethics, Data Privacy & Confidentiality
     Principles of medical ethics, including professional norms for protecting patient
    privacy and confidentiality as per IMC Act shall be binding and must be upheld
    and practiced.
     Registered Medical Practitioner would be required to fully abide by Indian
    Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002
    and with the relevant provisions of the IT Act, Data protection and privacy laws
    or any applicable rules notified from time to time for protecting patient privacy
    and confidentiality and regarding the handling and transfer of such personal
    information regarding the patient. This shall be binding and must be upheld and
    practiced.
     Registered Medical Practitioners will not be held responsible for breach of
    confidentiality if there is reasonable evidence to believe that a patient’s privacy
    8
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    and confidentiality has been compromised by a technology breach or by a
    person other than RMP. The RMPs should ensure that reasonable degree of
    care is undertaken during hiring such services.
     Misconduct It is specifically noted that in addition to all general requirements
    under the MCI Act for professional conduct, ethics etc, while using telemedicine
    all actions that wilfully compromise patient care or privacy and confidentiality, or
    violate any prevailing law are explicitly not permissible. Some examples of
    actions that are not permissible:
    o RMPs insisting on Telemedicine, when the patient is willing to travel to a
    facility and/or requests an in-person consultation
    o 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)
    o RMPs who use telemedicine to prescribe medicines from the specific
    restricted list
    o RMPs are not permitted to solicit patients for telemedicine through any
    advertisements or inducements 3.7.1.5 Penalties: As per IMC Act, ethics
    and other prevailing laws.
    9
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    Maintain Digital Trail/Documentation of Consultation
  15. It is incumbent on RMP to maintain the following records/ documents for the
    period as prescribed from time to time: consultations.
  16. Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/
    text record, video interaction logs etc.).
  17. Patient records, reports, documents, images, diagnostics, data etc. (Digital or
    non-Digital) utilized in the telemedicine consultation should be retained by the
    RMP.
  18. Specifically, in case a prescription is shared with the patient, the RMP is
    required to maintain the prescription records as required for in-person
    Fee for Telemedicine Consultation
     Telemedicine consultations should be treated the same way as in-person
    consultations from a fee perspective: RMP may charge an appropriate fee for
    the Telemedicine consultation provided.
     An RMP should also give a receipt/invoice for the fee charged for providing
    telemedicine based consultation. This must also carry the registration details of
    the RMP.
    Other areas covered by the Guidelines
    Consultation Between Patient and RMP Through a Caregiver – in which case
    authorization by the patient is required. In medical conditions like dementia or
    physical disability etc. The care giver is deemed to be authorized to consult on behalf
    of the patient. A detailed requirement is spelled out.
    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, ANM or any other health worker designated by an appropriate
    authority Proposed Set up. This would help the upcoming health and wellness center
    to initiate and coordinate the telemedicine consultation for the patient with a RMP at
    a higher center at district or State or National level.
    The guidelines do not permit technology platforms based on Artificial intelligence
    /Machine Learning to counsel the patients or prescribe any medicines to a patient.
    New technologies such as Artificial Intelligence, Internet of Things, advanced data
    science-based decision support systems etc. can assist and support a RMP on
    patient evaluation, diagnosis or management, the final prescription or counselling
    has to be directly delivered by the RMP.
    10
    Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    Ten DO’S & DONT’S to Follow for Teleconsultations
    Overall the guidelines have covered all aspects of telemedicine and the grey areas
    such as the legal aspects like consent, prescription and reimbursement. These
    guidelines will be the start of a new chapter in healthcare in India. The tele-health
    inclusion will open up consultations for primary health centers and the health and
    wellness center. It will also help nurse practitioners to get empowered and be utilised
    better when they are in the field.
    Telemedicine has long been waiting to happen in India and its arrival will surely see
    the dawn of a new era in the field of healthcare in India and perhaps help in
    achieving the health for all goal that has been a dream for so many decades.
    In the end be safe, ethical and respect the patient’s privacy. Always use your
    judgement and discretion before you provide a tele-consult.
    Reference:
    BOARD OF GOVERNORS – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
    Do’s Don’ts
    Be familiar with the System Don’t Try New Application for the first time
    Adequate Light & Dark Background Dark Room, Background Bright or Noisy Location or no
    background unnecessary sounds
    Dress Appropriately and look
    presentable
    Don’t Wear Loud Clothes
    Introduce Yourself – Before starting
  • Confirm if patient can see you and
    hear you
    If the Patient is unable to understand you have a caregiver
    who can speak on behalf of patient
    Prescribe safe medication – No
    harm or abuse
    Don’t Prescribe Schedule X Medicines or Narcotics
    If Physical Examination must for
    diagnosis – ask them for in-person
    consultation
    Don’t Prescribe medication without diagnosis
    For First consult Prefer – Video
    Consultation
    Avoid Telephone for first Consultation
    Take Consent & Preserve
    Document of the consultation
    Don’t use any device that cannot record and store your
    consultation
    Inform Patients you are Available
    for Teleconsults
    Don’t Solicit Patients for Tele-consults through
    advertisements
    Practice Within India Practice Outside India

References

  1. Basic Understanding of the National Guidelines for Practice of Telemedicine in India –
    Shroff S: Ref- Board of Governors – In supersession of the Medical Council of India –
    (https://www.mohfw.gov.in/pdf/Telemedicine.pdf)
Telemedicine Guidelines
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